Diabetes Mellitus, Hypertension
Conditions
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.
Interventions
BEHAVIORALCVRS Intervention
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
Sponsors
Korey Kennelty
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Development of implementation fidelity measures and adherence to fidelity measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Reach and adoption of intervention | 12 months following the start of the intervention at each site | Proportion of patients and providers participating who were approached |
| Development of payment contracts | 36 months following the start of recruitment | Create a template for payment contracts between clinical sites and the CVRS |
Countries
United States
Outcome results
None listed