Evaluation of Pharmacist-led Medication Reconciliation Service Benefits in Hospitalised Medical Patients

NCT06207500 | Terminated

• 1 other identifier: 8019163
• Study Type: interventional
• Target: 553
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Transitions of care often lead to medication errors and unnecessary healthcare utilisation. It has been repeatedly shown that medication reconciliation can at least partially reduce this risk. Objective: The aim of this prospective pragmatic trial was to evaluate the effectiveness of pharmacist-led medication reconciliation offered to medical patients as part of routine clinical practise. The main questions to be answered were:

• the effectiveness of pharmacist-led medication reconciliation on medication discrepancies at discharge and 30 days after discharge
• the effectiveness of pharmacist-led medication reconciliation on healthcare utilisation within 30 days after discharge. Participants in the intervention group were offered the following:
• medication reconciliation on admission
• medication reconciliation on discharge, coupled with patient counselling, provided by clinical pharmacists. Participants in the control group were offered standard care.

Conditions

Medication Reconciliation

Keywords

medication error; unplanned healthcare utilisation; transitions of care; pharmacist; patient discharge; patient counselling

Outcome Measures

Primary Outcomes (1)

• Unplanned healthcare utilisation within 30 days after discharge

  Unplanned healthcare utilisation within 30 days of hospital discharge was defined as any unplanned visit to a general practitioner, specialist, emergency department (ED), or hospitalisation or death. The visits were classified as unplanned, if sudden health problems required medical attention, and planned, if scheduled. Data on mortality due to any reason were also collected 30 days after discharge. For each patient, only the most detrimental outcome was classified.

  within 30 (±5) days after hospital discharge

Secondary Outcomes (4)

• Serious unplanned healthcare utilisation within 30 days after discharge

  within 30 (±5) days after hospital discharge

• Clinically important medication errors at discharge

  On the day of hospital discharge (up to 365 days from hospital admission)

• Medication discrepancies at 30 days

  At 30 (±5) days after hospital discharge

• All healthcare utilisation within 30 days after discharge

  within 30 (±5) days after hospital discharge

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Patients were offered pharmacist- led medication reconciliation on admission and discharge coupled with patient counselling.

Procedure: Pharmacist-led Medication Reconciliation

Control Group

NO INTERVENTION

Patients received standard care - only written instructions on discharge medications in the discharge letter, according to the standard practice.

Interventions

Pharmacist-led Medication Reconciliation PROCEDURE

The best possible medication history (BPMH) at hospital admission was obtained from medical and pharmacy records and by interviewing the patient or carers. The BPMH - an accurate and complete (or as close as possible) list of medications the patient is currently taking - was documented in the medication information system. At hospital admission the BPMH was compared with the therapy in hospital to identify discrepancies. All discrepancies were discussed with the treating physician, unintentional discrepancies were reconciled. Intentional discrepancies were documented in the medical records. Prior to discharge from hospital, the BPMH and the medications planned in the discharge therapy were compared again to ensure that all unintentional discrepancies were corrected. Intentional discrepancies were explained in the discharge letter. Individual patient counselling on discharge medications and pharmacotherapy changes was conducted and coupled with written instructions in lay language.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• All adult medical patients admitted to the study wards

You may not qualify if:

• patients who do not speak Slovenian,
• transferred from another ward,
• previously included in the same study.
• patients hospitalised only for diagnostic purposes,
• patients transferred to another ward or hospital,
• patients that died during hospitalisation,
• patients from the control group who were offered medication reconciliation

Sponsors & Collaborators

• The University Clinic of Pulmonary and Allergic Diseases Golnik: lead
• University of Ljubljana: collaborator

Study Sites (1)

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, Select State, 4202, Slovenia

Location

Related Publications (1)

• Jost M, Kerec Kos M, Kos M, Knez L. Effectiveness of pharmacist-led medication reconciliation on medication errors at hospital discharge and healthcare utilization in the next 30 days: a pragmatic clinical trial. Front Pharmacol. 2024 Mar 28;15:1377781. doi: 10.3389/fphar.2024.1377781. eCollection 2024.

  PMID: 38606174 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: Pragmatic prospective controlled clinical trial

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 17, 2024
• Study Start: September 30, 2019
• Primary Completion: October 18, 2020
• Study Completion: December 31, 2020
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)