N/A
N=60
De-implementation of Low Value Castration for Men With Prostate Cancer
Cancer of Prostate
Bottom Line
View on ClinicalTrials.gov: NCT03579680 ↗Enrolled (actual)
60
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: Feasibility - Site Level: Medical Center Director (MCD) Approval — 3; 1 sites
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ADT ORDER CHECK ATTESTATION (OR) (Behavioral); PROVIDER SCRIPT (SC) (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility - Site Level: Medical Center Director (MCD) Approval |
3; 1 | — |
| PRIMARY Feasibility - Site Level: Fully Operationalized Intervention |
2; 1 | — |
| PRIMARY Feasibility - Clinic Level: Clinics With Intervention Implementation |
2; 1 | — |
| SECONDARY Reach |
46; 14 | — |
| SECONDARY Penetration - Provider Script (SC) |
5 | — |
| SECONDARY Penetration - OR |
8 | — |
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 comparing two tailored deimplementation strategies to reduce chemical castration as localized prostate cancer treatment and treatment for non-metastatic biochemical recurrence with low PSA levels.
Eligibility Criteria
Inclusion Criteria
- Any provider at participating sites who prescribes ADT for prostate cancer patients
Exclusion Criteria
- Providers opting out of study
Data sourced from ClinicalTrials.gov (NCT03579680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.