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

NCT03445559 | Active Not Recruiting Results DMC

• 2 other identifiers: IIR 15-356HX002038
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 11

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Imaging; Veterans Affairs; Guideline Adherence; Implementation

Outcome Measures

Primary Outcomes (2)

• Facility-level Inappropriate Prostate Cancer Bone Scan Imaging Rates

  Facility-level utilization of bone scan imaging among men with newly diagnosed, low-risk prostate cancer. (Inappropriate Imaging according to NCCN guidelines)

  Through study completion, an average of 4 years

• Facility-level Appropriate Prostate Cancer Bone Scan Imaging Rates

  Facility-level utilization of bone scan imaging among men with newly diagnosed, high-risk prostate cancer. (Appropriate Imaging according to NCCN guidelines)

  Through study completion, an average of 4 years

Secondary Outcomes (3)

• Individual-level Inappropriate Prostate Cancer Imaging Rates

  Through study completion, an average of 4 years

• Individual-level Appropriate Prostate Cancer Imaging Rates

  Through study completion, an average of 4 years

• Provider Attitudes Regarding Prostate Cancer Imaging Guidelines and the Behavioral Intervention

  Through study completion, an average of 4 years

Study Arms (2)

Control

NO INTERVENTION

No intervention

Intervention

EXPERIMENTAL

The intervention is comprised of three components: 1) Clinical Order Check, 2) Academic Detailing, and 3) Audit and Feedback.

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

Interventions

Clinical Order Check BEHAVIORAL

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

Academic Detailing BEHAVIORAL

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

Audit and Feedback BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (11)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

Related Publications (19)

• 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.

  PMID: 37312342 BACKGROUND

• 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.

  PMID: 32065864 BACKGROUND

• 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.

  PMID: 33325343 BACKGROUND

• 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.

  PMID: 34017908 BACKGROUND

• 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.

  PMID: 31893532 BACKGROUND

• 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.

  PMID: 32068499 BACKGROUND

• 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.

  PMID: 32076639 BACKGROUND

• 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.

  PMID: 32462566 BACKGROUND

• 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.

  PMID: 32562045 BACKGROUND

• 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.

  PMID: 32511721 BACKGROUND

• 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.

  PMID: 32945730 BACKGROUND

• 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.

  PMID: 32990734 BACKGROUND

• 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.

  PMID: 32989262 BACKGROUND

• 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.

  PMID: 32797212 BACKGROUND

• 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.

  PMID: 37145663 BACKGROUND

• 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.

  PMID: 30246937 RESULT

• 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.

  PMID: 32721517 RESULT

• 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.

  PMID: 34663435 RESULT

• Makarov DV, Thomas JK, Ciprut S, Rivera AJ, Sherman SE, Braithwaite RS, Best SL, Blakely S, D'Agostino LA, Dahm P, Dash A, Leapman MS, Leppert JT, Sanchez A, Shelton JB, Tessier CD, Tenner CT, Gold HT, Shedlin MG, Zeliadt SB. Prostate Cancer Imaging Stewardship: a multimodal, physician-centered intervention for guideline-concordant imaging. J Natl Cancer Inst. 2025 Nov 1;117(11):2308-2316. doi: 10.1093/jnci/djaf210.

  PMID: 40796156 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Danil V. Makarov
• Organization: VA New York Harbor Healthcare System

Danil.Makarov@Va.gov

212-686-7500

Study Officials

• Danil V Makarov, MD MHS

  VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: April 9, 2018
• Primary Completion: February 28, 2023
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 17, 2026
• Results First Posted: February 14, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)