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. 2021 Mar:102:106282.
doi: 10.1016/j.cct.2021.106282. Epub 2021 Jan 12.

Dissemination of a telehealth cardiovascular risk service: The CVRS live protocol

Korey A Kennelty  1 , Nels J Engblom  2 , Barry L Carter  3 , Liz Hollingworth  4 , Barcey T Levy  5 , Rachel J Finkelstein  2 , Christopher P Parker  2 , Yinghui Xu  6 , Kayla L Jackson  4 , Jeffrey D Dawson  7 , Kathryn K Dorsey  2
Affiliations

Dissemination of a telehealth cardiovascular risk service: The CVRS live protocol

Korey A Kennelty et al. Contemp Clin Trials. 2021 Mar.

Abstract

Background: Medical clinics are increasingly hiring clinical pharmacists to improve management of cardiovascular disease (CVD). However, the limited number of clinical pharmacists employed in a clinic may not impact the large number of complex patients needing the services. We have developed a remote telehealth service provided by clinical pharmacists to complement CVD services provided by on-site clinical pharmacists and aid sites without a clinical pharmacist. This cardiovascular risk service (CVRS) has been studied in two NIH-funded trials, however, we identified barriers to optimal intervention implementation. The purpose of this study is to examine how to implement the CVRS into medical offices and see if the intervention will be sustained.

Methods: This is a 5-year, pragmatic, cluster-randomized clinical trial in 13 primary care clinics across the US. We randomized clinics to receive CVRS or usual care and will enroll 325 patient subjects and 288 key stakeholder subjects. We have obtained access to the electronic medical records (EMRs) of all study clinics to recruit subjects and provide the pharmacist intervention. The intervention is staggered so that after 12 months, the usual care sites will receive the intervention for 12 months. Follow-up will be accomplished though medical record abstraction at baseline, 12 months, 24 months, and 36 months.

Conclusions: This study will enroll subjects through 2021 and results will be available in 2024. This study will provide unique information on how the CVRS provided by remote clinical pharmacists can be effectively implemented in medical offices, many of which already employ on-site clinical pharmacists.

Clinical trial registration information: NCT03660631: http://clinicaltrials.gov/ct2/show/NCT03660631.

Keywords: Cardiovascular disease; Hypertension; Implementation; Pharmacists; Pragmatic clinic trials; Team-based care; Telehealth.

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Conflict of interest statement

Author declaration

1) We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome.

2) We confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed. We further confirm that the order of authors listed in the manuscript has been approved by all of us.

3) We confirm that neither the entire paper nor any of its content has been submitted, published, or accepted by another journal. The paper will not be submitted elsewhere if accepted for publication in the Journal.

4) We confirm that we have given due consideration to the protection of intellectual property associated with this work and that there are no impediments to publication, including the timing of publication, with respect to intellectual property. In so doing we confirm that we have followed the regulations of our institutions concerning intellectual property.

5) We confirm that any aspect of the work covered in this manuscript that has involved either experimental animals or human patients has been conducted with the ethical approval of all relevant bodies and that such approvals are acknowledged within the manuscript.

6) We understand that the Corresponding Author is the sole contact for the Editorial process (including Editorial Manager and direct communications with the office). He/she is responsible for communicating with the other authors about progress, submissions of revisions and final approval of proofs.

Figures

Figure 1.
Figure 1.
Depiction of Study Design and Aims
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