Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517160
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Comparison of MedBook Portal and Usual Care in Medication Reconciliation at Primary Healthcare Upon Hospital Discharge
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDRECON
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 11 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
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 11 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 ampampampamp 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 httpwwwgraphpadcomquickcalcsindexcfm 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 patientsamp39 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 patientsamp39 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 patientsamp39 discharge medication list from the MedBook Portal and no MedBook Portal Notice was attached to the patientsamp39 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 patients 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 doctors 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 patients 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
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 ampampampamp 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 httpwwwgraphpadcomquickcalcsindexcfm 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 patientsamp39 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 patientsamp39 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 patientsamp39 discharge medication list from the MedBook Portal and no MedBook Portal Notice was attached to the patientsamp39 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 patients 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 doctors 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None