- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03181906
Effectiveness of Pre-Consultation Medication Reconciliation Service in Reducing Unintentional Medication Discrepancies During Transition of Care From Hospital Discharge to Primary Care Setting
June 7, 2017 updated by: Kee Kok Wai, National Healthcare Group, Singapore
Effectiveness of Pre-Consultation Medication Reconciliation Service in Reducing Unintentional Medication Discrepancies During Transition of Care From Hospital Discharge to Primary Care Setting- A Randomised Controlled Trial
This study evaluates the the effectiveness of pre-consultation Medication Reconciliation Service in reducing unintentional medication discrepancies among patients who discharged from hospital to primary care.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Medication discrepancies during care transition were common.
Many factors contribute to the risk of medication discrepancies.
Despite medication reconciliation service being practiced in the hospital setting, there was limited knowledge on its effectiveness in the primary care setting.
This study aims to evaluate the effectiveness of a pre-consultation medication reconciliation service in reducing medication discrepancies in patients who transit from hospital to primary care.
Adult patients who made their first visit to the polyclinics following a recent hospital discharge and were prescribed with 5 or more chronic medications were randomised to 2 groups.
Pre-consultation medication reconciliation by a pharmacist was carried out for the intervention group.
Outcome was assessed by a different pharmacist who was blinded to the randomised allocation.
The control group underwent usual care without a pre-consultation medication reconciliation.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 21 years and older
- Patient or primary caregiver was able to provide informed consent
- Patient or primary caregiver was English, Mandarin or Malay speaking
- Patient was able to self-administer medications, or accompanied by a caregiver who assisted in administering medications
- Patient was prescribed 5 or more chronic medications
- The day of the study visit was the first follow-up visit in National Healthcare Group Polyclinics for chronic disease management after recent discharge from a local public hospital
Exclusion Criteria:
- Residents of nursing home
- The day of the study visit was for acute illness consult
- Unwilling to consent to a 30-day follow-up phone call.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-Consultation Medication Reconciliation
Participants underwent medication reconciliation service before their consultation with the attending doctor.
A best possible medication history (BPMH) was created and saved as an electronic draft in the electronic medical record system.
|
Medication reconciliation service to be done for participants randomised to the intervention group
|
No Intervention: Control
Participants in the control group proceeded with usual care, where the doctor reviewed the patient's condition and ordered an electronic prescription
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unintentional medication discrepancies
Time Frame: 1 day
|
Any unintentional medication discrepancies after doctor's consultation
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Types of medication discrepancies
Time Frame: 1 day
|
Type of medication discrepancies, by a validated instrument by Claeys et al, (Claeys C, Neve J, Tulkens PM, Spinewine A. Content Validity and Inter-Rater Reliability of an Instrument to Characterize Unintentional Medication Discrepancies.Drugs & Aging.
2012 July; 29(7): 577-91.)
|
1 day
|
Causes of medication discrepancies
Time Frame: 1 day
|
Causes of medication discrepancies, by a validated instrument by Claeys et al, (Claeys C, Neve J, Tulkens PM, Spinewine A. Content Validity and Inter-Rater Reliability of an Instrument to Characterize Unintentional Medication Discrepancies.Drugs & Aging.
2012 July; 29(7): 577-91.)
|
1 day
|
Medication adherence
Time Frame: 30 days
|
Medication adherence by The 8-item Morisky Medication Adherence Scale
|
30 days
|
30-day re-hospitalisation
Time Frame: 30 days
|
rate of re-hospitalisation 30 days after the study visit
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kok Wai Kee, MMED, National Healthcare Group Polyclinics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2016
Primary Completion (Actual)
February 28, 2017
Study Completion (Actual)
April 30, 2017
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 7, 2017
First Posted (Actual)
June 9, 2017
Study Record Updates
Last Update Posted (Actual)
June 9, 2017
Last Update Submitted That Met QC Criteria
June 7, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- DSRB2015/01219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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