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Using PCORI data to drive better decisional quality for men with localized prostate cancer
Investigator (PI): Saigal, Chris
Performing Organization (PO): (Current): University of California, Los Angeles, UCLA Health, David Geffen School of Medicine, Department of Urology / (310) 794-7700
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2021
Record Source/Award ID: PCORI/SDM-2017C2-8634
Funding: Total Award Amount: $1,903,649
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: What research finding is this project disseminating? Because of Patient-Centered Outcomes Research Institute (PCORI) support, population-based comparative estimates for patient-reported treatment outcomes for localized prostate cancer as well as information on variation by race are now readily available. The project team proposes to incorporate these data into its existing shared decision making (SDM) intervention, WiserCare. The PCORI-funded Comparative Effectiveness Analysis of Surgery and Radiation for localized prostate cancer (CEASAR) study evaluated three years of post-treatment disease-specific functional outcome data of 2,550 men from across the country with various prostate cancer treatments. Twenty-six percent of these men were nonwhite. Overall, study findings indicated that surgery resulted in worse sexual and urinary function than either radiation therapy or active surveillance. These unique data allow estimates of these outcomes obtained in a variety of care settings, not just academic ones, and reflect the prostate cancer treatment experiences of men from a variety of communities. The SDM intervention supports men who have localized prostate cancer and is clinic-based. The project team used a software-based decision aid (DA), integrated into clinical workflow, to minimize the number of staff required for its implementation. In this way, the team laid the groundwork for sustainability of the program. The DA educates men about prostate cancer, creates a personalized decision analysis model for the patient, assesses his preferences for outcomes of care using an interactive conjoint analysis approach, and provides him with a 14-page summary to review prior to meeting with his physician. The patient's physician receives a one-page summary of these items. Why is this research finding important? As the most prevalent non-skin cancer in men, prostate cancer poses a substantial burden; an estimated 161,360 men will face this cancer diagnosis in 2017. African Americans bear a heavier burden than other groups. Because many prostate cancers are indolent, the specter of overtreatment complicates decision making. Treatment impacts sexual, urinary, and bowel function. To help men with low-risk disease avoid incurring significant treatment side effects without an accompanying survival benefit, active surveillance has been promoted as an evidence-based choice for men to consider, but this approach remains underused. Data on the current quality of decision making in this area highlight the need for an effective SDM process for men with prostate cancer. One community-based study found a 10-fold variation across the United States in the use of surgery, and that 92 percent of men with the lowest-risk disease were subjected to aggressive treatment. Men making choices about treatment often learn about treatment side effect profiles reported from academic high-volume centers, which may not reflect outcomes available to them. With incorporation of the CEASAR study data into the project's approach, the team will be able to extend its SDM implementation into more communities by using data that is relevant to them. What is the goal of the dissemination project? The project has three specific aims. First, the team will update the existing DA software with CEASAR study data on prostate cancer treatment outcomes. Second, researchers will optimize the implementation of the updated SDM intervention in the existing study setting, University of California, Los Angeles (UCLA), by using patient research partners to increase fidelity, reliability, and maintenance of the intervention, while also measuring patient decision quality. Third, the team will study implementation of the SDM intervention in two other health systems, Vanderbilt University Medical Center and Olive View-UCLA Medical Center, which are located in different geographic areas with diverse provider networks and patient populations. The team will evaluate the same implementation and clinical effectiveness outcomes at all three study sites. What is the project team doing? At each of their respective sites, Bergman, David Penson, MD, MPH, and Saigal will oversee implementation of the SDM intervention and supervise data collection of the implementation outcomes. Study outcomes will be monitored using statistical control process charts created with the help of Inkelas, Conwill, and Nissenberg. Kirk will meet monthly with the rest of the governance team to evaluate wanted and unwanted variance in study outcomes and develop solutions. How will the project team evaluate their dissemination activities? The dissemination and implementation (D&I) evaluation plan will enable the team to study implementation of the SDM intervention under most of the conditions that a health care organization would expect to encounter. The Consolidated Framework for Implementation (CFIR) will be used to predict study organizational features in the three participating health systems that may affect the SDM intervention's uptake, reliability, and fidelity. The project team will measure implementation outcomes such as penetration, adoption, fidelity, and maintenance. Clinical effectiveness measures include decisional conflict, patient satisfaction and loyalty, and sense that shared decision making occurred. The team will also measure treatment choice and expects to see an increase in the selection of active surveillance among low-risk men. How is the project team involving patients and others in this dissemination project? The team has established strong stakeholder partnerships for this work, including with the California Prostate Cancer Coalition (CPCC) and Conwill, a prostate cancer patient advocate at Vanderbilt University. Project partners recognize the importance of providing DAs to men who are making this crucial treatment decision. Conwill and CPCC representatives Nissenberg and Kirk have provided valuable guidance throughout the conceptualization of the project (specifically, the need to include racially representative outcome data for patients, and the need to formally include the spouses, as desired by the patients, in the process). They are committed to continue providing input on behalf of prostate cancer survivors and spouses as this project progresses. The research team foresees a collaborative plan of dissemination of the SDM intervention through the CPCC support group network. Additionally, men with prostate cancer helped to identify the overall common set of treatment risks and benefits that are of major concern to patients and that are being evaluated in the SDM implementation. How will this project help ensure future uptake and use of PCORI results? By collecting and analyzing outcomes relevant to clinical growth (e.g., patient satisfaction, willingness to refer new patients to the physician and health system) and disseminating the findings, the team believes its results will encourage existing and new health systems to adopt and sustain this SDM intervention, which incorporates PCORI results. Additionally, on the basis of existing effectiveness data, the Movember Foundation--a global organization that supports prostate cancer survivorship programs--has already provided financial support for pending SDM implementation at other sites. With the implementation knowledge generated by this project, Movember partnerships will be more likely to be successful and to grow. Additionally, the CPCC is similarly interested in expanding the reach of this implementation of SDM and wants to incorporate findings from this study to promote effective use of SDM through its channels.
MeSH Terms:
  • African Americans
  • California
  • Comparative Effectiveness Research
  • Decision Making
  • Foundations
  • Geography
  • Humans
  • Male
  • Outcome Assessment, Health Care /*organization & administration
  • Patient Reported Outcome Measures
  • Patient Satisfaction
  • Patient-Centered Care /*organization & administration
  • Postoperative Complications
  • Program Development
  • Prostatic Neoplasms /radiotherapy
  • /surgery /*therapy
  • Research Support as Topic
  • Tennessee
  • United States
  • Watchful Waiting
  • Workflow
Country: United States
State: California
Zip Code: 90095
UI: 20191563
Project Status: Ongoing