Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-27 @ 10:21 PM
Study NCT ID:
NCT06059235
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2023-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Study Overview
Official Title:
Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPAPI-G
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: