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临床试验/NCT06517160
NCT06517160已完成不适用

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

Ministry of Health, Malaysia2 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
368
试验地点
2
主要终点
Percentage of prescriptions with medication discrepancies in the first prescription during the first follow-up visit at the primary health clinic after hospital discharge

研究概览

简要总结

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 368 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 June 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.

详细描述

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 June 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

Doctors at health clinics were not aware of the subjects in the control group.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

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

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

次要结局

  • Percentage of prescriptions with medication discrepancies in the discharge prescription(From enrollment to hospital discharge, time time frame might range from 1 hour to 2 days.)
  • Type of medication discrepancies(From enrollment to the first appointment date at the selected primary health clinic, the time frame might range from 1 week to 2 months)
  • Predictors associated with medication discrepancies(From enrollment to the first appointment date at the selected primary health clinic, the time frame might range from 1 week to 2 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Phang Yen Yen

Principal Investigator/ Senior Principal Assistant Director (Pharmacy Practice & Development)

Ministry of Health, Malaysia

研究点 (2)

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