Cluster-randomized trial to evaluate a centralized clinical pharmacy service in private family medicine offices
Open accessAbstract
Background: The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities. Methods and Results: This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects. There was no improvement in the Guideline Advantage score from baseline to 12 months in the control group (64.7% versus 63.1%, respectively; P =0.21). There was a statistically significant improvement in the intervention group from 63.3% at baseline to 67.8% at 12 months ( P =0.02). The estimated benefit of the intervention was 5.0%±2.4% (95% confidence interval=−0.5% to 10.4%; P =0.07). Several criteria were significantly better for intervention subjects, including appropriate statin therapy ( P <0.001), body mass index, screening ( P <0.001), and alcohol screening ( P <0.001). Only 13.7% of subjects with diabetes mellitus had hemoglobin A1c at goal at baseline, and this increased to 30.8% and 21.0% in the intervention and control group, respectively, at 12 months ( P =0.10). Conclusions: The centralized, remote pharmacist intervention was successfully implemented. The improvements in outcomes were modest, in part because of higher than expected baseline guideline adherence. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT 01983813
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Diabetes trials have inadequate equity-related considerations, which limits how relevant and applicable their data are to disadvantaged populations.
“There are inadequate equity-related considerations in DM trials limiting the relevance and applicability of their data to disadvantaged populations.1671”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1671]
The Discussion (page not provided) says this trial included few minority participants and that including more would improve its generalizability. That supports a concern about representation, but this was a trial of a pharmacy service for multiple cardiovascular risk conditions; it does not establish that diabetes trials generally have inadequate equity considerations or that their data are less applicable to disadvantaged populations broadly. (LLM, conf=0.84)
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- Authors
- Carter, B. L., Levy, B., Gryzlak, B., Xu, Y., Chrischilles, E., Dawson, J., Vander Weg, M., Christensen, A., James, P., & Polgreen, L.
- Affiliations
- University of Iowa (US)
- Department of Pharmacy Practice and Science, College of Pharmacy (B.L.C., B.G., L.P.)
- Department of Epidemiology, College of Public Health (B.L., B.G., E.C.)
- Department of Biostatistics, College of Public Health (J.D.)
- Department of Internal Medicine, Carver College of Medicine (M.V.W., A.C.)
- University of Washington (US)
- ORCID
- Venue
- Circulation: Cardiovascular Quality and Outcomes
- Published
- 2018-06
- Volume
- 11
- Issue
- 6
- Pages
- e004188-e004188
- ISSN
- 1941-7705 (ISSN-L)
- 1941-7713
- PMC
- PMC5996776
- OpenAlex
- W2806629360
- Cited by
- 46
- References
- 44
- Citations by year
- 2025: 3 · 2024: 7 · 2023: 9 · 2022: 13 · 2021: 4 · 2020: 6 · 2019: 2 · 2018: 2
- FWCI
- 3.85
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Circulation Cardiovascular Quality and Outcomes (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Heart, Lung, and Blood Institute (R01HL116311)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacy and Medical Practices
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Keywords
- clinical pharmacy services, guideline adherence, cardiovascular risk factors, statin therapy, diabetes mellitus, HbA1c, alcohol screening, rural primary care, team-based care, cardiovascular disease prevention
- MeSH terms
- Aged, Cardiovascular Diseases, Centralized Hospital Services, Female, Humans, Iowa, Male, Middle Aged, Patient Care Team, Pharmacists, Pharmacy Service, Hospital, Practice Patterns, Physicians', Preventive Health Services, Primary Health Care, Private Practice, Prospective Studies, Risk Factors, Time Factors, Cluster Analysis, Treatment Outcome, Models, Organizational, Practice Guidelines as Topic, Risk Assessment, Delivery of Health Care, Integrated, Remote Consultation, Guideline Adherence
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