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Medication ReconciliationMEDRECONNCT06517160

Comparison of MedBook Portal and Usual Care in Medication Reconciliation at Primary Healthcare Upon Hospital Discharge

A study testing MedBook Portal in people with Medication Reconciliation, run by Ministry of Health, Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Medication Reconciliation
What is being tested?
MedBook Portal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
1 siteMalaysia
Study dates
2 May 2023to 24 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Sarawak State Health Department

    Kuching, Sarawak, 93050

Other trials in Malaysia

About this study

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

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.

Read more

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.

Read the 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 \& 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\' 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\' 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\' discharge medication list from the MedBook Portal, and no MedBook Portal Notice was attached to the patients\' 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.

Being tested
MedBook Portal
Keywords
Medication Reconciliation, Medication Safety, Unintentional Medication Discrepancies, Primary Healthcare, Transition of Care, Electronic Health Record

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MedBook PortalOther

    Intervention Group (With MedBook Portal \& MedBook Portal Notice)

    1. MedBook Portal Notice in front of the patient home-based medical card
    2. Discharge prescriptions are uploaded into MedBook Portal and can be retrieved by doctors \& pharmacists.

    MedBook portal (https://aplikasi.jknsarawak.moh.gov.my/medbook) is a webpage that enable sharing of patient medication records among healthcare facilities under Ministry of Health. Sarawak State Health Department owned and managed this portal. All the information is kept under their server. Doctors in the Health Clinics and Study Pharmacists will be given access to this portal whereby each of the healthcare providers shall log in using their Identification Number and the password created by them. Doctor shall log in to MedBook Portal to check on discharge medication list when reviewing the patient at health clinic. MedBook Portal can be accessed both using a smartphone or a computer.

Study groups in NCT06517160
Study groupRoleWhat they receive
Control GroupNo interventionPatients will receive standard care, where doctors review previous medical records in the home-based medical card and discharge notes if provided by the patient during their first review. Doctors cannot access the patient's discharge medication list from the MedBook Portal, and no MedBook Portal Notice is attached to the patient's home-based medical card. The principal investigator will give a list of control group patients to the study pharmacist at the health clinic. Knowing their appointment dates, the study pharmacist will search for the first prescription after transitioning care from the hospital to the primary health clinic. The study pharmacist will then compare the discharge prescription in the MedBook Portal with the first prescription to identify medication discrepancies. Any discrepancies will be addressed by confirming with the doctor whether they are intentional or unintentional.
Intervention GroupExperimentalMedBook Portal Notice will be attached to the patient's home-based medical card for doctors and pharmacists at health clinics to identify recruited patients during their first follow-up after hospital discharge. During the doctor's review of intervention group patients, the doctor will log in to the MedBook Portal to check the discharge medication list and review the case based on the previous medical record in the home-based medical card and the discharge note, if provided. The doctor will then conduct medication reconciliation by comparing the discharge prescription with the new prescription. Study pharmacists at health clinics will screen patients' home-based medical cards when collecting medications. Study pharmacists will retrieve the discharge prescription from the MedBook Portal and conduct medication reconciliation by comparing the discharge prescription with the new prescription. Any discrepancies will be addressed by confirming with the doctor whether they are intentional.
Receives: Other: MedBook Portal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of prescriptions with medication discrepancies in the first prescription during the first follow-up visit at the primary health clinic after hospital discharge

    (Number of prescription with medication discrepancies during 1st health clinic follow up)/(Total prescription reconcilled at health clinic (with or without MedBook Portal))

    Measured: 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 (3)
  1. Percentage of prescriptions with medication discrepancies in the discharge prescription

    Number of prescription with medication errors/ Total prescription reconcilled upon discharge

    Measured: From enrollment to hospital discharge, time time frame might range from 1 hour to 2 days.

  2. Type of medication discrepancies

    Number of medication discrepancies detected will be grouped into 0, 1, 2, 3, 4, 5 errors. Chi-square test will be used to analyse the association of medication discrepancies at intervention group versus control group.

    Measured: From enrollment to the first appointment date at the selected primary health clinic, the time frame might range from 1 week to 2 months

  3. Predictors associated with medication discrepancies

    Multiple logistic regression

    Measured: From enrollment to the first appointment date at the selected primary health clinic, the time frame might range from 1 week to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start2 May 2023
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06517160
Sponsor's protocol ID
NMRR-22-02409-ODX
Acronym
MEDRECON
Status last verified
Sep 2024
First submitted
18 Jul 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No personal information will be disclosed and subjects will not be identified when the findings of the study are published. However, Study Protocol and Informed Consent Form, data are available upon reasonable request from the corresponding author.

Publications

  • Phang YY, Kuan JW, Oh AL, Ting CY, Osman NA, Moses S. Effectiveness of digital platform in reducing unintentional medication discrepancies at transition of care from hospital discharge to primary healthcare settings: a randomised controlled trial. BMC Prim Care. 2025 Jul 2;26(1):206. doi: 10.1186/s12875-025-02904-z.

    PubMed 40604512

Questions about this trial

What is this clinical trial studying?

A study testing MedBook Portal in people with Medication Reconciliation, run by Ministry of Health, Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: From enrollment to the first appointment date at the selected primary health clinic, the time frame might range from 1 week to 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06517160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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