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

NCT ID: NCT02805270

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 587 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-02-28

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.

Conditions

Adverse Drug Events

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

medication reconciliation intervention

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

Group Type: EXPERIMENTAL

medication reconciliation intervention

Intervention Type: OTHER

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

usual care

Usual care provided by ward pharmacist, nurses and doctors in the ward

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

medication reconciliation intervention

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Qaboos University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amna Al-Hashar, PhD candidate

Role: PRINCIPAL_INVESTIGATOR

Sultan Qaboos University College of Medicine and Health Sciences

References

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.

Reference Type: BACKGROUND

PMID: 16534045 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22751755 (View on PubMed)

Other Identifiers

MREC#715

Identifier Type: -

Identifier Source: org_study_id