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

Adverse Drug Events Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805270
• Other study ID #: MREC#715
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: June 20, 2016
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2016
• Source: Sultan Qaboos University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Oman: Ministry of Health in Sultanate of Oman
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adverse Drug Events
• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• medication reconciliation intervention
medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Qaboos University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with a preventable adverse drug event		30 days	No
Primary	number of potential adverse drug events		30 days	No
Secondary	number of emergency room visits		30 days	No
Secondary	number of unplanned hospital visits		30 days	No
Secondary	number of hospital readmissions		30 days	No
Secondary	number of patients who traveled abroad to seek second medical opinion		30 days	No