Clinical trial NCT06199986: DeADT - Living Well with Prostate Cancer
Official title: De-implementation of Low Value Castration for Men with Prostate Cancer - Living Well with Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Veterans
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: National Cancer Institute (NCI)
First posted: 2024-01-10
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot randomized 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 Ann Arbor 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 baseline and 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 will be matched with up to 8 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 pilot sites including reach, penetration, and feasibility at site and clinic levels.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Providers opting out of study

Primary outcomes:
measure: Effectiveness - Interruption in low value ADT injection (i.e., take a break from ADT)
timeFrame: Within 6 months of intervention
Secondary outcomes:
measure: Reach
timeFrame: Within 6 months of intervention
measure: Penetration - ADT Order Check Attestation (OR) Intervention
timeFrame: Within 6 months of intervention
measure: Feasibility - Site level: Medical Center Director (MCD) Approval
timeFrame: Within 1 month of request to participate being sent
measure: Feasibility - Site level: Fully Operationalized Intervention
timeFrame: Within 6 months of approval by MCD
measure: Feasibility - Clinic level: Clinics with Intervention Implementation
timeFrame: Within 6 months of intervention implementation
measure: Penetration - Provider Script (SC) Intervention
timeFrame: Within 6 months of intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System/University of Michigan
name: Sameer D Saini, MD
role: PRINCIPAL_INVESTIGATOR
References: