A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging
Primary Purpose
Prostate Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Order Check
Academic Detailing
Audit and Feedback
Sponsored by

About this trial
This is an interventional health services research trial for Prostate Cancer focused on measuring Prostate Cancer, Imaging, Veterans Affairs, Guideline Adherence, Implementation
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
Sites / Locations
- VA Palo Alto Health Care System, Palo Alto, CA
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Minneapolis VA Health Care System, Minneapolis, MN
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
- Syracuse VA Medical Center, Syracuse, NY
- VA Portland Health Care System, Portland, OR
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- VA Salt Lake City Health Care System, Salt Lake City, UT
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
- William S. Middleton Memorial Veterans Hospital, Madison, WI
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
No intervention
The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
Outcomes
Primary Outcome Measures
Facility-level inappropriate prostate cancer imaging rates
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)
Facility-level appropriate prostate cancer imaging rates
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)
Secondary Outcome Measures
Individual-level inappropriate prostate cancer imaging rates
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)
Individual-level appropriate prostate cancer imaging rates
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)
Provider attitudes regarding prostate cancer imaging guidelines and the behavioral intervention
Qualitative outcome assessed through semi-structured, in-depth interviews with participating providers
Net cost of implementation of the behavioral intervention
Budget impact analysis of intervention implementation
Full Information
NCT ID
NCT03445559
First Posted
February 20, 2018
Last Updated
September 8, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03445559
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Imaging, Veterans Affairs, Guideline Adherence, Implementation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Order Check
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Academic Detailing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Audit and Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Facility-level inappropriate prostate cancer imaging rates
Description
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)
Time Frame
Through study completion, an average of 4 years
Title
Facility-level appropriate prostate cancer imaging rates
Description
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)
Time Frame
Through study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
Individual-level inappropriate prostate cancer imaging rates
Description
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)
Time Frame
Through study completion, an average of 4 years
Title
Individual-level appropriate prostate cancer imaging rates
Description
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)
Time Frame
Through study completion, an average of 4 years
Title
Provider attitudes regarding prostate cancer imaging guidelines and the behavioral intervention
Description
Qualitative outcome assessed through semi-structured, in-depth interviews with participating providers
Time Frame
Through study completion, an average of 4 years
Title
Net cost of implementation of the behavioral intervention
Description
Budget impact analysis of intervention implementation
Time Frame
Through study completion, an average of 4 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danil V Makarov, MD MHS
Organizational Affiliation
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073-1003
Country
United States
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417-2309
Country
United States
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010-5011
Country
United States
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2716
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207-2964
Country
United States
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148-0001
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1532
Country
United States
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2254
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
37312342
Citation
Makarov DV, Holmes-Rovner M, Rovner DR, Averch T, Barry MJ, Chrouser K, Gee WF, Goodrich K, Haynes M, Krahn M, Saigal C, Sox HC, Stacey D, Tessier C, Waterhouse RL, Fagerlin A. Quality Improvement Summit 2016: Shared Decision Making and Prostate Cancer Screening. Urol Pract. 2018 Nov;5(6):444-451. doi: 10.1016/j.urpr.2017.11.005. Epub 2017 Dec 4.
Results Reference
background
PubMed Identifier
32065864
Citation
Skokan AJ, Dobbs RW, Harris AM, Tessier CD, Sajadi KP, Talwar R, Berger I, Guzzo TJ, Ziemba JB. Implementing a patient safety culture survey to identify and target process improvements in academic ambulatory urology practices: a multi-institutional collaborative. Can J Urol. 2020 Feb;27(1):10087-10092.
Results Reference
background
PubMed Identifier
33325343
Citation
Ziemba JB, Tessier CD, Harris AM. Patient safety education and perceptions of safety culture in American and Canadian urological residency training programs. Can J Urol. 2020 Dec;27(6):10431-10436.
Results Reference
background
PubMed Identifier
34017908
Citation
Hsiang W, Han X, Jemal A, Nguyen KA, Shuch B, Park H, Yu JB, Gross CP, Davidoff AJ, Leapman MS. The Association Between the Affordable Care Act and Insurance Status, Stage and Treatment in Patients with Testicular Cancer. Urol Pract. 2020 Jul;7(4):252-258. doi: 10.1097/upj.0000000000000109. Epub 2020 Jul 1.
Results Reference
background
PubMed Identifier
31893532
Citation
Grinberg AS, Sellinger JJ, Sprenkle PC, Bandin AJ, Nawaf CB, Syed JS, Leapman MS. Effect of Diaphragmatic Breathing on Procedural Anxiety During Transrectal Prostate Biopsy. Urology. 2020 Mar;137:26-32. doi: 10.1016/j.urology.2019.12.024. Epub 2019 Dec 29.
Results Reference
background
PubMed Identifier
32068499
Citation
Abello A, Leapman M, Kenney PA. Chasing the Pack: Association between Urology Hospital Rankings and Surgical Outcome. J Urol. 2020 May;203(5):890-891. doi: 10.1097/JU.0000000000000710. Epub 2019 Dec 20. No abstract available.
Results Reference
background
PubMed Identifier
32076639
Citation
You H, Shang W, Min X, Weinreb J, Li Q, Leapman M, Wang L, Tian J. Sight and switch off: Nerve density visualization for interventions targeting nerves in prostate cancer. Sci Adv. 2020 Feb 5;6(6):eaax6040. doi: 10.1126/sciadv.aax6040. eCollection 2020 Feb.
Results Reference
background
PubMed Identifier
32462566
Citation
Rajwa P, Hopen P, Mu L, Paradysz A, Wojnarowicz J, Gross CP, Leapman MS. Online Crowdfunding Response to Coronavirus Disease 2019. J Gen Intern Med. 2020 Aug;35(8):2482-2484. doi: 10.1007/s11606-020-05896-x. Epub 2020 May 27. No abstract available.
Results Reference
background
PubMed Identifier
32562045
Citation
Ghabili K, Park HS, Yu JB, Sprenkle PC, Kim SP, Nguyen KA, Ma X, Gross CP, Leapman MS. National trends in the management of patients with positive surgical margins at radical prostatectomy. World J Urol. 2021 Apr;39(4):1141-1151. doi: 10.1007/s00345-020-03298-6. Epub 2020 Jun 19.
Results Reference
background
PubMed Identifier
32511721
Citation
Leapman MS, Presley CJ, Zhu W, Soulos PR, Adelson KB, Miksad RA, Boffa DJ, Gross CP. Association of Programmed Cell Death Ligand 1 Expression Status With Receipt of Immune Checkpoint Inhibitors in Patients With Advanced Non-Small Cell Lung Cancer. JAMA Netw Open. 2020 Jun 1;3(6):e207205. doi: 10.1001/jamanetworkopen.2020.7205.
Results Reference
background
PubMed Identifier
32945730
Citation
Hsiang WR, Honig S, Leapman MS. Evaluation of Online Telehealth Platforms for Treatment of Erectile Dysfunction. J Urol. 2021 Feb;205(2):330-332. doi: 10.1097/JU.0000000000001378. Epub 2020 Sep 18. No abstract available.
Results Reference
background
PubMed Identifier
32990734
Citation
Salazar MC, Canavan ME, Walters SL, Herrin J, Schwartz JL, Leapman M, Boffa DJ. Evaluation of Cancer Care After Medicaid Expansion Under the Affordable Care Act. JAMA Netw Open. 2020 Sep 1;3(9):e2017544. doi: 10.1001/jamanetworkopen.2020.17544.
Results Reference
background
PubMed Identifier
32989262
Citation
Miccio JA, Talcott WJ, Jairam V, Park HS, Yu JB, Leapman MS, Johnson SB, King MT, Nguyen PL, Kann BH. Quantifying treatment selection bias effect on survival in comparative effectiveness research: findings from low-risk prostate cancer patients. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):414-422. doi: 10.1038/s41391-020-00291-3. Epub 2020 Sep 28.
Results Reference
background
PubMed Identifier
32797212
Citation
Becker DJ, Rude T, Walter D, Wang C, Loeb S, Li H, Ciprut S, Kelly M, Zeliadt SB, Fagerlin A, Lepor H, Sherman S, Ravenell JE, Makarov DV. The Association of Veterans' PSA Screening Rates With Changes in USPSTF Recommendations. J Natl Cancer Inst. 2021 May 4;113(5):626-631. doi: 10.1093/jnci/djaa120.
Results Reference
background
PubMed Identifier
37145663
Citation
Lane GI, Ellimoottil C, Wallner L, Lenherr S, Clemens JQ. Patient Reported Shared Decision Making in Urology from the Surgical Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey. Urol Pract. 2021 May;8(3):341-347. doi: 10.1097/UPJ.0000000000000216. Epub 2020 Dec 28.
Results Reference
background
PubMed Identifier
30246937
Citation
Kirk PS, Borza T, Caram MEV, Shumway DA, Makarov DV, Burns JA, Shelton JB, Leppert JT, Chapman C, Chang M, Hollenbeck BK, Skolarus TA. Characterising potential bone scan overuse amongst men treated with radical prostatectomy. BJU Int. 2019 Jul;124(1):55-61. doi: 10.1111/bju.14551. Epub 2018 Nov 12.
Results Reference
result
PubMed Identifier
32721517
Citation
Ciprut SE, Kelly MD, Walter D, Hoffman R, Becker DJ, Loeb S, Sedlander E, Tenner CT, Sherman SE, Zeliadt SB, Makarov DV. A Clinical Reminder Order Check Intervention to Improve Guideline-concordant Imaging Practices for Men With Prostate Cancer: A Pilot Study. Urology. 2020 Nov;145:113-119. doi: 10.1016/j.urology.2020.05.101. Epub 2020 Jul 25.
Results Reference
result
PubMed Identifier
34663435
Citation
Makarov DV, Ciprut S, Kelly M, Walter D, Shedlin MG, Braithwaite RS, Tenner CT, Gold HT, Zeliadt S, Sherman SE. Protocol: A multi-modal, physician-centered intervention to improve guideline-concordant prostate cancer imaging. Trials. 2021 Oct 18;22(1):711. doi: 10.1186/s13063-021-05645-3.
Results Reference
result
Learn more about this trial
A Multi-modal, Physician-centered Intervention to Improve Guideline-concordant Prostate Cancer Imaging
We'll reach out to this number within 24 hrs