Physician-focused Behavioral Intervention for Prostate Cancer Imaging

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

58 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary aim of this study is to determine whether a multi-modal, physician-focused behavioral intervention can improve facility-level guideline-concordant utilization of prostate cancer staging imaging. Other aims of this study include to use mixed methods to explore physician influence on guideline-concordant imaging and to determine the cost and cost impact of a physician-focused behavioral intervention to improve guideline-concordant prostate cancer imaging.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Physician-focused Behavioral Intervention for Prostate Cancer Imaging?

Research shows that interventions like audit and feedback, academic detailing, and clinical decision support tools can help improve the quality of care by encouraging doctors to follow guidelines more closely. These strategies have been used successfully in other healthcare settings to change physician behavior and improve patient outcomes. ^{1 2 3 4 5}

Is the physician-focused behavioral intervention for prostate cancer imaging safe for humans?

The research articles do not provide specific safety data for the physician-focused behavioral intervention, but these types of interventions generally focus on changing physician behavior and decision-making, which are not expected to pose direct safety risks to patients. ^{2 5 6 7 8}

How is the physician-focused behavioral intervention for prostate cancer imaging different from other treatments?

This treatment is unique because it focuses on changing physician behavior to ensure imaging for prostate cancer aligns with guidelines, using strategies like clinical order checks, academic detailing, and feedback. Unlike traditional treatments that focus on the patient, this intervention targets the decision-making process of doctors to reduce unnecessary imaging. ^{1 2 5 9 10}

Research Team

Danil V Makarov, MD MHS

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementing Continuous Quality Improvement in an Integrated Community Urology Practice: Lessons Learned. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Designing a theory-based intervention to improve the guideline-concordant use of imaging to stage incident prostate cancer. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Overview of outcomes research and management and its role in oncology practice. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Systems-level audit and feedback interventions to improve oncology care: a scoping review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Protocol: A multi-modal, physician-centered intervention to improve guideline-concordant prostate cancer imaging. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Clinical Reminder Order Check Intervention to Improve Guideline-concordant Imaging Practices for Men With Prostate Cancer: A Pilot Study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Using hospital medical record data to assess the accuracy of the SEER Los Angeles Cancer Surveillance Program for initial treatment of prostate cancer: a small pilot study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment patterns for prostate cancer: comparison of Medicare claims data to medical record review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A frequently used patient and physician-directed educational intervention does nothing to improve primary care of prostate conditions. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Qualitative study on decision-making by prostate cancer physicians during active surveillance. [2018]