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ADT Order Check Attestation (Or) for Prostate Cancer (DeADT-LW Trial)
N/A
Recruiting
Led By Samir Saini, 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 of request to participate being sent
Awards & highlights
DeADT-LW Trial Summary
This trial is comparing two different approaches to reduce unnecessary use of androgen deprivation therapy (ADT) for prostate cancer patients. One approach is using a reminder order check, while the other approach involves providing
Who is the study for?
This trial is for healthcare providers who prescribe ADT (androgen deprivation therapy) to prostate cancer patients at participating sites. Providers who choose not to participate in the study are excluded.Check my eligibility
What is being tested?
The DeADT trial is testing two strategies aimed at reducing unnecessary use of ADT in prostate cancer care: a clinical reminder order check versus a provider script/patient education approach, assessing which is more effective after six months.See study design
What are the potential side effects?
Since this trial focuses on implementation strategies rather than direct patient interventions, it does not directly involve medication or treatment side effects.
DeADT-LW Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 month of request to participate being sent
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month of request to participate being sent
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness - Interruption in low value ADT injection (i.e., take a break from ADT)
Secondary outcome measures
Feasibility - Clinic level: Clinics with Intervention Implementation
Feasibility - Site level: Fully Operationalized Intervention
Feasibility - Site level: Medical Center Director (MCD) Approval
+3 moreDeADT-LW Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Provider Script (Sc)Experimental Treatment1 Intervention
Study staff will enter an electronic health record progress note approximately one business day prior to a target low-value ADT clinic visit from a patient already receiving ADT. The note will include scripted talking points for the provider participant to help with discussion and recent PSA levels and can be edited, signed, or deleted by the provider, giving a quick and simple way to document the discussion. The progress note will prompt provider participants to indicate whether a patient prefers to continue or discontinue ADT. The progress note will include links to a patient-facing clinic handout which will be posted on an external website. Provider participants may modify, ignore, or delete the progress note.
Group II: ADT Order Check Attestation (Or)Experimental Treatment1 Intervention
Study staff will place a "Living Well ADT" health factor in the electronic medical record for patients already receiving ADT, and whose clinic visits the study team have confirmed to be targets for ADT de-implementation. Health factors will be entered as eligible clinic visits are identified. This health factor combined with a low PSA level (most recent PSA < 2) will trigger the ADT Order Check Attestation Intervention (Or) when the provider participant places an order for ADT (e.g., Lupron, Eligard, Goserelin, and Zoladex). Provider participants may override the order check by entering text indicating the reason and continue with the ordering process.
Group III: ControlActive Control1 Intervention
The study team will match up to 8 sites (i.e., medical centers) to the 4 randomized sites as contemporary controls where no interventions have been deployed to compare the primary outcome of interruption of low-value ADT injections. Low-value ADT injections, eligible clinic visits, and primary outcomes for a matched 6-month period will be ascertained through chart review and compared to intervention site primary outcomes.
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Who is running the clinical trial?
US Department of Veterans AffairsFED
868 Previous Clinical Trials
487,810 Total Patients Enrolled
9 Trials studying Prostate Cancer
2,463 Patients Enrolled for Prostate Cancer
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,058 Total Patients Enrolled
17 Trials studying Prostate Cancer
10,703 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,361 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,015 Patients Enrolled for Prostate Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this research study currently open and accepting participants?
"Indeed, based on the details available on clinicaltrials.gov, this trial is currently in search of eligible participants. The initial posting date was recorded as October 4th, 2022, and the most recent update occurred on January 9th, 2024."
Answered by AI
What is the current number of individuals being admitted into this research investigation?
"Indeed, the information on clinicaltrials.gov confirms that this trial is actively seeking patients. The study was initially posted on October 4th, 2022 and underwent its most recent update on January 9th, 2024. Recruitment for this clinical trial aims to enroll a total of 80 participants across one designated site."
Answered by AI
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