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Eur J Heart Fail. 2018 Sep;20(9):1350-1359. doi: 10.1002/ejhf.1213. Epub 2018 May 30.

PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.

Author information

1
Department of Cardiology, University Hospital, Leipzig University, Germany.
2
Department of Medicine, ABDA - Federal Union of German Associations of Pharmacists, Berlin, Germany.
3
Department of Internal Medicine III - Cardiology, Angiology and Intensive Care Medicine, Saarland University Medical Centre, University of the Saarland, Homburg/Saar, Germany.
4
Division of Cardiology and Metabolism; Department of Cardiology (CVK); and Berlin-Brandenburg Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin Berlin, Germany.
5
Department of Cardiology and Pneumology, University Medicine Göttingen (UMG), Göttingen, Germany.
6
Centre for Cardiovascular Telemedicine, Department of Cardiology and Angiology, Charité Universitätsmedizin Berlin, Germany.
7
Schwemlinger Gemeinschaftspraxis, Merzig, Germany.
8
Department of Clinical Pharmacology, University Heart Centre Freiburg-Bad Krozingen, Germany.
9
Drug Commission of German Pharmacists (AMK), Berlin, Germany.

Abstract

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119.

KEYWORDS:

Chronic heart failure; Community pharmacy services; Hospitalization; Interdisciplinary care; Medication adherence; Randomized controlled trial

PMID:
29846031
DOI:
10.1002/ejhf.1213
[Indexed for MEDLINE]

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