Medication Reviews Bridging Healthcare: a Cluster-randomised Crossover Trial
MedBridge
1 other identifier
interventional
2,637
1 country
4
Brief Summary
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 65 years 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 30 days; 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 log-linear Poisson generalized linear mixed models and frailty 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedStudy Start
First participant enrolled
February 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2020
CompletedJune 25, 2021
June 1, 2021
2.8 years
December 14, 2016
June 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of unplanned hospital visits, extracted from the patients' electronic medical record
Admissions plus visits to the emergency department
12 months
Secondary Outcomes (26)
Unplanned hospital admissions, extracted from the patients' electronic medical record
30 days
Unplanned hospital admissions, extracted from the patients' electronic medical record
3 months
Unplanned hospital admissions, extracted from the patients' electronic medical record
6 months
Unplanned hospital admissions, extracted from the patients' electronic medical record
12 months
Emergency department visits, extracted from the patients' electronic medical record
30 days
- +21 more secondary outcomes
Study Arms (3)
Comprehensive medication review (I1)
ACTIVE COMPARATORComprehensive medication review with active follow-up (I2)
ACTIVE COMPARATORUsual care (Control)
OTHERInterventions
* A thorough medication reconciliation, including a patient/carer interview, by a clinical pharmacist. * The clinical pharmacist performs a comprehensive medication review in collaboration with the ward physician and patient, similar to a level three clinical medication review as earlier described in the literature \[4\]. This includes a structured, critical examination of all of the patient's medications in relation to the patient's conditions, based on information from the patient and the medical record. The objective is to optimise the impact of medications and minimizing the number of medication-related problems. The effects of medication changes will be monitored during the hospital stay by the physician or pharmacist, depending on the specific situation. * Before discharge, the clinical pharmacist performs another medication reconciliation to check if the patient's prescriptions for medications to be used after hospital stay are consistent with the patient's medical record.
The same as I1 but with the following additions: * In case of any monitoring needs or necessary subsequent actions to be taken after hospital discharge, the clinical pharmacist and the ward physician send an electronic medication review referral to the patient's primary care physician upon discharge. * A first phone call to the patient or carer is made by the clinical pharmacist 2-7 days after the patient is discharged depending on health condition and the pharmacist's availability. This phone call aims to ensure that all information has been understood correctly and to find out if any problems, concerns or questions have arisen after discharge. * A second phone call will be made by the clinical pharmacist approximately 30 days after hospital discharge. This phone call aims to find out how the patient is managing the medication and if any problems, concerns or questions have arisen, and to provide the patient with a motivational "boost".
The control group will receive usual hospital care. According to Swedish legislation, usual care includes medication reconciliation upon admission. Next to that, the law requires a medication report addressing the patient's medication treatment to be given to the patient or carer upon hospital discharge and to be attached to the electronic discharge letter. This report contains a motivation and explanation to the changes in medication treatment that have been made during hospital stay, as well as the patient's updated medication list. These mandatory activities are currently carried out to various degree within the different hospitals and wards. Other activities as described in the interventions above may be carried out to a certain degree as well, but no clinical pharmacist will be involved.
Eligibility Criteria
You may qualify if:
- Admitted to one of the study wards
You may not qualify if:
- Has been subject to a medication review within the last 30 days as stated within their medical record;
- Residing in another than the hospital's county
- Being in a palliative stage as stated in their medical record
- Admitted for only one day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala County Council, Swedenlead
- Region Gävleborgcollaborator
- Västmanland County Council, Swedencollaborator
- Uppsala Universitycollaborator
- Uppsala Clinical Research Center, Swedencollaborator
Study Sites (4)
Gävle Hospital
Gävle, Gävleborg County, 80324, Sweden
Enköping Hospital
Enköping, Uppsala County, 74538, Sweden
Uppsala University Hospital
Uppsala, Uppsala County, 75185, Sweden
Västmanland Hospital
Västerås, Västmanlands Lan, 72334, Sweden
Related Publications (6)
Kempen TGH, Bertilsson M, Lindner KJ, Sulku J, Nielsen EI, Hogberg A, Vikerfors T, Melhus H, Gillespie U. Medication Reviews Bridging Healthcare (MedBridge): Study protocol for a pragmatic cluster-randomised crossover trial. Contemp Clin Trials. 2017 Oct;61:126-132. doi: 10.1016/j.cct.2017.07.019. Epub 2017 Jul 21.
PMID: 28739539BACKGROUNDKempen TGH, Hedstrom M, Olsson H, Johansson A, Ottosson S, Al-Sammak Y, Gillespie U. Assessment tool for hospital admissions related to medications: development and validation in older patients. Int J Clin Pharm. 2019 Feb;41(1):198-206. doi: 10.1007/s11096-018-0768-8. Epub 2018 Dec 26.
PMID: 30585296BACKGROUNDKempen TGH, Kalvemark A, Gillespie U, Stewart D. Comprehensive medication reviews by ward-based pharmacists in Swedish hospitals: What does the patient have to say? J Eval Clin Pract. 2020 Feb;26(1):149-157. doi: 10.1111/jep.13121. Epub 2019 Mar 4.
PMID: 30834647RESULTKempen TGH, Cam H, Kalvemark A, Lindner KJ, Melhus H, Nielsen EI, Sulku J, Gillespie U. Intervention fidelity and process outcomes of medication reviews including post-discharge follow-up in older hospitalized patients: Process evaluation of the MedBridge trial. J Clin Pharm Ther. 2020 Oct;45(5):1021-1029. doi: 10.1111/jcpt.13128. Epub 2020 Mar 14.
PMID: 32171028RESULTKempen TGH, Kalvemark A, Sawires M, Stewart D, Gillespie U. Facilitators and barriers for performing comprehensive medication reviews and follow-up by multiprofessional teams in older hospitalised patients. Eur J Clin Pharmacol. 2020 Jun;76(6):775-784. doi: 10.1007/s00228-020-02846-8. Epub 2020 Feb 19.
PMID: 32076745RESULTKempen TGH, Bertilsson M, Hadziosmanovic N, Lindner KJ, Melhus H, Nielsen EI, Sulku J, Gillespie U. Effects of Hospital-Based Comprehensive Medication Reviews Including Postdischarge Follow-up on Older Patients' Use of Health Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e216303. doi: 10.1001/jamanetworkopen.2021.6303.
PMID: 33929523RESULT
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Ulrika Gillespie
Uppsala University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 14, 2016
First Posted
December 21, 2016
Study Start
February 6, 2017
Primary Completion
December 11, 2019
Study Completion
June 3, 2020
Last Updated
June 25, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share