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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/9/2019
Start Date:April 9, 2018
End Date:February 28, 2022
Contact:Danil V Makarov, MD MHS
Email:Danil.Makarov@va.gov
Phone:(212) 686-7500

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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.

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.

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
We found this trial at
11
sites
Pittsburgh, Pennsylvania 15240
Phone: 412-360-3643
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Madison, WI
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Minneapolis, Minnesota 55417
Phone: 612-725-2000
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Minneapolis, MN
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New York, New York 10010
Principal Investigator: Danil V Makarov, MD MHS
Phone: 212-686-7500
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Palo Alto, California 94304
Phone: (650) 849-0112
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Portland, Oregon 97201
Phone: 503-220-8262
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Salt Lake City, UT
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Seattle, Washington 98108
Phone: 206-762-1010
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Syracuse, New York 13210
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West Haven, Connecticut 06516
Phone: 203-932-5711
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West Los Angeles, California 90073
Phone: (310) 478-3711
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