- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04800900
Effectiveness of Pharmaceutical Interventions in Hospitalized Patients (INFAR)
April 10, 2022 updated by: Márcio Galvão Guimarães de Oliveira, Federal University of Bahia
Effectiveness of Pharmaceutical Interventions in the Omission of Prescription and Desprescription of Medications in Hospitalized Patients
The presence of multimorbidities is very common among the elderly, which become major consumers of medicines.
The process of prescribing medicines for the elderly should be done with caution, as the use of some medications may present more risks than benefits in this range age.
Potentially inappropriate prescribing for the elderly has become a global concern for the promotion of an adequate pharmacotherapy, it becomes essential to be aware of the effectiveness and safety of medicines and the knowledge of which drugs whose risks of serious adverse reactions outweigh the benefit of your referral.
In this sense, the present study has aim to evaluate the effectiveness of pharmaceutical interventions in frequency of omission of drugs with proven efficacy for cardiovascular diseases and promotion of treatment prescription inappropriate and polypharmacy.
A prospective quasi experimental before and after study will be carried out in elderly patients diagnosed with cardiovascular disease admitted to the Ana Nery hospital, Salvador, Bahia, Brazil.
A convenience sample will be collected, the data will be released and revised in a database built in the SPSS software and analyzed in the program statistic R and SPSS.
At the end of the study, it is expected a decrease in the frequency of omission of medications and promotion of prescription drugs inappropriate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
332
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 40301-155
- Hospital Ana Nery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of cardiovascular disease
- Discharge after 24 hours
Exclusion Criteria:
* Death
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pharmaceutical intervention
A pharmacist will analyse patient's prescription, identify if there is prescribing omission and inappropriated drug prescribed and when necessary will require to doctors
|
A pharmacist will analyse patient's prescription, identify if there is prescribing omission and inappropriated drug prescribed and when necessary will require to doctors deprescribe or introduce or remove prescribed drugs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Effectiveness of pharmaceutical interventions measured by proportion of accepted interventions and all interventions
Time Frame: The acceptance of all pharmaceutical interventions related to inappropriate prescribed drugs and omission of prescription during the hospitalization of the patient will be evaluated, through study completion, an average of 1 year
|
The acceptance of all pharmaceutical interventions related to inappropriate prescribed drugs and omission of prescription during the hospitalization of the patient will be evaluated, through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of polypharmacy in elderly people with cardiovascular diseases measured by prescription containing five or more drugs
Time Frame: First prescription after 24 hours of admission, last prescription and discharge prescription through study completion, an average of 1 year
|
First prescription after 24 hours of admission, last prescription and discharge prescription through study completion, an average of 1 year
|
|
Incidence of omission of prescription drugs with proven efficacy for cardiovascular diseases measured by the START criteria
Time Frame: First prescription after 24 hours of admission, last prescription and discharge prescription through study completion, an average of 1 year
|
First prescription after 24 hours of admission, last prescription and discharge prescription through study completion, an average of 1 year
|
|
Incidence of potentially inappropriate drug prescription in elderly people with cardiovascular diseases measured by the Beers criteria
Time Frame: First prescription after 24 hours of admission, last prescription and discharge prescription through study completion, an average of 1 year
|
First prescription after 24 hours of admission, last prescription and discharge prescription through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2021
Primary Completion (Actual)
January 30, 2022
Study Completion (Actual)
January 30, 2022
Study Registration Dates
First Submitted
February 2, 2021
First Submitted That Met QC Criteria
March 14, 2021
First Posted (Actual)
March 16, 2021
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 10, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 41325820
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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