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Contemp Clin Trials. 2017 Oct;61:126-132. doi: 10.1016/j.cct.2017.07.019. Epub 2017 Jul 21.

Medication Reviews Bridging Healthcare (MedBridge): Study protocol for a pragmatic cluster-randomised crossover trial.

Author information

1
Pharmacy Department, Uppsala University Hospital, Ing.13 2 tr, 751 85 Uppsala, Sweden. Electronic address: thomas.kempen@medsci.uu.se.
2
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
3
Pharmacy Department, Västmanland County Council, Västerås, Sweden.
4
Centre for Research and Development, Uppsala University/Region Gävleborg, Gävle, Sweden; Department of Development, Region Gävleborg, Gävle, Sweden.
5
Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
6
Department of Development, Region Gävleborg, Gävle, Sweden.
7
Department of Infectious Diseases, Västerås Hospital, Västerås, Sweden.
8
Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
9
Pharmacy Department, Uppsala University Hospital, Ing.13 2 tr, 751 85 Uppsala, Sweden.

Abstract

BACKGROUND:

Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence.

AIM:

To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews.

DESIGN:

Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.

SETTING:

8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.

PARTICIPANTS:

Patients aged 65years or older, admitted to one of the study wards.

EXCLUSION CRITERIA:

Palliative stage; residing in other than the hospital's county; medication review within the last 30days; one-day admission.

INTERVENTIONS:

1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care.

PRIMARY OUTCOME MEASURE:

Incidence of unplanned hospital visits during a 12-month follow-up period.

DATA COLLECTION AND ANALYSES:

Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using hierarchical models.

RELEVANCE:

This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.

KEYWORDS:

Cluster analysis; Crossover design; Inappropriate prescribing; Integrated health care systems; Medication review; Pragmatic clinical trial

PMID:
28739539
DOI:
10.1016/j.cct.2017.07.019
[Indexed for MEDLINE]

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