Dissemination of the Cardiovascular Risk Service (CVRSLive)

Korey Kennelty

Status: Active, not recruiting

Conditions: Hypertension; Diabetes Mellitus

Treatments: Behavioral: CVRS Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03660631

201710812

Details and patient eligibility

About

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.

Full 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.

Enrollment: 542 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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542 participants in 2 patient groups

CVRS Early Intervention

Experimental group

Description:

Patients participating in intervention offices will receive the pharmacist-led CVRS intervention for 12 months.

Treatment:

Behavioral: CVRS Intervention

CVRS Delayed Intervention

Other group

Description:

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.

Treatment:

Behavioral: CVRS Intervention