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Spots Global Cancer Trial Database for Cancer Prevention Clinical Decision Support

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Trial Identification

Brief Title: Cancer Prevention Clinical Decision Support

Official Title: Implementing Cancer Prevention Using Patient-Provider Clinical Decision Support

Study ID: NCT02986230

Interventions

CP-CDS

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.

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, 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Essentia Health, Duluth, Minnesota, United States

Contact Details

Name: Thomas E Elliott, MD

Affiliation: HealthPartners Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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