Behaviors and Mental Disorders

All Conditions

Quality of Life

Routine collection of patient-reported symptom and Quality of life data using PediQUEST surveys

Routine collection of QOL and symptom data + feedback

Patients assigned to the control arm answered PediQUEST (PQ) surveys at most once a week and at least once a month. PQ-surveys were administered through a tablet computer if patient was at the clinic or ward or over the phone if patient was primarily at home. PQ-survey had 9 age- and respondent- adapted versions.

Control arm participants reported their satisfaction with the PediQUEST technology twice 4th and 8th PediQUEST administration. These surveys were embedded in PediQUEST.

Routine Data collection

Patients, parents and primary providers received printed reports summarizing patient/parent reported outcomes for last five visits. When child reported moderate-severe distress an email was automatically sent to primary providers (oncologist, nurses and psychosocial clinicians), as well as to the pain and palliative care services.

Feedback of patient-reported outcomes

Joanne Wolfe, MD

Over 50% of children dying from cancer still suffer from symptoms that could be effectively alleviated. The purpose of the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) Study was to evaluate whether providing feedback to families and providers about how the child is feeling improved child distress and quality of life (QoL) in children with advanced cancer.

PediQUEST is a computerized survey that asks the child and/or parents how the child has been feeling, i.e. whether the child had any physical or emotional symptoms, as well as how other aspects of life, such as school and friends, are going. After the survey is complete a report that summarizes patient/parent answers is printed. When a child reports moderate to high distress from any symptom an email is automatically sent to the primary providers (oncologist, nurse, and psycho-social clinician as well as the pain and palliative care services) alerting them about the child's distress.

In this study we evaluated whether using PediQUEST and providing printed reports to parents and providers reduced distress and improved quality of life in children with advanced cancer. In addition, we wanted to understand whether it was feasible to carry out a randomized controlled trial in children with advanced cancer. Finally, the data collected, will be used to describe the natural history of symptoms and quality of life as reported by the children.

Children enrolled in the study (or their parents) were asked to complete a PediQUEST survey at most once a week. A random half of the children received the feedback intervention, i.e. patients, parents, and providers received printed reports (and emails if the child was in distress). The other half only completed the PediQUEST surveys and did not receive reports. We analyzed data collected over 20 weeks of follow-up to see whether receiving PediQUEST reports had any effect on child distress and quality of life.

Introduction: Cancer is the leading cause of nonaccidental death in childhood.(Arias et al. 2003) In spite of significant scientific progress, one quarter of children with cancer still do not survive(Greenlee et al. 2000), and over 50% experience substantial suffering that could be alleviated.(Wolfe et al. 2000a) Pediatric palliative care is now an expected standard of care and research in this field has been established as a national priority by the Institute of Medicine (IOM).(Field et al. 2003) Earlier work by our group suggested that when parents and physicians recognized at an early stage that a child had no realistic chance of cure, they were more likely to integrate elements of effective palliation into the child's care. However, this early stage concordance about prognosis was rare.(Wolfe et al. 2000b) Communication and delivery of optimal care in the advanced stages of illness is especially challenging in children.(Shelton 1999) The anticipation of losing a child and physicians' own difficulties(Saunders 1979-80; Hilden et al. 2001) may hinder discussions about poor prognosis and impact on decision-making and integration of palliative care. Thus attention to symptom management and quality of life (QoL) in children with advanced cancer may be limited.

The collection of standardized symptom and QoL data has shown to enhance physician's recognition, knowledge and accuracy in the assessment and palliation of symptoms, and to increase patient-provider discussions about QoL issues and directly improve patient's QoL.(Detmar et al. 2002; Taenzer et al. 2000; Velikova et al. 2004) Whether these findings are applicable to children remains to be established.

One of the obstacles to routine symptom and QoL assessment in children is the need of developmentally adapted(Eiser et al. 2001b; Eiser et al. 2001c; Hain 1997) and parent-proxy tools(Eiser et al. 2001a), making the paper and pencil format extremely impractical. Computerized surveys offered a potential solution. Patient acceptance of such devices has been found to be high.(Buxton et al. 1998; Velikova et al. 2002; Velikova et al. 1999; Velikova et al. 2001) Our current project -the PediQUEST Study- consists of a pilot for a randomized controlled trial (RCT) aimed at assessing the effect of routinely reporting symptom and QoL data. We will use an innovative data collection strategy: a hand-held computer devise, the Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) that readily administers a user-appropriate survey instrument and generates reports summarizing how the patient feels.

As far as we are aware of, this will be the first RCT conducted in children with advanced cancer to evaluate a palliative care intervention. Given the challenges with doing research in this population, we propose to simultaneously focus on several goals.

Aims: Aim 1: (Feasibility study) Assess the feasibility of conducting a randomized controlled supportive care trial (RCT) in children with advanced cancer. Aim 2: (PediQUEST Evaluation) Preliminarily assess the effect of routinely feeding back QoL and symptom data to families and primary oncologists, and alerting supportive care teams about highly distressing symptoms. Aim 3: (Descriptive study) Prospectively explore determinants of child's suffering and parental-physician discordance regarding prognosis and treatment goals in children with advanced cancer.

Design: Aim 1: Cohort survey study; Aim 2: Pilot prospective RCT; Aim 3: Cohort study embedded in an RCT.

Setting: Three large US pediatric cancer centers. Subjects: 104 children 2-years old and above with advanced cancer and their parents were enrolled between December 2004 and June 2009.

Follow-up: Patients were initially followed up for 9 months or until death whatever occurred first. However, an interim analysis of the first 29 patients showed that 75% were alive at nine months, suggesting the enrollment of a healthier cohort. We therefore changed the follow-up period to 3 months with the option of multiple re-enrollments until the end of data collection (December 2009) or death.

Methods:

Feasibility study: All subjects approached for enrollment were invited to complete a one-time paper and pencil "Consent survey" regardless of their decision about whether to participate. All enrolled subjects were asked to complete a paper and pencil "Participation survey" after completing the study or dropping-out in order to explore determinants of attrition.

PediQUEST Evaluation and Descriptive studies: Symptom and QOL scores were tracked up to once a week. Surveys were embedded in the PediQUEST system and administered through tablet computers.

Participants' recruitment: Eligible children were identified through daily review of clinic roster with clinic staff including nurses, oncologists and/or nurse practitioners and verified with the patient's primary oncologist using a checklist sent over email. If after being introduced to the study and having had the opportunity to ask questions, child and parent(s) were willing to participate, parent(s) were asked to review and sign the informed permission/assent document covering the parent(s) and child's participation. A provider's completion of the eligibility checklist will indicate informed consent of providers.

Study Instruments:

1. PediQUEST survey (PQ-Survey): assessed symptoms, quality of life, and overall sickness. Nine survey versions were developed to allow for consistent measurement across the age ranges and respondents. Self-report started at 5 years of age; children aged 5 to 12 years answered shorter, age-adapted questionnaires which were complemented with additional parental questionnaires; teens answered a full self-report questionnaire. Parents of children between 2 and 4 years old answered a full survey on their child's behalf. If a child did not feel well, parents could complete the full questionnaire on their behalf. PQ-Surveys were pilot tested in 15 patients showing good acceptability and comprehensibility. PQ-surveys used four tools: 1) PQ-Memorial Symptom Assessment Scale (MSAS), adapted from previously validated child(Collins et al. 2000; Collins et al. 2002) and proxy(Drake et al. 2003) MSAS, measures frequency, severity and distress for 24 symptoms; 2) Pediatric Quality of Life Inventory (PedsQL), a 22-item health related quality of life instrument;(Seid et al. 1999; Varni et al. 2002; Varni et al. 2003) 3) Faces Pain Scale Revised (a faces pain scale, used to measure current pain intensity);(Hicks et al. 2001) 4) Sickness VAS scale (overall sickness measure created ad hoc).
2. Survey about Caring for Children with Cancer (SCCC): In addition, parent and physician perspectives regarding prognosis and treatment goals were collected at baseline and then every 3 months using a paper-and-pencil survey SCCC, adapted from our survey for bereaved parents.(Wolfe et al. 2000b)
3. Post death survey: If patients died within the study period parents were invited to complete a post-death survey at least four months following the death to assess distress during the last month of life and retrospective perspectives regarding the overall quality of care.
4. Satisfaction Surveys: Child and parent surveys were adapted from existing questionnaires.(Grogan et al. 1995; McCusker 1984; Weaver et al. 1993) Satisfaction with PQ technology was assessed using seven items for children eight years old and above and 11 items for parents. Surveys were embedded in the PediQUEST system and administered at fourth and eighth PediQUEST administration. A survey evaluating participant's satisfaction with the PediQUEST intervention (see below) was administered concurrently (eight items (parents), five items (children eight years old and above)) to all intervention participants. Provider satisfaction with the PQ intervention, and perceived usefulness of the PQ-system was assessed through an online survey administered at the end of data collection.

Intervention: Patients were randomly allocated to receive routine feedback about symptoms and QOL. The feedback intervention had two components: (i) PQ-reports: printed reports were made available to providers (inserted in charts before the visit) and families (handed immediately after survey completion at clinic or ward). PQ-reports consisted of bar plots of PedsQL and MSAS symptom scores from current and four prior administrations, a summary highlighting changes since last report, and a list of available resources for symptom control (for families), or generic pain management recommendations (for providers). Training on how to interpret PQ-reports was offered to families at enrollment and on an annual basis to providers; (ii) PQ emails: were automatically generated if PQ-MSAS individual symptom scores were ≥70, or if on two consecutive administrations the patient or parent reported a score of ≥70 for any frequency, severity or distress item, or a PedsQL total score ≤ 40. E-mails were sent to primary providers (oncologist, nurse, and psychosocial clinician), the local palliative care service, and, when pain was reported, the pain service (or equivalent). No instructions were imparted on how to respond to emails. Families and providers of patients in the control arm of the study did not receive feedback reports. The allocation process was embedded in PediQUEST and blinded to investigators until the patient completed the first survey. Because of the nature of the intervention this was an open label study. As a token of our appreciation, small non-monetary incentives were provided to children, parents, and providers.

Outcomes: This study explores the feasibility of conducting an RCT assessing a supportive care intervention in children with advanced cancer (aim 1). It also provides estimates of consent and attrition rates, its determinants, and the burden associated with repeated measurements. In addition, this pilot study will preliminarily assess the impact of feedback on child's distress and quality of life. Main outcomes of this efficacy study (aim 2) are presented below. This pilot study will render sufficient data for accurate sample size calculation for future studies and serve to explore determinants of suffering in children with advanced cancer (aim 3).

Statistical Analysis:

PediQUEST Evaluation (Aim 2): To assess the effect of PediQUEST, the proportion of patients with unrelieved symptoms in each arm will be compared using odds ratios and associated chi-square tests. To assess the progression of reported levels of child's distress and QOL trends, we will run a mixed effects model that assumes a linear trend in the outcome over 20 weeks of follow up for each subject. The model will examine the difference in the average trend over time (slope) between the intervention and control group by including a fixed effect term that represents the interaction of treatment status and time since study entry. Lack of difference between slope coefficients will support the null hypothesis of no effect by the intervention. Single point secondary outcomes will be analyzed by comparing both arms with a t test or Wilcoxon rank-sum test for continuous outcomes and odds ratios and associated chi-square tests for proportions.

Sample Size and Power Calculations A formal sample size estimation was not possible given the lack of data on distribution of scores in an advanced cancer population or their variation over time. For this reason we originally proposed to recruit 120 patients and their parents, a sample size driven by practical rather than statistical considerations that would serve as a basis for future sample size calculations. We estimated that 60 subjects per arm would allow for an adequate balance between arms and likely provide sufficient power to detect large clinical effects for single point measurements.

The PediQUEST Study: Evaluation of Pediatric Quality of Life and Evaluation of Symptoms Technology

Satisfaction with the technology and with the feedback system will be assessed twice at the fourth and eight PediQUEST administration. Specifically we will assess consumers'impressions about the technology, easiness of use, relevance.

Among those receiving the feedback intervention we also assessed whether reports helped parents understand their children's feelings better, facilitated communication with doctors and overall satisfaction with the technology and feedback.

Finally, we also assessed providers satisfaction with feedback reports including their impression about the reports and whether reports affected their behaviors regarding symptom management.

Child distress-unrelieved symptoms will be assessed through the proportion of patients with unrelieved symptoms (any symptom/s reported as causing moderate to high distress or FPS-R score \>=8 in 2 consecutive PediQUEST evaluations)

Trends of PedsQL total scores over time. PedsQL is a continuous variable (Range: 0-100. 100 highest quality of life).

Trends of MSAS total score over time(MSAS total score is a continuous variable; range: 0-100. 100 worst).

Trends over time of MSAS physical subscale scores (MSAS physical subscale score is a continuous variable. Range: 0-100. 100 highly symptomatic.)

Trends over time of MSAS psychological subscale scores (MSAS psychological subscale scores is a continuous variable. Range: 0-100. 100 highly symptomatic.)

Trends of PedsQL physical subscale scores over time. PedsQL physical score is a continuous variable (Range: 0-100. 100 highest quality of life).

Trends of PedsQL emotional subscale scores over time. PedsQL emotional score is a continuous variable (Range: 0-100. 100 highest quality of life).

Trends in Kessler-6 scores (general psychological distress scale) over 20 weeks. Continuous variable. Range:0-24 (24 is high distress).

N° of referrals to support services (Psychiatry service, Pastoral Care): continuous variable.

Proportion of patients receiving chemotherapy during the last month of life

Proportion of patients receiving home care assistance or hospice care

Time of documentation (N° of days before death) of discussions about prognosis

Time of documentation (N° of days before death) of discussions about resuscitation status

Proportion of patients who were intubated in the last 24 hrs of life.

Proportion of patients who died at the hospital

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Principal Investigator

Symptoms and General Pathology

Neoplasms

Rare Diseases

Chronic Disease

Head and Neck Neoplasms

Chronic Graft Versus Host Disease

Head and neck cancer patients monitored on registry

Patients who are diagnosed with head and neck cancer and monitored by the Otolaryngology - Head and Neck Surgery clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing paper-based systems for tracking patients. All head and neck cancer patients monitored by the clinic will be included.

Registry

Urmimala Sarkar, MD, MPH

To implement and evaluate a health information technology platform designed to support the management of patients with head and neck cancer in an urban, publicly-funded outpatient setting. This is an observational study; researchers will not assign specific interventions to study participants.

The investigators aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. The investigators will not assign specific interventions to the study participants, but rather observationally assess the effect of the HIT registry, designed to support routine medical care, on participants.

The investigators will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Otolaryngology - Head and Neck Surgery clinic that cares for patients with head and neck cancers. The study will assess patient outcomes and evaluate the time it takes for patients to progress through key treatment and post-treatment milestones before and after the HIT tool is implemented. The investigators will use models controlling for secular trend to estimate the effect of the tool on improving timely and successful completion of guideline-based care processes.

The HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based systems previously used by the clinic to monitor its head and neck cancer patients. It will be implemented clinic-wide for all patients being treated for head and neck cancers. The investigators are not assigning a specific intervention to patients, but rather supporting the clinic and health system in the development of a population management platform that improves routine care processes. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.

The HIT platform users are clinicians who are responsible for monitoring patients with head and neck cancer and agree to partner with the investigators to improve monitoring processes. The clinicians involved may be asked to voluntarily participate in surveys, interviews, focus groups, and program evaluations. Patient medical records will be reviewed, but patients monitored on the registry will not be contacted by researchers.

Procedures are in place to monitor the registry. First, quality assurance is performed by the research team, information technology analysts, and software engineers. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, the platform users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. Patients will be added to the registry by a clinician if they are diagnosed with head and neck cancer. The research team will support the clinicians in data analysis, although this will be performed with population-level, de-identified data. However, if unmediated adverse events are identified by the research team, the research team will alert the clinicians immediately. The HIT platform is designed to supplement, but not replace, the existing electronic health record. Data on the registry will be validated with source data and users will still engage with the source data and electronic health record as appropriate clinically and operationally.

Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers

Time from diagnosis to initiation of treatment

Proportion of patients that complete tumor board treatment recommendations

Time from diagnosis to presentation at tumor board

Time from diagnosis to first visit in oncology clinics

Proportion of patients who complete post-treatment radiation

Proportion of patients who are lost to follow-up

Agency for Healthcare Research and Quality (AHRQ)

University of California, San Francisco

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Lymphoma

Leukemia

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Lymphosarcoma

All participants will receive a tablet educational intervention (health IT platform) during the patient inpatient hospitalization for autologous or allogeneic transplant

Participants will receive a mobile tablet as an educational intervention during the patient's inpatient hospitalization

Education information system

Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow transplantation (BMT), is a potentially life-saving therapy for many malignant and non-malignant conditions. Despite advances over the past decade, which have led to improved outcomes, BMT remains an intense treatment modality often requiring prolonged inpatient-based care. While many patients endure the acute complications of the procedure, it is common for BMT patients and their caregivers to experience increased risk of financial and emotional burden, hospital readmission, and health service utilization. This highlights the importance of active involvement of BMT patients in their own health care (self-efficacy). For pediatric BMT patients, parents are the primary caregivers. As such, parental activation on behalf of the child (patient) plays a critical role in effective patient-parent-provider partnerships, which is increasingly recognized as the optimal model for health care delivery, particularly for those facing life-altering medical treatments. It is essential to develop effective strategies to enhance this partnership. Health information technology (IT)-mediated tools offer the potential to overcome constraints in health care delivery limited by provider time, complicated health information, and financial pressures. Significant gaps in knowledge exist on the use of health IT tools using low-cost and well-accepted delivery platforms in routine inpatient care, especially for high-risk or critically ill populations. The investigators hypothesize that a tablet-based tool displaying personal health information could provide a platform to promote caregiver (parent) activation and enhance health communication. In this clinical research study, the investigators will conduct a pilot study of an educational health IT system developed on a tablet (Apple iPad®) that the investigators refer to as a Personalized Engagement Tool (PET) or the "BMT Roadmap." The Apple iPad® was selected as the platform for delivery of the educational intervention given its ergonomic features. The implementation and evaluation of the BMT Roadmap information system in caregivers of children undergoing BMT have been based on the generation of user (caregivers and patients) needs that incorporated well-established user-centered design processes including qualitative and quantitative research methods (published and unpublished data). The assembled investigators represent a strong multidisciplinary team with complementary and integrated expertise who are well-poised to carry out the proposed research. The Protocol or Study Team includes pediatric BMT physicians, Center for Health Communications Research (CHCR) staff, health informaticist, biostatistician, and psychologist. This research study is innovative because it addresses a gap in the literature on the role of health IT in parent activation on behalf of the child in the inpatient setting of a high-risk BMT population. The BMT Roadmap information system provides a robust experimental framework for further testing the utility of other care components that relate to parent activation or participation and for potential adoption in other complex medical conditions. The new knowledge gained herein will thus contribute to the evidence base of how health IT improves health care quality and provide the basis of further study in a full-scale clinical trial.

PROTOCOL SYNOPSIS Title A Pilot Study of Patient and Caregiver Participation through an Educational Health Information Technology System ("The BMT Roadmap") in the Context of Hematopoietic Cell Transplantation

Objective To evaluate the usefulness and usability of a health information technology (IT) system ("The BMT Roadmap"). This educational system will be developed on an Apple iPad® with collaborators from the School of Information, Health Informatics, and the Center for Health Communications Research (CHCR). The BMT Roadmap will be used by caregivers of patients hospitalized for first-time autologous (self) or allogeneic (alternative donor) blood and marrow transplantation (BMT) as well as patients (age 10 years or older) who are hospitalized for first time autologous or allogeneic BMT. The investigators hypothesize that parents will use the BMT Roadmap to become more active participants on behalf of their child.

The information system will consist of 5 modules personalized to the study participant's child: (1) laboratory studies, (2) medications, (3) clinical trials enrolled on, (4) health care providers (BMT physicians, 7 Mott Nurses, BMT NPs, coordinators, pharmacists, nutritionist, social worker), and (5) criteria for discharge.

Sample Size Caregivers: The investigators aim to enroll 10 adult caregivers of patients (0-25 years of age) undergoing autologous (self) or allogeneic BMT (alternative donor); and Patients: 10 patients (10 years of age or older) undergoing autologous or allogeneic BMT. This sample size was determined based on the patient demographics of the University of Michigan Pediatric BMT Program. The number of participants who meet eligibility is approximately 50 per year. The investigators plan to enroll approximately 2 adult caregivers and 2 patients per month for an estimated accrual time of 5 months. This study allows for concurrent enrollment in other trials.

Study Design After signing an informed consent, participants will be provided with an Apple iPad®. Qualitative and quantitative research methods will be used to measure the study outcomes. There will be approximately 6-8 qualitative interviews per participant conducted periodically from pre-BMT until 100 days post-BMT. Additionally, 15-20 qualitative interviews will be conducted of BMT care providers, including physicians, nurses, pharmacists, nutritionists, social worker, and psychologist to evaluate their attitudes and perceptions of the BMT Roadmap information system. Quantitative survey instruments will only be administered to adult participants (age 18 years or older). Caregivers with children (patients) who are younger than 10 years of age may be eligible to participate even though their children are too young to assent or participate themselves.

Inclusion Criteria Caregivers: Caregiver (age 18 years or older) of a patient (0-25 years of age) who is an inpatient undergoing autologous or allogeneic BMT; Patients: patient (10 years or older) who is inpatient undergoing autologous or allogeneic BMT. Ability to speak and read proficiently in English (the study's instruments have not been translated and validated in languages other than English); Willing and able to provide informed consent; Willing to comply with study procedures and reporting requirements.

Treatment Plan This protocol is an educational intervention study (no more than minimal risk). It does not include treatment of an investigation agent treatment.

Study Endpoints The primary outcome measures will be the usefulness and the usability of the BMT Roadmap information system. Secondary measures will include standard-of-care patient-related clinical outcomes (length of stay and risk of day 30 and 100 readmission, infections, transplant-related mortality, and survival).

Data Analysis Descriptive statistics will be calculated for each survey instrument. Univariate analyses will be performed to assess associations between the instruments and demographic, social, and environmental characteristics of the parent (type of insurance, marital status, number of children in household), and disease-related characteristics of the patients.

A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers

University of Michigan Rogel Cancer Center

Intervention practices will implement an interactive preventive health record in addition to their standard personal health record functionality.

Control practices will continue to field their existing personal health record

The interactive preventive healthcare record (IPHR) is a patient-centered application that links patients to their clinician's record, explains information in lay language, displays tailored recommendations and educational resources, and makes preventive care actionable.

Interactive Preventive Health Record

Alexander H Krist, MD, MPH

Cancer screening can improve the length and quality of life, yet the average American receives only half of recommended services. Patient-centered personal health records with higher levels of functionality, combined with practice redesign to make use of these functions, can help patients obtain recommended cancer screening tests by linking them to their doctor's records, explaining information in lay language, displaying tailored recommendations and educational resources, providing logistical support and tools to stimulate action, and generating reminders. This project will measure whether making these resources available to primary care practices and patients promotes shared decision-making and increases the delivery of cancer screening compared to existing information systems.

We developed a theory-driven interactive Patient Health Record (PHR) that uses higher functionality to more deeply engage patients in health promotion. The model defines five levels of PHR functionality: (1) collecting patient information, (2) integrating with electronic health records (EHRs), (3) translating information into lay language, (4) providing individualized, guideline-based clinical recommendations, and (5) facilitating patient action. We hypothesize that implementing PHRs with these higher levels of functionality will inform and activate patients in ways that simpler PHRs cannot achieve and will increase uptake of preventive services. In Phase 1, we will randomize 46 practices from three practice-based research networks in eight states to implement a PHR with advanced versus simpler functionality. Control practices will use their existing PHR. Intervention practices will upgrade their PHR to feature an interactive preventive health record (IPHR) that we have previously developed and tested. Intervention practices will locally tailor the IPHR content and learn how to integrate new functions into practice. Phase 1 will feature an implementation assessment in intervention practices, based on the RE-AIM model, to measure Reach (creation of IPHR accounts by patients), Adoption (practice decision to use the IPHR), Implementation (consistency, fidelity, barriers, and facilitators of use), and Maintenance (sustained use). The randomized comparison of intervention and control practices will measure the incremental effect of the IPHR on shared decision-making and receipt of cancer screening tests compared to traditional PHRs (Effectiveness). Data sources will include the EHR/PHR/IPHR databases, patient and practice surveys, recruitment field notes, practice learning collaborative transcripts, practice diaries, and patient phone interviews. This study will inform future efforts to use patient-centered information technology to promote cancer prevention and the feasibility of national dissemination.

Implementing Personal Health Records to Promote Evidence-Based Cancer Screening

The percent of eligible patients who are up-to-date with all indicated cancer screenings (all-or-none measure).

To assess shared decision making a composite score based on the following measures will be calculated.

* Knowledge gained will be measured by using the IPHR, we will use questions from NCI's Health Information National Trends Survey (HINTS).
* To assess whether the IPHR helps patients weigh values regarding risks and benefits 2 measures will be used: (a) process (patient-clinician communication) and (b) patient perception (decisional conflict).

  1. Communication will be measured by using questions from AHRQ's Consumer Assessment of HealthCare Providers and Systems (CAHPS) survey.
  2. O'Connor's low literacy decisional conflict scale will be used to measure decisional conflict.
* To assess whether the IPHR fosters decision-making engagement at the desired level, Degner's locus of control metric will be used.

The difference in delivery of preventive services (Effectiveness) will be calculated for disadvantaged patients and the general population, using a two-level mixed-effects logistic regression for the all-or-none, composite, and individual screening tests.

To assess shared decision making a composite score based on the following measures will be calculated.

* Knowledge gained will be measured by using the IPHR, we will use questions from NCI's Health Information National Trends Survey (HINTS).
* To assess whether the IPHR helps patients weigh values regarding risks and benefits 2 measures will be used: (a) process (patient-clinician communication) and (b) patient perception (decisional conflict).

  1. Communication will be measured by using questions from AHRQ's Consumer Assessment of HealthCare Providers and Systems (CAHPS) survey.
  2. O'Connor's low literacy decisional conflict scale will be used to measure decisional conflict.
* To assess whether the IPHR fosters decision-making engagement at the desired level, Degner's locus of control metric will be used.

These scores will be calculated for disadvantaged patients (minorities and Medicaid patients) and the general population that use the IPHR, then compared.

Post-implementation patient phone interviews will be conducted then analyzed using grounded-theory approach to understand disadvantaged patients' perceptions of and experience with the IPHR. These results will be compared to the phone interviews done with patients from the general population.

Virginia Commonwealth University

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

Regional One Health

University of Tennessee

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients who elect to be monitored by an Active Surveillance protocol for prostate cancer

Patients who are diagnosed with prostate cancer and elect to be monitored by an Active Surveillance protocol by the Urology Clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing but suboptimal systems for tracking patients. All Active Surveillance patients monitored by the clinic will be included.

To implement and evaluate a health information technology platform designed to support the management of patients on active surveillance for prostate cancer in an urban, publicly-funded outpatient setting.

We aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. We will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Urology clinic that cares for patients with prostate cancer. We are conducting a prospective non-randomized pilot study that will follow men who choose active surveillance as a management strategy for prostate cancer. We aim to assess the impact of the HIT registry on patient monitoring and adherence.

The HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based or ineffective computer-based systems previously used by the clinic to monitor its active surveillance patients. It will be implemented clinic-wide for all patients being monitored by an active surveillance protocol. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.

Research involves materials that are collected for nonresearch purposes, as well as low-risk research employing survey, interview, focus group, program evaluation, and human factors methodologies. We will solicit structured feedback from registry users designed to continuously evaluate and improve performance in a clinical area to reduce patient safety gaps. Patient medical records will be reviewed, but patients monitored on the registry will not be contacted by researchers.

Procedures are in place to monitor the registry. First, quality assurance is performed by the research team, information technology analysts in the San Francisco Health Network, as well as by the third-party software provider. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. The HIT platform users include clinicians who are responsible for monitoring patients on active surveillance for prostate cancer. Patients who are enrolled in the active surveillance program will be added to the registry by a clinician. The research team will support the clinicians in data analysis, although this will be performed with population-level, de-identified data. However, if unmediated adverse events are identified by the research team, the research team will alert the clinicians appropriately. The research team will also develop training materials and conduct training sessions to ensure that all clinicians responsible for monitoring patients on active surveillance are provided with up-to-date resources and accessible support. The HIT platform is designed to supplement, but not replace, the existing electronic health record. Data on the registry will be validated with source data and users will still engage with the source data and electronic health record as appropriate clinically and operationally.

An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital

An Electronic Registry to Improve Adherence to Active Surveillance Monitoring Among Men With Prostate Cancer at a Safety-net Hospital: A Study Protocol

measured from date monitoring (e.g. prostate-specific antigen test or biopsy) is scheduled to date monitoring occurs.

Acceptability and feasibility of the intervention among clinicians will be measured using the Technology Acceptance Model (Venkatesh et al). Semi-structured interviews will be conducted to assess usefulness and ease of use.

The proportion of patients who are lost to follow-up, defined as three subsequent unsuccessful outreach attempts

Adherence to monitoring (e.g. prostate-specific antigen test every 3 months) will be assessed. Monitoring will be considered adherent if it occurs within 30 days of the recommendation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The PediQUEST Study: Evaluation of Pediatric Quality of Life and Evaluation of Symptoms Technology	NCT01838564	Pediatric Neopl... Quality of Life Outcome Assessm... Palliative Care	Routine Data co... Feedback of pat...	2 Years - 25 Years	Dana-Farber Cancer Institute
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers	NCT02409121	Leukemia Lymphoma Brain Tumor	Education infor...	10 Years - 75 Years	University of Michigan Rogel Cancer Center
The PediQUEST Study: Evaluation of Pediatric Quality of Life and Evaluation of Symptoms Technology	NCT01838564	Pediatric Neopl... Quality of Life Outcome Assessm... Palliative Care	Routine Data co... Feedback of pat...	2 Years - 25 Years	Dana-Farber Cancer Institute
Implementing Personal Health Records to Promote Evidence-Based Cancer Screening	NCT02138448	Cancer Health Promotio...	Interactive Pre...	18 Years - 75 Years	Virginia Commonwealth University
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
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
An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital	NCT03553732	Prostatic Neopl...	Registry	18 Years -	University of California, San Francisco
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

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