Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization

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.

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

Study Overview

• Status: Completed
• Conditions: Adverse Drug Events
• Intervention / Treatment: Other: medication reconciliation intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 587
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: medication reconciliation intervention; medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list	Other: medication reconciliation intervention; medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
No Intervention: usual care; Usual care provided by ward pharmacist, nurses and doctors in the ward

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of patients with a preventable adverse drug event	30 days
number of potential adverse drug events	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
number of emergency room visits	30 days
number of unplanned hospital visits	30 days
number of hospital readmissions	30 days
number of patients who traveled abroad to seek second medical opinion	30 days

Collaborators and Investigators

• Sponsor: Sultan Qaboos University
• Investigators: Principal Investigator: Amna Al-Hashar, PhD candidate, Sultan Qaboos University College of Medicine and Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 20, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: adverse drug events, preventable, potential, counselling, medication reconciliation
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: MREC#715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO