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Trial details
Trial details
Impact of pharmacist educational interventions on patients with anticoagulants
Current status:
Approved
|
Date registered:
16/03/2020
|
Date last updated:
10/03/2020
Trial version(s)
Current: 06/03/2020
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Main Information
Primary registry identifying number
LBCTR2020033424
Protocol number
LAU.SOP.LK2.11/Jul/2017
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 did not exist/was available at the start of the study
Date of registration in national regulatory agency
06/03/2020
Primary sponsor
Lebanese American University
Primary sponsor: Country of origin
Lebanon
Public title
Impact of pharmacist educational interventions on patients with anticoagulants
Acronym
N/A
Scientific title
Impact of pharmacist-conducted anticoagulation patient education and telephone follow-up on transitions of care: A randomized controlled trial
Acronym
N/A
Brief summary of the study: English
This was a randomized, non-blinded interventional study conducted at a tertiary care teaching hospital in Beirut, Lebanon. Participants were inpatients ≥ 18 years, discharged on a therapeutic dose of anticoagulant. Patients were randomized by block randomization. The control group received the standard anticoagulant discharge counseling provided by nurses. The intervention group was counseled by a pharmacist. All patients received a phone call from the study investigators at day at day 30 post-discharge. Patients counseled by pharmacists received an additional phone call at day 2 to 3. Primary outcome measures included readmission rates within 30 days post-discharge and bleeding events. Secondary outcomes included unplanned patient contact with prescribers post-discharge.
Brief summary of the study: Arabic
إن المعيار المعتمد حالياً في المستشفى يقضي بتوفير المرضى وعائلاتهم بالمعلومات اللازمة عن الأدوية الموصوفة بعد خروجهم من المستشفى. كل مقدمي الرعاية الصحية بما في ذلك الممرضين والأطباء والصيادلة متمرسون في توفير المعلومات المطلوبة عن الأدوية. نحن نرغب في تقييم أثر المعلومات الموفرة من قبل الصيادلة قبل مغادرة المرضى المستشفى حول الأدوية المسيلة للدم وخلال فترة المتابعة من 2 الى 3 أيام بعد مغادرة المستشفى وفي اليوم 30 بعد مغادرة المستشفى خصوصاَ بما يخص مخرجات السلامة كالنزيف.
Health conditions/problem studied: Specify
The most common indication for anticoagulation was atrial fibrillation, venous thromboembolism, aortic valve replacement, and mitral valve replacement
Interventions: Specify
Patients were randomized by block randomization. The control group received the standard anticoagulant discharge counseling provided by nurses. The intervention group was counseled by a pharmacist. All patients received a phone call from the study investigators at day at day 30 post-discharge. Patients counseled by pharmacists received an additional phone call at day 2 to 3.
Key inclusion and exclusion criteria: Inclusion criteria
Participants were inpatients ≥18 years discharged on an oral anticoagulant for treatment
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
58
Key inclusion and exclusion criteria: Age maximum
86
Key inclusion and exclusion criteria: Exclusion criteria
Excluded were those with severe cognitive impairment, inability to communicate or to be followed-up, discharged on an anticoagulant for prophylaxis.
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
Active
Study phase
N/A
Study design: Purpose
Health services research
Study design: Assignment
Parallel
Pharmaceutical class
Anticoagulants
Therapeutic indication
The most common indication for anticoagulation was atrial fibrillation, venous thromboembolism, aortic valve replacement, and mitral valve replacement
Therapeutic benefit
N/A - studied readmission rates
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
200
Actual enrollment target size
200
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/08/2017
Date of study closure: Type
Actual
Date of study closure: Date
31/07/2019
Recruitment status
Complete
Date of completion
31/07/2019
IPD sharing statement plan
No
IPD sharing statement description
N/A
Additional data URL
None
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
N/A
N/A
Sources of Monetary or Material Support
Name
N/A
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Lamis
Karaoui
Lebanese American University - School of Pharmacy, Byblos
Lebanon
+961-354-7254 ext 2318
lamis.karaoui@lau.edu.lb
Lebanese American University
Scientific
Nibal
Chamoun
Lebanese American University - School of Pharmacy, Byblos
Lebanon
+961-345-7254 ext 24017
nibal.chamoun@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
Lamis R. Karaoui
Pharmacist/Clinical Associate Professor
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Lebanese American University- University Medical Center Rizk Hospital
11/07/2017
Christine Chalhoub
christine.chalhoub@lau.edu.lb
+961 9 547254 ext. 2340
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Anticoagulation
2-Propanol (T51.2)
Anticoagulation
Interventions
Intervention
Description
Keyword
Patients were randomized into 2 groups.
The control group received the standard anticoagulant discharge counseling provided by nurses. The intervention group was counseled by a pharmacist. All patients received a phone call from the study investigators at day at day 30 post-discharge. Patients counseled by pharmacists received an additional phone call at day 2 to 3.
postdischarge counseling
Primary Outcomes
Name
Time points
Measure
Readmission rates and any bleeding event
day 3 and day 30 post-discharge
Number of patients readmitted at day 3 and day 30 post discharge
Key Secondary Outcomes
Name
Time points
Measure
Documented elements of education in the medical record and reported mortality
30 days post-discharge follow-up
number of patients receiving elements of education
Trial Results
Summary results in Lebanon
200 patients were included with 100 patients in each group. Baseline characteristics were similar between the two groups (p > 0.05). More patients in the pharmacist-counseled group contacted their physician within 3 days (14% versus 4%; p=0.010). No statistically significant difference in bleeding rates at day 3 and day 30 post-discharge between the two groups was observed. The documentation in the pharmacist-counseled group was better (p < 0.05), and more explicit education documents were provided by the pharmacist-counseled group (p < 0.001). Patients in the standard of care group were more aware of their next appointment date with the physician compared to the pharmacist-counseled group (52% versus 31%, p < 0.001).
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