Dissemination of the Cardiovascular Risk Service

NCT03660631 | Active Not Recruiting DMC

• 1 other identifier: 201710812
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 14

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.

Conditions

Hypertension; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Adherence to guidelines for primary and secondary prevention of cardiovascular disease

  12 months after the start of the intervention for each subject

• Reach and adoption of intervention

  12 months following the start of the intervention at each site

• Development of payment contracts

  36 months following the start of recruitment

• Development of payment contracts

  36 months following the start of recruitment

Study Arms (2)

CVRS Early Intervention

EXPERIMENTAL

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

Behavioral: CVRS Intervention

CVRS Delayed Intervention

OTHER

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.

Behavioral: CVRS Intervention

Interventions

CVRS Intervention 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; CVRS Early Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Diabetes with HA1c 9.0% or greater and/or
• Hypertension (uncomplicated) with systolic blood pressure 150 mm Hg or greater

You may not qualify if:

• Inability to give consent
• Nursing home residence
• No telephone
• Cancer with a life expectancy less than 24 months
• Pregnancy
• Diagnosis of dementia
• Plans to terminate care from the clinic within 24 months

Sponsors & Collaborators

• Korey Kennelty: lead

Study Sites (14)

Idaho State University

Pocatello, Idaho, 83201, United States

Location

University of Illinois at Chicago: Mile Square Health Center

Chicago, Illinois, 60608, United States

Location

Carle Foundation Hospital

Mahomet, Illinois, 61853, United States

Location

Carle Foundation Hospital

Rantoul, Illinois, 61866, United States

Location

Genesis Family Medical Center

Davenport, Iowa, 52804, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

UIHC River Crossing

Riverside, Iowa, 52327, United States

Location

Siouxland Family Medicine Center

Sioux City, Iowa, 51104, United States

Location

Northeast Iowa Family Practice Center

Waterloo, Iowa, 50702, United States

Location

Henry Ford Health System: Harbortown

Detroit, Michigan, 48207, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Texas Tech University Health Science Center

Amarillo, Texas, 79106, United States

Location

Community Health Center of Snohomish County

Everett, Washington, 98203, United States

Location

Related Publications (1)

• 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.

  PMID: 33444781 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Korey Kennelty, PharmD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: September 6, 2018
• Study Start: September 27, 2018
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months following the start of the study intervention.

Locations

US (14)