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

NCT03654963 | Completed

• 1 other identifier: 01
• Study Type: interventional
• Target: 1,702
• Locations: 1 country
• Sites: 2

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.

Conditions

Safety Issues

Keywords

medication reconciliation; safe pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of ADRs during hospital stay

  1 year

• Length of hospital stay

  1 year

• Death during hospital stay

  1 year

• Number of resources used during hospital stay

  1 year

Study Arms (2)

Control

NO INTERVENTION

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.

Medication reconciliation

EXPERIMENTAL

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

Interventions

Medication reconciliation PROCEDURE

Medication reconciliation is the systematic process described above.

Medication reconciliation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged ≥ 85 years
• patients with \> 10 drugs at admission
• Eligible patients will be included one-time only.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (2)

Regional Hospital La Carità

Locarno, 6600, Switzerland

Location

Regional Hospital Beata Vergine

Mendrisio, 6850, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34529065 DERIVED

MeSH Terms

Interventions

Medication Reconciliation

Intervention Hierarchy (Ancestors)

Medication Errors; Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Dr med Alessandro Ceschi, PD, FEAPCCT

  Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only pharmacy assistants and clinical pharmacists, who will obtain the best possible medication history and perform medication reconciliation, will know the assignment to either the intervention or the control group. Participants and outcomes assessor will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical and scientific director of the Istituto di Scienze Farmacologiche della Svizzera Italiana

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: November 5, 2018
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

CH (2)