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

Adherence, Medication Clinical Trial

— COPAPI-G  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059235
• Other study ID #: COPAPI-G
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: September 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Olivia Dalleur, PhD
• Phone: +3227642360
• Email: olivia.dalleur[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 125 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of barriers to adherence as measured by ASK-20 score (the sum of raw ASK-20 item scores)	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.	6weeks
Secondary	count of barriers to adherence measured by TBC ASK-20 (Total Barrier Count)	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.	6weeks
Secondary	quality of life measured with EQ5D (Visual analogical scale) score	Quality of life questionnaire. Comparison of estimated quality of life between baseline and 6 weeks in both arms	6weeks
Secondary	number of inappropriate medications per patient according to STOPP/START	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	6weeks
Secondary	number of Drug-drug interactions per patient from the Anrys list	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.	6weeks
Secondary	pain severity (from EQ-D)	Comparison of pain reported in EQ5D questionnaire from baseline to 6 weeks in both groups	6weeks
Secondary	number of hospital admissions reported by patient	comparison of reported hospitalisations in both groups during the study period (questionnaire)	6weeks