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

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VA Office of Research and Development

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Behavioral: Audit and Feedback
Behavioral: Academic Detailing
Behavioral: Clinical Order Check

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03445559
HX002038 (Other Grant/Funding Number)
IIR 15-356

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

58 participants in 2 patient groups

Control
No Intervention group
Description:
No intervention
Intervention
Experimental group
Description:
The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
Treatment:
Behavioral: Clinical Order Check
Behavioral: Academic Detailing
Behavioral: Audit and Feedback

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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