Pharmacological Optimization by a Specialized Outpatient Consultation Team

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Polypharmacy

• Study Type: Observational
• Enrollment (Anticipated): 104

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Universitario de Navarra (HUN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months
Frailty(changes between baseline and follow-up)	Frailty will be assessed by Fried criteria and Frail-VIG.	12 months
Healthcare use	Comparison of healthcare use (hospital admissions, primary care and emergency visits) between baseline and follow-up consultations.	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	12 months

Collaborators and Investigators

• Sponsor: Fundacion Miguel Servet

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 25, 2021
• Primary Completion (ANTICIPATED): November 20, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (ACTUAL): June 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Outpatient; Polypharmacy; Geriatrics; Pharmacist; Functional capacity; Medication review; Comprehensive Geriatric Assessment; Cognitive capacity
• Other Study ID Numbers: PHARM-OPTIMIZ GERIATRÍA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We plan to share data under reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No