Pharmacological Optimization by a Specialized Outpatient Consultation Team

NCT05408598 | Unknown

• 1 other identifier: PHARM-OPTIMIZ GERIATRÍA
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• 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)

  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)

  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)

  12 months

• Change in functional capacity: Strenght (Handgrip)

  The change in Strenght measured at baseline and follow-up

  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

  12 months

Secondary Outcomes (4)

• Quality of life (changes between baseline and follow-up)

  12 months

• Frailty(changes between baseline and follow-up)

  12 months

• Healthcare use

  12 months

• Burden of medications between baseline and follow-up.

  12 months

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling older adults ( ≥ 75 years old) with polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion).

You may qualify if:

• ≥ 75 years old
• Willing to provide informed consent
• Life expectancy ≥ 3 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra (HUN)

Pamplona, Navarre, 31008, Spain

Location

Related Publications (2)

• 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.

  PMID: 39968007 DERIVED

• 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.

  PMID: 37523939 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Geriatric Unit

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: June 7, 2022
• Study Start: June 25, 2021
• Primary Completion: November 20, 2022
• Study Completion: March 1, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-06

Locations

ES (1)