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NCT Number: NCT03660631

Dissemination of the Cardiovascular Risk Service

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Idaho State University, Pocatello, Idaho, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CVRS Intervention

Behavioral
  • 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

Primary outcomes

  1. Factors influencing intervention implementation fidelity

    Time frame: 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.

  2. Effect of physician/pharmacist collaboration on implementation fidelity

    Time frame: 12 months following the start of the intervention at each site

    Development of implementation fidelity measures and adherence to fidelity measures

Secondary outcomes

  1. Adherence to guidelines for primary and secondary prevention of cardiovascular disease

    Time frame: 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

  2. Reach and adoption of intervention

    Time frame: 12 months following the start of the intervention at each site

    Proportion of patients and providers participating who were approached

  3. Development of payment contracts

    Time frame: 36 months following the start of recruitment

    Create a template for payment contracts between clinical sites and the CVRS

  4. Development of payment contracts

    Time frame: 36 months following the start of recruitment

    The number of clinical sites that successfully negotiate payment contracts with the CVRS

Sponsors and collaborators

Lead sponsor

Korey Kennelty

Other

Registry information

Acronym: CVRSLive

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Sep 6, 2018
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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