DeADT - Living Well With Prostate Cancer

Prostate Cancer Clinical Trial

— DeADT-LW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06199986
• Other study ID #: 1656029
• Secondary ID: R37CA222885
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Ted Skolarus
• Phone: (734) 936-0054
• Email: tskolarus[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. Provider participants receive only one intervention. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Providers opting out of study

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• ADT Order Check Attestation (Or)
Clinical reminder order check in electronic health record
• Provider Script (Sc)
Provider script added to progress note in electronic health record

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Measures will be taken at baseline and 6 months.	Within 6 months of intervention
Secondary	Reach	The proportion of provider participants who have prescribed ADT before, were asked to participate in the study, and did not opt out of the study.	Within 6 months of intervention
Secondary	Penetration - Provider Script (SC) Intervention	The total number of SC interventions assigned to providers that were signed, indicating that ADT was not prescribed.	Within 6 months of intervention
Secondary	Penetration - ADT Order Check Attestation (OR) Intervention	Proportion of OR intervention where the provider participant did not override the order check and prescribe ADT.	Within 6 months of intervention
Secondary	Feasibility - Site level: Medical Center Director (MCD) Approval	The percentage of pilot 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
Secondary	Feasibility - Site level: Fully Operationalized Intervention	The percentage of approved pilot sites with fully operationalized intervention, i.e. intervention successfully programmed into site EHR and ready to be implemented.; Depending on randomization arm, this includes either health factor placement or script assignment prior to at least one patient visit.	Within 6 months of approval by MCD
Secondary	Feasibility - Clinic level: Clinics with Intervention Implementation	The percentage of clinics at approved pilot 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. Clinics may include Urology, Medical Oncology, and Radiation Oncology.	Within 6 months of intervention implementation