Clinical trial NCT03660631: Dissemination of the Cardiovascular Risk Service
Official title: Dissemination of the Cardiovascular Risk Service
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Diabetes Mellitus
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient subjects will participate in their office's randomization group (intervention or control) for the 1st 12 months of their participation. After 12 months, each patient subject in the control group will receive the study intervention for months 13-24. Patient subjects in the intervention will be followed by study pharmacists during months 13-24.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Factors influencing intervention implementation fidelity
timeFrame: 12 months following the start of the intervention at each site
measure: Effect of physician/pharmacist collaboration on implementation fidelity
timeFrame: 12 months following the start of the intervention at each site
Secondary outcomes:
measure: Adherence to guidelines for primary and secondary prevention of cardiovascular disease
timeFrame: 12 months after the start of the intervention for each subject
measure: Reach and adoption of intervention
timeFrame: 12 months following the start of the intervention at each site
measure: Development of payment contracts
timeFrame: 36 months following the start of recruitment
measure: Development of payment contracts
timeFrame: 36 months following the start of recruitment
Other outcomes:
Locations:
city: Pocatello
country: United States
facility: Idaho State University
state: Idaho
city: Chicago
country: United States
facility: University of Illinois at Chicago: Mile Square Health Center
state: Illinois
city: Mahomet
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Rantoul
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Davenport
country: United States
facility: Genesis Family Medical Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Riverside
country: United States
facility: UIHC River Crossing
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Family Medicine Center
state: Iowa
city: Waterloo
country: United States
facility: Northeast Iowa Family Practice Center
state: Iowa
city: Detroit
country: United States
facility: Henry Ford Health System: Harbortown
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Amarillo
country: United States
facility: Texas Tech University Health Science Center
state: Texas
city: Everett
country: United States
facility: Community Health Center of Snohomish County
state: Washington
Study officials:
affiliation: University of Iowa
name: Korey Kennelty, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.