PolypharmacyRGNCT05944328
Effectiveness of an Intervention of Pharmacotherapeutic Plans to Reduce Medication-related Problems in Geriatric Residences
A study testing systematic and structured review of patient pharmacotherapeutic treatment plans in people with Polypharmacy, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Background: Patients living in Geriatric Residences (RG) have increased aging, comorbidity, spending on health resources and mortality. High drug use is associated with an increased risk of falls, disability, and death. It is estimated that 20-50% of inappropriate medications are consumed in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Polypharmacy
- What is being tested?
- systematic and structured review of patient pharmacotherapeutic treatment plans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 862 participants
- Where
- 1 siteSpain
- Study dates
- 22 Feb 2023to 1 Jun 2024
- 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 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Pharmacological treatment with at least one drug and for a period of more than three months
Who cannot join
- Individuals who at the time of the pharmaceutical review were in hospital
- Patients nearing the end of life
- Patients whose participation was considered by the doctor responsible to be potentially detrimental
- Patients not covered by the public healthcare or pharmacy system were excluded.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Cecilia Campabadal Prats
Tarragona, 43003
Cecília Campabadal Prats, 679716123, cprats.tgn.ics@gencat.cat
About this study
Official title: Effectiveness of a Structured Pharmaceutical Review Intervention of Pharmacotherapeutic Plans to Reduce Medication-related Problems in Geriatric Residences: a Quasi-experimental Pragmatic Assay
Background: Patients living in Geriatric Residences (RG) have increased aging, comorbidity, spending on health resources and mortality. High drug use is associated with an increased risk of falls, disability, and death. It is estimated that 20-50% of inappropriate medications are consumed in the elderly.
Hypothesis: A pharmaceutical intervention based on a clinical review of the pharmacotherapeutic plan of patients in RG will be useful in optimizing the prescription in terms of safety, reducing by 10% or more the inappropriate prescriptions.
Read more
Objectives: Evaluate the effectiveness of a structured pharmaceutical intervention based on the clinical review of the pharmacotherapeutic plan to improve its adequacy.
Decrease inadequate prescriptions in patients admitted to RG by 10%
Methodology: Pre-post, quasi-experimental intervention study with control group with prospective follow-up of a cohort of patients in RG. The intervention consists of the clinical review of the pharmacotherapeutic plan carried out by the pharmacist and subsequently agreed in the Pharmacotherapeutic Advisory Committee.
Determinations: The study variables will be evaluated at baseline and 3 months post-intervention. The primary variable is number of inappropriate prescriptions.
Statistical analysis: Percentage change will be measured before and after the intervention. Descriptive statistics will be performed for quantitative variables such as qualitative and comparison of means and proportions.
Expected results: Achieve a 10% decrease in inappropriate prescriptions
Applicability and Relevance: This study will expand the collaboration between the Pharmacy and Primary Care physicians, promoting the continuum of care, strengthening the safety culture, and improving prescribing habits.
- Conditions
- Polypharmacy
- Being tested
- systematic and structured review of patient pharmacotherapeutic treatment plans
- Keywords
- pharmaceutical intervention, polypharmacy, nursing home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic and structured review of patient pharmacotherapeutic treatment plansOther
The intervention consisted of a systematic and structured review of patient pharmacotherapeutic treatment plans to identify problems or situations of risk related to pharmacological treatments and to propose changes or improvements to optimise them. phases:
Individualised review of pharmacological treatment plans to detect drug-related problems:
Indication, Appropriateness, Effectiveness, Safety When a drug-related problem was detected according to the above criteria, the pharmacist proposed an adjustment to the pharmacotherapeutic plan. The proposals could include: discontinuation of the drug, change of drug, change to a therapeutic equivalent, initiation of treatment, change of dosage, change of frequency or intensified monitoring.
The proposals made by the pharmacist were assessed and agreed upon by a committee comprising the doctors responsible and the pharmacist. Thereafter, the consensual proposals for change were discussed with the patient.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: systematic and structured review of patient pharmacotherapeutic treatment plans |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-related problems
Total count
Measured: Basal
Drug-related problems
Total count
Measured: Three months
Drug-related problems
average prm per patient
Measured: Basal
Drug-related problems
average prm per patient
Measured: Three months
Drug-related problems
% patients with prm
Measured: Basal
Drug-related problems
% patients with prm
Measured: Three months
Polymedication:
Average number of drugs
Measured: Basal
Polymedication:
Average number of drugs
Measured: Three months
Polymedication:
number of polymedicated patients (> 10 drugs)
Measured: Basal
Polymedication:
number of polymedicated patients (>10 drugs)
Measured: Three months
Secondary outcomes (11)
Sociodemographic variables
genre: female/male
Measured: Basal
Sociodemographic variables
median age
Measured: Basal
Sociodemographic variables
average months in the geriatric residence
Measured: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
number of prm classified as indication
Measured: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
number of prm classified as adequate
Measured: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
number of prm classified as effectiveness
Measured: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
number of prm classified as security
Measured: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
number of prm classified as indication
Measured: Three months
Description and classification of the DRPs detected Description and classification of the DRPs detected
number of prm classified as adequate
Measured: Three months
Description and classification of the DRPs detected Description and classification of the DRPs detected
number of prm classified as effectiveness
Measured: Three months
Description and classification of the DRPs detected Description and classification of the DRPs detected
number of prm classified as security
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start22 Feb 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 862 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944328
- Sponsor's protocol ID
- 22/191-P
- Acronym
- RG
- Status last verified
- Mar 2023
- First submitted
- 20 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Campabadal-Prats C, Aragones E, Romeu M, Salom-Garrigues C, Bejarano F, Martin Lujan F, Canadell L. Effectiveness of a structured pharmaceutical review of pharmacotherapeutic plans to reduce drug-related problems in nursing homes: a study protocol of a pragmatic quasi-experimental trial. Front Pharmacol. 2025 Jul 11;16:1522650. doi: 10.3389/fphar.2025.1522650. eCollection 2025.
PubMed 40717969
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Structured Pharmaceutical Review Intervention of Pharmacotherapeutic Plans to Reduce Medication-related Problems in Geriatric Residences: a Quasi-experimental Pragmatic Assay
- ClinicalTrials.gov ID
- NCT05944328
- Acronym / sponsor ID
- RG / 22/191-P
- Conditions
- Polypharmacy
- Keywords
- pharmaceutical intervention, polypharmacy, nursing home
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 862 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 13 Jul 2023 (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.
Background: Patients living in Geriatric Residences (RG) have increased aging, comorbidity, spending on health resources and mortality. High drug use is associated with an increased risk of falls, disability, and death. It is estimated that 20-50% of inappropriate medications are consumed in the elderly.
Hypothesis: A pharmaceutical intervention based on a clinical review of the pharmacotherapeutic plan of patients in RG will be useful in optimizing the prescription in terms of safety, reducing by 10% or more the inappropriate prescriptions.
Objectives: Evaluate the effectiveness of a structured pharmaceutical intervention based on the clinical review of the pharmacotherapeutic plan to improve its adequacy.
Decrease inadequate prescriptions in patients admitted to RG by 10%
Methodology: Pre-post, quasi-experimental intervention study with control group with prospective follow-up of a cohort of patients in RG. The intervention consists of the clinical review of the pharmacotherapeutic plan carried out by the pharmacist and subsequently agreed in the Pharmacotherapeutic Advisory Committee.
Determinations: The study variables will be evaluated at baseline and 3 months post-intervention. The primary variable is number of inappropriate prescriptions.
Statistical analysis: Percentage change will be measured before and after the intervention. Descriptive statistics will be performed for quantitative variables such as qualitative and comparison of means and proportions.
Expected results: Achieve a 10% decrease in inappropriate prescriptions
Applicability and Relevance: This study will expand the collaboration between the Pharmacy and Primary Care physicians, promoting the continuum of care, strengthening the safety culture, and improving prescribing habits.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: systematic and structured review of patient pharmacotherapeutic treatment plans |
| control group | No intervention | – |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older
- Pharmacological treatment with at least one drug and for a period of more than three months
Key exclusion criteria (4 listed)
- Individuals who at the time of the pharmaceutical review were in hospital
- Patients nearing the end of life
- Patients whose participation was considered by the doctor responsible to be potentially detrimental
- Patients not covered by the public healthcare or pharmacy system were excluded.
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 |
|---|---|---|
| systematic and structured review of patient pharmacotherapeutic treatment plansThe intervention consisted of a systematic and structured review of patient pharmacotherapeutic treatment plans to identify problems or situations of risk related to pharmacological treatments and to propose changes or improvements to optimise them. phases: Individualised review of pharmacological treatment plans to detect drug-related problems: Indication, Appropriateness, Effectiveness, Safety When a drug-related problem was detected according to the above criteria, the pharmacist proposed an adjustment to the pharmacotherapeutic plan. The proposals could include: discontinuation of the drug, change of drug, change to a therapeutic equivalent, initiation of treatment, change of dosage, change of frequency or intensified monitoring. The proposals made by the pharmacist were assessed and agreed upon by a committee comprising the doctors responsible and the pharmacist. Thereafter, the consensual proposals for change were discussed with the patient. | Other | intervention group |
Primary outcome
Drug-related problems
Time frame: Basal
Total count
Drug-related problems
Time frame: Three months
Total count
Drug-related problems
Time frame: Basal
average prm per patient
Drug-related problems
Time frame: Three months
average prm per patient
Drug-related problems
Time frame: Basal
% patients with prm
Drug-related problems
Time frame: Three months
% patients with prm
Polymedication:
Time frame: Basal
Average number of drugs
Polymedication:
Time frame: Three months
Average number of drugs
Polymedication:
Time frame: Basal
number of polymedicated patients (> 10 drugs)
Polymedication:
Time frame: Three months
number of polymedicated patients (>10 drugs)
11 secondary outcomes
Sociodemographic variables
Time frame: Basal
Sociodemographic variables
Time frame: Basal
Sociodemographic variables
Time frame: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
Time frame: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
Time frame: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
Time frame: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
Time frame: Basal
Description and classification of the DRPs detected Description and classification of the DRPs detected
Time frame: Three months
Description and classification of the DRPs detected Description and classification of the DRPs detected
Time frame: Three months
Description and classification of the DRPs detected Description and classification of the DRPs detected
Time frame: Three months
Description and classification of the DRPs detected Description and classification of the DRPs detected
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 40717969Campabadal-Prats C, Aragones E, Romeu M, Salom-Garrigues C, Bejarano F, Martin Lujan F, Canadell L. Effectiveness of a structured pharmaceutical review of pharmacotherapeutic plans to reduce drug-related problems in nursing homes: a study protocol of a pragmatic quasi-experimental trial. Front Pharmacol. 2025 Jul 11;16:1522650. doi: 10.3389/fphar.2025.1522650. eCollection 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systematic and structured review of patient pharmacotherapeutic treatment plans in people with Polypharmacy, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Jul 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug-related problems (time frame: Basal). The study lists 10 primary outcomes in all. 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 NCT05944328, which also lists 1 linked publication.
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 13 Jul 2023.