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Implementation of a patient decision aid for men with localized prostate cancer: evaluation of patient outcomes and practice variation.

ABSTRACT: Men with localized prostate cancer often have unrealistic expectations. Practitioners are poor judges of men's preferences, contributing to preference misdiagnosis and unwarranted practice variation. Patient decision aids (PtDAs) can support men with decisions about localized prostate cancer. This is a comparative case study of two strategies for implementing PtDAs in clinical pathways for men with localized prostate cancer, evaluating (a) PtDA use; (b) impact on men, practitioners, and health system outcomes; and (c) factors influencing sustained use.Guided by the Knowledge to Action Framework, this comparative case study will be conducted using administrative data, interviews, and surveys. Cases will be bound by geographic location (one hospital in Ontario; province of Saskatchewan) and time. Eligible participants will be all men newly diagnosed with localized prostate cancer, with outcomes assessed using administrative data and interviews. Nurses, urologists, radiation oncologists, and managers will be surveyed and a smaller sample interviewed. Cases will be established for each setting with findings compared across cases. Changes in the proportions of men given the PtDA over 2 years will be determined from administrative data. Factors associated with receiving the PtDA will be explored using multivariable logistic regression analysis. To assess the impact of the PtDA, outcomes will be described using mean and standard deviation (men's decisional conflict) and frequency and proportions (practitioners consulted, uptake of treatment). To estimate the effect of the PtDA on these outcomes, adjusted mean differences and odds ratios will be calculated using exploratory multivariable general linear regression and binary or multinomial logistic regression. Factors influencing sustained PtDA use will be assessed using descriptive analysis of survey findings and thematic analysis of interview transcripts.Determining how to embed PtDAs effectively within clinical pathways for men with localized prostate cancer is essential. PtDAs have the potential to strengthen men's active role in making prostate cancer decisions, enhance uptake of shared decision-making by practitioners, and reduce practice variation. Our team of researchers and knowledge users will use findings to improve current PtDA use and consider scaling-up implementation.

SUBMITTER: Stacey D

PROVIDER: S-EPMC4930601 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Implementation of a patient decision aid for men with localized prostate cancer: evaluation of patient outcomes and practice variation.

Stacey Dawn D Taljaard Monica M Smylie Jennifer J Boland Laura L Breau Rodney H RH Carley Meg M Jana Kunal K Peckford Larry L Blackmore Terry T Waldie Marian M Wu Robert Chi RC Legare France F

Implementation science : IS 20160702 1

<h4>Background</h4>Men with localized prostate cancer often have unrealistic expectations. Practitioners are poor judges of men's preferences, contributing to preference misdiagnosis and unwarranted practice variation. Patient decision aids (PtDAs) can support men with decisions about localized prostate cancer. This is a comparative case study of two strategies for implementing PtDAs in clinical pathways for men with localized prostate cancer, evaluating (a) PtDA use; (b) impact on men, practiti ...[more]

PMID: 27368830

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Project description:OBJECTIVE:The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. METHODS:A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. RESULTS:A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. CONCLUSION:The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.

Project description:BackgroundThe American Urological Association White Paper on Implementation of Shared Decision Making (SDM) into Urological Practice suggested SDM represents the state of the art in counseling for patients who are faced with difficult or uncertain medical decisions. The Michigan Urological Surgery Improvement Collaborative (MUSIC) implemented a decision aid, Personal Patient Profile-Prostate (P3P), in 2018 to help newly diagnosed prostate cancer patients make shared decisions with their clinicians. We conducted a qualitative study to assess statewide implementation of P3P throughout MUSIC.MethodsWe recruited urologists and staff from 17 MUSIC practices (8 implementation and 9 comparator practices) to understand how practices engaged patients on treatment discussions and to assess facilitators and barriers to implementing P3P. Interview guides were developed based on the Tailored Interventions for Chronic Disease (TICD) Framework. Interviews were transcribed for analysis and coded independently by two investigators in NVivo, PRO 12. Additionally, quantitative program data were integrated into thematic analyses.ResultsWe interviewed 15 urologists and 11 staff from 16 practices. Thematic analysis of interview transcripts indicated three key themes including the following: (i) P3P is compatible as a SDM tool as over 80% of implementation urologists asked patients to complete the P3P questionnaire routinely and used P3P reports during treatment discussions; (ii) patient receptivity was demonstrated by 370 (50%) of newly diagnosed patients (n = 737) from 8 practices enrolled in P3P with 78% completion rate, which accounts for 39% of all newly diagnosed patients in these practices; and (iii) urologists' attitudes towards SDM varied. Over a third of urologists stated they did not rely on a decision aid. Comparator practices indicated habit, inertia, or concerns about clinic flow as reasons for not adopting P3P and some were unconvinced a decision aid is needed in their practice.ConclusionUrologists and staff affiliated with MUSIC implementation sites indicated that P3P focuses the treatment discussion on items that are important to patients. Experiences of implementation practices indicate that once initiated, there were no negative effects on clinic flow and urologists indicated P3P saves time during patient counseling, as patients were better prepared for focused discussions. Lack of awareness, personal habits, and inertia are reasons for not implementing P3P among the comparator practices.

Project description:IntroductionMen diagnosed with localized prostate cancer must navigate a highly preference-sensitive decision between treatment options with varying adverse outcome profiles. We evaluated whether use of a decision support tool previously shown to decrease decisional conflict also impacted the secondary outcome of post-treatment decision regret.MethodsParticipants were randomized to receive personalized decision support via the Personal Patient Profile-Prostate or usual care prior to a final treatment decision. Symptoms were measured just before randomization and 6 months later; decision regret was measured at 6 months along with records review to ascertain treatment choices. Regression modeling explored associations between baseline variables including race and D`Amico risk, study group, and 6-month variables regret, choice, and symptoms.ResultsAt 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201 of 257 (78%) completely answered the regret scale. Regret was not significantly different between participants randomized to the P3P intervention compared to the control group (P = 0.360). In univariate analyses, we found that Black men, men with hormonal symptoms, and men with bowel symptoms reported significantly higher decision regret (all P < 0.01). Significant interactions were detected between race and study group (intervention vs. usual care) in the multivariable model; use of the Personal Patient Profile-Prostate was associated with significantly decreased decisional regret among Black men (P = 0.037). Interactions between regret, symptoms and treatment revealed that (1) men choosing definitive treatment and reporting no hormonal symptoms reported lower regret compared to all others; and (2) men choosing active surveillance and reporting bowel symptoms had higher regret compared to all others.ConclusionThe Personal Patient Profile-Prostate decision support tool may be most beneficial in minimizing decisional regret for Black men considering treatment options for newly-diagnosed prostate cancer.Trial registrationNCT01844999.

Project description:BackgroundRelatively little is known about the relationship between race/ethnicity and patient-reported outcomes after contemporary treatments for localized prostate cancer.ObjectiveTo test the hypothesis that treatment-related changes in urinary, bowel, sexual, and hormonal function vary by race/ethnicity.Design, setting, and participantsThe Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study that enrolled 3708 men diagnosed with localized prostate cancer in 2011-2012.Outcome measurements and statistical analysisPatient-reported disease-specific function was measured using the 26-item Expanded Prostate Index Composite (EPIC) at baseline and 6 and 12 mo after enrollment. Mean treatment differences in function were compared by race using risk-adjusted generalized estimating equations.Results and limitationsWhile all race/ethnic groups reported considerable declines in scores for urinary incontinence after radical prostatectomy (RP) when compared to active surveillance, African-American men reported a greater difference than white men did (adjusted difference-in-differences 8.4 points, 95% confidence interval 2.0-14.8; p=0.01). No difference in bother scores was noted and the overall proportion of explained variation attributable to race/ethnicity was relatively small in comparison to primary treatment and baseline function. No clinically significant racial variation was noted for the sexual, bowel, irritative voiding, or hormone domains. Limitations include the lack of well-established thresholds for clinical significance using the EPIC instrument.ConclusionWhile these data demonstrate that incontinence at 1 yr after RP may be worse for African-American compared to white men, the difference appears to be modest overall. Treatment selection and baseline function explain a much greater proportion of the variation in function after treatment.Patient summaryWe observed that the effect of treatment for prostate cancer on patient-reported function did not vary dramatically by race/ethnicity. Compared to white men, African-American men experienced a somewhat more pronounced decline in urinary continence after radical prostatectomy, but the corresponding changes in bother scores were not significantly different between the two groups.

Project description:BackgroundMaking evidence-based decisions often requires comparison of two or more options. Research-based evidence may exist which quantifies how likely the outcomes are for each option. Understanding these numeric estimates improves patients' risk perception and leads to better informed decision making. This paper summarises current "best practices" in communication of evidence-based numeric outcomes for developers of patient decision aids (PtDAs) and other health communication tools.MethodAn expert consensus group of fourteen researchers from North America, Europe, and Australasia identified eleven main issues in risk communication. Two experts for each issue wrote a "state of the art" summary of best evidence, drawing on the PtDA, health, psychological, and broader scientific literature. In addition, commonly used terms were defined and a set of guiding principles and key messages derived from the results.ResultsThe eleven key components of risk communication were: 1) Presenting the chance an event will occur; 2) Presenting changes in numeric outcomes; 3) Outcome estimates for test and screening decisions; 4) Numeric estimates in context and with evaluative labels; 5) Conveying uncertainty; 6) Visual formats; 7) Tailoring estimates; 8) Formats for understanding outcomes over time; 9) Narrative methods for conveying the chance of an event; 10) Important skills for understanding numerical estimates; and 11) Interactive web-based formats. Guiding principles from the evidence summaries advise that risk communication formats should reflect the task required of the user, should always define a relevant reference class (i.e., denominator) over time, should aim to use a consistent format throughout documents, should avoid "1 in x" formats and variable denominators, consider the magnitude of numbers used and the possibility of format bias, and should take into account the numeracy and graph literacy of the audience.ConclusionA substantial and rapidly expanding evidence base exists for risk communication. Developers of tools to facilitate evidence-based decision making should apply these principles to improve the quality of risk communication in practice.

Project description:BackgroundColorectal cancer is common in North America. Two surgical options exist for rectal cancer patients: low anterior resection with re-establishment of bowel continuity, and abdominoperineal resection with a permanent stoma. A rectal cancer decision aid was developed using the International Patient Decision Aid Standards to facilitate patients being more actively involved in making this decision with the surgeon. The overall aim of this study is to evaluate this decision aid and explore barriers and facilitators to implementing in clinical practice.MethodsFirst, a pre- and post- study will be guided by the Ottawa Decision Support Framework. Eligible patients from a colorectal cancer center include: 1) adult patients diagnosed with rectal cancer, 2) tumour at a maximum of 10 cm from anal verge, and 3) surgeon screened candidates eligible to consider both low anterior resection and abdominoperineal resection. Patients will be given a paper-version and online link to the decision aid to review at home. Using validated tools, the primary outcomes will be decisional conflict and knowledge of surgical options. Secondary outcomes will be patient's preference, values associated with options, readiness for decision-making, acceptability of the decision aid, and feasibility of its implementation in clinical practice. Proposed analysis includes paired t-test, Wilcoxon, and descriptive statistics. Second, a survey will be conducted to identify the barriers and facilitators of using the decision aid in clinical practice. Eligible participants include Canadian surgeons working with rectal cancer patients. Surgeons will be given a pre-notification, questionnaire, and three reminders. The survey package will include the patient decision aid and a facilitators and barriers survey previously validated among physicians and nurses. Principal component analysis will be performed to determine common themes, and logistic regression will be used to identify variables associated with the intention to use the decision aid.DiscussionThis study will evaluate the impact of the rectal cancer decision aid on patients and help with planning strategies to overcome barriers and facilitate implementation of the decision aid in routine clinical practice. To our knowledge this is the first study designed to evaluate a decision aid in the field of colorectal surgery.

Dataset Information

Implementation of a patient decision aid for men with localized prostate cancer: evaluation of patient outcomes and practice variation.

Publications

Implementation of a patient decision aid for men with localized prostate cancer: evaluation of patient outcomes and practice variation.

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