Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 75 Years to 125 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores)
Time Frame: 6weeks
ASK-20 (questionnaire) consists of 20 clinically actionable items representing multiple factors that affect medication adherence. Each of the 20 items score from 1 to 5. A score of 20 means low barriers to adherence; A score of 100 means maximum barriers to adherence. Comparizon of ASK-20 score from baseline to 6weeks in both arms. Hahn SR, Park J, Skinner EP, Yu-Isenberg KS, Weaver MB, Crawford B, Flowers PW. Development of the ASK-20 adherence barrier survey. Curr Med Res Opin. 2008 Jul;24(7):2127-38. doi: 10.1185/03007990802174769. Epub 2008 Jun 12. PMID: 18554431.
Secondary Outcomes
- count of barriers to adherence measured by TBC ASK-20 (Total Barrier Count)(6weeks)
- quality of life measured with EQ5D (Visual analogical scale) score(6weeks)
- number of inappropriate medications per patient according to STOPP/START(6weeks)
- number of Drug-drug interactions per patient from the Anrys list(6weeks)
- pain severity (from EQ-D)(6weeks)
- number of hospital admissions reported by patient(6weeks)
