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

NCT ID: NCT06207500

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 553 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-12-31

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.

Detailed Description

Design: pragmatic, prospective, controlled clinical trial

Setting: Five general medical wards at the University Clinic of Respiratory and Allergic Diseases in Slovenia:

• one intervention ward with a routine pharmacist-led medication reconciliation service
• four control wards

Data collection:

• Data collection and outcome assessment were performed by research pharmacists who were clinical pharmacists or final year clinical pharmacy residents not involved in the treatment of the included patients.
• Data for the assessment of medication errors at discharge were obtained from the patients' medical records and the study documentation.
• The reason for the patient's hospitalisation was obtained from the discharge letter and divided into acute or planned admissions. The main diagnosis was the reason for admission, while all other patient diagnoses listed were used to assess comorbidity.
• Patient comorbidity was assessed using the Charlson Comorbidity Index
• For patients in the control group the BPMH was collected in the same way as in the intervention group. However, it was only used for study purposes and was not documented in the patients' medical records
• Data on healthcare utilisation and medication discrepancies after hospital discharge were collected through patients or caregivers' phone interview.

Conditions

Medication Reconciliation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: ACTIVE_COMPARATOR

Pharmacist-led Medication Reconciliation

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmacist-led Medication Reconciliation

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 Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All adult medical patients admitted to the study wards

Exclusion Criteria

• patients who do not speak Slovenian,
• transferred from another ward,
• previously included in the same study.

Subsequent exclusion from the analysis:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana

OTHER

Sponsor Role: collaborator

The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role: lead

Responsible Party

Maja Jošt

Clinical Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Clinic of Respiratory and Allergic Diseases Golnik

Golnik, Select State, Slovenia

Countries

Slovenia

References

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.

Reference Type: DERIVED

PMID: 38606174 (View on PubMed)

Other Identifiers

8019163

Identifier Type: -

Identifier Source: org_study_id