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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02805270
Other study ID # MREC#715
Secondary ID
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


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
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