PolypharmacyNCT05408598
Pharmacological Optimization by a Specialized Outpatient Consultation Team
An observational study of Polypharmacy, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
Background Polypharmacy is a common condition among older adults and is a major issue of concern for its association with adverse drug reactions and adverse health outcomes, including falls, functional and cognitive impairment, frailty, and increased use of healthcare resources. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Polypharmacy
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jun 2021to 1 Mar 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Community-dwelling older adults ( ≥ 75 years old) with polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion).
Who may be able to join
- ≥ 75 years old
- Willing to provide informed consent
- Life expectancy ≥ 3 months
- Present polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion).
Who cannot join
- Refusal to sign the informed consent form by the patient/primary caregiver/legal guardian or inability to obtain it.
- Participation in a clinical trial related to medication.
- In the event of a no-show or cancellation of the appointment at the first visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive and Functional Trajectories in Older Adults After a Pharmacologic Multidisciplinary Intervention: a Study Protocol
Background Polypharmacy is a common condition among older adults and is a major issue of concern for its association with adverse drug reactions and adverse health outcomes, including falls, functional and cognitive impairment, frailty, and increased use of healthcare resources. Therefore, an appropriate interprofessional collaboration is essential to face this growing concern. In our outpatient clinic, we have initiated a new approach to provide specialized care for older adults based on a close collaboration between different professionals to optimize drug therapy. With the aim to assess the impact of this specialized outpatient clinic on patients' abilities, a prospective study will be conducted in community-dwelling older adults with polypharmacy.
Methods The present study will be conducted with geriatric outpatients with polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion) in the Navarra University Hospital, a Spanish Public tertiary University Hospital. At least 104 patients aged 75 years or older, with a life expectancy ≥ 3 months willing to provide informed consent will be recruited from the outpatient clinic. Drug optimization in the first consultation will be accompanied by subsequent face-to-face and/or telephone follow-up at intermediate (~ 3 months) and end of study (~ 6 months). The primary endpoint will be the change in functional and cognitive capacities measured at baseline and follow-up. Secondary endpoints will be the analysis of medication changes (i.e. number of medications and drugs, type of intervention, anticholinergic burden, and the number of STOPP/START criteria), change in patient's quality of life, rate of falling, and use of healthcare resources.
Discussion Regarding geriatric outpatients, studies in which medication review has been conducted by a multidisciplinary team (at least comprising a physician and a pharmacist) functional and cognitive patient's capacities have not been reported. What this study adds is the impact of a specialized consultation team focused on pharmacotherapy optimization in functional and cognitive abilities of community-dwelling older adults with polypharmacy. A multidisciplinary approach to polypharmacy could be an effective way for improving patients' functional and cognitive abilities. We expect that the association of different complementary professional roles working together will have a synergistic effect and will be an effective strategy for this purpose.
- Conditions
- Polypharmacy
- Keywords
- Geriatrics, Pharmacist, Outpatient, Polypharmacy, Medication review, Functional capacity, Cognitive capacity, Comprehensive Geriatric Assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional capacity: Barthel Index (spanish version)
The change in Barthel Index measured at baseline and follow-up (measure of Basic Activities of Daily Living)
Measured: 12 months
Change in functional capacity: Lawton Scale (spanish version)
The change in Lawton Scale measured at baseline and follow-up (measure of Instrumental Activities of Daily Living)
Measured: 12 months
Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión)
The change in SPPB measured at baseline and follow-up (measure of balance, gait, and rising from a chair)
Measured: 12 months
Change in functional capacity: Strenght (Handgrip)
The change in Strenght measured at baseline and follow-up
Measured: 12 months
Change in cognitive function by the "Índice de Incapacidad psíquica de la Cruz Roja" (IPCR).
The change in IPCR measured at baseline and follow-up
Measured: 12 months
Secondary outcomes (4)
Quality of life (changes between baseline and follow-up)
Quality of life, assessed by the questionnaire EQ-5D-5L (Spanish version) and a subjectively rated visual analog scale (EQ VAS).
Measured: 12 months
Frailty(changes between baseline and follow-up)
Frailty will be assessed by Fried criteria and Frail-VIG.
Measured: 12 months
Healthcare use
Comparison of healthcare use (hospital admissions, primary care and emergency visits) between baseline and follow-up consultations.
Measured: 12 months
Burden of medications between baseline and follow-up.
The analysis of medication changes between baseline and follow-up will comprise: number of medications and drugs, anticholinergic burden assessed by drug burden index (DBI) and Anticholinergic Burden Calculator (ACB) scales, and number of STOPP/START criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start25 Jun 2021
- Primary completion20 Nov 2022 (estimated)
- Study completion1 Mar 2023 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolás Martínez Velilla, Fundacion Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408598
- Sponsor's protocol ID
- PHARM-OPTIMIZ GERIATRÍA
- Status last verified
- Jun 2022
- First submitted
- 1 Mar 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share data under reasonable request
Publications
Roncal-Belzunce V, Gutierrez-Valencia M, Cedeno-Veloz BA, San Miguel R, Marin-Epelde I, Galbete A, Preciado Goldaracena J, Ezpeleta MI, Garaioa-Aramburu K, Martinez-Velilla N. Impact of a Multidisciplinary Approach to Polypharmacy Management in Community-Dwelling Older Adults: Insights From a Specialized Outpatient Clinic. Aging Med (Milton). 2025 Feb 18;8(1):e70001. doi: 10.1002/agm2.70001. eCollection 2025 Feb.
PubMed 39968007Roncal-Belzunce V, Cedeno-Veloz BA, Elcano RSM, Gutierrez-Valencia M, Izquieta VR, Guruceaga-Eguillor I, Marin-Epelde I, Echeverria-Beistegui I, Sanchez-Latorre M, Galbete A, Garaioa-Aramburu K, Martinez-Velilla N. Cognitive and functional trajectories in geriatric outpatients after a pharmacologic multidisciplinary intervention: A study protocol. Rev Esp Geriatr Gerontol. 2023 Sep-Oct;58(5):101386. doi: 10.1016/j.regg.2023.101386. Epub 2023 Jul 29.
PubMed 37523939
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Functional Trajectories in Older Adults After a Pharmacologic Multidisciplinary Intervention: a Study Protocol
- ClinicalTrials.gov ID
- NCT05408598
- Acronym / sponsor ID
- PHARM-OPTIMIZ GERIATRÍA
- Conditions
- Polypharmacy
- Keywords
- Geriatrics, Pharmacist, Outpatient, Polypharmacy, Medication review, Functional capacity, Cognitive capacity, Comprehensive Geriatric Assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 7 Jun 2022 (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 Polypharmacy is a common condition among older adults and is a major issue of concern for its association with adverse drug reactions and adverse health outcomes, including falls, functional and cognitive impairment, frailty, and increased use of healthcare resources. Therefore, an appropriate interprofessional collaboration is essential to face this growing concern. In our outpatient clinic, we have initiated a new approach to provide specialized care for older adults based on a close collaboration between different professionals to optimize drug therapy. With the aim to assess the impact of this specialized outpatient clinic on patients' abilities, a prospective study will be conducted in community-dwelling older adults with polypharmacy.
Methods The present study will be conducted with geriatric outpatients with polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion) in the Navarra University Hospital, a Spanish Public tertiary University Hospital. At least 104 patients aged 75 years or older, with a life expectancy ≥ 3 months willing to provide informed consent will be recruited from the outpatient clinic. Drug optimization in the first consultation will be accompanied by subsequent face-to-face and/or telephone follow-up at intermediate (~ 3 months) and end of study (~ 6 months). The primary endpoint will be the change in functional and cognitive capacities measured at baseline and follow-up. Secondary endpoints will be the analysis of medication changes (i.e. number of medications and drugs, type of intervention, anticholinergic burden, and the number of STOPP/START criteria), change in patient's quality of life, rate of falling, and use of healthcare resources.
Discussion Regarding geriatric outpatients, studies in which medication review has been conducted by a multidisciplinary team (at least comprising a physician and a pharmacist) functional and cognitive patient's capacities have not been reported. What this study adds is the impact of a specialized consultation team focused on pharmacotherapy optimization in functional and cognitive abilities of community-dwelling older adults with polypharmacy. A multidisciplinary approach to polypharmacy could be an effective way for improving patients' functional and cognitive abilities. We expect that the association of different complementary professional roles working together will have a synergistic effect and will be an effective strategy for this purpose.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older adults ( ≥ 75 years old) with polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion).
Key inclusion criteria (4 listed)
- ≥ 75 years old
- Willing to provide informed consent
- Life expectancy ≥ 3 months
- Present polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion).
Key exclusion criteria (3 listed)
- Refusal to sign the informed consent form by the patient/primary caregiver/legal guardian or inability to obtain it.
- Participation in a clinical trial related to medication.
- In the event of a no-show or cancellation of the appointment at the first visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in functional capacity: Barthel Index (spanish version)
Time frame: 12 months
The change in Barthel Index measured at baseline and follow-up (measure of Basic Activities of Daily Living)
Change in functional capacity: Lawton Scale (spanish version)
Time frame: 12 months
The change in Lawton Scale measured at baseline and follow-up (measure of Instrumental Activities of Daily Living)
Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión)
Time frame: 12 months
The change in SPPB measured at baseline and follow-up (measure of balance, gait, and rising from a chair)
Change in functional capacity: Strenght (Handgrip)
Time frame: 12 months
The change in Strenght measured at baseline and follow-up
Change in cognitive function by the "Índice de Incapacidad psíquica de la Cruz Roja" (IPCR).
Time frame: 12 months
The change in IPCR measured at baseline and follow-up
4 secondary outcomes
Quality of life (changes between baseline and follow-up)
Time frame: 12 months
Frailty(changes between baseline and follow-up)
Time frame: 12 months
Healthcare use
Time frame: 12 months
Burden of medications between baseline and follow-up.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 39968007Roncal-Belzunce V, Gutierrez-Valencia M, Cedeno-Veloz BA, San Miguel R, Marin-Epelde I, Galbete A, Preciado Goldaracena J, Ezpeleta MI, Garaioa-Aramburu K, Martinez-Velilla N. Impact of a Multidisciplinary Approach to Polypharmacy Management in Community-Dwelling Older Adults: Insights From a Specialized Outpatient Clinic. Aging Med (Milton). 2025 Feb 18;8(1):e70001. doi: 10.1002/agm2.70001. eCollection 2025 Feb.
- Derived from this study: PubMed 37523939Roncal-Belzunce V, Cedeno-Veloz BA, Elcano RSM, Gutierrez-Valencia M, Izquieta VR, Guruceaga-Eguillor I, Marin-Epelde I, Echeverria-Beistegui I, Sanchez-Latorre M, Galbete A, Garaioa-Aramburu K, Martinez-Velilla N. Cognitive and functional trajectories in geriatric outpatients after a pharmacologic multidisciplinary intervention: A study protocol. Rev Esp Geriatr Gerontol. 2023 Sep-Oct;58(5):101386. doi: 10.1016/j.regg.2023.101386. Epub 2023 Jul 29.
- Individual participant dataSharing planned: Undecided. We plan to share data under reasonable request
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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?
An observational study of Polypharmacy, run by Fundacion Miguel Servet 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 4 inclusion and 3 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 3 Nov 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 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?
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?
Change in functional capacity: Barthel Index (spanish version) (time frame: 12 months). 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 NCT05408598, 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 3 Nov 2022.