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Cancer Prevention Clinical Decision Support (CPW)

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

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.


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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

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.




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


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986230


Locations
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United States, Minnesota
Heidi Ekstrom
Minneapolis, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: Thomas E Elliott, MD HealthPartners Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02986230     History of Changes
Other Study ID Numbers: 15-010
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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