Clinical trial NCT03654963: Study to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes
Official title: Parallel Group Randomized Controlled Trial to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Keywords: medication reconciliation
safe pharmacotherapy
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 1702
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: centralized randomization; a unique list of randomization will be generated by the clinical trial unit (CTU) of the EOC with an ad hoc software, and patients will be allocated 1:1 in either the intervention or the control group.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite post-discharge healthcare use variable
timeFrame: Within 30 days after initial discharge
Secondary outcomes:
measure: Incidence of ADRs during hospital stay
timeFrame: 1 year
measure: Length of hospital stay
timeFrame: 1 year
measure: Death during hospital stay
timeFrame: 1 year
measure: Number of resources used during hospital stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Locarno
country: Switzerland
facility: Regional Hospital La Carità
city: Mendrisio
country: Switzerland
facility: Regional Hospital Beata Vergine
Study officials:
affiliation: Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale
name: Dr med Alessandro Ceschi, PD, FEAPCCT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.