DeADT - Living Well With Prostate Cancer (DeADT-LW)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: ADT Order Check Attestation (Or); Behavioral: Provider Script (Sc)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Providers opting out of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: ADT Order Check Attestation (Or); Clinical reminder order check in electronic health record
Experimental: 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.	Behavioral: Provider Script (Sc); Provider script added to progress note in electronic health record
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness - Interruption in Low Value ADT Injection (i.e., Take a Break From ADT)	The proportion of patients receiving ADT whose prescribed ADT injections were interrupted, as shown by count of patients whose injections were interrupted.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	The percentage of provider participants who have prescribed ADT before, were asked to participate in the study, and did not opt out of the study.	6 months
Penetration - ADT Order Check Attestation (OR) Intervention	Proportion of OR interventions where the provider participant did not override the order check and prescribe ADT. These providers received the education session about the order checks in the study. However, because of technological problems, the order check did not activate within the 6-month study period.	6 months
Penetration - Provider Script (SC) Intervention	The total number of SC intervention notes assigned to participant providers by the study team that were actually signed by the providers.	6 months
Feasibility - Site Level: Medical Center Director (MCD) Approval	The percentage of sites (i.e., medical centers) asked to participate that received MCD approval to implement the intervention (Order Check or Progress Note/Patient Handout). Each site has only one MCD.	Within 1 month of request to participate being sent
Feasibility - Site Level: Fully Operationalized Intervention	The percentage of approved sites with fully operationalized intervention, i.e. intervention programmed into site EHR and ready to be implemented. Depending on randomization arm, this included either health factor placement or script assignment prior to at least one patient visit.	6 months
Feasibility - Clinic Level Activation: Clinics With Intervention Implementation	The percentage of approved sites with at least 1 intervention implemented, i.e. at least 1 health factor assigned and/or at least 1 progress note assigned to a provider participant.	Within 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Cancer Institute (NCI); US Department of Veterans Affairs
• Investigators: Principal Investigator: Sameer D Saini, MD, VA Ann Arbor Healthcare System/University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): April 16, 2024
• Study Completion (Actual): April 16, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Veterans; Prostate Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 1656029; R37CA222885 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Members of the scientific community who would like a copy of the de-identified final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at jennifer.burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Final data sets will be copied onto an encrypted CD. The CD will be sent to the requestor via FedEx.
• IPD Sharing Time Frame: Data will be available once RCT is complete and up to 6 years after the end of the fiscal year in which the project is terminated.
• IPD Sharing Access Criteria: Members of the scientific community who would like a copy of the de-identified final data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing Jennifer Burns at jennifer.burns@va.gov. They should state their reason for requesting the data and their plans for analyzing the data. Final data sets will be copied onto an encrypted CD. The CD will be sent to the requestor via FedEx.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No