Cancer Prevention Clinical Decision Support (CPW)

• ClinicalTrials.gov Identifier: NCT02986230
• Recruitment Status: Enrolling by invitation
• First Posted: December 8, 2016
• Last Update Posted: July 2, 2019
• Sponsor: HealthPartners Institute
• Information provided by (Responsible Party): HealthPartners Institute

Study Description

Brief Summary:

The objective of this project is to implement and evaluate the effectiveness of a sophisticated Web-based, electronic health record (EHR)-linked clinical decision support (CDS) system designed to improve primary and secondary cancer preventive care.

This project will engage a rural population with substantial healthcare disparities and gaps in the receipt of primary and secondary cancer prevention. Results will advance dissemination and implementation research methods that can reduce health disparities and improve healthcare for millions in medically under-served areas.

Condition or disease	Intervention/treatment	Phase
Cancer Prevention	Other: Cancer prevention wizard (CPW)	Not Applicable

Detailed Description:

The objective of this project is to implement and evaluate the effectiveness of a sophisticated Web-based, electronic health record (EHR)-linked clinical decision support (CDS) system designed to improve primary and secondary cancer preventive care. To achieve this objective, a link from EHR data to evidence-based cancer prevention algorithms in a secure Web site is created to: (a) identify at the point of care all eligible patients not up to date on their cancer prevention interventions; and (b) present to both patient and primary care provider (PCP) and/or a key member of the primary care team, certified medical assistant (CMA), appropriate evidence-based primary cancer prevention interventions and cancer screening options at the point of care. The Cancer Prevention-CDS will focus on breast cancer screening in women aged 50-74, colorectal cancer screening for both sexes aged 50-75, cervical cancer screening for women aged 21-65, human papilloma virus (HPV) vaccination for both sexes aged 11-26, and referrals for weight management and smoking cessation in all adults aged 18 and older. Effectiveness is assessed by cluster-randomizing 30 primary care clinics with roughly 285 PCPs and 153,000 study-eligible patients into one of three experimental conditions: Group 1: PCP-focused CDS intervention in which the PCP triggers use of the CDS system and engages patients in appropriate cancer prevention strategies. Group 2: SDMT-focused CDS intervention in which the CMA triggers use of the CDS system along with additional shared decision making tools and interacts with the patient to engage them in appropriate cancer prevention strategies before seeing their PCP, who will approve or discuss the plan with their patient. Group 3: clinics provide usual care with no intervention-related activity related to cancer prevention. With 10 clinics, 95 PCPs, and 51,000 potentially eligible patients per study arm, this study will formally test the hypothesis that Groups 1 and 2 are superior to Group 3 over an 18-month follow-up period with respect to: (a) significantly higher rates of appropriate screening for breast, cervix, and colorectal cancer, as defined by the United States Preventive Services Task Force; and (b) significantly higher rates of human papillomavirus (HPV) vaccination in males and females aged 11-26 years. The investigators further posit that Groups 1 and 2 will have higher short-term health care costs but better long-term cost-effectiveness than Group 3. The Consolidated Framework for Implementation Research (CFIR) and RE-AIM conceptual frameworks will be used to guide implementation planning, organization, conduct, and impact evaluation of the intervention in a large rural healthcare system.

This project will engage a rural population with substantial healthcare disparities and gaps in the receipt of primary and secondary cancer prevention. Results will advance dissemination and implementation research methods that can reduce health disparities and improve healthcare for millions in medically under-served areas.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150000 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Implementing Cancer Prevention Using Patient-Provider Clinical Decision Support
• Actual Study Start Date: May 1, 2018
• Estimated Primary Completion Date: February 2020
• Estimated Study Completion Date: June 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: PCP-focused group; The PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.	Other: Cancer prevention wizard (CPW); The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
Experimental: SDMT-focused group; The SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.	Other: Cancer prevention wizard (CPW); The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

Outcome Measures

Primary Outcome Measures :

1. Cancer screening tests [ Time Frame: within 18 months of index date ]

Eligibility Criteria

• Ages Eligible for Study: 11 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• meet above age criteria
• pcp practice at randomized clinic

Exclusion Criteria:

• current or past cancer diagnosis (excludes nonmelanoma skin cancer)
• hospice care or cancer chemotherapy
• Alzheimer's disease codes
• major cardiovascular event in 12 months prior to index date

Contacts and Locations

Locations

United States, Minnesota

Heidi Ekstrom

Minneapolis, Minnesota, United States, 55425

Sponsors and Collaborators

HealthPartners Institute

Investigators

• Principal Investigator: Thomas E Elliott, MD; HealthPartners Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harry ML, Truitt AR, Saman DM, Henzler-Buckingham HA, Allen CI, Walton KM, Ekstrom HL, O'Connor PJ, Sperl-Hillen JM, Bianco JA, Elliott TE. Barriers and facilitators to implementing cancer prevention clinical decision support in primary care: a qualitative study. BMC Health Serv Res. 2019 Jul 31;19(1):534. doi: 10.1186/s12913-019-4326-4.

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT02986230 History of Changes
• Other Study ID Numbers: 15-010
• First Posted: December 8, 2016
• Last Update Posted: July 2, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by HealthPartners Institute:

Cancer prevention; Clinical Decision Support; Rural Health; Shared Decision Making