Clinical trial NCT05780762: Impact of an Intervention Integrating the MPHS Nursing Model of Care on the Partnership in Health, With the Patient Followed in Primary Care by an Advanced Practice Nurse (APN) for One or More Stabilized Chronic Pathologies
Official title: Impact of an Intervention Integrating the MPHS Nursing Model of Care on the Partnership in Health, With the Patient Followed in Primary Care by an Advanced Practice Nurse (APN) for One or More Stabilized Chronic Pathologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Keywords: advanced practice nurse (APN)
patient partnership
health literacy
self-management
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2023-03-23
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The WHO and our governance advocate that health professionals should organize care around the patient, considering his or her values, needs and preferences, and enabling the patient to develop the capacity to self-manage the chronic health problems he or she faces. Chronic disease is an ongoing dynamic process and adaptation to this process is complicated by the interaction of several determinants: self-management capacity, level of health literacy, quality of life and experience of care. To best support chronic disease, the recommendation is to adopt a management strategy that allows chronic patients to play an active role in the management of their condition and in the day-to-day decision-making process. The management of chronic pathologies is one of the specialties in which Advanced Practice Nurses are positioned, in primary care, outside hospital. Nursing care benefits from care models that allow for more adapted responses, regarding particular care situations, or certain patient typologies. The Humanistic Partnership Health Care Model (MPHS) implement in current Advanced Practice Nurse (APN) practice.

Detailed description: The IMPACT program proposes to integrate the MPHS model into primary care, within advanced practice nursing care, to strengthen the partnership of the patient with chronic disease. This model will allow the advanced practice nurse to co-construct with the patient partner a care trajectory that will be integrative, considering his aspirations and priorities to carry out his life project, while coping with his chronic pathology(ies). To do this, particular attention to the determinants of adaptation to chronic disease: self-management capacity, health literacy, quality of life and experience of care is pay.

The IMPACT program will use the theoretical framework of the MPHS model of care to structure the advanced practice nursing care management and will incorporate validated measurement tools to address the determinants of patient adaptation to chronic disease. The specific management of the IMPACT program will consist of 3 phases: (1) co-definition of the health situation, (2) co-planning of care and co-actions, and (3) co-assessment with the patient and the team caring for him/her.

Eligibility criteria: Inclusion Criteria:

* Followed by APN, within the framework of an organizational protocol established with a patient's referring physician, for the management of one or more chronic pathology(ies) from the following list: stroke; chronic arterial disease; heart disease, coronary artery disease; type 1 diabetes and type 2 diabetes; chronic respiratory failure; Parkinson's disease; epilepsy
* Affiliated or entitled to a social security plan
* Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

- Patient not referred by a physician for APN follow-up

Primary outcomes:
measure: The patient/advanced practice nurse partnership
timeFrame: At month 9
Secondary outcomes:
measure: The patient/advanced practice nurse partnership across the continuum of care
timeFrame: baseline, 3 and 6 months
measure: Perception of health-related quality of life
timeFrame: At inclusion, 3, 6 and 9 months.
measure: Health literacy level
timeFrame: at inclusion, 3, 6 and 9 months
measure: Impact of the quality of advanced practice nurse consultation from patient's perspective
timeFrame: At baseline, 3, 6 and 9 months
measure: Adoption of IMPACT program by advanced practice nurse
timeFrame: 3 years
measure: Participation in IMPACT program
timeFrame: 3 years
measure: IMPACT program satisfaction for advanced practice nurse
timeFrame: 3 years
measure: effectiveness of IMPACT program
timeFrame: 3 years
measure: Context of IMPACT program
timeFrame: 3 years
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Direction de la Prévention et de la Santé des Populations
Study officials:
affiliation: CHUSE
name: Franck CHAUVIN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUSE
name: Elise VEROT, MD
role: PRINCIPAL_INVESTIGATOR
References: