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

September 22, 2023 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6weeks
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
6weeks
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
6weeks
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.
6weeks
pain severity (from EQ-D)
Time Frame: 6weeks
Comparison of pain reported in EQ5D questionnaire from baseline to 6 weeks in both groups
6weeks
number of hospital admissions reported by patient
Time Frame: 6weeks
comparison of reported hospitalisations in both groups during the study period (questionnaire)
6weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COPAPI-G

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adherence, Medication

Clinical Trials on pharmaceutical care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe