Dissemination of the Cardiovascular Risk Service

NCT ID: NCT03660631

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 542 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2024-12-30

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.

Conditions

Hypertension; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CVRS Early Intervention

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

Group Type: EXPERIMENTAL

CVRS Intervention

Intervention Type: BEHAVIORAL

1. Evaluate gaps in therapy

2. Contact patients regularly by email, phone and/or text message

3. Assess and counsel for medication adherence, side effects, life-style behaviors

4. Develop an action plan and send recommendations to provider

CVRS Delayed 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.

Group Type: OTHER

CVRS Intervention

Intervention Type: BEHAVIORAL

1. Evaluate gaps in therapy

2. Contact patients regularly by email, phone and/or text message

3. Assess and counsel for medication adherence, side effects, life-style behaviors

4. Develop an action plan and send recommendations to provider

Interventions

CVRS Intervention

1. Evaluate gaps in therapy

2. Contact patients regularly by email, phone and/or text message

3. Assess and counsel for medication adherence, side effects, life-style behaviors

4. Develop an action plan and send recommendations to provider

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korey Kennelty

OTHER

Sponsor Role: lead

Responsible Party

Korey Kennelty

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Korey Kennelty, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

Idaho State University

Pocatello, Idaho, United States

University of Illinois at Chicago: Mile Square Health Center

Chicago, Illinois, United States

Carle Foundation Hospital

Mahomet, Illinois, United States

Carle Foundation Hospital

Rantoul, Illinois, United States

Genesis Family Medical Center

Davenport, Iowa, United States

University of Iowa

Iowa City, Iowa, United States

UIHC River Crossing

Riverside, Iowa, United States

Siouxland Family Medicine Center

Sioux City, Iowa, United States

Northeast Iowa Family Practice Center

Waterloo, Iowa, United States

Henry Ford Health System: Harbortown

Detroit, Michigan, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Temple University

Philadelphia, Pennsylvania, United States

Texas Tech University Health Science Center

Amarillo, Texas, United States

Community Health Center of Snohomish County

Everett, Washington, United States

Countries

United States

References

Kennelty KA, Engblom NJ, Carter BL, Hollingworth L, Levy BT, Finkelstein RJ, Parker CP, Xu Y, Jackson KL, Dawson JD, Dorsey KK. Dissemination of a telehealth cardiovascular risk service: The CVRS live protocol. Contemp Clin Trials. 2021 Mar;102:106282. doi: 10.1016/j.cct.2021.106282. Epub 2021 Jan 12.

Reference Type: DERIVED

PMID: 33444781 (View on PubMed)

Other Identifiers

201710812

Identifier Type: -

Identifier Source: org_study_id