NCT02805270

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
587

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

June 15, 2016

Last Update Submit

June 20, 2016

Conditions

Keywords

adverse drug events, preventable, potential, counselling, medication reconciliation

Outcome Measures

Primary Outcomes (2)

  • number of patients with a preventable adverse drug event

    30 days

  • number of potential adverse drug events

    30 days

Secondary Outcomes (4)

  • 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

Study Arms (2)

medication reconciliation intervention

EXPERIMENTAL

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

Other: medication reconciliation intervention

usual care

NO INTERVENTION

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

Interventions

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

medication reconciliation intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 16534045BACKGROUND
  • 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.

    PMID: 22751755BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Amna Al-Hashar, PhD candidate

    Sultan Qaboos University College of Medicine and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 21, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share