Physician-focused Behavioral Intervention for Prostate Cancer Imaging

Not currently recruiting at 11 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Prior malignancy, Age over 85, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special program can help doctors follow guidelines more effectively when ordering imaging tests for prostate cancer. The program includes educating doctors (known as Academic Detailing), checking their orders (Clinical Order Check), and providing feedback (Audit and Feedback). It targets urologists and other healthcare providers in VA hospitals who have recently treated men with prostate cancer. The goal is to determine if this approach can align imaging practices with current guidelines and assess its cost impact. Patients are not being directly recruited for this study. As an unphased trial, this study offers a unique opportunity to improve healthcare practices without direct patient involvement.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications.

What prior data suggests that this behavioral intervention is safe for prostate cancer imaging?

Research has shown that the methods used in this trial—academic detailing, audit and feedback, and clinical order checks—are generally safe and well-tolerated. These methods aim to improve how doctors use imaging for prostate cancer.

Studies have found that academic detailing, which involves providing doctors with personalized education, enhances the quality of care without causing harm. Audit and feedback give doctors reports on their performance, improving imaging practices and reducing complications from biopsies. Clinical order checks ensure medical orders follow guidelines and are a regular part of healthcare, posing no safety risks.

Since this trial does not test a new drug or medical procedure but focuses on improving current practices, safety concerns are minimal. The interventions aim to make medical care more effective and guideline-compliant, which is safer for patients in the long run. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the physician-focused behavioral intervention for prostate cancer imaging because it seeks to optimize the use of imaging through a three-part approach: Clinical Order Check, Academic Detailing, and Audit and Feedback. Unlike the standard practice, which often involves a mix of imaging techniques without a structured protocol, this intervention aims to improve decision-making by educating doctors and providing them with real-time feedback. This method has the potential to enhance the appropriateness of imaging orders, leading to better patient care and more efficient use of healthcare resources. By focusing on changing physician behavior rather than introducing new medications or devices, this intervention could revolutionize how imaging is integrated into prostate cancer management.

What evidence suggests that this trial's interventions could be effective for improving prostate cancer imaging?

Research has shown that combining strategies can enhance how doctors order imaging tests for prostate cancer. In this trial, participants in the intervention arm will receive a combination of Clinical Order Check, Academic Detailing, and Audit and Feedback. One study used these methods together to help doctors better adhere to guidelines when requesting imaging tests. This study, involving 2,302 patients, demonstrated positive changes in imaging practices, making them more appropriate and efficient. By providing doctors with feedback and detailed guidance, these strategies ensure tests are used only when necessary, benefiting patient care and reducing unnecessary procedures. ^{1 5 6 7 8}

Who Is on the Research Team?

Danil V Makarov, MD MHS

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

This trial is for Urology Chiefs, attending urologists, Physician Assistants, and Nurse Practitioners at the VA who've treated at least 5 men with new prostate cancer in the last 6 months. It's not for residents or those over 85 years old, without certain medical data, a history of other cancers, or patients diagnosed post-mortem.

Inclusion Criteria

Provider Criteria: Urology Chiefs and attending urologists employed through the VA (full time, part time) at one of the 10 participating sites

Physician Assistants and Nurse Practitioners employed through the VA at one of the 10 participating sites that work in the respective urology clinics

The investigators have obtained a waiver of HIPAA authorization and informed consent to analyze electronic health records of patients that are diagnosed with ICD-9 code 185 or ICD-10 code C61 during the study period at the 10 participating sites.

Exclusion Criteria

Patients who died within 3 months of diagnosis

Patients diagnosed at autopsy or by death certificate

I am over 85 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Assessment

Assessment of imaging rates 6 months prior to the intervention

6 months

Intervention

Implementation of a multi-modal, physician-focused behavioral intervention including audit and feedback, academic detailing, and CPRS Clinical Order Check

3 months

Follow-up

Participants are monitored for changes in imaging rates and provider attitudes post-intervention

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Academic Detailing
• Audit and Feedback
• Clinical Order Check

Trial Overview The study tests if a multi-part intervention aimed at doctors can make prostate cancer imaging more guideline-concordant. Methods include Clinical Order Checks to guide decisions, Academic Detailing for education on best practices, and Audit and Feedback to review physician performance.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 3 Interventions

The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.

Group II: Control Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40796156/

Prostate Cancer Imaging Stewardship: a multi-modal ... Outcomes were assessed among 2,302 patients with incident prostate cancer aged 18-85 years. PCIS combines three evidence-based provider-focused ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03445559

A Multi-modal, Physician-centered Intervention to Improve ... The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback. ... Prostate Cancer Imaging ...

3. academic.oup.com academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djaf210/8231078

Prostate Cancer Imaging Stewardship: a multimodal ... PCIS combines 3 evidence-based behavioral interventions: Audit and Feedback, Academic Detailing, and an electronic medical record (EMR) Clinical ...

4. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141706266

IIR 15-356 – HSR Study - VA Health Systems Research - VA.gov Audit and Feedback will be used to provide individual and facility-level feedback on prostate cancer imaging performance to participating providers quarterly ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143917306488

Designing a theory-based intervention to improve the ... Prostate cancer imaging stewardship consists of interventions (clinical order check, academic detailing, and audit and feedback) implemented at the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8522153/

Protocol: A multi-modal, physician-centered intervention to ... The study's specific aims seek to understand the effects of the intervention on (1) facility-level prostate cancer imaging rates, (2) physician experience with ...

7. withpower.com withpower.com/trial/phase-prostatic-neoplasms-3-2018-ce8a8

Physician-focused Behavioral Intervention for Prostate ... Research shows that interventions like audit and feedback, academic detailing, and clinical decision support tools can help improve the quality of care by ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT03445559/Prot_SAP_000.pdf

A multi-modal, physician-centered intervention to improve ... Almost half of Veterans with localized prostate cancer (the most common non-cutaneous malignancy among US men) undergo inappropriate, wasteful imaging.