Clinical trial · Interventional
De-implementation of Low Value Castration for Men With Prostate Cancer
NCT03579680CI-TRIAL-00080472DeADTcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADT ORDER CHECK ATTESTATION (OR) | Behavioral | — | UNRESOLVED |
| PROVIDER SCRIPT (SC) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ADT ORDER CHECK ATTESTATION (OR)
- description
- 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 have a strong evidence-base for changing provider behavior. Study staff will place a "health factor" structured data element 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.
- interventionNames
- Behavioral: ADT ORDER CHECK ATTESTATION (OR)
- type
- EXPERIMENTAL
- label
- PROVIDER SCRIPT (SC)
- description
- 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 EMR progress note 1 business day prior to a target clinic visit. The note includes talking points for the provider to help with a discussion. 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 low-value ADT. Appropriate documentation of the decision will be tracked for fidelity. We will also have a patient handout entitled: "Living well with prostate cancer: Is hormone therapy still right for you?" as a patient engagement and information resource.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: \- Any provider at participating sites who prescribes ADT for prostate cancer patients Exclusion Criteria: \- Providers opting out of study
References
Publications (3)
- DERIVEDSkolarus TA, Hawley ST, Forman J, Sales AE, Sparks JB, Metreger T, Burns J, Caram MV, Radhakrishnan A, Dossett LA, Makarov DV, Leppert JT, Shelton JB, Stensland KD, Dunsmore J, Maclennan S, Saini S, Hollenbeck BK, Shahinian V, Wittmann DA, Deolankar V, Sriram S. Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies. Implement Sci Commun. 2024 Apr 9;5(1):37. doi: 10.1186/s43058-024-00576-x. PMID 38594740
- DERIVEDSkolarus TA, Forman J, Sparks JB, Metreger T, Hawley ST, Caram MV, Dossett L, Paniagua-Cruz A, Makarov DV, Leppert JT, Shelton JB, Stensland KD, Hollenbeck BK, Shahinian V, Sales AE, Wittmann DA. Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer. Implement Sci Commun. 2021 Oct 28;2(1):124. doi: 10.1186/s43058-021-00224-8. PMID 34711274
- DERIVEDSkolarus TA, Hawley ST, Wittmann DA, Forman J, Metreger T, Sparks JB, Zhu K, Caram MEV, Hollenbeck BK, Makarov DV, Leppert JT, Shelton JB, Shahinian V, Srinivasaraghavan S, Sales AE. De-implementation of low value castration for men with prostate cancer: protocol for a theory-based, mixed methods approach to minimizing low value androgen deprivation therapy (DeADT). Implement Sci. 2018 Nov 29;13(1):144. doi: 10.1186/s13012-018-0833-7. PMID 30486836