Clinical trial NCT03445559: A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging
Official title: A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Imaging
Veterans Affairs
Guideline Adherence
Implementation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-02-26
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The proposed behavioral intervention will be implemented according to a stepped wedge cluster-randomized design. This is a single direction cross-over randomized trial where every site serves, at some point, as both a control and an intervention site. The first time point will be a baseline measurement, where none of the study sites have yet received the intervention. At subsequent time points, study sites initiate the intervention. The time at which each site initiates implementation of the intervention is randomized.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Facility-level Inappropriate Prostate Cancer Bone Scan Imaging Rates
timeFrame: Through study completion, an average of 4 years
measure: Facility-level Appropriate Prostate Cancer Bone Scan Imaging Rates
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Individual-level Inappropriate Prostate Cancer Imaging Rates
timeFrame: Through study completion, an average of 4 years
measure: Individual-level Appropriate Prostate Cancer Imaging Rates
timeFrame: Through study completion, an average of 4 years
measure: Provider Attitudes Regarding Prostate Cancer Imaging Guidelines and the Behavioral Intervention
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: New York
country: United States
facility: VA NY Harbor Healthcare System, New York, NY
state: New York
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: VA NY Harbor Healthcare System, New York, NY
name: Danil V Makarov, MD MHS
role: PRINCIPAL_INVESTIGATOR
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