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Trial details
Value of pharmacy services upon admission to an orthopedic surgery unit
Current status:
Approved
|
Date registered:
09/12/2020
|
Date last updated:
09/12/2020
Trial version(s)
Current: 05/12/2020
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2020124680
Protocol number
LAU.SOP.ER2. 30/Sep/2019.
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
not aware of existence of the registry since it is a new registry.
Date of registration in national regulatory agency
05/12/2020
Primary sponsor
Lebanese American University
Primary sponsor: Country of origin
Lebanon
Public title
Value of pharmacy services upon admission to an orthopedic surgery unit
Acronym
N/A
Scientific title
Value of pharmacy services upon admission to an orthopedic surgery unit
Acronym
N/A
Brief summary of the study: English
This was a prospective single-arm study conducted in a tertiary care teaching hospital in Lebanon between October 2019 and April 2020. The study aimed to assess the impact of pharmacist-conducted medication reconciliation performed within 48 hours of hospital admission to the orthopedic surgical department. Participants were adult inpatients hospitalized for orthopedic surgeries with ≥1 outpatient medications. Properly trained pharmacy resident obtained the Best Possible Medication History (BPMH) and led on the reconciliation process. The primary endpoint was the number of reconciliation errors (REs) identified. Descriptive statistics were used to report participants’ responses and relevant findings. Linear regression was performed with the number of REs as a continuous dependent variable using Backward method. Results were assumed to be significant when p was < 0.05.
Brief summary of the study: Arabic
إن الممارسة الحالية في المركز الطبي للجامعة اللبنانية الأمريكية - مستشفى رزق تتمثل في أن يسأل الفريق الطبي المريض و / أو العائلة عن التاريخ الطبي السابق والأدوية الحالية من أجل ضمان باستكمال مناسب للأدوية الحالية التي كنت تأخذها في المنزل أثناء إقامتك في المستشفى وتحسين استخدام الأدوية التي تأخذها في المستشفى. يتم تدريب جميع مقدمي الخدمات الصحية بما في ذلك الممرضات والأطباء والصيادلة على أخذ تاريخ الدواء. من خلال هذا البحث، نود تقييم تأثير التوفيق الدوائي التي يقودها الصيدلي على المرضى البالغين الذين تم إدخالهم إلى المستشفى لعمل جراحي في قسم الجراحة العظمية مقارنةً بالمعلومات عن التاريخ المرضي التي يأخذها أعضاء آخرون في الفريق الطبي غير الصيدلي. بعد 48 ساعة من دخول المريض ، يقوم الدكتور الصيدلي المقيم بإجراء مقابلات مع المرضى و / أو أفراد الأسرة من أجل الحصول على تاريخ كامل حول تاريخ المرضي والأدوية الحالية التي يأخذها المريض في المنزل قبل القدوم للمستشفى. وهذا يشمل أسئلة حول الحالات الطبية ، والحساسية الدوائية ، والأدوية التي تؤخذ في المنزل التي يحددها الطبيب ، والأدوية في المنزل التي تم شراؤها من الصيدلية دون وصفات طبية وأي أدوية تحتوي على أعشاب طبية أو مكملات غذائية. يسأل الدكتور الصيدلي المقيم أيضًا عن وقت آخر جرعة دواء تم تناولها من كل الأدوية التي يأخذها المريض. يُطلب من كل هذه الأسئلة التأكد من أن الفريق لديه سجل كامل من أجل توفير أفضل رعاية ممكنة في المستشفى.
Health conditions/problem studied: Specify
Orthopedic surgery patients including elective and emergency surgeries.
Interventions: Specify
A post-graduate year 1 pharmacy resident interviewed the eligible patients after obtaining their written informed consent to participate in the study. While interviewing patients for medication history, the pharmacy resident inquired about all prescription and over the counter medications. The pharmacy resident asked both open-ended and closed-ended questions to trigger the patient to remember medications that they may have forgotten to mention such as creams, ointments, inhalers, eye drops, ear drops, vitamins, and herbal or dietary supplements. To ensure complete documentation of the BPMH, the resident also inquired about the level of compliance, the last dose taken, and potential recent changes to select medication regimens. In order to obtain the BPMH, the pharmacy resident relied on more than one information source such as interviewing the family/caregiver, inspecting the medication bottles, or reviewing the patient’s previous health record available at the institution. The pharmacy resident documented all the information on the “Medication Reconciliation Data Collection Form” that was developed to guide the BPMH process and record the reconciliation findings. This form included general demographic data, surgery type, total number of home medications and their indications, history of drug allergies, and results of the critical analysis of discrepancies. The different sections of this data collection form and the patient interview tips were adapted from the Medications at Transitions and Clinical Handoffs (MATCH) Toolkit for Medication Reconciliation.12 Afterwards, the pharmacy resident compared the obtained history from the patient to the medications ordered by the physician for the patient’s current admission. When deemed necessary, the pharmacy resident intervened in the management of the patient’s medication regimens during the reconciliation process by contacting the physician and clarifying any changes that need to be implemented to the current medication regimens.
Key inclusion and exclusion criteria: Inclusion criteria
Included patients were ≥18 years old, admitted for at least 48 hours to the Orthopedic Surgery Department for elective or emergency surgeries, and currently taking at least one regular prescription 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
Patients were excluded if they were admitted for less than 2 days or were unable to communicate in English or Arabic.
Type of Study
Type
Interventional
Type of intervention
Quality improvement
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Single Arm Study
Study design: Masking
N/A
Study design: Control
N/A
Study phase
N/A
Study design: Purpose
Health services research
Study design: Assignment
Single
Pharmaceutical class
All
Therapeutic indication
Orthopedic surgery patients (elective and emergency surgeries)
Therapeutic benefit
The primary outcome consisted of the number of REs, defined as any unjustified or unintended discrepancy between the patient’s medications prior to admission/surgery, and the inpatient medication list, 24-48 hours after admission. Secondary outcomes included the number of pharmacy resident’s interventions performed to resolve discrepancies.
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
100
Actual enrollment target size
100
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/10/2019
Date of study closure: Type
Actual
Date of study closure: Date
30/04/2020
Recruitment status
Complete
Date of completion
30/04/2020
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
NA
NA
Sources of Monetary or Material Support
Name
NA
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Elsy
Ramia
LAU-Byblos
Lebanon
03-167962
elsy.ramia@lau.edu.lb
LAU SOP
Scientific
Elsy
Ramia
LAU-Byblos
Lebanon
03-167962
elsy.ramia@lau.edu.lb
LAU SOP
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
LAUMCRH
Elsy Ramia, PharmD, MPH, BCPS
Clinical Assistant Professor
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
30/09/2019
Christine Chalhoub
christine.chalhoub@lau.edu.lb
03212327
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Orthopedic surgery
Orthopaedic follow-up care, unspecified (Z47.9)
Orthopedic surgery
Interventions
Intervention
Description
Keyword
Medication reconciliation
A post-graduate year 1 pharmacy resident interviewed the eligible patients after obtaining their written informed consent to participate in the study. While interviewing patients for medication history, the pharmacy resident inquired about all prescription and over the counter medications. The pharmacy resident asked both open-ended and closed-ended questions to trigger the patient to remember medications that they may have forgotten to mention such as creams, ointments, inhalers, eye drops, ear drops, vitamins, and herbal or dietary supplements. To ensure complete documentation of the BPMH, the resident also inquired about the level of compliance, the last dose taken, and potential recent changes to select medication regimens. In order to obtain the BPMH, the pharmacy resident relied on more than one information source such as interviewing the family/caregiver, inspecting the medication bottles, or reviewing the patient’s previous health record available at the institution. The pharmacy resident documented all the information on the “Medication Reconciliation Data Collection Form” that was developed to guide the BPMH process and record the reconciliation findings. This form included general demographic data, surgery type, total number of home medications and their indications, history of drug allergies, and results of the critical analysis of discrepancies. The different sections of this data collection form and the patient interview tips were adapted from the Medications at Transitions and Clinical Handoffs (MATCH) Toolkit for Medication Reconciliation. Afterwards, the pharmacy resident compared the obtained history from the patient to the medications ordered by the physician for the patient’s current admission. When deemed necessary, the pharmacy resident intervened in the management of the patient’s medication regimens during the reconciliation process by contacting the physician and clarifying any changes that need to be implemented to the current medication regimens.
Medication reconciliation, patient safety, quality improvement, orthopedic surgery
Primary Outcomes
Name
Time points
Measure
Number of Reconciliation Errors (REs)
within 48 hours of admission
any unjustified or unintended discrepancy between the patient’s medications prior to admission/surgery, and the inpatient medication list, 24-48 hours after admission.
Key Secondary Outcomes
Name
Time points
Measure
Number of pharmacy resident’s interventions
within 48hours of admission
interventions performed to resolve unintended discrepancies identified.
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