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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03445559
• Other study ID #: IIR 15-356
• Secondary ID: HX002038
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: February 28, 2024

Study information

• Verified date: September 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View 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. — View 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 S — View 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. — View 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. — View 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. — View 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. — View 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):55-6 — View 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. — View 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. — View 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 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Through study completion, an average of 4 years
Primary	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)	Through study completion, an average of 4 years
Secondary	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)	Through study completion, an average of 4 years
Secondary	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)	Through study completion, an average of 4 years
Secondary	Provider attitudes regarding prostate cancer imaging guidelines and the behavioral intervention	Qualitative outcome assessed through semi-structured, in-depth interviews with participating providers	Through study completion, an average of 4 years
Secondary	Net cost of implementation of the behavioral intervention	Budget impact analysis of intervention implementation	Through study completion, an average of 4 years