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NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH le Corbusier - Firminy, Firminy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IMPACT Program

Other

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.

usal care

Other

usual management with a Nurse in Advanced Practice.

Primary outcomes

  1. 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

  1. The patient/advanced practice nurse partnership across the continuum of care

    Time frame: baseline, 3 and 6 months

    Measurement 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.

  2. Perception of health-related quality of life

    Time frame: At 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"

  3. Health literacy level

    Time frame: at inclusion, 3, 6 and 9 months

    Measurement 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".

  4. Impact of the quality of advanced practice nurse consultation from patient's perspective

    Time frame: At baseline, 3, 6 and 9 months

    Measurement 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"

  5. Adoption of IMPACT program by advanced practice nurse

    Time frame: 3 years

    Adoption 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

  6. Participation in IMPACT program

    Time frame: 3 years

    Participation 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

  7. IMPACT program satisfaction for advanced practice nurse

    Time frame: 3 years

    IMPACT program satisfaction will be assessed by semi-structured interview with advanced practice nurse

  8. effectiveness of IMPACT program

    Time frame: 3 years

    Effectiveness of IMPACT program will be assessed by proportion of patients completing the proposed follow-up package

  9. Context of IMPACT program

    Time frame: 3 years

    Context 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amandine BAUDOT, CRA

CONTACT

[email protected]

(0)477829450 ext. +33

Elise VEROT, MD

CONTACT

[email protected]

(0)682309796 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: IMPACT

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 23, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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