Cancer Prevention Clinical Decision Support (CP-CDS)

HealthPartners Institute

Status: Completed

Conditions: Cancer Prevention

Treatments: Other: CP-CDS

Study type: Interventional

Funder types: Other

Identifiers

NCT02986230

15-010

Details and patient eligibility

About

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.

Full 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, EHR data is sent to evidence-based cancer prevention algorithms, housed on a secure Web site. The algorithms: (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), appropriate evidence-based primary cancer prevention interventions and cancer screening options at the point of care. The cancer prevention (CP)-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: CP-CDS intervention in which the decision support is printed for the PCP and patient, designed to engage patients in discussions about appropriate cancer prevention strategies. Group 2: CP-CDS + shared decision making tools (SDMT) intervention in which the CP-CDS is printed along with additional shared decision making tools. Group 3: clinics provide usual care (UC) 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 12-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. Secondary analysis will evaluate the impact of the intervention on lung cancer screening. 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 Reach, Effectiveness, Adoption, Implementation, and Maintenance (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.

Enrollment: 35,953 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35,953 participants in 3 patient groups

CP-CDS

Experimental group

Description:

The CP-CDS 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.

Treatment:

Other: CP-CDS

CP-CDS + SDMT

Experimental group

Description:

The CP-CDS + SDMT 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 CP-CDS + SDMT arm also provides shared decision making tools to patient and provider at the time of the visit.

Treatment:

Other: CP-CDS

Usual Care

No Intervention group

Description:

The usual care group will have no access to the CP-CDS, or the CP-CDS + SDMT.