Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic

NCT ID: NCT06059235

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2024-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adherence, Medication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention

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

Group Type EXPERIMENTAL

pharmaceutical care

Intervention Type OTHER

consultation with a pharmacist performing advanced pharmaceutical care : 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

controle

Medication history (during assessment consultation) + usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pharmaceutical care

consultation with a pharmacist performing advanced pharmaceutical care : 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

75 Years

Maximum Eligible Age

125 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Olivia Dalleur, PhD

Role: CONTACT

+3227642360

Fanny Vaillant, MPharm

Role: CONTACT

+3227642360

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gilard Isabelle

Role: primary

0032 2 764 3559

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COPAPI-G

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.