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

Impact of Routine Pharmacist-led Medication Reconciliation on Medication Discrepancies and Post-hospital Healthcare Utilisation

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.

Study Overview

• Status: Terminated
• Conditions: Medication Reconciliation
• Intervention / Treatment: Procedure: Pharmacist-led Medication Reconciliation

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.

• Study Type: Interventional
• Enrollment (Actual): 553
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Select State
    • Golnik, Select State, Slovenia, 4202
      • University Clinic of Respiratory and Allergic Diseases Golnik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; Patients were offered pharmacist- led medication reconciliation on admission and discharge coupled with patient counselling.	Procedure: 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.
No Intervention: Control Group; Patients received standard care - only written instructions on discharge medications in the discharge letter, according to the standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious unplanned healthcare utilisation within 30 days after discharge	Serious unplanned healthcare utilisation were defined as any unplanned ED visit or hospitalisation or death within 30 days from hospital discharge.	within 30 (±5) days after hospital discharge
Clinically important medication errors at discharge	Unintentional discrepancies and undocumented intentional discrepancies between the therapy the patient was taking before admission (BMPH) and the therapy recommended in the discharge letter were defined as medication errors. Their clinical importance was assessed using a 4-point Likert scale ranging from not important, not very important, very important to life-threatening medication errors. Very important and life-threatening medication errors represent clinically important medication errors.	On the day of hospital discharge (up to 365 days from hospital admission)
Medication discrepancies at 30 days	Medication discrepancies 30 (±5) days after hospital discharge were defined as the discrepancies between the discharge therapy and the therapy the patient was taking 30 (±5) days after hospital discharge. The discrepancies were defined as intentional if the patient intentionally took the therapy differently than recommended in the discharge letter. The reason for the discrepancy was also recorded - the patient's own informed decision or due to instructions from the treating physician (general practitioner, specialist). Unintentional discrepancies were defined as discrepancies from the therapy recommended in the discharge letter of which the patients were unaware. The clinical importance of unintentional discrepancies was assessed using a 4-point Likert scale, ranging from not important, not very important, very important, to life- threatening.	At 30 (±5) days after hospital discharge
All healthcare utilisation within 30 days after discharge	Healthcare visits within 30 days of hospital discharge were defined as any visit to a general practitioner, specialist, emergency department (ED), or hospitalisation. These 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

Collaborators and Investigators

• Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Collaborators: University of Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): October 18, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: transitions of care; pharmacist; patient discharge; medication error; unplanned healthcare utilisation; patient counselling
• Other Study ID Numbers: 8019163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No