Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic (COPAPI-G)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Enrolling

Conditions: Adherence, Medication

Treatments: Other: pharmaceutical care

Study type: Interventional

Funder types: Other

Identifiers

NCT06059235

COPAPI-G

Details and patient eligibility

About

The goal of this clinical trial is to assess the impact of pharmaceutical consultations in older patients having a comprehensive geriatric assessment at geriatric day-clinic. The main question it aims to answer is: What is the impact on patient adherence Participants will benefit from medication history taking, medication review, therapeutic education, shared decision-making and follow-up phone call. Researchers will compare with a control group, benefiting from medication history taking and usual care from the geriatric day-clinic.

Full description

Research question: What is the impact of a clinical pharmacy activity (including a medication history, a medication review, therapeutic education, a shared decision step and a follow-up call) on medication adherence in elderly patients followed up for geriatric assessment at the geriatric day hospital? Design: Intervention study, randomized, controlled, open-label, with evaluation at 2 months. The study will run from January 1, 2023 to September 1, 2024 (20 months), at the CUSL geriatric day hospital.

Participants: patients admitted to the geriatric day hospital for a geriatric assessment will be eligible for the project. A geriatric assessment comprises 2 consultations at the geriatric day hospital: a "assessment" consultation, where the patient meets the members of the multidisciplinary team, and a "results" consultation, where the geriatrician provides the patient with care recommendations.

The general practitioners, pharmacists and nursing home referral nurse (if applicable) of the participants in the intervention group will be invited to take part in a satisfaction survey.

Intervention: The intervention includes several clinical pharmacy activities

• Medication history (during assessment consultation)
• Medication review and consultation with the geriatrician
• Therapeutic education (during results consultation)
• Shared decision-making (during results consultation)
• One-week follow-up call Control: usual care. Outcomes: primary: comparison at 1.5 months (telephone FUP) after outcome consultation of ASK-20 total Adherence Survey score (measures medication adherence and identifies barriers to adherence).

Secondary outcomes measured at 1.5 months:

• ASK-20 TBC measures
• EQ5D quality-of-life scores
• number of inappropriate medications according to STOPP&START
• number of drug interactions DDI
• pain score
• hospital admissions during the FUP period Various indicators related to pharmaceutical activity will also be collected.

This project will serve as a rationale for the long-term development of a clinical pharmacy activity at the day hospital, and will help maintain CUSL's status as an innovator in clinical pharmacy.

Enrollment: 300 estimated patients

Sex: All

Ages: 75 to 125 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 75+
• patients admitted to the geriatric day hospital for a geriatric assessment will be eligible for the project. A geriatric assessment comprises 2 consultations at the geriatric day hospital: a "major assessment" consultation, where the patient meets the members of the multidisciplinary team, and a "results" consultation, where the geriatrician provides the patient with care recommendations.

Exclusion criteria

• less than 75
• not speaking French
• exlusion based on geriatrician advice

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

intervention

Experimental group

Description:

Package of clinical pharmacy activities including : * Medication history (during assessment consultation) * Medication review and consultation with the geriatrician * Therapeutic education (during results consultation) * Shared decision (at results consultation) * One-week follow-up call + usual care

Treatment:

Other: pharmaceutical care

controle

No Intervention group

Description:

Medication history (during assessment consultation) + usual care