Stable Chronic Condition
Conditions
Brief summary
Access to primary care in France is increasingly constrained due to demographic changes, regional disparities in physician distribution, and the rising prevalence of chronic diseases. APNs were introduced to improve access to care and the coordination of patient management. While the international literature suggests their effectiveness, robust data in the French context remain limited. The objective of this study is to evaluate the impact of a coordinated general practitioner (GP)+APN care pathway on patients' quality of life.
Detailed description
EQUIPAGE is a pragmatic, multicenter, open-label, randomized controlled superiority trial. A total of 880 adult patients with stable chronic conditions will be randomized (1:1) between standard care by GP alone and coordinated GP+APN care. The follow-up period is 24 months. The primary outcome measure is the change in physical quality of life at 12 months as measured by the SF-36. Secondary outcomes include hospitalizations, emergency department visits, mortality, adherence, and patient satisfaction. Analyses will be based on mixed-effects models accounting for repeated measures and the multicenter design. This trial will provide the first randomized data on the impact of APNs in primary care in France and will help inform decisions regarding the organization of care.
Interventions
OTHERCare Pathways
A process evaluation will be conducted to document the implementation of the " intervention . It will focus on care pathways, the distribution of consultations, APN activities, deviations from the protocol, and the organizational characteristics of the facilities.
Sponsors
Le Mans Universite
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old or older patients, * patients with a stable chronic condition falling under the indications defined by the french decree of July 18, 2018, * patients under the care of a general practitioner (GP), * patients who have signed an informed consent form.
Exclusion criteria
* patients with cognitive impairments that compromise their ability to participate in the study, * patients who require exclusively medical care without the possibility of coordination, * patients already receiving care in a setting that includes a primary care nurse; * pregnant women; * patients with no legal capacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical quality of life | 12 months | The primary outcome is the change in physical quality of life at 12 months, measured by the physical composite score of the SF-36 questionnaire. This score aggregates four dimensions: physical activity, physical limitations, physical pain, and perceived health. The SF-36 is a validated tool for measuring health-related quality of life (Ware \& Sherbourne, 1992). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of an MG+AP care pathway 1 | 24 months | Measured by the number of unplanned hospitalizations and the number of visits to hospitals and/or emergency departments, in relation to the condition(s) justifying inclusion. |
Contacts
CONTACTAurelie TROTIN
CONTACTViolaine DUMUR
Outcome results
None listed