PolypharmacyNCT05820945
A Pharmaceutical Intervention to Reduce Drug-Related Problems in a Home Healthcare Program
A study testing Pharmacist-led medication review in people with Polypharmacy and Potentially Inappropriate Medications, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of patients in a home healthcare program will be effective in improving the quality and safety of treatments. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy, Potentially Inappropriate Medications
- What is being tested?
- Pharmacist-led medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2020to 22 Mar 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient in the home care program
- Sixty-five years of age or older
- Active pharmacological treatment plan with at least one drug
Who cannot join
- The responsible physician considers that participation may harm the patient
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Pharmacy, Camp de Tarragona Health Area, Catalan Health Institute
Tarragona, 43005
Clara Salom Garrigues, Pharm, +34 665139877, csalom.tgn.ics@gencat.cat
Enric Aragonès Benaiges, MD, PhD
About this study
Official title: Evaluation of a Pharmacist-Led Intervention to Reduce Drug-Related Problems in Patients Included in a Home Healthcare Program: A Pragmatic Randomized Clinical Trial
The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of patients in a home healthcare program will be effective in improving the quality and safety of treatments. This study aims to evaluate the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients (catalan home healthcare program at primary care level), compared to the usual management.
Read the detailed description
ATDOM is the catalan home healthcare program at primary care level. Patients in home care program are frequently polymedicated, which entails a high risk of drug-related problems (DRPs). The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of ATDOM patients will be effective in improving the quality and safety of treatments, reducing DRPs in terms of indication, adequacy, effectiveness, and safety.
The main objective of this study is therefore to evaluate the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients, compared to the usual management.
Specifically, the investigators want to determine, through a six-month intervention, the effectiveness in reducing DRPs per patient and polypharmacy. Additionally, the investigators will evaluate in the intervention group the implementation of the proposals for change or improvement by the responsible physician.
This is a pragmatic randomized clinical trial with a comparable control group, with prospective follow-up of an intervention for the adequacy of the pharmacological treatment of patients in the ATDOM program assigned to primary care teams of the Camp de Tarragona Primary Care Directorate. PRMs, proposals and implementation will be determined.
A descriptive statistical analysis will be carried out using multivariate adjustments.
If the evaluation results are favorable, widespread implementation of the program would be possible. It could be extended to all ATDOM patients or outpatients in general. Thus, interdisciplinary teamwork would be strengthened to favor the health care continuum.
- Being tested
- Pharmacist-led medication review
- Keywords
- Medication reconciliation, Medication review, Pharmacist practice pattern, Primary health care, Domiciliary care, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led medication reviewOther
Clinical review by a primary care pharmacist of the primary care clinical history and the pharmacological treatment plan. After the review process, a meeting will be held between the pharmacist and the responsible physician in order to present proposals for pharmacotherapeutic optimization.
| Study group | Role | What they receive |
|---|---|---|
| Medication review group | Experimental | Pharmacist-led medication review at patient level, and change proposals at physician level. Receives: Other: Pharmacist-led medication review |
| Control group | No intervention | Usual pharmacotherapy management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication-related problems
Change in number of medication-related problems
Measured: Baseline and 6 months follow-up
Medication related-problems per patient
Change in number of medication-related problems per patient
Measured: Baseline and 6 months follow-up
Patients with one or more MRPs
Change in number of patients with one or more MRPs
Measured: Baseline and 6 months follow-up
Drugs per patient
Change in number of concomitant drugs per patient
Measured: Baseline and 6 months follow-up
Polymedicated patients
Change in number of polymedicated patients. We define polypharmacy as the simultaneous use of 8 or more different drugs.
Measured: Baseline and 6 months follow-up
Secondary outcomes (2)
Proposals issued
Number of proposals issued by the pharmacist.
Measured: Baseline
Proposals implemented
Number of proposals implemented by the physician
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start2 Mar 2020
- Primary completion22 Sep 2023 (estimated)
- Study completion22 Mar 2024 (estimated)
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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups in parallel for the duration of the study: (a) intervention group (medication review), in which the patients will receive pharmacist-led medication review, and change proposals through their physician, and (b) control group, in which the patients will be subjected to usual pharmacotherapy management.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut, University Rovira i Virgili
- Responsible party
- Principal investigator, Clara Salom, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Clara Salom Garrigues, Pharm, Principal investigator, DAP Camp de Tarragona, Institut Català de la Salut.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820945
- Sponsor's protocol ID
- 19/141-P
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD underlying the published results will be shared.
Publications
Salom-Garrigues C, Aragones E, Giralt M, Campabadal Prats C, Bejarano-Romero F, Martin-Lujan F, Romeu M, Canadell L. Prevalence and associated factors for drug-related problems and polypharmacy identified by a pharmacist-led medication review in patients enrolled in a home healthcare program. BMC Geriatr. 2026 Feb 6;26(1):316. doi: 10.1186/s12877-026-07045-1.
PubMed 41652338Salom-Garrigues C, Aragones E, Giralt M, Campabadal Prats C, Bejarano-Romero F, Canadell L. Evaluation of a pharmacist-led intervention to reduce drug-related problems in patients included in a home healthcare program: study protocol for a pragmatic randomized clinical trial. BMC Geriatr. 2024 Feb 19;24(1):170. doi: 10.1186/s12877-024-04763-2.
PubMed 38373937
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Pharmacist-Led Intervention to Reduce Drug-Related Problems in Patients Included in a Home Healthcare Program: A Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05820945
- Acronym / sponsor ID
- 19/141-P
- Keywords
- Medication reconciliation, Medication review, Pharmacist practice pattern, Primary health care, Domiciliary care, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut, University Rovira i Virgili
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 22 Sep 2023 (estimated)
- Study completion
- 22 Mar 2024 (estimated)
- First posted
- 20 Apr 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.
The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of patients in a home healthcare program will be effective in improving the quality and safety of treatments. This study aims to evaluate the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients (catalan home healthcare program at primary care level), compared to the usual management.
Detailed description
ATDOM is the catalan home healthcare program at primary care level. Patients in home care program are frequently polymedicated, which entails a high risk of drug-related problems (DRPs). The investigators' hypothesis is that the individualized review of the pharmacotherapeutic plans of ATDOM patients will be effective in improving the quality and safety of treatments, reducing DRPs in terms of indication, adequacy, effectiveness, and safety.
The main objective of this study is therefore to evaluate the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients, compared to the usual management.
Specifically, the investigators want to determine, through a six-month intervention, the effectiveness in reducing DRPs per patient and polypharmacy. Additionally, the investigators will evaluate in the intervention group the implementation of the proposals for change or improvement by the responsible physician.
This is a pragmatic randomized clinical trial with a comparable control group, with prospective follow-up of an intervention for the adequacy of the pharmacological treatment of patients in the ATDOM program assigned to primary care teams of the Camp de Tarragona Primary Care Directorate. PRMs, proposals and implementation will be determined.
A descriptive statistical analysis will be carried out using multivariate adjustments.
If the evaluation results are favorable, widespread implementation of the program would be possible. It could be extended to all ATDOM patients or outpatients in general. Thus, interdisciplinary teamwork would be strengthened to favor the health care continuum.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups in parallel for the duration of the study: (a) intervention group (medication review), in which the patients will receive pharmacist-led medication review, and change proposals through their physician, and (b) control group, in which the patients will be subjected to usual pharmacotherapy management.
| Arm | Type | Receives |
|---|---|---|
| Medication review group | Experimental | Other: Pharmacist-led medication reviewPharmacist-led medication review at patient level, and change proposals at physician level. |
| Control group | No intervention | –Usual pharmacotherapy management. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patient in the home care program
- Sixty-five years of age or older
- Active pharmacological treatment plan with at least one drug
Key exclusion criteria (1 listed)
- The responsible physician considers that participation may harm the patient
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 |
|---|---|---|
| Pharmacist-led medication reviewClinical review by a primary care pharmacist of the primary care clinical history and the pharmacological treatment plan. After the review process, a meeting will be held between the pharmacist and the responsible physician in order to present proposals for pharmacotherapeutic optimization. | Other | Medication review group |
Primary outcome
Medication-related problems
Time frame: Baseline and 6 months follow-up
Change in number of medication-related problems
Medication related-problems per patient
Time frame: Baseline and 6 months follow-up
Change in number of medication-related problems per patient
Patients with one or more MRPs
Time frame: Baseline and 6 months follow-up
Change in number of patients with one or more MRPs
Drugs per patient
Time frame: Baseline and 6 months follow-up
Change in number of concomitant drugs per patient
Polymedicated patients
Time frame: Baseline and 6 months follow-up
Change in number of polymedicated patients. We define polypharmacy as the simultaneous use of 8 or more different drugs.
2 secondary outcomes
Proposals issued
Time frame: Baseline
Proposals implemented
Time frame: 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 41652338Salom-Garrigues C, Aragones E, Giralt M, Campabadal Prats C, Bejarano-Romero F, Martin-Lujan F, Romeu M, Canadell L. Prevalence and associated factors for drug-related problems and polypharmacy identified by a pharmacist-led medication review in patients enrolled in a home healthcare program. BMC Geriatr. 2026 Feb 6;26(1):316. doi: 10.1186/s12877-026-07045-1.
- Derived from this study: PubMed 38373937Salom-Garrigues C, Aragones E, Giralt M, Campabadal Prats C, Bejarano-Romero F, Canadell L. Evaluation of a pharmacist-led intervention to reduce drug-related problems in patients included in a home healthcare program: study protocol for a pragmatic randomized clinical trial. BMC Geriatr. 2024 Feb 19;24(1):170. doi: 10.1186/s12877-024-04763-2.
- Individual participant dataSharing planned: Yes. All IPD underlying the published results will be shared.
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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.
Clara Salom Garrigues, Pharm principal investigator
DAP Camp de Tarragona, Institut Català de la Salut.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led medication review in people with Polypharmacy and Potentially Inappropriate Medications, 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 3 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: status not confirmed, as of the sponsor's last update on 20 Apr 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?
Contact Clara Salom Garrigues, Pharm (+34 665139877, csalom.tgn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication-related problems (time frame: Baseline and 6 months follow-up). The study lists 5 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 NCT05820945, 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 20 Apr 2023.