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.

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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