NCT07671716

Brief Summary

About 20% of emergency room admissions among people over the age of 75 are related to medication-induced adverse events. These events are exacerbated by polypharmacy, which can be inappropriate when prescribed medications have an uncertain benefit-risk balance or cause harmful drug interactions. Among potentially inappropriate medications (PIMs), those with anticholinergic and/or sedative properties are the most harmful to older adults and yet are very frequently prescribed. Indeed, in France, 33% of older patients living at home are treated with this type of medication, the use of which is associated with cognitive decline, falls, functional decline (loss of independence), excess mortality, reduced quality of life, and hospitalizations. Thus, reducing the burden of anticholinergic and sedative medications in older adults is a key priority in the prevention of iatrogenic risk. Among the strategies developed to reduce the use of PIMs in older patients, deprescribing interventions-defined as the supervised discontinuation of inappropriate treatment-have been gradually implemented in recent years. However, few interventional studies on the deprescribing of anticholinergic and/or sedative medications have demonstrated positive results. To better understand the inconsistent effectiveness of deprescribing programs, studies have been conducted to identify the barriers and facilitators of deprescribing, and three key areas have been identified to facilitate the implementation of such programs:

  • Involve and support patients in the co-design of the intervention (participatory research) and throughout the intervention itself to reach a shared decision.
  • Work in an interdisciplinary manner by combining the areas of expertise of outpatient healthcare professionals regarding patient knowledge and support with the expertise of hospital-based professionals in the field of aging.
  • Work in a coordinated manner to foster interprofessional cooperation and ensure the transferability of the deprescribing pathway in real-world settings through multi-professional consultation. The DIOPAS project aims to develop and implement a multidisciplinary, participatory deprescribing program for older community-dwelling patients being treated by medications with anticholinergic and/or sedative properties. The first step involves the co-development of the intervention, which is the focus of this CC-DIOPAS study. This study proposes a participatory co-development approach to the intervention, bringing together the various types of professionals (from both primary care and hospital) involved in medication optimization, as well as community-dwelling patients and patient partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 2, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Potentialy inapropriate medicationDeprescribingParticipative researchQualitative studyIntervention co-development

Outcome Measures

Primary Outcomes (1)

  • Logic model for the deprescribing pathway

    Logic model for the community-to-hospital deprescribing pathway (DIOPAS intervention), developed by the mixed working group.

    Through study completion, an average of 6 months (Following the last working group meeting)

Study Arms (1)

Healthcare professionals and patients

Health professionals and patients will be asked during focus groups and workshop on the co-developed deprescribing program

Behavioral: Focus groups and workshops of healthcare professionals and patients

Interventions

This is a qualitative study conducted in two successive phases. First, three focus groups comprising patients and healthcare professionals from both hospital and primary care settings will assess their needs, expectations, and initiatives regarding support for deprescribing, and identify the barriers and facilitators to implement a multidisciplinary pathway. In a second phase, a multidisciplinary working group will be tasked with developing a logic model for deprescribing. This group will include hospital-based healthcare professionals, primary care professionals, and patients, with the aim of designing an intervention that is both implementable and transferable to real-world settings (2-5 workshops).

Healthcare professionals and patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Hospital healthcare professionals involved in geriatric outpatient care and in the medication management of older patients: geriatricians, hospital pharmacists, and nurses * Primary care healthcare professionals involved in the medication management of the target population: general practitioners, community pharmacists, and private practice nurses * Patients who met the study's eligibility criteria regarding age and polypharmacy so that the co-designed intervention takes into account their needs and expectations, as well as their opinions regarding the methodology used (participative research). Partner patients will also be solicited.

You may qualify if:

  • Healthcare Professionals:
  • In hospitals:
  • Geriatricians, hospital pharmacists, or registered nurses;
  • Practicing in a geriatric day hospital at the university hospitals in Lyon, Grenoble, Marseille, Nîmes, or Nantes;
  • Agree to participate in focus group meetings or the working group.
  • In primary care facilities:
  • General practitioners, community pharmacists, or independent registered nurses;
  • Practicing within a primary care facility in the geographic areas served by the university hospitals of Lyon, Grenoble, Marseille, Nîmes, or Nantes;
  • Agree to participate in focus group meetings or the working group.
  • Patients:
  • Patients of the primary care facilities :
  • Patients aged 65 to 80;
  • Patients receiving outpatient care (not hospitalized) at a primary care facility within the geographic areas of the University Hospitals of Lyon;
  • Patients taking at least 5 chronic medications prescribed per day (polypharmacy);
  • Agree to participate in focus group meetings or the working group;
  • +3 more criteria

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital des Charpennes, Institut du Vieillissement

Villeurbanne, 69100, France

Location

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 26, 2026

Study Start

April 28, 2025

Primary Completion

November 27, 2025

Study Completion

January 16, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Locations