Study to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes (MedRec)

Parallel Group Randomized Controlled Trial to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes

Medication reconciliation is a systematic process by which health care professionals obtain the most complete and accurate information about the drugs regularly taken by patients. Internationally, the value of this procedure is mainly attributed to the reduction in the number of adverse drug events, which can cause drug-related morbidity and mortality, as well as unnecessary health care costs.

As part of the Progress! Pilot project Safe Pharmacotherapy at the interface points, promoted by the Federal Office of Public Health, coordinated by the Swiss Patients Safety Foundation and held in several Swiss hospitals, medication reconciliation at hospital admission was introduced at the regional hospital Beata Vergine in Mendrisio, from 2014 to 2016. During this pilot project it was shown that medication reconciliation after obtaining the best possible medication history by a pharmacist at hospital admission, in comparison with the standard medication history obtained by the physician at admission, reduced the number of clinically relevant drug discrepancies.

A structured, well-established and practicable procedure of medication reconciliation that improves patient safety assuring a better quality of care at hospital admission might provide evidence that medication reconciliation could be a valuable intervention to be applied systematically in all EOC hospitals at admission, as well as subsequently potentially at the other hospital interfaces.

The purpose of this study is to evaluate whether obtaining the best possible medication history and performing medication reconciliation at hospital admission results in improving some specific healthcare outcomes.

The study seeks primarily to determine if obtaining the best possible medication history and performing medication reconciliation, in comparison with the standard medication history, reduces the number of subsequent unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge). As secondary objectives, the study aims at assessing if best possible medication history with medication reconciliation, in comparison with the standard medication history, reduces the incidence of adverse drug reactions during hospital stay, shortens length of stay, leads to a reduction in the use of hospital resources, and/or is associated with a decreased number of deaths.

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Procedure: Medication reconciliation

Detailed Description

Patients of the control group will not receive the best possible medication history with medication reconciliation at admission. The standard physician-acquired medication history will be performed as usual.

Eligible patients, randomized within the intervention arm, will receive medication reconciliation according to the following steps:

1. The pharmacy assistant will obtain the best possible medication history by compiling a comprehensive list of the medications the patient is taking and details about how the drugs are taken. In order to confirm the accuracy of the history, the pharmacy assistant will use at least two sources of information, one of which being, when possible, the interview with the patient and/or family members, in addition to referral letters, prescriptions and drug lists from primary care centres, and other.
2. The clinical pharmacist will reconcile best possible medication history with prescribed medicines and, to resolve unclear or ambiguous discrepancies between the two lists and/or to propose any adaptations of the pharmacotherapy, the clinical pharmacist will refer to the medical doctor.
3. The medical doctor will decide potential changes in pharmacotherapy and communicate them to the patient providing complete information on medicines.

• Study Type: Interventional
• Enrollment (Actual): 1702
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Locarno, Switzerland, 6600
    • Regional Hospital La Carità
  • Mendrisio, Switzerland, 6850
    • Regional Hospital Beata Vergine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients admitted to the inpatient wards of the two regional hospitals Beata Vergine in Mendrisio and La Carità in Locarno, fulfilling one of the following inclusion criteria, will be eligible for the study:

• patients aged ≥ 85 years
• patients with > 10 drugs at admission

Patients with home care as well as patients from elderly homes, meeting the inclusion criteria, will be factored in the study population.

Eligible patients will be included one-time only.

Exclusion Criteria:

The presence of any of the following exclusion criteria will lead to patient exclusion:

• patients admitted to intensive care unit who do not reach inpatient wards
• patients who are planned to stay within inpatient wards for less than 48 hours
• patients who have been admitted to any of the EOC hospital wards within the previous 3 months and have been discharged at home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients of the control group will not receive the best possible medication history with medication reconciliation at admission. The standard physician-acquired medication history will be performed as usual.
Experimental: Medication reconciliation; The pharmacy assistant will obtain the best possible medication history by compiling a comprehensive list of the medications the patient is taking. To confirm the accuracy of the history, the pharmacy assistant will use at least two sources of information, one of which being, when possible, the interview with the patient and/or family members. The clinical pharmacist will reconcile the best possible medication history with prescribed medicines and, to resolve unclear or ambiguous discrepancies between the two lists and/or to propose any adaptations of the pharmacotherapy, the clinical pharmacist will refer to the medical doctor. The medical doctor will decide potential changes in pharmacotherapy and communicate them to the patient.	Procedure: Medication reconciliation; Medication reconciliation is the systematic process described above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite post-discharge healthcare use variable	Total number of unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge).	Within 30 days after initial discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ADRs during hospital stay	To measure the incidence of ADRs developed by patients during the hospital stay, the active pharmacovigilance system currently in use at the Centro Regionale di Farmacovigilanza del Canton Ticino, will be exploited. EMRs identified through this system and referring to patients from both the two study sites, aged ≥85 years or with more than 10 medications at admission, will be manually validated (to discard false positive cases). Subsequently, ADRs will be categorized as not serious or serious (according to the WHO seriousness criteria, for resulting in death, being life threatening, prolonging hospitalization, resulting in persistent disability or incapacity and other). Outcome assessor will be masked to group allocation. At the end of the analysis, ADRs will be matched to either the intervention or the control group	1 year
Length of hospital stay		1 year
Death during hospital stay		1 year
Number of resources used during hospital stay	Laboratory tests, radiologic exams, echocardiography, electrocardiograms	1 year

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Investigators: Principal Investigator: Dr med Alessandro Ceschi, PD, FEAPCCT, Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale

Publications and helpful links

General Publications

• Ceschi A, Noseda R, Pironi M, Lazzeri N, Eberhardt-Gianella O, Imelli S, Ghidossi S, Bruni S, Pagnamenta A, Ferrari P. Effect of Medication Reconciliation at Hospital Admission on 30-Day Returns to Hospital: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2124672. doi: 10.1001/jamanetworkopen.2021.24672.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: medication reconciliation; safe pharmacotherapy
• Other Study ID Numbers: 01 (Miami VAHS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No