Cancer Prevention Clinical Decision Support (CPW)
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| ClinicalTrials.gov Identifier: NCT02986230 |
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Recruitment Status :
Completed
First Posted : December 8, 2016
Last Update Posted : April 12, 2021
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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 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30252 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 |
| Actual Primary Completion Date : | October 31, 2020 |
| Actual Study Completion Date : | February 28, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
- Cancer screening tests [ Time Frame: within 18 months of index date ]
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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 |
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
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
| United States, Minnesota | |
| Heidi Ekstrom | |
| Minneapolis, Minnesota, United States, 55425 | |
| Principal Investigator: | Thomas E Elliott, MD | HealthPartners Institute |
| Responsible Party: | HealthPartners Institute |
| ClinicalTrials.gov Identifier: | NCT02986230 |
| Other Study ID Numbers: |
15-010 |
| First Posted: | December 8, 2016 Key Record Dates |
| Last Update Posted: | April 12, 2021 |
| Last Verified: | March 2021 |
| 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 |
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Cancer prevention Clinical Decision Support Rural Health Shared Decision Making |