A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: Clinical Order Check; Behavioral: Academic Detailing; Behavioral: Audit and Feedback

• Registration Number: NCT03445559
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

Detailed Description

Almost half of Veterans with localized prostate cancer (the most common non-cutaneous malignancy among US men) receive inappropriate, wasteful imaging. The VHA Blueprint for Excellence prioritizes increasing operational effectiveness. Prior studies seeking to limit inappropriate imaging did not assess barriers and achieved mixed results. The investigators' team has explored the causes of guideline-discordant prostate cancer imaging and found that 1) patients with newly diagnosed prostate cancer have little concern for radiographic staging but rather focus on treatment, 2) physician trust imaging guidelines but are apt to follow their own intuition, fear medico-legal consequences, and succumb to influence from colleagues who image frequently. In spite of such discrepant views, most VHA physicians suggested or supported a large-scale effort to improve imaging use across VHA.

The investigators propose a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on VHA prostate cancer imaging use. The multi-level intervention, developed according to the Theoretical Determinants Framework, combines traditional physician behavior change methods with novel methods of communication and data collection. The intervention consists of three components: 1) a system of audit and feedback to clinicians informing individual clinicians and their sites about how their behavior compares to their peers' and to published guidelines 2) a program of academic detailing with the goal to educate providers about prostate cancer imaging, and 3) a CPRS Clinical Order Check for potentially inappropriate imaging. The intervention will be introduced to 10 participating geographically-distributed study sites.

The investigators will assess imaging rates 6 months prior to the intervention and 3 months following the intervention. 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 and perceptions of the intervention and its implementation, and 3) the costs of both implementing the intervention and affecting change in imaging use. These aims will support a subsequent intervention to improve guideline-concordant imaging across VHA. Experience gained through this project will be leveraged to improve guideline-concordant care and increase operational effectiveness in other domains.

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-26
• Study Start: 2018-04-09
• Primary Completion: 2023-02-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

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
• Providers may be any gender or race/ethnicity

Qualitative portion only:

• Urology Chiefs and/or frontline staff physicians
• participating PAs & NPs having cared for at least 5 men with incident prostate cancer within the previous 6 months
• Patients will not be directly recruited into the study.
• 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.

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Exclusion Criteria

Provider Criteria:

• Urology Residents will be excluded.

Patients

• Patients will be excluded if they have a history of prior malignancy

• Are over the age of 85

• Diagnosed at autopsy or by death certificate

• Died within 3 months of diagnosis

• Not having data on at least one of the following:

  • PSA
  • clinical stage
  • Gleason score

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Facility-level appropriate prostate cancer imaging rates	Through study completion, an average of 4 years	Facility-level utilization of bone scan or abdominal/pelvic CT or abdominal/pelvic MRI among men with newly diagnosed, high-risk prostate cancer. (Appropriate Imaging)
Facility-level inappropriate prostate cancer imaging rates	Through study completion, an average of 4 years	Facility-level utilization of bone scan or abdominal/pelvic CT or abdominal/pelvic MRI among men with newly diagnosed, low-risk prostate cancer. (Inappropriate Imaging)

Secondary Outcome Measures

Name	Time	Method
Net cost of implementation of the behavioral intervention	Through study completion, an average of 4 years	Budget impact analysis of intervention implementation
Individual-level inappropriate prostate cancer imaging rates	Through study completion, an average of 4 years	Provider-level utilization of bone scan or abdominal/pelvic CT or abdominal/pelvic MRI among men with newly diagnosed, low-risk prostate cancer. (Inappropriate Imaging)
Provider attitudes regarding prostate cancer imaging guidelines and the behavioral intervention	Through study completion, an average of 4 years	Qualitative outcome assessed through semi-structured, in-depth interviews with participating providers
Individual-level appropriate prostate cancer imaging rates	Through study completion, an average of 4 years	Provider-level utilization of bone scan or abdominal/pelvic CT or abdominal/pelvic MRI among men with newly diagnosed, high-risk prostate cancer. (Appropriate Imaging)

Trial Locations

Locations (11)

William S. Middleton Memorial Veterans Hospital, Madison, WI; 🇺🇸 Madison, Wisconsin, United States

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY; 🇺🇸 New York, New York, United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA; 🇺🇸 West Los Angeles, California, United States

VA Palo Alto Health Care System, Palo Alto, CA; 🇺🇸 Palo Alto, California, United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States

VA Salt Lake City Health Care System, Salt Lake City, UT; 🇺🇸 Salt Lake City, Utah, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

Syracuse VA Medical Center, Syracuse, NY; 🇺🇸 Syracuse, New York, United States

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States