Safety IssuesINFARNCT04800900
Effectiveness of Pharmaceutical Interventions in Hospitalized Patients
A study testing Pharmaceutical intervention in people with Safety Issues, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Safety Issues
- What is being tested?
- Pharmaceutical intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Feb 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cardiovascular disease
- Discharge after 24 hours
Who cannot join
- Death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Safety Issues
- Being tested
- Pharmaceutical intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pharmaceutical intervention | Experimental | A pharmacist will analyse patient's prescription, identify if there is prescribing omission and inappropriated drug prescribed and when necessary will require to doctors Receives: Other: Pharmaceutical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of pharmaceutical interventions measured by proportion of accepted interventions and all interventions
Measured: 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 outcomes (3)
Incidence of polypharmacy in elderly people with cardiovascular diseases measured by prescription containing five or more drugs
Measured: 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
Measured: 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
Measured: First prescription after 24 hours of admission, last prescription and discharge prescription through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start4 Feb 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Márcio Galvão Guimarães de Oliveira, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800900
- Sponsor's protocol ID
- 41325820
- Acronym
- INFAR
- Status last verified
- Apr 2022
- First submitted
- 2 Feb 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gama RS, Passos LC, Amorim WW, Souza RM, Oliveira MG. Reducing Anticholinergic Burden in Hospitalised Older Adults: Analysis From the INFAR Study. Basic Clin Pharmacol Toxicol. 2026 Jan;138(1):e70160. doi: 10.1111/bcpt.70160.
PubMed 41345711Gama RS, Passos LC, Amorim WW, Souza RM, Oliveira MG. Effectiveness of Pharmacist Interventions in Improving Medication Use in Hospitalised Older Patients Diagnosed With Cardiovascular Diseases: INFAR Before-and-After Study. J Eval Clin Pract. 2025 Jun;31(4):e70190. doi: 10.1111/jep.70190.
PubMed 40581959
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pharmaceutical Interventions in the Omission of Prescription and Desprescription of Medications in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04800900
- Acronym / sponsor ID
- INFAR / 41325820
- Conditions
- Safety Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmaceutical intervention | Experimental | Other: Pharmaceutical interventionA pharmacist will analyse patient's prescription, identify if there is prescribing omission and inappropriated drug prescribed and when necessary will require to doctors |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of cardiovascular disease
- Discharge after 24 hours
Key exclusion criteria (1 listed)
- Death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical interventionA 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 | Other | Pharmaceutical intervention |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 41345711Gama RS, Passos LC, Amorim WW, Souza RM, Oliveira MG. Reducing Anticholinergic Burden in Hospitalised Older Adults: Analysis From the INFAR Study. Basic Clin Pharmacol Toxicol. 2026 Jan;138(1):e70160. doi: 10.1111/bcpt.70160.
- Derived from this study: PubMed 40581959Gama RS, Passos LC, Amorim WW, Souza RM, Oliveira MG. Effectiveness of Pharmacist Interventions in Improving Medication Use in Hospitalised Older Patients Diagnosed With Cardiovascular Diseases: INFAR Before-and-After Study. J Eval Clin Pract. 2025 Jun;31(4):e70190. doi: 10.1111/jep.70190.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical intervention in people with Safety Issues, run by Federal University of Bahia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800900, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.