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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05780762
Acronym
IMPACT
Enrollment
420
Registered
2023-03-23
Start date
2024-04-12
Completion date
2028-11-30
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

Keywords

advanced practice nurse (APN), patient partnership, health literacy, self-management

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.

Interventions

care 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 with the team caring for him or her, and incorporating evidence-based measurement tools.

OTHERusal care

usual management with a Nurse in Advanced Practice.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER
Ministry of Health, France
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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).

Design outcomes

Primary

MeasureTime frameDescription
The patient/advanced practice nurse partnershipAt month 9The 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

MeasureTime frameDescription
The patient/advanced practice nurse partnership across the continuum of carebaseline, 3 and 6 monthsMeasurement of the impact of the intervention on the partnership via the Partners In Health scale French version.This questionnaire 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.
Perception of health-related quality of lifeAt inclusion, 3, 6 and 9 months.Measurement of the perception of health-related quality of life via the World Health Organisation Quality Of Life questionnaire. This questionnaire questions 4 domains: physical health, psychological health, social sphere and environment. The patient answers according to 3 groups of 5 modalities of the Likert scale. The first group goes from " very weak " to " very good"; the second goes from " very unsatisfied " to "very satisfied" ; the third goes from "not at all" to " extremely"
Health literacy levelat inclusion, 3, 6 and 9 monthsMeasurement of health literacy level via the European Health Literacy Survey (HLS-EU16) questionnaire validated in French version. It consists of 16 items, for which the patient answers according 4 modalities "very easy" to "very difficult".
Impact of the quality of advanced practice nurse consultation from patient's perspectiveAt baseline, 3, 6 and 9 monthsMeasurement of the impact of the advanced practice nurse consultation on the patient's perceived ability to understand and cope with his or her health problems and illness via the PEI questionnaire vf (Patient Enablement Instrument French version) questionnaire. It consists of 6 questions to which the patient responds in 3 ways "much more", "more", or "as before the visit or less"
Adoption of IMPACT program by advanced practice nurse3 yearsAdoption of IMPACT program by advanced practice nurse will be assessed by number of advanced practice nurses including patients and number of patients followed by each APN
Participation in IMPACT program3 yearsParticipation in IMPACT program will be assessed by number of patients who agreed to be followed with this model of care/number of patients who were offered follow-up
IMPACT program satisfaction for advanced practice nurse3 yearsIMPACT program satisfaction will be assessed by semi-structured interview with advanced practice nurse
effectiveness of IMPACT program3 yearsEffectiveness of IMPACT program will be assessed by proportion of patients completing the proposed follow-up package
Context of IMPACT program3 yearsContext of IMPACT program will be assessed with semi-structured interviews with advanced practice nurse which will evaluate factors favoring and hindering the implementation, the adaptation, the achievement and sustainbility of the IMPACT program

Countries

France

Contacts

CONTACTElise VEROT, MD
elise.verot@univ-st-etienne.fr(0)682309796
CONTACTAmandine BAUDOT, CRA
Amandine.Baudot@chu-st-etienne.fr(0)477829450
PRINCIPAL_INVESTIGATORElise VEROT, MD

CHUSE

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026