3 step process including person to person meeting and questionnaires taking about 30 minutes.

Interview

Michael A. Kallen, PhD

The goal of this research study is to collect information to plan how to design a computer program for cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care. Researchers want to learn how to make this program practical for use by future patients, caregivers, doctors, and nurses.

The Computer Program:

In this study, researchers will interview cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care.

The computer program will be designed to help doctors and nurses monitor the symptoms of patients. The program will also be designed to help doctors and nurses make decisions about how to care for patients.

Interview Session:

If you agree to take part in this study, you will be interviewed by a research staff member. The study chair may also attend the interview. The interview will be held at the Palliative Care outpatient clinic.

The interview session will be done in 3 steps, which are described below. Each step will take about 10 minutes.

First, you will read questionnaires about patient symptoms. These questionnaires are drafts of the ones that will be included in the software program.

You will then look at a draft of the computer program's layout.

Last, you will be interviewed. You will be asked to discuss your experiences as a patient or caregiver in reporting symptoms and health status to doctors and nurses. You will also be asked to discuss what might make the program more usable.

During the interview, you may also be asked to answer sample questions on the draft questionnaires and discuss how readable you think the questions are. For example, you will discuss your opinion about the font size, text placement, and color scheme.

Study Data:

The interview session will be audio-taped. To protect your confidentiality, only your first name will be used during the interview session. Patients and their caregivers will also be interviewed separately to protect privacy.

Patient responses will not be disclosed to caregivers, and caregiver responses will not be disclosed to patients. The patient's palliative care doctor will be told, however, if patients or caregivers show signs of emotional difficulties.

When the audio recording is transcribed (typed) by the research staff, all names will be coded so that no one can be identified by name. The audio recordings will be stored in password-protected files that are available only to the study chair and staff.

After the results of the study are published, the audio recordings will be destroyed by the study staff.

Length of Study:

Your study participation will be over after the interview session.

This is an investigational study.

Up to 26 participants will be enrolled in this study. This includes up to 9 patients and 9 caregivers in this part of the study, and up to 4 doctors and 4 nurses in a second part of the study. All will be enrolled at M. D. Anderson.

Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study

A Qualitative Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record

Through focused interviews with specific tasks: review PRO domains and questionnaires for the care mode; review user interface design and work flow; discuss user expectations of the system to assess the usability of a system's user interface design.

M.D. Anderson Cancer Center

Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

See the 'detailed description' section to read about the intervention(s) clinicians will use during the active implementation phase of the randomized stepped-wedge design.

The uterine fibroid Option Grid patient decision aid facilitates choice awareness and deliberation about treatment options when clinicians and patients discuss the management of uterine fibroids. The content is organized in a tabular format and is based on patients' frequently asked questions.

Uterine Fibroid Option Grid encounter patient decision aid (text only)

The Picture Option Grid uses the same evidence as the text version while integrating images and simpler text, thus utilizing pictorial superiority to help patients better understand and remember information more easily compared to just using words.

Uterine Fibroid Option Grid encounter patient decision aid (text + Pictures)

Clinicians can click a link in the electronic health record that will lead them to the EBSCO Health website where they can click the treatment options relevant to the patient and generate a decision aid.

Uterine Fibroid Option Grid encounter patient decision aid (online)

Glyn Elwyn, MD, PhD

UPFRONT is a study that aims to use two implementation frameworks - the Consolidated Framework for Implementation Research and the Normalization Process Theory - to guide the implementation of a uterine fibroid patient decision aid, known as Option Grid, at five diverse gynecology settings across the United States. Option Grid provides evidence-based information on the various treatment options to help women across socioeconomic strata with symptomatic uterine fibroids make a preference-sensitive decision.

Background \& significance

Uterine fibroids are non-cancerous overgrowths of smooth muscle in the uterus. As they grow, a proportion of fibroids give rise to problems, such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and/or difficulty becoming pregnant. Some fibroids cause miscarriage, preterm birth, and increase the risk of cesarean birth. Multiple treatments are available: medication, removal of the inner layer of the uterus wall (endometrial ablation), removal of the uterus (hysterectomy) or part of the fibroid (myomectomy), or blocking some of the blood supply to the uterus (uterine artery embolization). Given the different consequences of treatment options, such as time away from work and impact on fertility, choosing the best option is sensitive to individual preferences. This study seeks to improve healthcare delivery and treatment choices for women of different socioeconomic status (SES) and health literacy levels experiencing symptoms from uterine fibroids.

Approximately 50% of women of reproductive age have fibroids, and at least 50% of these women have significant symptoms. These women report substantial impairment in quality of life and increased costs associated with the impact on daily living. While existing evidence is inconclusive about disparities in treatment choice, the associated socioeconomic burden is even greater in African-American women and those of lower SES. Despite a greater incidence and severity of symptomatic fibroids among African-American women, Hispanic women, and women of lower SES, one study shows that these women are less likely to undergo laparoscopic intervention, while another study found no significant differences between procedure rates between African-American and white women. Nevertheless, African-American women are more likely to experience poor treatment outcomes than white women.

A systematic review (2002) indicated that insufficient evidence exists about the comparative effectiveness of treatments for uterine fibroids. Viswanathan confirmed this view in 2007, saying that "the dearth of high-quality evidence is remarkable given how commonly this problem occurs." A report by Velentgas et al demonstrated similar outcomes between the uterine-sparing treatment options (endometrial ablation, uterine artery embolization, and myomectomy) on the onset of new or recurrent symptoms post-treatment. Myomectomy and uterine artery embolization led to a reduced risk of having a subsequent procedure compared to endometrial ablation. The lack of comparative evidence demonstrating superiority of any one treatment reinforces the role of shared decision making (SDM) in this context.

SDM is considered the pinnacle of patient-centered, ethical care and aims to promote two-way communication between clinicians and patients. Patient decision aids are interventions that provide evidence-based information to patients so they can make decisions that align with their preferences, thus facilitating the SDM process. For example, Option Grid encounter patient decision aids (ePDAs) are available in various formats (paper, picture, online interactive) and present information in a tabular format so patients can compare options. The use of Option Grids, and other similar ePDAs in other settings, also provide evidence that these tools are effective. A stepped-wedge study showed higher levels of SDM when Option Grid decision aids were used with patients who had knee osteoarthritis, as well as an increase in patient knowledge, without lengthening the encounter's duration. Similar results were found when Option Grid ePDAs were used by pediatricians with parents facing decisions about circumcision. In addition, five randomized trials using ePDAs at the Mayo Clinic, Rochester, Minnesota, have demonstrated their impact on SDM, whereas there is less evidence that PDAs used solely by patients before clinical encounters lead to observed changes in SDM.

The investigators have clear evidence from existing research and their own consultation with patient partners that women with fibroids wish to consider treatment trade-offs and engage in decision making processes. A trial of a pre-ePDA for women with uterine fibroids demonstrated impact on knowledge and satisfaction but no effect on concordance between preferences and decisions. A pre-post study by the current team has demonstrated that using the existing uterine fibroids Option Grid led to higher levels of SDM according to both observational and patient-reported measures. Despite interest among patients with uterine fibroids to participate in their healthcare decisions, and the positive impact of uterine fibroids ePDAs on SDM, implementation of SDM approaches in routine care remains challenging.

Implementation of SDM remains difficult across a range of healthcare settings, and success depends on more than simply distributing PDAs to patients. System and organizational barriers exist, related to incentives and established behavior patterns. There is evidence, however, that it is possible to implement SDM, particularly if it is supported by clinical champions, organizational strategies, and effective electronic medical record integration efforts, especially where tools fit well into workflows) and are useful with a diverse range of patients. The investigators searched for, but were unable to find, implementation studies of uterine fibroids ePDAs in clinical settings and conclude that a relevant gap exists.

To fill this gap, the investigators will use a multi-component SDM implementation strategy guided by the Consolidated Framework for Implementation Research and the Normalization Process Theory. The strategy includes: (1) assessment of organizational readiness for SDM using Measuring Organizational Readiness for patient Engagement (MORE) - a team-based survey to develop a tailored strategy at each site addressing potential organizational barriers to implementation; (2) online or in-person introduction to SDM and the Option Grid tools (this will include feedback and coaching); (3) clinician access to multiple formats of Option Grid ePDAs (text, picture, and online interactive version and printed Spanish versions), and; (4) the integration of a suggested SDM approach and new evidence (as appropriate) into existing clinical practice guidelines where feasible (e.g., the American College of Obstetricians and Gynecologists).

Study aims

The investigators propose to incorporate new comparative effectiveness evidence about uterine fibroid treatments into a multi-component SDM implementation strategy. The investigators will evaluate the impact of a multi-component SDM implementation strategy for the care of women who seek treatment for uterine fibroids at five diverse gynecology settings and across socioeconomic strata. The investigators will also examine the real-world clinical context from the five participating sites to determine the characteristics of a successfully (or not successfully) sustained a multi-component SDM strategy.

Study description

Procedure Prior to the pre-implementation phase, a minimum of 10 stakeholders from each site will complete the Measuring Organizational Readiness for patient Engagement (MORE) survey which is designed to measure a healthcare organization's willingness and ability to effectively implement patient engagement in healthcare. Participating clinicians will also complete the ADOPT survey to assess their attitudes toward patient decision aids at the start of the pre-implementation phase.

During the pre-implementation phase, eligible patients will be identified in advance by the project team at each project site through the sites' outpatient appointment systems. After their clinical encounter, clinic staff will provide eligible patients with a tablet computer to complete the consent form and fill out the survey. Patients will provide their email address in the survey so they can receive the follow-up survey three months post-encounter. To measure the extent to which clinicians involve patients in decision-making process, research assistants at each site will randomly audio-record five clinical encounters for each participating clinician.

The study interventions will be carefully described during a two-month initiation period for clinicians at participating sites, to occur between the pre- and active implementation periods.

Each site will decide which intervention (or a combination) they want to implement, as well as potentially suggest new ways of introducing the tool(s) to patients. This will be part of the implementation strategy and informed by the assessment of organizational readiness for patient engagement at each site completed during the pre-implementation phase. The study staff at each site will identify eligible patients ahead of their visits through their outpatient scheduling systems and will have the opportunity to mail or, where allowed by clinic policy, email the Option Grid before their appointment. Patients receiving the tools in advance would be instructed (with a cover letter) to use the tool to prepare for their encounter with their clinician. Patients will be encouraged to assess whether the frequently asked questions are issues that are also of concern to them, and to ask clinic staff to explain any parts which seem unclear to them.

The clinician will also have the option of presenting the Option Grid during the clinical encounter. To facilitate this process, the reception staff (or someone else in the clinic) could provide the tool to the patient before the visit just in case they did not bring their mailed copy. Or, the medical assistant can provide the tool to the patient upon rooming. The method of Option Grid presentation will be tailored to best fit the clinic flow at each site. Clinicians who have access to the online version of Option Grid will record use of the electronic tool into the patient's electronic medical record. Third, clinicians can give the Option Grid to the patient at the end of the encounter, so they can take it home and review its contents with others. This can be done by printing a paper copy, or if using the online version, by sending a URL link to the patient via email. Following the encounter, the patient will be provided with a tablet computer in order to provide consent and fill out the study surveys. Patients will be sent a follow-up link via email three months after the encounter to complete the follow-up survey. Like the pre-implementation phase, a research assistant at each site will audio-record five consecutive clinical encounters for each participating clinician to measure the extent to which clinicians involve patients in the decision-making process and complete the fidelity checklist.

To assess whether the intervention was sustainably implemented, the investigators will capture the perspective of professionals directly involved in the work of implementing complex interventions in healthcare using the NOMAD Normalization Process Theory instrument. The investigators will also assess clinician attitude using the ADOPT survey and conduct interviews with participating clinicians to determine the utility of the intervention, conduct a fidelity assessment, and calculate the percentage of eligible patients receiving the intervention. In addition, the investigators will have interview data which will help the investigators determine if systemic use is sustained.

Stepped wedge trial with randomization at the clinic level. Patient enrollment will occur at five gynecology clinics in the United States. The uterine fibroid Option Grid patient decision aid intervention will be implemented in the 'active' implementation phase of the trial following a brief initiation session at each clinic to introduce clinicians to the intervention.

Data analysts will be blinded to the setting randomization.

Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings

Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings: a Randomized Stepped-wedge Study

All patient survey data will be stored in a Qualtrics database, a HIPAA-compliant web-based data management system. The investigators will assign a unique study identification number to each member of the study team (including clinicians). All data including clinician demographic information (age, gender, and years of experience post-fellowship or year of residency) and the ADOPT, NoMAD and MORE survey responses will be stored in the Qualtrics database. All audio-recordings of clinical encounters and semi-structured interviews will be loaded by site-based project staff into Dartmouth's HIPAA-compliant SharePoint system that only the Dartmouth study team will be able to access. Each recording will be labeled with a unique identification number.

MORE is designed to measure a healthcare organization's willingness and ability to effectively implement patient engagement in healthcare. The measure contains 25 items each of which is scored on a four-point Likert-type scale (1=avoid/not important; 4=definitely involve/very important). Data from the measure will be analyzed to identify barriers and facilitators to implementation at each site.

A measure of clinician attitudes to patient decision aids (PDA)s. Clinicians are asked to select one or more words that best describes their attitudes to the potential use of PDAs from a pool of ten words. It can be completed by clinicians who have, or have not, used PDAs.

Observer OPTION-5 is a validated five-item scale, with each item rated from '0' to '4' where '0' represents absence of a shared decision making specific competency and '4' represents optimal performance.

The fidelity assessment checklist enables the investigators to determine if an Option Grid was used, how and when it was delivered to the patient, whether or not the clinician made a treatment recommendation or elicited patient preference, and the identification of the final treatment decision. The checklist will help the investigators understand if the clinicians are using the tools as intended following initiation.

A 23-item instrument used for capturing the perspective of professionals who will be involved in implementing and using Option Grid in practice. The instrument contains four sections that ask questions on the various facets of implementing and using the intervention such as the effect that it has on workflow, the work and resources needed to drive implementation, and critical appraisal of the Option Grid, etc.

Semi-structured interviews, guided by the Normalization Process Theory, will be conducted with clinicians to assess the utility of the Option Grid tools and how they implemented the intervention in practice

collaboRATE is a three-item, patient-reported experience measure of how patients perceive the effort that clinicians make to achieve three core aspects of shared decision making: informing patients, eliciting preferences, and integrating preferences into decisions made. Patients answer each question on a scale of 0 to 9. The measure is scored by using the percentage of patients who give the highest possible score of 9 for each item.

Patients will be asked to complete only the symptom severity subscale portion of the 37-item UFS-QOL questionnaire. The eight-item subscale asks patients how distressed their symptoms have made them feel over the past three months. Each item is scored on a Likert-type scale from '1' (None of the time) to '5' (All of the time).

COST is a patient-reported outcome measure to assess financial toxicity in patients with cancer. The measure contains 11 items. Study stakeholders, including patient partners, felt that the majority of the items were not applicable for this study and wanted to minimize respondents' burden, so the investigators opted to only use 1 item. The questions reads: "I worry about the financial problems I will have in the future as a result of my illness or treatment", and the response scale is from '0' (not at all) to '4' (very much).

3-item validated measure of health literacy. The items are the following: How confident are you filling out medical forms by yourself? How often do you have someone (like a family member, friend, hospital/clinic worker, or caregiver) help you read hospital materials? How often do you have problems learning about your medical condition because of difficulty understanding written information? Patients who circle 'extremely' or 'quite a bit' on the Likert-type scale are considered to have high health literacy

The follow-up survey will query eligible patients to self-report the number of outpatient (or visit to primary care clinician), inpatient, or emergency visits during the three-month follow-up period.

Patients will identify their intended treatment choice in the post-encounter survey. The investigators will also ask patients in the 3-month follow-up survey whether they have seen another clinician about another treatment, whether an Option Grid tool was used in that encounter, and to identify the final treatment option they selected.

The investigators will collect the patient's email address, health insurance status, age, race, gender, and spoken language via the survey they complete on the tablet computer post-encounter.

Brigham and Women's Hospital

Mayo Clinic

Montefiore Medical Center

Barnes-Jewish Hospital

Patient-Centered Outcomes Research Institute

Dartmouth-Hitchcock Medical Center

Principal Investigator

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Postoperative Complications

Head and Neck Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

All Drugs and Chemicals

Psychotropic Drugs

Imidacloprid

Bupropion

Nicotine

Varenicline

The study intervention consists of a smoking cessation counselling meeting by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery. The goal of this first intervention meeting is to implement an individual treatment plan for preoperative smoking cessation.

Patients randomised to the control arm will get advice only. Their preoperative course will be as if they were not participating in this study, meaning they will receive inconsistent perioperative smoking cessation advice from nurses, surgeons, or anaesthesiologists but no further study-specific smoking cessation intervention. Importantly, participants in the control group will not be discouraged from using perioperative smoking cessation aids and can still obtain help on one's own initiative.

The study intervention consists of an interview by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery with individual counselling and offered nicotine substitution. The intervention meeting is based on the Chronic Care Model (CCM) to improve quality of ambulatory care.

In brief, the intervention includes:

* Informative content about advantages of smoking cessation
* Scheduling service for a motivational interview by a TSS in office to implement a treatment plan
* For participants willing to quit smoking a preoperative quit day will be scheduled after the first intervention meeting 2-3 weeks before surgery
* Patients will be encouraged by a TSS to use nicotine replacement. Bupropion or Vareniclin will be provided on an individual basis
* TSS will schedule repeated follow-up meetings to support smoking abstinence or nicotine reduction before and after surgery for all patients

Intensive preoperative smoking cessation counselling

Studienkoordination Tumorzentrum

Christian Fankhauser, PD Dr. med.

Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be lack of time and training of surgeons and anesthesiologists. The investigators therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four weeks before surgery compared to patients in the advice only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption.

Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups.

Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing surgery.

Patients will be randomised in a 1:1 ratio to either the intervention or control group using service of the University of Graz (www.randomizer.at). Before randomisation patients will be pre-stratified for age (≤60, \>60 years) and procedure (intermediate versus high-risk procedures). Both factors have been identified in a previous retrospective cohort study at our institution as risk factors for complications. For that reason, minimization, as an efficient way to control for confounding in small to moderately sized trials, will be used. Also, minimization automatically ensures concealment of random allocation since there is no pre-existing randomization list.

Throughout the study patient data is collected in the electronic health record (LUKiS) in an uncoded manner. Allocation will be blinded. At the end of the study the LUKiS reporting team will generate a report, which will include all study data in a de-identified form. The analysis of the report with the pseudonymized data will be performed by the project statistician.

Preoperative Smoking Cessation in Patients Undergoing Surgery

Preoperative Smoking Cessation Program in Patients Undergoing Intermediate to High-risk Surgery: a Randomized, Single-blinded, Controlled Trial

The primary endpoint is the Comprehensive Complication Index (CCI) within 90 days of surgery. The CCI is calculated as the sum of all Clavien-Dindo complications that are weighted for their severity (multiplication of the median preference values from patients and physicians). The final formula yields a continuous scale that ranks the cumulative burden from any combination of complications from 0 to 100 with higher values indicating a higher cumulative burden in a single patient. As a composite complication score, the CCI has the advantage of reflecting the overall burden of the postoperative course that affects the health of patients and their quality of life. In addition, the CCI is a powerful endpoint in trials, as it allows sample size up to nine times lower compared with traditional morbidity endpoints.

Days of hospital stay for planned surgery

Costs of hospital stay for planned surgery

Readmission rates for in-patient hospital stay after surgery

Number of patients who successfully quit smoking

Decrease or increase of daily nicotine consumption

The outcome is measured using the Hospital anxiety and depression scale (HADS) before surgery. The score ranges from 0 to 42 with higher values indicating a higher probability of a mood disorder.

unplanned postoperative intermediate care or intensive care unit admission

Stage of the Transtheoretical Model of behaviour change

The outcome is measured using the 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100 with higher values indicating a more favorable health state.

Luzerner Kantonsspital

Heart and Blood Diseases

Heart Failure

Heart Diseases

Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:

* Heart Failure
* COPD
* Cancer

Bedside nurses who provide care at the inpatient level for the following diseases:

* Heart Failure
* COPD
* Cancer

The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.

Storytelling Intervention for Patient Participants

Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.

Storytelling Intervention for Nurse Participants

The purpose of this research is to develop patient-centered palliative care interventions to improve patient-provider communication and Quality of Life (QoL) of ethnic and racial minority patients living with life-limiting illnesses. Eliciting personal experiences is an effective way for patients to communicate their cultural values and beliefs. This study will assess how to integrate the patients' personal experience narratives into the electronic health record (EHR). The primary hypothesis is that the implementation of a patient-centered intervention to elicit personal experiences that are included in the EHR will improve patient-provider communication and patients' QoL.

Racial and ethnic minority patients with a Life Limiting Illnes (LLI) in the United States are underserved in many ways, including quality of palliative care. Specific disparities have been reported in palliative care for minority patients, including sub-optimal patient-provider communication and resulting lower QoL. A potential approach to improve communication is to elicit patients' personal narratives that address their cultural or spiritual values and beliefs, and include them in the EHR. The objective of this observational study is to assess the feasibility and efficacy of a palliative care nursing intervention designed to 1) identify barriers and facilitators for eliciting and recording relevant narratives from the perspectives of the key stakeholders: minority patients with LLI; 2) to conduct usability testing, applying a user-system-environment evaluation process to determine essential requirements for integration of the patient-centered narratives into the EHR; and 3) identify barriers and facilitators of integration of the patient's narrative into daily workflow from the perspectives of key stakeholders: acute care bedside nurse.

Personalized Experiences to Inform Improved Communication for Minorities With Life Limiting Illness

This study will utilize an observational design to define and refine the storytelling intervention, seeking input from the key stakeholders: providers (acute care bedside nurses).The SUS scale is a 10 item Likert scale which gives a global view of subjective assessment of usability with five item responses options from strongly agree to strongly disagree. SUS yields a single number representing a composite measure of the overall usability of the system being studied. Note that scores for individual items are not meaningful on their own. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7, and 9, the score contribution is the scale position minus 1. For items 2,4,6,8, and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of the SUS, with the higher the number, the better the outcome.

Using an observational design, this measure (exit interviews) were completed with 20 inpatient participants and 18 nurse participants. The qualitative data from the interviews were used to define and refine the storytelling intervention. The data collected from the exit interview is qualitative in nature and therefore does not have a numerical value.

National Institute of Nursing Research (NINR)

University of Colorado, Denver

Patients admitted to University of Colorado Hospital with at least one of the following diagnoses:

* Heart Failure
* COPD
* Cancer

Storytelling Intervention for Patient Participants: The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.

Inpatient Participants

Bedside nurses who provide care at the inpatient level for the following diseases:

* Heart Failure
* COPD
* Cancer

Storytelling Intervention for Nurse Participants: Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the "strength" of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material.

Nurse Participants

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Heather Coats, PhD, APRN-BC, PI

Number of Completed Exit Interviews From Patients on Feasibility of Their Use of Their Narrative Integrated Into EHR

Patient Participants did not complete this secondary measure. This was only the nurse participants completing the NIH System Usability Scale

Usability Assessment Via the System Usability Scale(SUS), Range of 0 to 100, With Higher Number Representing a Better Outcome SUS Scores Have a Range of 0 to 100, the Higher the Number Represents a Better Outcome.

Overall Study

Nutritional and Metabolic Diseases

Overweight

Obesity

Body Weight

Weight Loss

Overnutrition

Nutrition Disorders

Body Weight Changes

Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to under-served population groups

Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support

The 3 major intervention components are diet, physical activity, and the behavioral modification curriculum. Scheduled interactions are educational podcasts (a series of audiovisual, digital media files) paired with a follow-up phone counseling session with a trained behavioral interventionist. A patient portal message will be sent to participants when a new podcast is posted. Interactive sessions will be weekly (weeks 1-16), biweekly (weeks 17-24), and monthly (weeks 25-52). The goal for weight loss is ≥ 7% of initial weight over the course of 12 months. Participants will restrict caloric intake with the goal of 1,200-1,500 kcal/day for those weighing \< 114 kg and 1,500-1,800 kcal/day for those weighing ≥ 114 kg. The physical activity goal will be for participants to gradually increase to 175-200 minutes of moderate-intensity activity per week by the 24th week. Participants will also be asked to self-monitor their dietary intake and physical activity using the "Lose It!" app.

Active Intervention Group

All participants in the Comparison Group will receive a mandatory 13 contacts per year including 3 informational sessions on nutrition, physical activity and social support and 10 contacts via patient portal or email regarding intervention topics. The Look AHEAD Comparison Group was designed to be realistic, achievable, and an acceptable intervention that encouraged optimal study retention.

Comparison Group

Julia Graber

Karen Johnson, MD

Karen C. Johnson, MD, MPH

The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD\* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) to test the hypothesis that a multicomponent, multilevel behavioral weight loss intervention (Active Intervention Group) adapted for underserved groups and delivered through Health Information Technology (Health IT) tools via the Electronic Health Record (EHR) patient portal, will result in significantly greater weight loss 12 months after enrollment compared to the Comparison Group.

\*The Look AHEAD study was a multi-center, randomized clinical trial involving overweight and obese persons with type 2 diabetes, aimed to determine the effects on the cardiovascular outcomes of an intensive lifestyle intervention (ILI) for weight loss, in comparison to the diabetes support and education intervention (DSE).

This research project is a collaborative effort between the University of Tennessee Health Science Center (UTHSC) and Regional One Health, one of the largest nonprofit physician practice groups located in western Tennessee and in the surrounding rural areas - part of the Delta area with some of the highest rates of obesity in the nation. Obesity and excess body fat are associated with many diseases and adverse health consequences. Obesity is associated with an increased risk of morbidity and mortality from cancer and may worsen cancer survivorship and quality of life. Obesity also disproportionally affects underserved population groups such as racial and ethnic minorities, persons with lower socioeconomic status, and persons living in rural areas. Although numerous research studies have shown that behavioral weight loss interventions combined with dietary modification and increased physical activity are the most effective in achieving weight loss and guidelines have endorsed such interventions, there is limited literature describing behavioral weight loss strategies in real-world clinical practice settings. There are also no published studies on the effectiveness of practice-based, multicomponent behavioral interventions for weight loss in underserved populations in urban or rural settings, using Health IT and the EHR patient portal. The investigators of this study propose a practice-based clinical trial delivering the intervention via the Health IT EHR patient portal combined with supportive telephonic follow-up that specifically addresses the concerns and needs of underserved populations living in either an urban or rural area. If successful, this intervention would demonstrate an approach that could be applicable to challenging populations and would demonstrate how to develop, implement, and sustain an effective weight loss intervention integrated within a trusted healthcare system's Health IT that may prevent cancer. During Stage 1 (12 months), the investigators will refine the intervention for Health IT delivery by conducting formative research (key informant interviews and focus groups). With patients, they will seek to identify the barriers to implementing the Look AHEAD ILI behavioral weight loss intervention and adapt and modify ILI components to make them acceptable for underserved populations in both urban and rural settings and integrate those components into the EHR patient portal (Active Intervention group). The investigators will also adapt the Look AHEAD Comparison condition (DSE group) for the Comparison condition. With healthcare providers, the study team will seek to determine how a Health IT intervention integrated at the system level, can facilitate delivery of guideline concordant weight management care. During Stage 2 (years 2-5), the investigators will conduct a clinical trial and randomly assign 250 participants at the Regional One Health partner practice sites in urban and rural settings in a 1:1 ratio to either the Comparison Group or the Active Intervention Group and determine weight change (primary outcome) over time in both groups. In this study, investigators will also assess how social determinants of health are related to patient uptake and engagement with the Health IT patient portal and patient success with weight loss.

This is a 2-arm, parallel, randomized, controlled clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to either a behavioral weight loss intervention group delivered via Health IT with telephonic support (Active Intervention Group) or the Comparison Group. Because intervention delivery does not depend on clinic site, the study team has opted for a more powerful individual randomization over cluster randomization (but the team will potentially include clinic site as a grouping effect in the analysis).

The randomized portion of this protocol will employ a blinding design so that the CHAMPS study personnel and investigators who are collecting and assessing outcome data (i.e., weight) will not know a participant's group assignment status (blinded to assignment). Neither the participants, nor the study staff who provide the intervention, will be blinded to assignment. All participants will be asked not to reveal their CHAMPS study group assignment to blinded clinic personnel. All intervention-related information will be kept separately from outcome data and will not be accessible to blinded staff.

Choosing Healthy Activities and Lifestyle Management Through Portal Support

Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk

Investigators will prepare and distribute a dataset maintaining confidentiality of individual participants. The final study analytical database will be processed according to HIPAA definitions for public data sharing and participant data will be de-identified using processes such as: removal of identifiers, translation of dates and ages to delta time values, and assignment of random study identifiers. A series of de-identified data files representing the final analytical data set will be available and provided in a standard format that is readable across a variety of applications and operating system platforms. Other documentation may include: data dictionary, data code book, valid variable ranges, protocol, MOP, intervention manual or programs, and any electronic versions of any paper forms that were used. The data release documentation will provide detailed, organized documentation of study variables and clear instructions on how to install and access the data.

This is calculated for each follow-up visit as ((weight at FU visit - baseline weight) / (baseline weight)) × 100%.

How social determinants of health, assessed via the Social Needs Screening Tool, relate to patient success with weight loss

How social determinants of health, assessed via the Social Determinants of Health Questions Adapted from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 Questionnaire, relate to patient success with weight loss

How social determinants of health, assessed using z codes for Social Determinants of Health constructs abstracted from the Electronic Health Record using ICD -10 codes, relate to patient success with weight loss

National Cancer Institute (NCI)

Regional One Health

University of Tennessee

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.

Electronic health record nudge which prompts physicians to order plasma-based NGS testing for eligible patients with newly diagnosed lung cancer.

iNUDGE

Meagan Hume, MPH

Shayma Kazmi, MD

Ramy Sedhom, MD

Samuel J Kerr, MD

Christopher A D'Avella, MD

Christine Ciunci, MD

Charu Aggarwal, MD, MPH

This study expands the application of an electronic health record (EHR) "nudge" used to prompt physicians' clinical practice to order molecular testing at the time of initial diagnosis for patients with specific types of advanced lung cancer. The primary goal is to have these test results available prior to starting treatment so that physicians can make molecularly-informed treatment decisions. The second goal is to better understand factors that contribute to whether or not the EHR-nudge implementation is successful.

At the University of Pennsylvania Health System (UPHS), a behavioral economics (BE) informed "nudge" strategy was piloted to guide physicians' clinical practice to include concurrent use of plasma and tissue-based next generation sequencing (NGS) testing at the time of initial diagnosis for patients with newly diagnosed metastatic non-squamous (mNSq) non-small cell lung cancer (NSCLC). These findings have demonstrated that behavioral, electronic health record (EHR)-based nudges are feasible and can promote guideline concordant diagnostic testing at both community and academic sites. The overarching goal of this current trial is to expand the application of this BE informed nudge approach, which has been operationalized within Epic, the EHR used at UPHS, to six satellite hospitals.

Our central hypothesis is that this approach will dramatically increase adoption of comprehensive molecular testing and enhance the delivery of molecularly informed 1L therapy in patients with newly diagnosed mNSq NSCLC.

Molecular testing will be defined as i) comprehensive: EGFR, ALK, BRAF, ROS1, MET, RET, and NTRK testing, ii) incomplete: \<6 genes tested, and iii) no testing performed. Clinically actionable mutations will be defined as an alteration in one of the seven genes on the comprehensive gene list with an FDA approved targeted therapy in the 1L setting, plus KRAS G12C, EGFR exon 20 insertion, and ErbB2 mutations. Molecularly informed first line therapy will be defined as one that is informed by results of NGS, obtained by plasma, tissue or both.

Intervention

An EHR-based nudge intervention that allows for default placement of a plasma based molecular genotyping order at time of the first new patient visit will be implemented. Subsequently, results detected on the default plasma NGS order will be conveyed to providers in the form of an electronic clinical decision support notification.

As part of the downstream EHR-based nudge intervention workflow, an electronic clinical decision support (e-CDS) system for alterations detected on plasma genotyping will be created and implemented into the EHR as a "Research (non-chargeable) Encounter" to alert the provider team caring for the patient. This support program will be created to notify clinicians of targetable mutations, as well as absence of mutations detected on plasma testing as a means of improving the timely delivery of molecularly informed therapy.

Study Design

Objective 1: In a stepped wedge cluster randomized trial of patients with newly diagnosed mNSq NSCLC, test the effectiveness of a behavioral economics (BE) informed EHR nudge intervention to increase timely receipt of comprehensive molecular test results before 1L therapy by integration of concurrent tissue and plasma molecular testing.

The design of this trial will include 3 clusters, representing 6 community hospitals. There will be an initial period in which no clusters are exposed to the intervention. Subsequently, at regular intervals (the "steps") one cluster (or a group of clusters) will be randomized to cross from the control to the intervention under evaluation. This process will continue until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Data collection will continue throughout the study, so that each cluster will contribute observations under both control and intervention observation periods. Two years of baseline data will be obtained from all study sites for comparison.

Objective 2: Evaluate contextual mechanisms contributing to the adoption, reach, and effectiveness of EHR nudge interventions with a lens for health equity.

Using rigorous approaches proven successful in our prior work, the investigators will recruit 10-15 patient and clinician participants from each site (estimated 40-60 participants total) to complete semi-structured interviews following the active trial period. The goal of this objective is to understand contextual mechanisms (e.g., patient, clinician, clinic, structural factors) shaping adoption, reach, and effectiveness of each intervention and identify how response may differ by race and ethnicity, socioeconomic status, and other key social determinants of health. These data will be analyzed using qualitative comparative analysis, a mixed method approach well suited to identify mechanisms in pragmatic trials with smaller sample sizes.

This study employs a stepped-wedge cluster randomized clinical trial design. Randomization will occur at the group (site) level. Sites will be turned on according to the stepped-wedge cluster randomized design but will run in parallel.

This intervention is directed towards physicians. Individuals will not be randomized.

Liquid Biopsy Based NGS in Newly Diagnosed NSCLC

iNUDGE: INtegration of liqUiD Biopsy Based Next Generation Gene sEquencing in Newly Diagnosed NSCLC - A Stepped Wedge Cluster Randomized Clinical Trial

A Clinical Study Report will be made available to the study sponsor.

Were comprehensive molecular test results available prior to initiation of 1L therapy? (Yes/No)

Amongst eligible patients, calculate the proportion of patients for whom the EHR nudge fired successfully (Yes/No). Applicable for the patients enrolled in the time periods following randomization.

Reported as number of days, median. Applicable for the patients enrolled in the time periods following randomization.

Relative and absolute change in completion of comprehensive testing by tissue and plasma, plasma alone, or tissue alone will be tabulated.

Summarize reasons for failure of completion of testing i. Tissue related (QNS) ii. Patient related factors (unable to biopsy, patient declined biopsy etc.) iii. Assay related factors (plasma assay does not detect mutations) iv. Other

i. Calculated as time to therapy from the date of diagnosis of Stage IV disease (date of biopsy) ii. Calculated as time to therapy from the date of first new patient visit with medical oncology

i. Targeted therapy ii. Chemo-immunotherapy iii. Immunotherapy iv. Clinical trial or n v. None

i. Time from initial diagnosis to date of death or last follow up. ii. 1 year and 2-year overall survival rates will be calculated for the intervention group, and compared to baseline.

Loxo Oncology, Inc.

Charu Aggarwal

Leslye M. Heisler Associate Professor of Lung Cancer Excellence and Associate Director, Penn Center for Precision Medicine

Carcinoma

Breast Neoplasms

Hyperplasia

Carcinoma in Situ

Carcinoma, Lobular

Breast Diseases

Skin Diseases

Participants will self-administer FHIR-enhanced RealRisks with access to risk communication games, family history pedigree and modules on chemoprevention and genetics testing, if relevant to them based on their risk and family history. The investigators are interested in gaining short-term feedback on patient activation and other patient reported outcomes, which will be assessed before and within 2 weeks after using RealRisks.

RealRisks is a web-based patient-centered decision aid (DA) designed to improve: 1) accuracy of breast cancer risk perceptions; 2) chemoprevention knowledge, and 3) informed choice. The DA includes audio and modules about breast cancer risk (including interactive games on risk communication) and chemoprevention. Through RealRisks, the investigators will collect information on breast cancer risk factors to calculate a patient's BCSC breast cancer risk score and also factors that influenced decision-making about chemoprevention through the preference elicitation game. RealRisks generates an action plan for patients summarizing their personalized breast cancer risk profile and preference elicitation for chemoprevention. Of note, the tool is designed for patients with varying levels of health literacy and numeracy and is available in English and Spanish.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study	NCT00878267	Advanced Cancer	Interview	21 Years -	M.D. Anderson Cancer Center
Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings	NCT03985449	Uterine Fibroid	Uterine Fibroid... Uterine Fibroid... Uterine Fibroid...	18 Years -	Dartmouth-Hitchcock Medical Center
Preoperative Smoking Cessation in Patients Undergoing Surgery	NCT05192837	Smoking Cessati... Smoking Reducti... Surgery--Compli... Surgery Cancer Postoperative C... Perioperative C... Smoking Abdominal Cance... Thoracic Cancer Urologic Cancer Gynecologic Can... Head and Neck C...	Intensive preop...	18 Years -	Luzerner Kantonsspital
Personalized Experiences to Inform Improved Communication for Minorities With Life Limiting Illness	NCT03391115	COPD Heart Failure Cancer	Storytelling In... Storytelling In...	18 Years -	University of Colorado, Denver
Choosing Healthy Activities and Lifestyle Management Through Portal Support	NCT05410353	Weight Loss Overweight and ... Behavior, Healt...	Active Interven... Comparison Grou...	16 Years -	University of Tennessee
Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study	NCT00878267	Advanced Cancer	Interview	21 Years -	M.D. Anderson Cancer Center
Liquid Biopsy Based NGS in Newly Diagnosed NSCLC	NCT05853887	Non Small Cell ... Newly Diagnosed... Non-Squamous No...	iNUDGE	-	Abramson Cancer Center at Penn Medicine
Liquid Biopsy Based NGS in Newly Diagnosed NSCLC	NCT05853887	Non Small Cell ... Newly Diagnosed... Non-Squamous No...	iNUDGE	-	Abramson Cancer Center at Penn Medicine
Choosing Healthy Activities and Lifestyle Management Through Portal Support	NCT05410353	Weight Loss Overweight and ... Behavior, Healt...	Active Interven... Comparison Grou...	16 Years -	University of Tennessee
Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings	NCT03985449	Uterine Fibroid	Uterine Fibroid... Uterine Fibroid... Uterine Fibroid...	18 Years -	Dartmouth-Hitchcock Medical Center
Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study	NCT00878267	Advanced Cancer	Interview	21 Years -	M.D. Anderson Cancer Center
FHIR-Enhanced RealRisks to Improve Accuracy of Breast Cancer Risk Assessments	NCT05810025	Breast Cancer	RealRisks	35 Years - 74 Years	Columbia University

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