Dissemination of the Cardiovascular Risk Service

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dissemination of the Cardiovascular Risk Service

Conditions
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Hypertension, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: CVRS Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CVRS Early Intervention<br>Patients participating in intervention offices will receive the pharmacist-led CVRS intervention for 12 months. | Behavioral: CVRS Intervention<br>* 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<br>|
| Other: CVRS Delayed Intervention<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Development of payment contracts | Create a template for payment contracts between clinical sites and the CVRS | 36 months following the start of recruitment | 
| Development of payment contracts | The number of clinical sites that successfully negotiate payment contracts with the CVRS | 36 months following the start of recruitment |