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Clinical Trials/NCT05780762
NCT05780762RecruitingNot Applicable

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

Centre Hospitalier Universitaire de Saint Etienne9 sites in 1 country420 target enrollmentStarted: April 12, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
420
Locations
9
Primary Endpoint
The patient/advanced practice nurse partnership

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A patient receiving care from an advanced practice nurse (APN) for the management of one or more of the following chronic conditions: stroke; chronic arterial disease; heart disease, coronary artery disease; type 1 diabetes and type 2 diabetes; chronic respiratory failure; Parkinson's disease; epilepsy.
  • Care provided by an IPA falls under one of the following categories:
  • Either as direct care when the IPA practices within a healthcare facility, in accordance with current regulations, Or as care referred or prescribed by a physician when the IPA practices in private practice.
  • 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

  • - A patient who is not under the care of a nurse practitioner under the conditions set forth in the Public Health Code (lack of authorized direct access or a required physician referral, depending on the practice model).

Arms & Interventions

IMPACT program - experimental group

Experimental

patients followed for one or more stabilized chronic pathologies and benefiting from usual care with an Advanced Practice Nurse AND benefiting from the IMPACT program, which combines management at 3 levels: (1) co-definition of the health situation, (2) co-planning of care and co-actions, and (3) co-assessment with the patient and his or her care team, and incorporates evidence-based measurement tools.

Intervention: IMPACT Program (Other)

Usal care : control group

Sham Comparator

patients followed for one or several stabilized chronic pathology(ies) and benefiting from a usual management with a Nurse in Advanced Practice.

Intervention: usal care (Other)

Outcomes

Primary Outcomes

The patient/advanced practice nurse partnership

Time Frame: At month 9

The patient/advanced practice nurse partnership will be assessed by a measure via the PIH-Fv (Partners In Health scale French version) questionnaire at 9 months. The PIH-Fv (Partners In Health scale in French version) questionnaire was developed and validated in French by Hudon et al. The PIH-Fv scale is a self-assessment questionnaire that includes 12 items, which are answered using 9-point Likert-type scales. The total score goes from 0 to 96: 0 representing poor self-management and 96 better self-management.

Secondary Outcomes

  • Impact of the quality of advanced practice nurse consultation from patient's perspective(At baseline, 3, 6 and 9 months)
  • The patient/advanced practice nurse partnership across the continuum of care(baseline, 3 and 6 months)
  • Perception of health-related quality of life(At inclusion, 3, 6 and 9 months.)
  • Context of IMPACT program(3 years)
  • Health literacy level(at inclusion, 3, 6 and 9 months)
  • Adoption of IMPACT program by advanced practice nurse(3 years)
  • Participation in IMPACT program(3 years)
  • IMPACT program satisfaction for advanced practice nurse(3 years)
  • effectiveness of IMPACT program(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (9)

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