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Clinical Trials/NCT06059235
NCT06059235RecruitingNot Applicable

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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 sites in 1 country300 target enrollmentStarted: January 9, 2023Last updated:
Conditions

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)

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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