Dissemination of the Cardiovascular Risk Service

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus; Hypertension
• Interventions: Behavioral: CVRS Intervention

• Registration Number: NCT03660631
• Lead Sponsor: Korey Kennelty

Brief Summary

The objective of this study is to evaluate the implementation of of a remote, pharmacist-led cardiovascular risk service (CVRS) in 12 large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients.

Detailed Description

Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. Yet effective implementation of research-based interventions that reduce CVD-related illness and death remains a substantial challenge. The objective of this study is to test the scalability of a pharmacist-led, remote CVD risk and prevention services model in large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients, using a pragmatic cluster-randomized design. This service is called the Cardiovascular Risk Service (CVRS). There are limited data on the barriers and facilitators of implementation to enhance the CVRS in these types of diverse, complex health-systems. Therefore, scaling up our effective, innovative team-based intervention will require an assessment of barriers and facilitators to CVRS adoption, implementation, and maintenance. Our central hypothesis is that barriers and facilitators to CVRS implementation will vary across diverse primary care offices. We will use mixed methods including interviews, observations, and an innovative physician-pharmacist collaboration survey we developed to predict implementation of pharmacy-based services. The rationale for this proposed study is that overcoming barriers to implementation of a novel strategy to improve secondary prevention of CVD will lead to innovative strategies for broader adoption by health systems throughout the US.

Study Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Study Start: 2018-09-27
• Primary Completion: 2023-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

• Patient Subjects:

  • English or Spanish speaking

  • Seen in the clinic at least once in the previous 12 months

  • Currently has one of the following diseases:

    1. Diabetes with HA1c 9.0% or greater and/or
    2. Hypertension (uncomplicated) with systolic blood pressure 150 mm Hg or greater

Exclusion Criteria

• Inability to give consent

• Nursing home residence

• No telephone

  • Additional patient subject exclusions:

• Cancer with a life expectancy less than 24 months

• Pregnancy

• Diagnosis of dementia

• Plans to terminate care from the clinic within 24 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVRS Early Intervention	CVRS Intervention	Patients participating in intervention offices will receive the pharmacist-led CVRS intervention for 12 months.
CVRS Delayed Intervention	CVRS Intervention	Patients participating in control site offices will not have any contact with the CVRS pharmacist for the first 12 months of their participation in the study. They will receive the study intervention during months 13-24.

Primary Outcome Measures

Name	Time	Method
Factors influencing intervention implementation fidelity	12 months following the start of the intervention at each site	Themes will be identified through interviews with key individuals involved in implementation of study intervention. Data from interviews will be analyzed using ATLAS ti to determine frequency and density of themes identified in interviews.
Effect of physician/pharmacist collaboration on implementation fidelity	12 months following the start of the intervention at each site	Development of implementation fidelity measures and adherence to fidelity measures

Secondary Outcome Measures

Name	Time	Method
Reach and adoption of intervention	12 months following the start of the intervention at each site	Proportion of patients and providers participating who were approached
Development of payment contracts	36 months following the start of recruitment	The number of clinical sites that successfully negotiate payment contracts with the CVRS
Adherence to guidelines for primary and secondary prevention of cardiovascular disease	12 months after the start of the intervention for each subject	The percent of select Guideline Advantage criteria met by subjects in the Early Intervention arm versus the Delayed Intervention arm

Trial Locations

Locations (13)

University of Illinois at Chicago: Mile Square Health Center; 🇺🇸 Chicago, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Siouxland Family Medicine Center; 🇺🇸 Sioux City, Iowa, United States

Idaho State University; 🇺🇸 Pocatello, Idaho, United States

Genesis Family Medical Center; 🇺🇸 Davenport, Iowa, United States

UIHC River Crossing; 🇺🇸 Riverside, Iowa, United States

Northeast Iowa Family Practice Center; 🇺🇸 Waterloo, Iowa, United States

Community Health Center of Snohomish County; 🇺🇸 Everett, Washington, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Tech University Health Science Center; 🇺🇸 Amarillo, Texas, United States

Carle Foundation Hospital; 🇺🇸 Rantoul, Illinois, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Henry Ford Health System: Harbortown; 🇺🇸 Detroit, Michigan, United States