Pharmacological Optimization by a Specialized Outpatient Consultation Team

NCT ID: NCT05408598

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-25

Study Completion Date

2023-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Polypharmacy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ≥ 75 years old
* Willing to provide informed consent
* Life expectancy ≥ 3 months
* Present polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion).

Exclusion Criteria

* 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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Miguel Servet

OTHER

Sponsor Role lead

Responsible Party

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Nicolás Martínez Velilla

Head of Geriatric Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario de Navarra (HUN)

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 39968007 (View on PubMed)

Roncal-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.

Reference Type DERIVED
PMID: 37523939 (View on PubMed)

Other Identifiers

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PHARM-OPTIMIZ GERIATRÍA

Identifier Type: -

Identifier Source: org_study_id

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