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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVRS Early Intervention | Experimental | Patients participating in intervention offices will receive the pharmacist-led CVRS intervention for 12 months. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVRS Intervention | Behavioral |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Korey Kennelty, PharmD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Idaho State University | Pocatello | Idaho | 83201 | United States | ||
| University of Illinois at Chicago: Mile Square Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33444781 | Derived | 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. |
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12 months following the start of the study intervention.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 17, 2024 | |
| Unrelease | Nov 18, 2024 | |
| Release | Nov 18, 2024 |
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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.
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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 |
| Chicago |
| Illinois |
| 60608 |
| United States |
| Carle Foundation Hospital | Mahomet | Illinois | 61853 | United States |
| Carle Foundation Hospital | Rantoul | Illinois | 61866 | United States |
| Genesis Family Medical Center | Davenport | Iowa | 52804 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| UIHC River Crossing | Riverside | Iowa | 52327 | United States |
| Siouxland Family Medicine Center | Sioux City | Iowa | 51104 | United States |
| Northeast Iowa Family Practice Center | Waterloo | Iowa | 50702 | United States |
| Henry Ford Health System: Harbortown | Detroit | Michigan | 48207 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Texas Tech University Health Science Center | Amarillo | Texas | 79106 | United States |
| Community Health Center of Snohomish County | Everett | Washington | 98203 | United States |
| Reset | Nov 26, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 17, 2024 | Nov 18, 2024 | |||
| Nov 18, 2024 | Nov 26, 2024 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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