Back to resultsImpact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization
Primary Purpose
Adverse Drug Events
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
medication reconciliation intervention
Sponsored by
About this trial
This is an interventional prevention trial for Adverse Drug Events focused on measuring adverse drug events, preventable, potential, counselling, medication reconciliation
Eligibility Criteria
Inclusion Criteria:
- admitted to one of the two medical wards, male and female medical wards.
- was on at least one medication prior to admission
- spoke Arabic or English and can be (the patient or care giver) interviewed for medication history
- stayed in the hospital for at least 24 hours
- discharged on at least one chronic medication or is at least on one chronic medication even if not prescribed upon discharge
Exclusion Criteria:
- could not be interviewed due to language barrier, impaired cognition or other reasons and did not have a care giver
- was under specialties other than medical specialties, but was admitted to medical wards because of lack of beds in their respective wards
- was pregnant
- was already included in the study at a previous admission
- left the hospital against medical advice
- with length of stay of >60 days.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
medication reconciliation intervention
usual care
Arm Description
medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
Usual care provided by ward pharmacist, nurses and doctors in the ward
Outcomes
Primary Outcome Measures
number of patients with a preventable adverse drug event
number of potential adverse drug events
Secondary Outcome Measures
number of emergency room visits
number of unplanned hospital visits
number of hospital readmissions
number of patients who traveled abroad to seek second medical opinion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02805270
Brief Title
Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization
Official Title
Implementation of a Medication Reconciliation Intervention and Its Impact on the Rate of ADEs and Healthcare Utilization 30 Days Following Discharge From the Hospital. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Qaboos University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The implementation of a medication reconciliation intervention including: medication reconciliation on admission and discharge, bedside medication counselling and take-home medication list, on the development of adverse drug events within 30 days post discharge as primary outcome. Secondary outcome is the evaluation of its impact on health care resource utilization
Detailed Description
This is a randomized controlled trial in 587 patients randomized to intervention and usual care. The intervention is medication reconciliation on admission and discharge, bedside medication counselling and take-home medication list. Usual care is ward pharmacy practice. The primary outcomes are preventable and potential adverse drug events at 30 days post discharge. The secondary outcome is health care utilization: length of stay, emergency room visits, unplanned hospital visits, readmissions and travel abroad to seek medical attention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events
Keywords
adverse drug events, preventable, potential, counselling, medication reconciliation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
587 (Actual)
8. Arms, Groups, and Interventions
Arm Title
medication reconciliation intervention
Arm Type
Experimental
Arm Description
medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
Arm Title
usual care
Arm Type
No Intervention
Arm Description
Usual care provided by ward pharmacist, nurses and doctors in the ward
Intervention Type
Other
Intervention Name(s)
medication reconciliation intervention
Intervention Description
medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
Primary Outcome Measure Information:
Title
number of patients with a preventable adverse drug event
Time Frame
30 days
Title
number of potential adverse drug events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
number of emergency room visits
Time Frame
30 days
Title
number of unplanned hospital visits
Time Frame
30 days
Title
number of hospital readmissions
Time Frame
30 days
Title
number of patients who traveled abroad to seek second medical opinion
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
admitted to one of the two medical wards, male and female medical wards.
was on at least one medication prior to admission
spoke Arabic or English and can be (the patient or care giver) interviewed for medication history
stayed in the hospital for at least 24 hours
discharged on at least one chronic medication or is at least on one chronic medication even if not prescribed upon discharge
Exclusion Criteria:
could not be interviewed due to language barrier, impaired cognition or other reasons and did not have a care giver
was under specialties other than medical specialties, but was admitted to medical wards because of lack of beds in their respective wards
was pregnant
was already included in the study at a previous admission
left the hospital against medical advice
with length of stay of >60 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amna Al-Hashar, PhD candidate
Organizational Affiliation
Sultan Qaboos University College of Medicine and Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16534045
Citation
Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E, Kachalia A, Horng M, Roy CL, McKean SC, Bates DW. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006 Mar 13;166(5):565-71. doi: 10.1001/archinte.166.5.565.
Results Reference
background
PubMed Identifier
22751755
Citation
Kripalani S, Roumie CL, Dalal AK, Cawthon C, Businger A, Eden SK, Shintani A, Sponsler KC, Harris LJ, Theobald C, Huang RL, Scheurer D, Hunt S, Jacobson TA, Rask KJ, Vaccarino V, Gandhi TK, Bates DW, Williams MV, Schnipper JL; PILL-CVD (Pharmacist Intervention for Low Literacy in Cardiovascular Disease) Study Group. Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial. Ann Intern Med. 2012 Jul 3;157(1):1-10. doi: 10.7326/0003-4819-157-1-201207030-00003.
Results Reference
background
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Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization
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