Clinical trial NCT02805270: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Drug Events
Keywords: adverse drug events, preventable, potential, counselling, medication reconciliation
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 587
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: number of patients with a preventable adverse drug event
timeFrame: 30 days
measure: number of potential adverse drug events
timeFrame: 30 days
Secondary outcomes:
measure: number of emergency room visits
timeFrame: 30 days
measure: number of unplanned hospital visits
timeFrame: 30 days
measure: number of hospital readmissions
timeFrame: 30 days
measure: number of patients who traveled abroad to seek second medical opinion
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Sultan Qaboos University College of Medicine and Health Sciences
name: Amna Al-Hashar, PhD candidate
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.