Clinical trial NCT06059235: Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic
Official title: Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adherence, Medication
Keywords: pharmaceutical care
geriatrics
consultation
medication review
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 300
Sex: ALL
Minimum age (years): 75
Maximum age (years): 125
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores)
timeFrame: 6weeks
Secondary outcomes:
measure: count of barriers to adherence measured by TBC ASK-20 (Total Barrier Count)
timeFrame: 6weeks
measure: quality of life measured with EQ5D (Visual analogical scale) score
timeFrame: 6weeks
measure: number of inappropriate medications per patient according to STOPP/START
timeFrame: 6weeks
measure: number of Drug-drug interactions per patient from the Anrys list
timeFrame: 6weeks
measure: pain severity (from EQ-D)
timeFrame: 6weeks
measure: number of hospital admissions reported by patient
timeFrame: 6weeks
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References: