DeADT - Living Well With Prostate Cancer

NCT06199986 | Completed Results

• 2 other identifiers: 1656029R37CA222885
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Veterans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Reach

  6 months

• Penetration - ADT Order Check Attestation (OR) Intervention

  6 months

• Penetration - Provider Script (SC) Intervention

  6 months

• Feasibility - Site Level: Medical Center Director (MCD) Approval

  Within 1 month of request to participate being sent

• Feasibility - Site Level: Fully Operationalized Intervention

  6 months

Study Arms (3)

ADT Order Check Attestation (Or)

EXPERIMENTAL

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)

Provider Script (Sc)

EXPERIMENTAL

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)

Control

NO INTERVENTION

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.

Interventions

ADT Order Check Attestation (Or) BEHAVIORAL

Clinical reminder order check in electronic health record

ADT Order Check Attestation (Or)

Provider Script (Sc) BEHAVIORAL

Provider script added to progress note in electronic health record

Provider Script (Sc)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Providers opting out of study

Sponsors & Collaborators

• University of Michigan: lead
• US Department of Veterans Affairs: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Ted Skolarus
• Organization: University of Chicago

tskolarus@bsd.uchicago.edu

773 702-0881

Study Officials

• Sameer D Saini, MD

  VA Ann Arbor Healthcare System/University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 10, 2024
• Study Start: October 4, 2022
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)