Prostate Cancer Clinical Trial

De-implementation of Low Value Castration for Men With Prostate Cancer

Summary

This study will use a theory-based, mixed methods approach to identify, tailor and pilot two different de-implementation strategies that vary widely in delivery, impact, and expected results for reducing low value androgen deprivation therapy (ADT) use in preparation for a randomized comparative effectiveness trial comparing two tailored deimplementation strategies to reduce chemical castration as localized prostate cancer treatment and treatment for non-metastatic biochemical recurrence with low PSA levels.

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Full Description

Prostate cancer is the leading cancer among Veterans. One in three Veterans with prostate cancer is chemically castrated at some point with long-acting injectable drugs (i.e., androgen deprivation therapy, or ADT). This impacts the well-being of thousands of Veterans annually. Although some patients benefit in terms of survival and symptom improvement, chemical castration with ADT is also commonly performed when there are little to no health benefits to patients raising questions of low value care. A growing awareness of castration harms (e.g., heart attack, osteoporosis, loss of sexual function) creates patient safety concerns. Despite this, ADT use in low value cases, such as for localized prostate cancer treatment, persists in the Veterans Health Administration (VHA) with five-fold variation across its facilities. Ineffective and harmful practices such as chemical castration of prostate cancer patients with ADT outside of the evidence base are ideal targets for de-implementation. De-implementation, or stopping low value practices, has the potential to improve patient outcomes and decrease healthcare costs. However, provider preferences regarding de-implementation are not well understood, and possible de-implementation interventions range from blunt formulary restriction policies to informed decision-making. Both intervention strategies need tailoring based on provider input for acceptability and feasibility in clinical practice, including piloting prior to trialing. As many medical practices lack evidence and cause harm, robust, behavioral theory-based methods for incorporating provider preferences into de-implementation strategy development will advance both implementation research and practice.

This study will use a theory-based, mixed methods approach to identify, tailor and pilot two different de-implementation strategies that vary widely in delivery, impact, and expected results for reducing low value ADT use, in preparation for a randomized comparative effectiveness trial.

This innovative mixed-methods research program has three aims, of which Aim 3 is represented in this registration.

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 VHA will be interviewed to identify key preferences and deimplementation 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 deimplementation strategy tailoring. The investigators will conduct national surveys of US Government urologists to prioritize key barriers identified in Aim

1 for stopping incident castration as localized prostate cancer treatment using a discrete choice experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot deimplementation strategies in preparation for Aim 3 piloting.

Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment and treatment for non-metastatic biochemical recurrence with low PSA levels. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction/ order check attestation at the organizational level and the other on physician/ patient informed decision-making at different facilities. Pilot outcomes will include feasibility at the site level, feasibility at the clinic level, reach, and penetration in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies. This innovative approach to de-implementation strategy development will transform how and why castration is performed for localized prostate cancer and nonmetastatic biochemical recurrence with low PSA levels through combining provider and patient preferences and strategy tailoring. This work will advance de-implementation science for low value care and foster participation in a subsequent de-implementation evaluation trial by addressing barriers, facilitators and concerns through pilot tailoring.

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Eligibility Criteria

Inclusion Criteria:

- Any provider at participating sites who prescribes ADT for prostate cancer patients

Exclusion Criteria:

- Providers opting out of study

Study is for people with:

Prostate Cancer

Estimated Enrollment:

200

Study ID:

NCT03579680

Recruitment Status:

Active, not recruiting

Sponsor:

University of Michigan

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There is 1 Location for this study

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VA Ann Arbor Healthcare System
Ann Arbor Michigan, 48105, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

200

Study ID:

NCT03579680

Recruitment Status:

Active, not recruiting

Sponsor:


University of Michigan

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