Dissemination of the Cardiovascular Risk Service

Hypertension Clinical Trial

— CVRSLive  

Official title:

Dissemination of the Cardiovascular Risk Service

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03660631
• Other study ID #: 201710812
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 542
• Est. completion date: August 1, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

Behavioral:
• CVRS Intervention
Evaluate gaps in therapy Contact patients regularly by email, phone and/or text message Assess and counsel for medication adherence, side effects, life-style behaviors Develop an action plan and send recommendations to provider

Locations

Country	Name	City	State
United States	Texas Tech University Health Science Center	Amarillo	Texas
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Illinois at Chicago: Mile Square Health Center	Chicago	Illinois
United States	Genesis Family Medical Center	Davenport	Iowa
United States	Henry Ford Health System: Harbortown	Detroit	Michigan
United States	Community Health Center of Snohomish County	Everett	Washington
United States	University of Iowa	Iowa City	Iowa
United States	Carle Foundation Hospital	Mahomet	Illinois
United States	Temple University	Philadelphia	Pennsylvania
United States	Idaho State University	Pocatello	Idaho
United States	Carle Foundation Hospital	Rantoul	Illinois
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

Sponsors (1)

Lead Sponsor	Collaborator
Korey Kennelty

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors influencing intervention implementation fidelity	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.	12 months following the start of the intervention at each site
Primary	Effect of physician/pharmacist collaboration on implementation fidelity	Development of implementation fidelity measures and adherence to fidelity measures	12 months following the start of the intervention at each site
Secondary	Adherence to guidelines for primary and secondary prevention of cardiovascular disease	The percent of select Guideline Advantage criteria met by subjects in the Early Intervention arm versus the Delayed Intervention arm	12 months after the start of the intervention for each subject
Secondary	Reach and adoption of intervention	Proportion of patients and providers participating who were approached	12 months following the start of the intervention at each site
Secondary	Development of payment contracts	Create a template for payment contracts between clinical sites and the CVRS	36 months following the start of recruitment
Secondary	Development of payment contracts	The number of clinical sites that successfully negotiate payment contracts with the CVRS	36 months following the start of recruitment