DeADT - Living Well With Prostate Cancer

NCT ID: NCT06199986

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2024-04-16

Brief Summary

The goal of this randomized de-implementation trial is to compare two strategies to reduce low-value androgen deprivation therapy (ADT) use for prostate cancer care. The aim of the study is to compare implementation of the two strategies: use of a clinical reminder order check intervention versus a provider script/patient education approach, and their impacts on low-value ADT use after six months. The main goal of both interventions will be to decrease ADT overuse for patients with prostate cancer, but to do this in a way that is acceptable to the clinicians who treat these patients. The interventions will be initiated for providers only across 4 participating facilities. Provider participants will engage with one of the interventions triggered in the electronic health record when their patients are deemed likely to be receiving low-value ADT. Each provider participant receives only one of the interventions. The intervention is triggered for every clinic visit involving a patient deemed to be receiving low-value ADT, so provider participants may receive their assigned intervention multiple times. Researchers will compare provider use of both strategies to determine implementation outcomes and whether one was more effective in reducing low-value ADT use.

Detailed Description

Project Background:

Prostate cancer is a leading male cancer. One in three men with prostate cancer is chemically castrated at some point with long-acting injectable drugs (i.e., androgen deprivation therapy or ADT). 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 and overuse. A growing awareness of castration harms (e.g., heart attack, osteoporosis, loss of sexual function) also creates patient safety concerns. Despite this, ADT use in low-value cases, such as for localized prostate cancer treatment and biochemical recurrence in non-metastatic disease persists.

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. For example, stopping low-value chemical castration overuse could prevent harm, limit spending, and maintain survival. However, provider preferences regarding de-implementation are not well understood, and possible de-implementation interventions range from blunt formulary restriction policies to shared decision-making. Blunt policy interventions such as formulary restriction of ADT (e.g., pre-authorization, order templates) might seem warranted given patient safety concerns, yet could result in significant provider resistance and work-arounds if introduced poorly. More nuanced, patient-centered interventions such as shared decision-making (e.g., decision aid, talking points) likely involve extra clinical time. 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.

Project Objectives:

This study will compare two different de-implementation strategies that vary in delivery, impact, and expected results for reducing low-value ADT use.

Research Plan/Methods:

Compare two tailored de-implementation strategies to reduce chemical castration as localized prostate cancer treatment and treatment for non-metastatic biochemical recurrence with low PSA levels.

The specific aim is to evaluate the implementation of an ADT order check (Or) versus a provider script (Sc) on decreased low-value ADT use after six months.

The study team will recruit Site Champions (e.g., Urology Chiefs) at each of the participating sites (i.e., medical centers). All clinicians who prescribe ADT at participating sites will be eligible to receive the interventions. Ann Arbor team members will send clinicians an email with an attached Research Information Sheet providing an opportunity to opt out of participation. Opting out means that they will not be asked to participate in surveys or other approaches to measuring provider responses and the interventions will not be triggered for any of their patients or clinic visits.

No other inclusion or exclusion criteria will be applied. No patients will be recruited for this study; however, identifiable data will be collected from national VA CDW, Central Cancer Registry, and Vital Status data, and chart reviews will be conducted using CPRS/Capri/JLV/ WebVRAM, to identify target clinic visits and assess outcomes. Identifiers will be stripped as early as possible, once analytic data sets are created.

Implementation outcomes will be collected from VA CDW/Cancer Registry/Vital Status records and CPRS/Capri/JLV/WebVRAM for all clinic visits documented as providing low-value ADT at 6 months. An anonymous clinic assessment survey will be administered to Site Champions at baseline and an ADT provider assessment will be administered to participating site providers at baseline and 1-month post-intervention through VA Qualtrics.

Outcomes Analyses

Primary analyses: Comparing the effectiveness of two de-implementation strategies, Or and Sc, on low-value ADT use after six months. The primary outcome is interruption of ADT injections, evaluated through a combination of chart reviews and informatics data generated through the ordering process. The intervention sites were matched with 4 control sites acting as contemporary controls for ADT overuse and effectiveness outcomes.

Secondary outcomes: The secondary outcomes focus on implementation of the strategies and interventions across sites including reach, penetration, and feasibility at site and clinic levels.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADT Order Check Attestation (Or)

Study staff will place a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team have confirmed to be targets for ADT de-implementation. Health factors will be entered as eligible clinic visits are identified. This health factor combined with a low PSA level (most recent PSA \< 2) will trigger the ADT Order Check Attestation Intervention (Or) when the provider participant places an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants may override the order check by entering text indicating the reason and continue with the ordering process.

Group Type: EXPERIMENTAL

ADT Order Check Attestation (Or)

Intervention Type: BEHAVIORAL

Clinical reminder order check in electronic health record

Provider Script (Sc)

Study staff will enter an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note will include scripted talking points for the provider participant to help with discussion and recent PSA levels and can be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note will prompt provider participants to indicate whether a patient prefers to continue or discontinue ADT. The progress note will include links to a patient-facing clinic handout which will be posted on an external website. Provider participants may modify, ignore, or delete the progress note.

Group Type: EXPERIMENTAL

Provider Script (Sc)

Intervention Type: BEHAVIORAL

Provider script added to progress note in electronic health record

Control

The study team will match up to 8 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions have been deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period will be ascertained through chart review and compared to intervention site primary outcomes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ADT Order Check Attestation (Or)

Clinical reminder order check in electronic health record

Intervention Type: BEHAVIORAL

Provider Script (Sc)

Provider script added to progress note in electronic health record

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

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Sameer D. Saini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameer D Saini, MD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System/University of Michigan

Locations

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1656029

Identifier Type: -

Identifier Source: org_study_id

R37CA222885

Identifier Type: NIH

Identifier Source: secondary_id

View Link