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UnknownNCT05408598

Pharmacological Optimization by a Specialized Outpatient Consultation Team

Cognitive and Functional Trajectories in Older Adults After a Pharmacologic Multidisciplinary Intervention: a Study Protocol

Status
Unknown
Phase
Study type
Observational
Enrollment
104 (estimated)
Sponsor
Fundacion Miguel Servet · Academic / Other
Sex
All
Age
75 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2021-06-25
Primary completion
2022-11-20
Completion
2023-03-01
First posted
2022-06-07
Last updated
2022-11-03

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05408598. Inclusion in this directory is not an endorsement.