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

NCT ID: NCT03654963

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1702 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2020-01-08

Brief Summary

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.

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.

Conditions

Safety Issues

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Medication reconciliation

Intervention Type: PROCEDURE

Medication reconciliation is the systematic process described above.

Interventions

Medication reconciliation

Medication reconciliation is the systematic process described above.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Eligible patients will be included one-time only.

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Ceschi

Medical and scientific director of the Istituto di Scienze Farmacologiche della Svizzera Italiana

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr med Alessandro Ceschi, PD, FEAPCCT

Role: PRINCIPAL_INVESTIGATOR

Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale

Locations

Regional Hospital La Carità

Locarno, , Switzerland

Regional Hospital Beata Vergine

Mendrisio, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 34529065 (View on PubMed)

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id