Dataset Information

De-implementation of low value castration for men with prostate cancer: protocol for a theory-based, mixed methods approach to minimizing low value androgen deprivation therapy (DeADT).

ABSTRACT: BACKGROUND:Men with prostate cancer are often castrated with long-acting injectable drugs termed androgen deprivation therapy (ADT). Although many benefit, ADT is also used in patients with little or nothing to gain. The best ways to stop this practice are unknown, and range from blunt pharmacy restrictions to informed decision-making. This study will refine and pilot two different de-implementation strategies for reducing ADT use among those unlikely to benefit in preparation for a comparative effectiveness trial. METHODS/DESIGN:This innovative mixed methods research program has three aims. Aim 1: To assess preferences and barriers for de-implementation of chemical castration in prostate cancer. Guided by the theoretical domains framework (TDF), urologists and patients from facilities with the highest and lowest castration rates across the VA will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment. This qualitative work will inform Aim 2 while gathering rich information for two proposed pilot intervention strategies. Aim 2: To use a discrete choice experiment (DCE), a novel barrier prioritization approach, for de-implementation strategy tailoring. The investigators will conduct national surveys of urologists to prioritize key barriers identified in Aim 1 for stopping incident castration as localized prostate cancer treatment using a DCE experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot de-implementation strategies in preparation for Aim 3 piloting. Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction at the organizational level and the other on physician/patient informed decision-making at different facilities. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies. DISCUSSION:Our innovative approach to de-implementation strategy development is directly aligned with state-of-the-art complex implementation intervention development and implementation science. This work will broadly advance de-implementation science for low value cancer care, and foster participation in our de-implementation evaluation trial by addressing barriers, facilitators, and concerns through pilot tailoring. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03579680 , First Posted July 6, 2018.

SUBMITTER: Skolarus TA

PROVIDER: S-EPMC6262964 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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De-implementation of low value castration for men with prostate cancer: protocol for a theory-based, mixed methods approach to minimizing low value androgen deprivation therapy (DeADT).

Skolarus Ted A TA Hawley Sarah T ST Wittmann Daniela A DA Forman Jane J Metreger Tabitha T Sparks Jordan B JB Zhu Kevin K Caram Megan E V MEV Hollenbeck Brent K BK Makarov Danil V DV Leppert John T JT Shelton Jeremy B JB Shahinian Vahakn V Srinivasaraghavan Sriram S Sales Anne E AE

Implementation science : IS 20181129 1

<h4>Background</h4>Men with prostate cancer are often castrated with long-acting injectable drugs termed androgen deprivation therapy (ADT). Although many benefit, ADT is also used in patients with little or nothing to gain. The best ways to stop this practice are unknown, and range from blunt pharmacy restrictions to informed decision-making. This study will refine and pilot two different de-implementation strategies for reducing ADT use among those unlikely to benefit in preparation for a comp ...[more]

PMID: 30486836

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Project description:BackgroundMany men with prostate cancer will be exposed to androgen deprivation therapy (ADT). While evidence-based ADT use is common, ADT is also used in cases with no or limited evidence resulting in more harm than benefit, i.e., overuse. Since there are risks of ADT (e.g., diabetes, osteoporosis), it is important to understand the behaviors facilitating overuse to inform de-implementation strategies. For these reasons, we conducted a theory-informed survey study, including a discrete choice experiment (DCE), to better understand ADT overuse and provider preferences for mitigating overuse.MethodsOur survey used the Action, Actor, Context, Target, Time (AACTT) framework, the Theoretical Domains Framework (TDF), the Capability, Opportunity, Motivation-Behavior (COM-B) Model, and a DCE to elicit provider de-implementation strategy preferences. We surveyed the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on the likelihood of stopping overuse as ADT monotherapy for localized prostate cancer ("yes"/"probably yes," "probably no"/"no"), and characterized corresponding Likert scale responses to seven COM-B statements. We used multivariable regression to identify associations between stopping ADT overuse and COM-B responses.ResultsOur survey was completed by 84 respondents (13% response rate), with 27% indicating "probably no"/"no" to stopping ADT overuse. We found differences across respondents who said they would and would not stop ADT overuse in demographics and COM-B statements. Our model identified 2 COM-B domains (Opportunity-Social, Motivation-Reflective) significantly associated with a lower likelihood of stopping ADT overuse. Our DCE demonstrated in-person communication, multidisciplinary review, and medical record documentation may be effective in reducing ADT overuse.ConclusionsOur study used a behavioral theory-informed survey, including a DCE, to identify behaviors and context underpinning ADT overuse. Specifying behaviors supporting and gathering provider preferences in addressing ADT overuse requires a stepwise, stakeholder-engaged approach to support evidence-based cancer care. From this work, we are pursuing targeted improvement strategies.Trial registrationClinicalTrials.gov, NCT03579680.

Project description:ObjectivesThe objective of the study is to compare the efficacy and safety of alternative androgen therapy (AAT) with enzalutamide + androgen deprivation therapy (ADT) and flutamide + ADT in the treatment of Japanese men with metastatic or nonmetastatic castration-resistant prostate cancer (CRPC) who progressed despite combined androgen blockade (CAB) with bicalutamide + ADT. AAT treatment sequence was also investigated.Materials and methodsThe open-label, Phase 4 AFTERCAB study (NCT02918968) was conducted from November 2016 to March 2020 in Japanese men aged ≥20 years with asymptomatic or mildly symptomatic CRPC. Patients were initially randomized to enzalutamide (160 mg/day) + ADT (enzalutamide first) or flutamide (375mg/day [125mg three times daily]) + ADT (flutamide first) as first-line therapy. Following prostate-specific antigen (PSA) progression, other disease progression, or discontinuation of first-line therapy due to an adverse event (AE), patients switched to the other treatment as second-line therapy. The primary endpoint was time to PSA progression with first-line therapy (TTPP1). Secondary endpoints included TTPP2 (TTPP1 + time to PSA progression with second-line therapy). AEs were monitored to assess safety.ResultsOverall, 206 men were randomized (enzalutamide first, n = 102; flutamide first, n = 104) and stratified by study site and disease stage; 133 patients transitioned to second-line therapy (enzalutamide first, n = 48; flutamide first, n = 85). TTPP1 was significantly improved with enzalutamide first versus flutamide first (median 21.4 months vs. 5.8 months; hazard ratio [HR] 0.42; 95% confidence interval [CI] [0.29, 0.61]). TTPP2 was numerically improved with enzalutamide first versus flutamide first (median not reached vs. 21.2 months; HR 0.76; 95% CI [0.48, 1.19]). Both treatments were generally well tolerated, with AEs consistent with their known safety profiles.ConclusionFirst-line AAT with enzalutamide + ADT provided a significant improvement in time to PSA progression versus flutamide + ADT. Enzalutamide + ADT may therefore be the preferred first-line AAT option in Japanese men with metastatic or nonmetastatic CRPC who progress despite CAB with bicalutamide + ADT.

Project description:BackgroundThe use of low-value care (LVC) is a persistent problem that calls for knowledge about strategies for de-implementation. However, studies are dispersed across many clinical fields, and there is no overview of strategies that can be used to support the de-implementation of LVC. The extent to which strategies used for implementation are also used in de-implementing LVC is unknown. The aim of this scoping review is to (1) identify strategies for the de-implementation of LVC described in the scientific literature and (2) compare de-implementation strategies to implementation strategies as specified in the Expert Recommendation for Implementing Change (ERIC) and strategies added by Perry et al. METHOD: A scoping review was conducted according to recommendations outlined by Arksey and O'Malley. Four scientific databases were searched, relevant articles were snowball searched, and the journal Implementation Science was searched manually for peer-reviewed journal articles in English. Articles were included if they were empirical studies of strategies designed to reduce the use of LVC. Two reviewers conducted all abstract and full-text reviews, and conflicting decisions were discussed until consensus was reached. Data were charted using a piloted data-charting form. The strategies were first coded inductively and then mapped onto the ERIC compilation of implementation strategies.ResultsThe scoping review identified a total of 71 unique de-implementation strategies described in the literature. Of these, 62 strategies could be mapped onto ERIC strategies, and four strategies onto one added category. Half (50%) of the 73 ERIC implementation strategies were used for de-implementation purposes. Five identified de-implementation strategies could not be mapped onto any of the existing strategies in ERIC.ConclusionsSimilar strategies are used for de-implementation and implementation. However, only a half of the implementation strategies included in the ERIC compilation were represented in the de-implementation studies, which may imply that some strategies are being underused or that they are not applicable for de-implementation purposes. The strategies assess and redesign workflow (a strategy previously suggested to be added to ERIC), accountability tool, and communication tool (unique new strategies for de-implementation) could complement the existing ERIC compilation when used for de-implementation purposes.

Project description:Background/aimsConsiderable efforts have been made to improve guideline adherence in healthcare through de-implementation, such as decreasing the prescription of inappropriate medicines. However, we have limited knowledge about the effectiveness, barriers, facilitators and consequences of de-implementation strategies targeting inappropriate medication prescribing in secondary care settings. This review was conducted to understand these factors to contribute to better replication and optimisation of future de-implementation efforts to reduce low-value care.MethodsA systematic review of randomised control trials was conducted. Papers were identified through CINAHL, EMBASE, MEDLINE and Cochrane register of controlled trials to February 2021. Eligible studies were randomised control trials evaluating behavioural strategies to de-implement inappropriate prescribing in secondary healthcare. Risk of bias was assessed using the Cochrane Risk of Bias tool. Intervention characteristics, effectiveness, barriers, facilitators and consequences were identified in the study text and tabulated.ResultsEleven studies were included, of which seven were reported as effectively de-implementing low-value prescribing. Included studies were judged to be mainly at low to moderate risk for selection biases and generally high risk for performance and reporting biases. The majority of these strategies were clinical decision support at the 'point of care'. Clinical decision support tools were the most common and effective. They were found to be a low-cost and simple strategy. However, barriers such as clinician's reluctance to accept recommendations, or the clinical setting were potential barriers to their success. Educational strategies were the second most reported intervention type however the utility of educational strategies for de-implementation remains varied. Multiple barriers and facilitators relating to the environmental context, resources and knowledge were identified across studies as potentially influencing de-implementation. Various consequences were identified; however, few measured the impact of de-implementation on usual appropriate practice.ConclusionThis review offers insight into the intervention strategies, potential barriers, facilitators and consequences that may affect the de-implementation of low-value prescribing in secondary care. Identification of these key features helps understand how and why these strategies are effective and the wider (desirable or undesirable) impact of de-implementation. These findings can contribute to the successful replication or optimisation of strategies used to de-implement low-value prescribing practices in future.Trial registrationThe review protocol was registered at PROSPERO (ID: CRD42021243944).

Dataset Information

De-implementation of low value castration for men with prostate cancer: protocol for a theory-based, mixed methods approach to minimizing low value androgen deprivation therapy (DeADT).

Publications

De-implementation of low value castration for men with prostate cancer: protocol for a theory-based, mixed methods approach to minimizing low value androgen deprivation therapy (DeADT).

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