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

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ClinicalTrials.gov Identifier: NCT02805270
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Sultan Qaboos University

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

Condition or disease Intervention/treatment Phase
Adverse Drug Events Other: medication reconciliation intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 587 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: medication reconciliation intervention
medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
Other: medication reconciliation intervention
medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list

No Intervention: usual care
Usual care provided by ward pharmacist, nurses and doctors in the ward



Primary Outcome Measures :
  1. number of patients with a preventable adverse drug event [ Time Frame: 30 days ]
  2. number of potential adverse drug events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. number of emergency room visits [ Time Frame: 30 days ]
  2. number of unplanned hospital visits [ Time Frame: 30 days ]
  3. number of hospital readmissions [ Time Frame: 30 days ]
  4. number of patients who traveled abroad to seek second medical opinion [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805270


Sponsors and Collaborators
Sultan Qaboos University
Investigators
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Principal Investigator: Amna Al-Hashar, PhD candidate Sultan Qaboos University College of Medicine and Health Sciences
Publications:
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Responsible Party: Sultan Qaboos University
ClinicalTrials.gov Identifier: NCT02805270    
Other Study ID Numbers: MREC#715
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sultan Qaboos University:
adverse drug events, preventable, potential, counselling, medication reconciliation
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders