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

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Imidacloprid

The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.

Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.

* Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
* Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
* Social worker (30 mins): values clarification exercise
* Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience

Decision Support Workshop

Toni Zhong, MD, MHS

The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education.

Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. The breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. However ¼ of women report being dissatisfied with some component of their cancer or reconstructive care. Failure of the physician to provide adequate information about treatment options is the most frequent source of cancer patient dissatisfaction and breast reconstruction patients have expressed a need for further information regarding the complex decision to pursue breast reconstruction. In such scenarios of complex medical decision-making, decision support techniques may be an effective solution to information provision and shared decision-making. As a result, the investigators developed a pre-consultation educational group intervention delivered in a group setting for women considering breast reconstruction, with the aims to fill an existing information-gap, promote high-quality decision-making and enhance decision self-efficacy and other decision measures. This pilot study will be the first step in the evaluation of the educational group intervention and the results will be used to determine the feasibility and inform the optimal design for a definitive randomized controlled trial. This study will first examine the feasibility and acceptability of the intervention through implementation in a pilot, mixed-methods, 1:1 allocation parallel-arm randomized controlled trial.

Decision Support Workshop for Breast Reconstruction

Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)

As this is a pilot study, the feasibility of conducting the study is highly important. The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months.

The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded. This will be recorded directly after each day the treatment is delivered.

Patients are to complete the primary outcome one week after initial consultation. However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls.

Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.

The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).

The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation.

Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).

Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient \> 0.90) and is sensitive to change when measured before and after an intervention.

PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.

The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The "Satisfaction with Information" Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction.

A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.

The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)

The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins.

The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.

This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.

Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support.

The Physicians' Services Incorporated Foundation

University Health Network, Toronto

Adverse events were not assessed. Patients were not at risk for adverse events from this intervention ( 2 hour group workshop), as it was not medically invasive.

The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.

Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.

* Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
* Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
* Social worker (30 mins): values clarification exercise
* Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience

Standard Care

Total

Age, Continuous

Sex: Female, Male

Canada

Region of Enrollment

Decisional conflict at baseline. Standard Care n=19, Decision Support Workshop n=20.

The decisional conflict scale measures personal perceptions of uncertainty in choosing options. It is a 16-item 5-response instrument that reports a total score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).

Decisional conflict Scale

All patients reported baseline clinical characteristics. One patient in each arm did not have evaluable decisional self-efficacy and conflict scores post-treatment, so their baseline scores were not included in the analysis of these variables. Therefore, for these measures at baseline, n=19 in the standard care arm and n=20 in the workshop arm.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Decision Support Workshop for Breast Reconstruction	NCT01857882	Breast Cancer	Decision Suppor...	18 Years - 79 Years	University Health Network, Toronto
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

Spots Global Cancer Trial Database for decision support intervention