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Completed

NCT Number: NCT02986230

Cancer Prevention Clinical Decision Support

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essentia Health

Duluth, Minnesota, 55805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-CDS

Other

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.

Other names: Cancer Prevention Wizard

Primary outcomes

  1. Composite Cancer Screening Tests up to Date

    Time frame: 1 year post index date

    Participants up to date on composite endpoint of breast, cervical, and colorectal cancer screening at 1 year post index date.

  2. HPV Vaccination up to Date

    Time frame: 1 year post index date

    Participants up to date on HPV vaccination at 1 year post index date.

Secondary outcomes

  1. Lung Cancer Screening up to Date

    Time frame: 1 year post index date

    Participants up to date on lung cancer screening at 1 year post index date.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

Implementing Cancer Prevention Using Patient-Provider Clinical Decision Support

Acronym: CP-CDS

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 8, 2016
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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