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ADT ORDER CHECK ATTESTATION (OR) for Prostate Cancer (DeADT Trial)

N/A

Waitlist Available

Led By Ted Skolarus, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 month

Awards & highlights

DeADT Trial Summary

This trial will test two different ways to stop using a low-value prostate cancer treatment, androgen deprivation therapy (ADT). The goal is to find the best way to stop using ADT, in preparation for a future trial comparing this treatment to others.

Eligible Conditions

Prostate Cancer

DeADT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility - Clinic level: Clinics with Intervention Implementation

Feasibility - Site level: Fully Operationalized Intervention

Feasibility - Site level: MCD Approval

Secondary outcome measures

Penetration -

Penetration - SC

Reach

DeADT Trial Design

2Treatment groups

Experimental Treatment

Group I: PROVIDER SCRIPT (SC)Experimental Treatment1 Intervention

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.

Group II: ADT ORDER CHECK ATTESTATION (OR)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PROVIDER SCRIPT (SC)

2018

N/A

~60

ADT ORDER CHECK ATTESTATION (OR)

2018

N/A

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,845 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,377,998 Total Patients Enrolled

18 Trials studying Prostate Cancer

10,783 Patients Enrolled for Prostate Cancer

Ted Skolarus, MDPrincipal Investigator - University of Michigan/Department of Veterans Affairs

University of Michigan C.S. Mott Children's Hospital, University of Michigan Hospital, VA Ann Arbor Healthcare System, Von Voigtlander Women's Hospital

Wayne State University School Of Medicine (Medical School)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended outcome of this clinical experiment?

"This drug trial's primary objective, which will be assessed within 3 months of approval, is to attain Medical Centre Director Approval. Secondary goals include Penetration - SC (percentage of intervention clinic notes assigned), Penetration - OR (percentage of order checks justified), and cRCT Secondary Outcome (primary ADT use after 12 months)."

Answered by AI

Are there any vacancies in the clinical trial for participants?

"Currently, according to the clinicaltrials.gov website, this particular trial is not recruiting any new patients as its last update was on November 7th 2022. Nevertheless, there are 1,253 other trials actively seeking participants at present."

Answered by AI

Recent research and studies

Implementation ScienceJournal

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, Ted A., Sarah T. Hawley, Daniela A. Wittmann, Jane Forman, Tabitha Metreger, Jordan B. Sparks, Kevin Zhu, et al.. 2018. “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)”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-018-0833-7.

Implementation Science CommunicationsJournal

Learning from the “tail End

Skolarus, Ted A., Jane Forman, Jordan B. Sparks, Tabitha Metreger, Sarah T. Hawley, Megan V. Caram, Lesly Dossett, et al.. 2021. “Learning from the “tail End” of De-implementation: The Case of Chemical Castration for Localized Prostate Cancer”. Implementation Science Communications. Springer Science and Business Media LLC. doi:10.1186/s43058-021-00224-8.

clinicaltrials.govStudy

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

Ted Skolarus 2018. "De-implementation of Low Value Castration for Men With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03579680.