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Trial details
Pharmacist-Led Medication Reconciliation Upon Discharge from the Orthopedic Surgery Department
Current status:
Approved
|
Date registered:
19/03/2024
Trial version(s)
Current: 19/12/2023
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2023125487
Protocol number
LAU.SOP.ER1.14/Sep/2022
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
The clinical trial was submitted several times before its commencement, but the website was down.
Date of registration in national regulatory agency
14/09/2022
Primary sponsor
Lebanese American University
Primary sponsor: Country of origin
Lebanon
Public title
Pharmacist-Led Medication Reconciliation Upon Discharge from the Orthopedic Surgery Department
Acronym
Scientific title
Pharmacist-Led Medication Reconciliation Upon Discharge from the Orthopedic Surgery Department: An Interventional Randomized Controlled Trial
Acronym
Brief summary of the study: English
Medication reconciliation is a formal process of comparing the medications a patient is taking with the newly prescribed medications to avoid potential problems or discrepancies. Medication reconciliation should be done at every transition of care. The current practice at Lebanese hospitals’ orthopedic surgery departments does not involve pharmacy services. This study is an interventional, randomized, non-blinded, controlled trial conducted at the Lebanese American University Medical Center—Rizk Hospital. Participants were ≥ 18 years old and discharged from the orthopedic surgery unit with at least one discharge medication. Patients were randomized either to the intervention arm or to the control arm. In the intervention arm, a pharmacist is involved in the discharge process by completing medication reconciliation, providing patient counseling, and conducting telephone follow-up. However, in the control arm, they received the normal standard of care. All patients received a phone call from the primary investigator on day 30 post-discharge to record the endpoints. The primary outcome was to compare the number of unintended medication discrepancies. The secondary outcome consisted of the occurrence of adverse drug events, patient satisfaction, and a composite endpoint of unplanned physician contact, emergency room admission, and hospital readmission on day 30 post-discharge (and individual components of the composite endpoint).
Brief summary of the study: Arabic
التوفيق بين الأدوية هو عملية رسمية لمقارنة الأدوية التي يتناولها المريض مع الأدوية الموصوفة حديثًا لتجنب المشاكل أو التناقضات المحتملة. ينبغي إجراء التوفيق بين الأدوية في كل مرحلة انتقالية للرعاية. الممارسة الحالية في أقسام جراحة العظام في المستشفيات اللبنانية لا تشمل خدمات الصيدلة. نظرًا لأن الصيادلة هم خبراء الدواء، فإننا نعتقد أن التعليم التفصيلي الذي يقدمه الصيادلة للمرضى يمكن أن يساعد في تحديد المزيد من الأخطاء الدوائية، وبالتالي منع الأحداث الدوائية الضارة. الدراسة عبارة عن تجربة تدخلية عشوائية غير معماة، أجريت في المركز الطبي في الجامعة اللبنانية الأميركية - مستشفى رزق. كان عمر المشاركين ≥ 18 عامًا وخرجوا من وحدة جراحة العظام باستخدام دواء خروج واحد على الأقل. تم اختيار المرضى بشكل عشوائي إما إلى ذراع التدخل حيث يشارك الصيدلي في عملية الخروج من خلال استكمال التوفيق الدوائي وتوفير استشارات المرضى والمتابعة الهاتفية أو ذراع التحكم حيث تلقوا المستوى الطبيعي من الرعاية. وبعد 30 يومًا، سنقوم بإحصاء عدد التناقضات غير المقصودة التي تم تحديدها في كل فرع ومقارنتها من حيث الأهمية. سنقوم أيضًا بإجراء نقطة نهاية مركبة للاتصال غير المخطط له بالطبيب، والدخول إلى غرفة الطوارئ، وإعادة الدخول إلى المستشفى في اليوم 30 بعد الخروج (والمكونات الفردية لنقطة النهاية المركبة). سيتم حساب حدوث الأحداث الدوائية الضارة في اليوم 30 بعد الخروج من المستشفى وسيتم حساب رضا المريض في اليوم 30 بعد الخروج من المستشفى.
Health conditions/problem studied: Specify
Number of unintended medication discrepancies identified after patient discharge from the orthopedic department
Interventions: Specify
Involving a pharmacist in the discharge process from the orthopedic surgery department by performing medication reconciliation, patient counseling, and telephone follow-up in addition to the standard of care.
Key inclusion and exclusion criteria: Inclusion criteria
Subjects must meet all the inclusion criteria to participate in the study • Informed Consent • Adult (≥18 years) • Discharged from orthopedic surgery unit with ≥ 1 discharge medication
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
95
Key inclusion and exclusion criteria: Exclusion criteria
Subjects meeting any of the exclusion criteria at baseline screening will be excluded • Did not provide consent • Previously enrolled in another study • Being transferred to another hospital • Being transferred to another unit within the hospital
Type of Study
Type
Interventional
Type of intervention
Quality improvement
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
N/A
Study design: Purpose
Health services research
Study design: Assignment
Parallel
Pharmaceutical class
n/a
Therapeutic indication
n/a
Therapeutic benefit
n/a
Biospecimen retention
None retained
Biospecimen description
n/a
Target sample size
200
Actual enrollment target size
178
Date of first enrollment: Type
Actual
Date of first enrollment: Date
19/10/2022
Date of study closure: Type
Actual
Date of study closure: Date
30/04/2023
Recruitment status
Complete
Date of completion
30/04/2023
IPD sharing statement plan
No
IPD sharing statement description
n/a
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
Souad
Diab
Beirut
Lebanon
70336597
souad.diab@lau.edu
Lebanese American University
Scientific
Elsy
Ramia
Beirut
Lebanon
03167962
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
LAU Medical Center - Rizk Hospital
Souad Diab
Pharmacist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
14/09/2022
Elsy Ramia
elsy.ramia@lau.edu.lb
03167962
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Medication reconciliation upon discharge from the orthopedic department
2-Propanol (T51.2)
Medication Reconciliation
Interventions
Intervention
Description
Keyword
Medication reconciliation and patient counseling before discharge
Incorporating pharmacists in the discharge process by completing medication reconciliation and providing patient counseling
Medication Reconciliation and Patient Counseling
Patient telephone follow up
Pharmacist telephone follow-up of the patient 3 days post-dischage
Follow-up
Primary Outcomes
Name
Time points
Measure
Unintended medication discrepancies identified
Day 30 post-discharge
Number of unintended medication discrepancies identified
Key Secondary Outcomes
Name
Time points
Measure
unplanned physician contact, Emergency Room admission, hospital readmission
Day 30 post-discharge
Composite endpoint of unplanned physician contact, Emergency Room admission, hospital readmission (and individual components of the composite endpoint)
Adverse Drug Events
Day 30 post-discharge
Number and type of adverse drug events
Patient Satisfaction
Day 30 post-discharge
HCAHPS survey
Trial Results
Summary results in Lebanon
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