Adverse Drug EventsNCT02805270
Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization
A study testing medication reconciliation intervention in people with Adverse Drug Events, run by Sultan Qaboos University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Events
- What is being tested?
- medication reconciliation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
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
Read the 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
- Being tested
- medication reconciliation intervention
- Keywords
- adverse drug events, preventable, potential, counselling, medication reconciliation
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication reconciliation interventionOther
medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
| Study group | Role | What they receive |
|---|---|---|
| medication reconciliation intervention | Experimental | medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list Receives: Other: medication reconciliation intervention |
| usual care | No intervention | Usual care provided by ward pharmacist, nurses and doctors in the ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with a preventable adverse drug event
Measured: 30 days
number of potential adverse drug events
Measured: 30 days
Secondary outcomes (4)
number of emergency room visits
Measured: 30 days
number of unplanned hospital visits
Measured: 30 days
number of hospital readmissions
Measured: 30 days
number of patients who traveled abroad to seek second medical opinion
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amna Al-Hashar, PhD candidate, Principal investigator, Sultan Qaboos University College of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805270
- Sponsor's protocol ID
- MREC#715
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16534045Kripalani 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.
PubMed 22751755
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02805270
- Acronym / sponsor ID
- MREC#715
- Conditions
- Adverse Drug Events
- Keywords
- adverse drug events, preventable, potential, counselling, medication reconciliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medication reconciliation intervention | Experimental | Other: medication reconciliation interventionmedication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list |
| usual care | No intervention | –Usual care provided by ward pharmacist, nurses and doctors in the ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medication reconciliation interventionmedication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list | Other | medication reconciliation intervention |
Primary outcome
number of patients with a preventable adverse drug event
Time frame: 30 days
number of potential adverse drug events
Time frame: 30 days
4 secondary outcomes
number of emergency room visits
Time frame: 30 days
number of unplanned hospital visits
Time frame: 30 days
number of hospital readmissions
Time frame: 30 days
number of patients who traveled abroad to seek second medical opinion
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Background: PubMed 16534045Schnipper 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.
- Background: PubMed 22751755Kripalani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amna Al-Hashar, PhD candidate principal investigator
Sultan Qaboos University College of Medicine and Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing medication reconciliation intervention in people with Adverse Drug Events, run by Sultan Qaboos University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with a preventable adverse drug event (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.