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Trial details
Evaluation of Pharmacist-Initiated Discharge Medication Reconciliation and Patient Counseling Procedures in the Emergency Department
Current status:
Approved
|
Date registered:
19/03/2024
|
Date last updated:
08/11/2023
Trial version(s)
Current: 19/09/2023
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2023095432
Protocol number
PIDMR3
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LBCTR website was not accessible
Date of registration in national regulatory agency
Primary sponsor
None
Primary sponsor: Country of origin
None
Public title
Evaluation of Pharmacist-Initiated Discharge Medication Reconciliation and Patient Counseling Procedures in the Emergency Department
Acronym
Scientific title
Evaluation of Pharmacist-Initiated Discharge Medication Reconciliation and Patient Counseling Procedures in the Emergency Department
Acronym
Brief summary of the study: English
This was a randomized controlled study that included adult patients discharged from the ED at the Lebanese American University Medical Center – Rizk Hospital (LAUMC-RH) with at least one discharge medication during the period of data collection from December 2021 to April 2022. The control group consisted of patients receiving the standard of care, while the intervention group was counseled at discharge by a pharmacy resident. The intervention group received follow-up calls at days 3, 14, and 30, while the control group wasonly followed-up with telephone calls on day 30 post-discharge. The pharmacy resident conducted the follow-up phone calls. Additionally, the pharmacy resident identified discrepancies that were reported to and discussed withthe prescribing physician and an intervention was performed if needed. The primary endpoint was the number of unintended medication discrepancies identified by the pharmacy resident that are categorized as: omission, commission, different dose/route/frequency, or different medication ordered. The secondary endpoints included the occurrence of ADEs, composite endpoint of re-admissions and ED visit at day 30, and patient satisfaction.
Brief summary of the study: Arabic
هذه دراسة شملت مرضى بالغين خرجوا من قسم الطوارئ في المركز الطبي بالجامعة اللبنانية الأمريكية – مستشفى رزق (LAUMC-RH) مع دواء واحد على الأقل للخروج خلال فترة جمع البيانات من ديسمبر 2021 إلى أبريل 2022. تتألف المجموعة من المرضى الذين يتلقون مستوى الرعاية، في حين تم تقديم المشورة لمجموعة التدخل عند الخروج من قبل أحد المقيمين الصيدلية. تلقت مجموعة التدخل مكالمات متابعة في الأيام 3 و14 و30، في حين تمت متابعة المجموعة الضابطة فقط من خلال مكالمات هاتفية في اليوم 30 بعد الخروج من المستشفى. أجرى مقيم الصيدلية مكالمات هاتفية للمتابعة. بالإضافة إلى ذلك، حدد الطبيب المقيم في الصيدلية التناقضات التي تم الإبلاغ عنها ومناقشتها مع الطبيب الموصوف وتم إجراء التدخل إذا لزم الأمر. كانت نقطة النهاية الأولية هي عدد التناقضات غير المقصودة في الأدوية التي حددها طبيب الصيدلية والتي تم تصنيفها على النحو التالي: الإغفال، أو العمولة، أو جرعة/طريق/تكرار مختلف، أو طلب دواء مختلف. وشملت نقاط النهاية الثانوية حدوث ADEs، ونقطة النهاية المركبة لإعادة القبول وزيارة قسم الطوارئ في اليوم 30، ورضا المرضى.
Health conditions/problem studied: Specify
Medication reconciliation upon discharge from the emergency department
Interventions: Specify
Pharmacist-Initiated Discharge Medication Reconciliation and Patient Counseling Procedures
Key inclusion and exclusion criteria: Inclusion criteria
Participants were eligible if they met the following inclusion criteria: adult patients (≥18 years old) who were discharged from the ED with at least one newly prescribed discharge medication.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
Key exclusion criteria consisted of patients who were admitted from ED to LAUMCRH as inpatients, transferred to another hospital, or did not provide consent to participate in the study.
Type of Study
Type
Interventional
Type of intervention
Educations programs
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
N/A
Study design: Purpose
Health services research
Study design: Assignment
Parallel
Pharmaceutical class
N/A
Therapeutic indication
N/A
Therapeutic benefit
Reduction of reconciliation errors
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
100
Actual enrollment target size
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/12/2021
Date of study closure: Type
Actual
Date of study closure: Date
30/05/2022
Recruitment status
Complete
Date of completion
30/05/2022
IPD sharing statement plan
Yes
IPD sharing statement description
Data available upon request
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Elsy
Ramia
Lebanese American University - Byblos
Lebanon
03-167962
elsy.ramia@lau.edu.lb
Lebanese American University
Scientific
Elsy
Ramia
Lebanese American Univeristy - Byblos
Lebanon
03-167962
elsy.ramia@lau.edu.lb
Lebanese American University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Lebanese American University Medical Center Rizk Hospital
Dr. Elsy Ramia
Pharmacy Education
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
17/09/2021
Ms. Karmen Baroudi
karmen.baroudy@lau.edu.lb
03953388
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Interventions
Intervention
Description
Keyword
Medication Reconciliation and Discharge Counseling
Patients were randomly assigned to either the control group or the intervention group with a 1:1 allocation, by block randomization using a block size of 4. Patients in the control group received the standard of care provided by the ED staff (physicians, medical residents, and/or nurses) upon admission and discharge whereby patients only received a prescription of the newly prescribed medications at the ED, with no formal medication reconciliation done. Patients in the intervention group received a pharmacist-conducted medication reconciliation and discharge counseling by the pharmacy resident. Prior to discharge from the ED, the pharmacy resident also documented any unintended medication discrepancies detected, and reported it to the prescribing physician. Interventions were made to the medical team and changes were done as needed. The pharmacy resident conducted follow-up telephone interviews with all patients after ED discharge to collect relevant patient outcome measures: day 30 in the control group and days 3, 14, and 30 in the intervention group. The resident addressed drug-related questions and referred medical concerns to the prescribing physician. Patients had the option to withdraw consent at any time during the study.
Medication Reconciliation, Counseling, Pharmacist
Primary Outcomes
Name
Time points
Measure
the number of unintended medication discrepancies identified by the pharmacy resident categorized as: omission, commission, different dose/route/frequency, or different medication ordered.
at day 30 post discharge
the number of unintended medication discrepancies identified by the pharmacy resident categorized as: omission, commission, different dose/route/frequency, or different medication ordered as analyzed by the pharmacy resident.
Key Secondary Outcomes
Name
Time points
Measure
the composite endpoint of hospital readmission, ED visits, and physician contact
at 30 days post-discharge
Number of hospital readmission, ED visits, and physician contact as reported by the patient
Trial Results
Summary results in Lebanon
Among 81 patients, 42 (52%) patients were randomly assigned to the intervention group, and 39 (48%) patients to the control group. At day 30, The mean number of medication discrepancies was significantly lower in the intervention group (p = .000). 63.6% of patients in the control group had at least one medication discrepancy identified. The most common type of discrepancy was drug commission and drug omission; they mostly occurred in the control group and this difference was statistically significant. 10 patients from the control group reported concerns on day 30, as compared to none from the intervention group (p = 0.003). Overall, patients from the intervention group had a better understanding of their medications that was statistically significant.
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial