Clinical trial NCT05408598: Pharmacological Optimization by a Specialized Outpatient Consultation Team
Official title: Cognitive and Functional Trajectories in Older Adults After a Pharmacologic Multidisciplinary Intervention: a Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polypharmacy
Keywords: Geriatrics
Pharmacist
Outpatient
Polypharmacy
Medication review
Functional capacity
Cognitive capacity
Comprehensive Geriatric Assessment
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 104
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in functional capacity: Barthel Index (spanish version)
timeFrame: 12 months
measure: Change in functional capacity: Lawton Scale (spanish version)
timeFrame: 12 months
measure: Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión)
timeFrame: 12 months
measure: Change in functional capacity: Strenght (Handgrip)
timeFrame: 12 months
measure: Change in cognitive function by the "Índice de Incapacidad psíquica de la Cruz Roja" (IPCR).
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life (changes between baseline and follow-up)
timeFrame: 12 months
measure: Frailty(changes between baseline and follow-up)
timeFrame: 12 months
measure: Healthcare use
timeFrame: 12 months
measure: Burden of medications between baseline and follow-up.
timeFrame: 12 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra (HUN)
state: Navarra
Study officials:
References: