NCT03579680: DeADT

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

Completed NA Results posted Last updated 5 September 2024

What this trial tests

NA trial testing ADT ORDER CHECK ATTESTATION (OR) in Cancer of Prostate in 60 participants. Completed in 6 April 2023.

Timeline

22 August 2018

Primary endpoint
8 November 2022

6 April 2023

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	60
Start date	22 August 2018
Primary completion	8 November 2022
Estimated completion	6 April 2023
Sites	1 location across United States

Drugs / interventions tested

• ADT ORDER CHECK ATTESTATION (OR)
• PROVIDER SCRIPT (SC)

Conditions studied

• Cancer of Prostate — all drugs for Cancer of Prostate →

Sponsor

University of Michigan

Who can join

Eligibility, any sex, with Cancer of Prostate. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility - Site Level: Medical Center Director (MCD) Approval Primary · Within 1 month

The percentage of pilot sites asked to participate that received MCD approval to implement the intervention (Order Check or Progress Note/Patient Handout)

Group	Value	95% CI
ADT ORDER CHECK ATTESTATION (OR)	3
PROVIDER SCRIPT (SC)	1

Feasibility - Site Level: Fully Operationalized Intervention Primary · Within 6 months of approval

The percentage of approved pilot sites with fully operationalized intervention, i.e. intervention successfully programmed into site Electronic Health Records 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.

Group	Value	95% CI
ADT ORDER CHECK ATTESTATION (OR)	2
PROVIDER SCRIPT (SC)	1

Feasibility - Clinic Level: Clinics With Intervention Implementation Primary · Within 6 months of 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. Clinics may include Urology, Medical Oncology, and Radiation Oncology.

Group	Value	95% CI
ADT ORDER CHECK ATTESTATION (OR)	2
PROVIDER SCRIPT (SC)	1

Reach Secondary · Within 6 months of intervention

The percentage of providers prescribing ADT for prostate cancer sent an information sheet who did not opt out of the study.

Group	Value	95% CI
ADT ORDER CHECK ATTESTATION (OR)	46
PROVIDER SCRIPT (SC)	14

Penetration - Provider Script (SC) Secondary · Within 6 months of intervention

Percentage of SC intervention clinic notes assigned to providers that were signed.

Group	Value	95% CI
PROVIDER SCRIPT (SC)	5

Penetration - OR Secondary · Within 6 months of intervention

Percentage of OR intervention order checks justified.

Group	Value	95% CI
ADT ORDER CHECK ATTESTATION (OR)	8

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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).
   Skolarus TA, Hawley ST, Wittmann DA, Forman J, et al · · 2018 · cited 11× · PMID 30486836 · DOI 10.1186/s13012-018-0833-7
2. Learning from the "tail end" of de-implementation: the case of chemical castration for localized prostate cancer.
   Skolarus TA, Forman J, Sparks JB, Metreger T, et al · · 2021 · cited 8× · PMID 34711274 · DOI 10.1186/s43058-021-00224-8
3. Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies.
   Skolarus TA, Hawley ST, Forman J, Sales AE, et al · · 2024 · cited 3× · PMID 38594740 · DOI 10.1186/s43058-024-00576-x