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

September 8, 2023 updated by: VA Office of Research and Development
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-1207
        • VA Palo Alto Health Care System, Palo Alto, CA
      • West Los Angeles, California, United States, 90073-1003
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417-2309
        • Minneapolis VA Health Care System, Minneapolis, MN
    • New York
      • New York, New York, United States, 10010-5011
        • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
      • Syracuse, New York, United States, 13210-2716
        • Syracuse VA Medical Center, Syracuse, NY
    • Oregon
      • Portland, Oregon, United States, 97207-2964
        • VA Portland Health Care System, Portland, OR
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    • Utah
      • Salt Lake City, Utah, United States, 84148-0001
        • VA Salt Lake City Health Care System, Salt Lake City, UT
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2254
        • William S. Middleton Memorial Veterans Hospital, Madison, WI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Intervention
The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
Behavioral: Clinical Order Check
A Clinical Order Check is an evidence-based, systems-level method to affect significant behavior change. It addresses the intervention functions of education, enablement and incentivization which are effective methods to change behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources. All VA facilities currently use locally adapted clinical reminders. This strategy is technologically simple, straightforward, and is considered to be a best practice within the VA IT community. The reminder will be self-explanatory and non-intrusive to workflow.
Behavioral: Academic Detailing
Academic detailing is an individual and facility-level intervention consistently shown to improve provider behavior. This strategy addresses the intervention functions of persuasion, coercion, modeling, and education which are effective methods for affecting behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources. During the meeting, the detailer will follow a script explaining that the visit is part of an experimental program to provide physicians with up-to-date, unbiased information about imaging to stage prostate cancer.
Behavioral: Audit and Feedback
Audit and feedback is an effective, individual-level intervention for changing healthcare provider behavior, resulting in small but potentially clinically important benefits. Audit and feedback addresses the intervention functions of education, persuasion and incentivization, all of which are important for addressing beliefs about capabilities and consequences, knowledge, and social influence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facility-level inappropriate prostate cancer imaging rates
Time Frame: 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)
Through study completion, an average of 4 years
Facility-level appropriate prostate cancer imaging rates
Time Frame: 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)
Through study completion, an average of 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual-level inappropriate prostate cancer imaging rates
Time Frame: 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)
Through study completion, an average of 4 years
Individual-level appropriate prostate cancer imaging rates
Time Frame: 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)
Through study completion, an average of 4 years
Provider attitudes regarding prostate cancer imaging guidelines and the behavioral intervention
Time Frame: Through study completion, an average of 4 years
Qualitative outcome assessed through semi-structured, in-depth interviews with participating providers
Through study completion, an average of 4 years
Net cost of implementation of the behavioral intervention
Time Frame: Through study completion, an average of 4 years
Budget impact analysis of intervention implementation
Through study completion, an average of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Danil V Makarov, MD MHS, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2018

Primary Completion (Actual)

February 28, 2023

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 15-356
  • HX002038 (Other Grant/Funding Number: VA HSR&D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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