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

NCT ID: NCT03579680

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2023-04-06

Brief 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.

Detailed 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.

Conditions

Cancer of Prostate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

ADT ORDER CHECK ATTESTATION (OR)

Experimental: ADT ORDER CHECK ATTESTATION (OR) Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but have a strong evidence-base for changing provider behavior. Study staff will place a "health factor" structured data element in the EMR of patients whose clinic visits study staff have confirmed to be targets for ADT de-implementation. This health factor combined with a low PSA level will trigger the ADT Order Check Attestation Intervention (Or) when the provider places an order for ADT.

Group Type: EXPERIMENTAL

ADT ORDER CHECK ATTESTATION (OR)

Intervention Type: BEHAVIORAL

Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but have a strong evidence-base for changing provider behavior.

PROVIDER SCRIPT (SC)

Experimental: PROVIDER SCRIPT (SC) The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior. Study staff will enter a pre-populated CPRS EMR progress note 1 business day prior to a target clinic visit. The note includes talking points for the provider to help with a discussion. It can be edited and cosigned by the provider, giving a quick and simple way to document the discussion. The progress note template asks providers to indicate whether patient prefers to continue or discontinue low-value ADT. Appropriate documentation of the decision will be tracked for fidelity. We will also have a patient handout entitled: "Living well with prostate cancer: Is hormone therapy still right for you?" as a patient engagement and information resource.

Group Type: EXPERIMENTAL

PROVIDER SCRIPT (SC)

Intervention Type: BEHAVIORAL

The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior.

Interventions

ADT ORDER CHECK ATTESTATION (OR)

Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but have a strong evidence-base for changing provider behavior.

Intervention Type: BEHAVIORAL

PROVIDER SCRIPT (SC)

The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Providers opting out of study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Ted Skolarus

Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ted Skolarus, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan/Department of Veterans Affairs

Locations

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Countries

United States

References

Skolarus TA, Hawley ST, Forman J, Sales AE, Sparks JB, Metreger T, Burns J, Caram MV, Radhakrishnan A, Dossett LA, Makarov DV, Leppert JT, Shelton JB, Stensland KD, Dunsmore J, Maclennan S, Saini S, Hollenbeck BK, Shahinian V, Wittmann DA, Deolankar V, Sriram S. Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies. Implement Sci Commun. 2024 Apr 9;5(1):37. doi: 10.1186/s43058-024-00576-x.

Reference Type: DERIVED

PMID: 38594740 (View on PubMed)

Skolarus TA, Forman J, Sparks JB, Metreger T, Hawley ST, Caram MV, Dossett L, Paniagua-Cruz A, Makarov DV, Leppert JT, Shelton JB, Stensland KD, Hollenbeck BK, Shahinian V, Sales AE, Wittmann DA. Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer. Implement Sci Commun. 2021 Oct 28;2(1):124. doi: 10.1186/s43058-021-00224-8.

Reference Type: DERIVED

PMID: 34711274 (View on PubMed)

Skolarus TA, Hawley ST, Wittmann DA, Forman J, Metreger T, Sparks JB, Zhu K, Caram MEV, Hollenbeck BK, Makarov DV, Leppert JT, Shelton JB, Shahinian V, Srinivasaraghavan S, Sales AE. 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). Implement Sci. 2018 Nov 29;13(1):144. doi: 10.1186/s13012-018-0833-7.

Reference Type: DERIVED

PMID: 30486836 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R37CA222885-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00133932-1

Identifier Type: -

Identifier Source: org_study_id