Clinical trial NCT06517160: Comparison of MedBook Portal and Usual Care in Medication Reconciliation at Primary Healthcare Upon Hospital Discharge
Official title: A Randomised Controlled Trial to Compare MedBook Portal and Standard Care in Medication Reconciliation at Transitions of Care From Hospital Discharge to Primary Healthcare Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Reconciliation
Keywords: Medication Reconciliation
Medication Safety
Unintentional Medication Discrepancies
Primary Healthcare
Transition of Care
Electronic Health Record
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: University Malaysia Sarawak
First posted: 2024-07-24
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized controlled trial was conducted to examine the efficacy of the MedBook portal in reducing medication discrepancies after discharge. The MedBook portal is a webpage that enables the sharing of patient medication profiles among healthcare facilities under the Ministry of Health. A total of 398 adult patients in general medical wards, who were discharged from Sarawak General Hospital, Sibu Hospital, Miri Hospital, and Sarikei Hospital, and referred to ten public primary health clinics located near these hospitals, were recruited for this study. Eligible subjects were randomized into an intervention group and a control group in a 1:1 ratio. This study was conducted from May 2023 to July 2024.

Study pharmacists conducted medication reconciliation before randomization by comparing the discharge prescription with the pre-admission medications and inpatient medication charts to identify discrepancies. Discrepancies were confirmed with the doctor to determine if they were intentional or unintentional.

Control group patients received standard care, with discharge notes and appointment dates provided upon discharge. In Malaysia, there is no shared electronic medication record system between primary and secondary healthcare; thus, information is transferred manually via discharge notes and home-based medical cards. During initial health clinic visits, doctors reviewed patients' medical records based on home-based medical cards and discharge notes, if available. Pharmacists conducted medication reconciliation by comparing new prescriptions with previous records. Discrepancies were confirmed with the doctor to determine if they were intentional or unintentional. Control group doctors could not access the MedBook Portal, and no MedBook Portal Notice was attached to home-based medical cards.

The MedBook Portal Notice was attached to patients' home-based medical cards for identification at follow-up appointments. Doctors logged into the MedBook Portal to access discharge medication lists and conducted medication reconciliation by comparing discharge prescriptions with new prescriptions. Study pharmacists screened patients' home-based medical cards at the pharmacy, identified recruited patients via the MedBook Portal Notice, and conducted medication reconciliation by comparing new prescriptions with discharge medication lists in the portal. Discrepancies were confirmed with the doctor to determine if they were intentional or unintentional.

Detailed description: Study Design, Population and Setting This prospective, multicentre randomised controlled trial compared the prevalence of medication discrepancies in the first prescription upon transition of care from hospitals to primary health clinics between MedBook Portal and standard care. The MedBook portal is a webpage that enables the sharing of patient medication records among healthcare facilities under Ministry of Health. Doctors in the health clinics and pharmacists log in to MedBook Portal to check the discharge medication list when reviewing the patient at the clinic. The study adhered to the Consolidated Standards of Reporting Trials (CONSORT) Statement guideline, employing a 1:1 allocation ratio allocation ratio to two groups: the intervention group and the control group.

The targeted population was the adult patients in Sarawak who were discharged from the public tertiary or secondary hospitals, including Sarawak General Hospital, Sibu Hospital, Sarikei Hospital, and Miri Hospital, and referred to ten public primary health clinics located nearby these hospitals. The ten public primary health clinics were Batu Kawa Health Clinic, Kota Sentosa Health Clinic, Kota Samarahan Health Clinic, Jalan Oya Health Clinic, Lanang Health Clinic, Sibu Jaya Health Clinic, Miri Health Clinic, Tudan Health Clinic, Sarikei Health Clinic, and Bintangor Health Clinic.

Data collection took place over a year from May 2023 to July 2024. The research was granted with ethical approval by the Medical Research \&amp;amp;amp;amp; Ethics Committee (MREC), Ministry of Health Malaysia \[NMRR-22-02409-ODX (IIR)\].

This study enrolled adult patients aged 18 years and older who were admitted to general medical wards who had comorbidities related to cardiovascular, renal, respiratory, or endocrine system, as well as patients referred to the selected primary health clinics after hospital discharge and possessed home-based medical cards. Patients discharged during public holidays or weekends were excluded.

Medication Reconciliation Upon Hospital Discharge The discharge prescription served as the primary reference for discharge reconciliation, as it contained the list of medications that the pharmacy would use for preparation and dispensing to patients upon discharge. Study pharmacists conducted discharge medication reconciliation before randomisation. This process involved comparing the medications listed in the discharge prescription with those documented in the medication history assessment form (representing pre-admission medications) and the inpatient medication charts (representing medications initiated during admission) to identify any discrepancies before preparing the discharge medications. If any disparities were found, study pharmacists confirmed with the doctor to determine whether they were intentional or unintentional medication discrepancies, with any amendments documented on the discharge prescription.

Randomisation and blinding The recruited patients were randomised into the intervention and control groups in a 1: 1 ratio before discharge. Randomisation was conducted using an online program available at http://www.graphpad.com/quickcalcs/index.cfm. A research coordinator was appointed to administer the randomisation and inform the study pharmacist to deliver the intervention according to the assigned group. The research coordinator had no direct contact with patients, study pharmacists and doctors. Additionally, the research coordinator managed the patient list, including their assigned codes and group allocation. Subsequently, the research coordinator sent the patient list to the principal investigator to remind the patient of the follow-up dates at the health clinic. Due to the nature of the intervention, neither patients, doctors, nor study pharmacists were blinded to the group assignments.

Control Group The control group received standard care, where upon discharge, patients were provided with discharge notes by nurses along with their appointment dates at the health clinics. In Malaysia, there is currently no shared electronic medication record system between primary and secondary healthcare; hence, information on medical history and medication history has to be transferred manually via discharge note and home-based medical card. During their initial visit at the health clinic, doctors reviewed patients\&amp;#39; medical records based on information from their home-based medical cards and discharge notes, if provided by the patient. Pharmacists at the health clinics conducted medication reconciliation by comparing the new prescriptions received against the patients\&amp;#39; previous medical records in their home-based medical cards and discharge notes, if available. Any identified discrepancies were addressed through confirmation with the doctor to determine whether they were intentional or unintentional.

In contrast, doctors in the control group were unable to access a patients\&amp;#39; discharge medication list from the MedBook Portal, and no MedBook Portal Notice was attached to the patients\&amp;#39; home-based medical card. The principal investigator provided a patient list in the control group to the study pharmacist at the health clinic. By knowing their appointment date, the study pharmacist searched for the first prescription upon transitioning care from the hospital to the primary health clinic. Subsequently, the study pharmacist compared the discharge prescription in MedBook Portal with the first prescription to identify any medication discrepancies. If discrepancies were found, study pharmacists confirmed with the doctor to determine whether they were intentional or unintentional. However, the study pharmacist might not be able to retrieve the first prescription immediately on the appointment date due to the absence of a MedBook Portal Notice. Consequently, the study pharmacist could only address any identified discrepancies with the prescriber at a later time.

Intervention Group The MedBook Portal Notice was attached to the patient's home-based medical card to enable doctors and pharmacists at health clinics to identify the recruited patients. This appointment would be their first follow-up at health clinics after discharge from the hospital.

During the doctor's review of the patient in the intervention group, the doctor logged into the MedBook Portal to access the discharge medication list and reviewed the case based on the previous medical record in the home-based medical card and the discharge note, if provided by the patient during their first visit. Subsequently, the doctor conducted medication reconciliation by comparing the list of medications in the discharge prescription against the new prescription prepared.

At the health clinics, study pharmacists screened patients' home-based medical cards presented at the pharmacy when collecting medications. Upon identifying the recruited patients via the MedBook Portal Notice, pharmacists logged into the MedBook Portal to access the discharge medication list. They then conducted medication reconciliation by comparing the new prescription received against the discharge medication list in the portal. Interventions were carried out by the study pharmacists through confirmation with the doctor to determine whether any identified medication discrepancies were intentional or unintentional.

Operational Definitions Medication discrepancy is defined as any variation or difference in medication regimen identified when comparing an old medication list with newly prescribed medications. Intentional medication discrepancy is a justified discrepancy due to a change in the patient's clinical condition. Unintentional medication discrepancy is an unjustified discrepancy identified after checking with prescriber and it is a medication error, specifically prescribing error Medication discrepancies are classified discrepant dose, discrepant frequency, polypharmacy, drug omission, drug addition, and inappropriate drug.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years and above in general medical wards.
* Patients who had any of the following comorbidities: (1) cardiovascular related diseases, e.g.: hypertension, acute coronary syndrome, heart failure, stroke, atrial fibrillation; (2) endocrine related diseases, e.g.: diabetes, thyroid disorders; (3) renal related diseases, e.g.: chronic kidney disease, end stage renal failure; (4) respiratory related diseases, e.g.: asthma, chronic obstructive pulmonary disease.
* Patients who are referred to the selected primary health clinics after hospital discharge.
* Patients with home-based medical card.

Exclusion Criteria:

• Patients discharged during public holidays or weekends will be excluded from this study.

Primary outcomes:
measure: Percentage of prescriptions with medication discrepancies in the first prescription during the first follow-up visit at the primary health clinic after hospital discharge
timeFrame: From enrollment to the first appointment date at the selected primary health clinic, the time frame might range from 1 week to 2 months
Secondary outcomes:
measure: Percentage of prescriptions with medication discrepancies in the discharge prescription
timeFrame: From enrollment to hospital discharge, time time frame might range from 1 hour to 2 days.
measure: Type of medication discrepancies
timeFrame: From enrollment to the first appointment date at the selected primary health clinic, the time frame might range from 1 week to 2 months
measure: Predictors associated with medication discrepancies
timeFrame: From enrollment to the first appointment date at the selected primary health clinic, the time frame might range from 1 week to 2 months
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Sarawak State Health Department
state: Sarawak
Study officials:
affiliation: Sarawak State Health Department
name: Yen Yen Phang
role: PRINCIPAL_INVESTIGATOR
References: