DeADT: De-implementation of Low Value Castration for Men With Prostate Cancer
Study Details
Study Description
Brief Summary
This study will use a theory-based, mixed methods approach to identify, tailor and pilot two different de-implementation strategies that vary widely in delivery, impact, and expected results for reducing low value androgen deprivation therapy (ADT) use in preparation for a randomized comparative effectiveness trial. As part of our 2-year MERIT extension, we will 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Prostate cancer is the leading cancer among Veterans. One in three Veterans with prostate cancer is chemically castrated at some point with long-acting injectable drugs (i.e., androgen deprivation therapy, or ADT). This impacts the well-being of thousands of Veterans annually. 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. A growing awareness of castration harms (e.g., heart attack, osteoporosis, loss of sexual function) creates patient safety concerns. Despite this, ADT use in low value cases, such as for localized prostate cancer treatment, persists in the Veterans Health Administration (VHA) with five-fold variation across its facilities. 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. However, provider preferences regarding de-implementation are not well understood, and possible de-implementation interventions range from blunt formulary restriction policies to informed decision-making. 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.
This study will use a theory-based, mixed methods approach to identify, tailor and pilot two different de-implementation strategies that vary widely in delivery, impact, and expected results for reducing low value ADT use, in preparation for a randomized comparative effectiveness trial.
This innovative mixed-methods research program has three aims. Aim 1: To assess preferences and barriers for de-implementation of chemical castration in prostate cancer. Guided by the Theoretical Domains Framework (TDF), urologists and patients from facilities with the highest and lowest castration rates across VHA will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment. This qualitative work will inform Aim 2 while gathering rich information for two proposed pilot intervention strategies. Aim 2: To use a discrete choice experiment (DCE), a novel barrier prioritization approach, for de-implementation strategy tailoring. The investigators will conduct national surveys of US Government urologists to prioritize key barriers identified in Aim 1 for stopping incident castration as localized prostate cancer treatment using a discrete choice experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot de-implementation strategies in preparation for Aim 3 piloting. Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment and treatment for non-metastatic biochemical recurrence with low PSA levels. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction/order check attestation at the organizational level and the other on physician/patient informed decision-making at different facilities. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies. This innovative approach to de-implementation strategy development will transform how and why castration is performed for localized prostate cancer and non-metastatic biochemical recurrence with low PSA levels through combining provider and patient preferences and strategy tailoring. This work will advance de-implementation science for low value care and foster participation in a subsequent de-implementation evaluation trial by addressing barriers, facilitators and concerns through pilot tailoring.
The 2-year extension of our 4-year ESI MERIT supports logical progression to a multilevel, comparative effectiveness de-implementation trial to reduce low value ADT across a national delivery system.
Our 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. We will first examine low-value ADT use during 6 months of piloting at 4 VA sites, as well as refine our proposed RE-AIM implementation outcomes and ascertainment, study of moderators (e.g., fidelity) and causal mechanisms underlying implementation interventions. The pilot work will inform the subsequent 20 site de-implementation comparative effectiveness trial by addressing preferences and concerns through pilot tailoring. Based on the pilot work, we will refine our site engagement strategies and study protocol methods and materials for the trial. This work will advance de-implementation science for low value cancer care.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ADT ORDER CHECK ATTESTATION (OR) Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but has a strong evidence-base for changing provider behavior. Study staff will place a "health factor" in the EMR of patients whose clinic visits study staff have confirmed to be targets for ADT de-implementation. This health factor combined with a low PSA level will trigger the ADT Order Check Attestation Intervention (Or) when the provider places an order for ADT. |
Behavioral: ADT ORDER CHECK ATTESTATION (OR)
Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but has a strong evidence-base for changing provider behavior.
|
| Experimental: PROVIDER SCRIPT (SC) The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior. Study staff will enter a pre-populated CPRS progress note 1 business day prior to target clinic visit. The note includes talking points for the provider to help with a discussion with the Veteran. It can be edited and cosigned by the provider, giving a quick and simple way to document the discussion. The progress note template asks providers to indicate whether patient prefers to continue or discontinue ADT. Appropriate use of the indication will be tracked for fidelity. |
Behavioral: PROVIDER SCRIPT (SC)
The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior.
|
Outcome Measures
Primary Outcome Measures
- Provider Interviews [30-45 minutes]
Guided by the Theoretical Domains Framework, urologists from facilities with the highest and lowest castration rates across an integrated delivery system will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment.
- cRCT Primary Outcome [6 months]
Primary ADT use after six months
Secondary Outcome Measures
- Patient Interviews [30-45 minutes]
To better understand patient perspectives into not initiating or stopping castration with ADT, the investigators also plan to conduct up to 15 patient interviews from high outlier sites. The investigators will use the VA Corporate Data Warehouse (CDW)Oncology data to identify these patients.
- cRCT Secondary Outcome [12 months]
Primary ADT use after 12 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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Any urologist who has experience caring for more than 10 prostate cancer patients on ADT and expresses interest in prostate cancer care
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Will consider non-physician providers (e.g., nurse practitioners) if they prescribe a significant amount of ADT
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Patients from high outlier site receiving ADT as primary prostate cancer treatment
Exclusion Criteria:
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Providers caring for 10 or fewer prostate cancer patients on ADT
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Patients with dementia or other significant mental impairment noted in their medical record
For the 20-site cRCT, we will recruit sites from the VA facilities with highest levels of low-value ADT use. We will target facilities with high rates of low-value ADT for localized prostate cancer and non-metastatic biochemical recurrence.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Ann Arbor Healthcare System | Ann Arbor | Michigan | United States | 48105 |
Sponsors and Collaborators
- University of Michigan
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ted Skolarus, MD, University of Michigan/Department of Veterans Affairs
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00133932-1
- 1R37CA222885-01