CVRSLive: Dissemination of the Cardiovascular Risk Service

Sponsor

Korey Kennelty (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03660631

Collaborator

(none)

542

Enrollment

Locations

Arms

58.1

Anticipated Duration (Months)

38.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Diabetes Mellitus	Behavioral: CVRS Intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

542 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Dissemination of the Cardiovascular Risk Service

Actual Study Start Date :

Sep 27, 2018

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CVRS Early Intervention Patients participating in intervention offices will receive the pharmacist-led CVRS intervention for 12 months.	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
Other: 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.	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

Arm

Intervention/Treatment

Experimental: CVRS Early Intervention

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

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

Other: 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.

Behavioral: CVRS Intervention

Outcome Measures

Primary Outcome Measures

Factors influencing intervention implementation fidelity [12 months following the start of the intervention at each site]
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.
Effect of physician/pharmacist collaboration on implementation fidelity [12 months following the start of the intervention at each site]
Pearson correlation coefficient between provider/pharmacist survey scores and implementation fidelity

Secondary Outcome Measures

Adherence to guidelines for primary and secondary prevention of cardiovascular disease [12 months after the start of the intervention for each subject]
The percent of select Guideline Advantage criteria met by subjects in the Early Intervention arm versus the Delayed Intervention arm
Relationship of physician-pharmacist collaboration survey scores to sustainability themes [24 months following enrollment of each subject]
A list of themes identified via qualitative analysis of interview and focus group data about the factors that are critical for intervention sustainability
Relationship of physician-pharmacist collaboration survey scores to sustainability themes [24 months following enrollment of each subject]
Cross-site comparisons of sustainability themes by Collaboration survey scores
Development of payment contracts [36 months following the start of recruitment]
Create a template for payment contracts between clinical sites and the CVRS
Development of payment contracts [36 months following the start of recruitment]
The number of clinical sites that successfully negotiate payment contracts with the CVRS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

Diabetes with HA1c 9.0% or greater and/or
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Idaho State University	Pocatello	Idaho	United States	83201
2	University of Illinois at Chicago: Mile Square Health Center	Chicago	Illinois	United States	60608
3	Carle Foundation Hospital	Mahomet	Illinois	United States	61853
4	Carle Foundation Hospital	Rantoul	Illinois	United States	61866
5	Genesis Family Medical Center	Davenport	Iowa	United States	52804
6	University of Iowa	Iowa City	Iowa	United States	52242
7	UIHC River Crossing	Riverside	Iowa	United States	52327
8	Siouxland Family Medicine Center	Sioux City	Iowa	United States	51104
9	Northeast Iowa Family Practice Center	Waterloo	Iowa	United States	50702
10	Henry Ford Health System: Harbortown	Detroit	Michigan	United States	48207
11	University of North Carolina	Chapel Hill	North Carolina	United States	27514
12	Temple University	Philadelphia	Pennsylvania	United States	19140
13	Texas Tech University Health Science Center	Amarillo	Texas	United States	79106
14	Community Health Center of Snohomish County	Everett	Washington	United States	98203

Sponsors and Collaborators

Korey Kennelty

Investigators

Principal Investigator: Korey Kennelty, PharmD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Korey Kennelty, Associate Professor, University of Iowa

ClinicalTrials.gov Identifier:

NCT03660631

Other Study ID Numbers:

201710812

First Posted:

Sep 6, 2018

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of May 17, 2022