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Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic (COPAPI-G)

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ClinicalTrials.gov Identifier: NCT06059235
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adherence, Medication Other: pharmaceutical care Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Concordance : a New Concept for Clinical Pharmacy in Partnership With Patients at a Geriatric Day Clinic
Actual Study Start Date : January 9, 2023
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Other: 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
No Intervention: controle
Medication history (during assessment consultation) + usual care


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. count of barriers to adherence measured by TBC ASK-20 (Total Barrier Count) [ Time Frame: 6weeks ]
    Each of the 20 items Of the ASK-20 (questionnaire) was dichotomized as positive - indicating a barrier, or negative. TBC counts the barriers per patient. Comparison of TBC from baseline to 6 weeks 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.

  2. quality of life measured with EQ5D (Visual analogical scale) score [ Time Frame: 6weeks ]
    Quality of life questionnaire. Comparison of estimated quality of life between baseline and 6 weeks in both arms

  3. number of inappropriate medications per patient according to STOPP/START [ Time Frame: 6weeks ]
    Detection od potentially inappropriate medications (PIM) using STOPP&START version 2 in medication treatment and comparison of number of PIM between baseline and 6 weeks in both arms

  4. number of Drug-drug interactions per patient from the Anrys list [ Time Frame: 6weeks ]
    Comparison in both arms of drug-drug interactions detected at baseline and 6 weeks in medication treatment according to Anrys et al. Anrys P, Spinewine A. An International Consensus List of Potentially Clinically Significant Drug-Drug Interactions in Older People: Clinical Utility? J Am Med Dir Assoc. 2022 Mar;23(3):522. doi: 10.1016/j.jamda.2021.11.038. Epub 2022 Jan 10. PMID: 35026145.

  5. pain severity (from EQ-D) [ Time Frame: 6weeks ]
    Comparison of pain reported in EQ5D questionnaire from baseline to 6 weeks in both groups

  6. number of hospital admissions reported by patient [ Time Frame: 6weeks ]
    comparison of reported hospitalisations in both groups during the study period (questionnaire)


Eligibility Criteria
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Ages Eligible for Study:   75 Years to 125 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06059235


Contacts
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Contact: Olivia Dalleur, PhD +3227642360 olivia.dalleur@uclouvain.be
Contact: Fanny Vaillant, MPharm +3227642360 fanny.vaillant@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Gilard Isabelle    0032 2 764 3559    copapig@saintluc.uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT06059235    
Other Study ID Numbers: COPAPI-G
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
pharmaceutical care
geriatrics
consultation
medication review