search
Back to results

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)

Primary Purpose

Chronic Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IMPACT Program
usal care
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Disease focused on measuring advanced practice nurse (APN), patient partnership, health literacy, self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    IMPACT program - experimental group

    Usal care : control group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    The patient/advanced practice nurse partnership
    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 Outcome Measures

    The patient/advanced practice nurse partnership across the continuum of care
    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.
    Perception of health-related quality of life
    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 level
    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".
    Impact of the quality of advanced practice nurse consultation from patient's perspective
    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"
    Adoption of IMPACT program by advanced practice nurse
    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
    Participation in IMPACT program
    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
    IMPACT program satisfaction for advanced practice nurse
    IMPACT program satisfaction will be assessed by semi-structured interview with advanced practice nurse
    effectiveness of IMPACT program
    Effectiveness of IMPACT program will be assessed by proportion of patients completing the proposed follow-up package
    Context of IMPACT program
    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

    Full Information

    First Posted
    December 5, 2022
    Last Updated
    June 16, 2023
    Sponsor
    Centre Hospitalier Universitaire de Saint Etienne
    Collaborators
    Ministry of Health, France
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05780762
    Brief 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
    Acronym
    IMPACT
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    February 28, 2025 (Anticipated)
    Study Completion Date
    March 2, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Saint Etienne
    Collaborators
    Ministry of Health, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease
    Keywords
    advanced practice nurse (APN), patient partnership, health literacy, self-management

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    420 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IMPACT program - experimental group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usal care : control group
    Arm Type
    Sham Comparator
    Arm Description
    patients followed for one or several stabilized chronic pathology(ies) and benefiting from a usual management with a Nurse in Advanced Practice.
    Intervention Type
    Other
    Intervention Name(s)
    IMPACT Program
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    usal care
    Intervention Description
    usual management with a Nurse in Advanced Practice.
    Primary Outcome Measure Information:
    Title
    The patient/advanced practice nurse partnership
    Description
    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.
    Time Frame
    At month 9
    Secondary Outcome Measure Information:
    Title
    The patient/advanced practice nurse partnership across the continuum of care
    Description
    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.
    Time Frame
    baseline, 3 and 6 months
    Title
    Perception of health-related quality of life
    Description
    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"
    Time Frame
    At inclusion, 3, 6 and 9 months.
    Title
    Health literacy level
    Description
    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".
    Time Frame
    at inclusion, 3, 6 and 9 months
    Title
    Impact of the quality of advanced practice nurse consultation from patient's perspective
    Description
    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"
    Time Frame
    At baseline, 3, 6 and 9 months
    Title
    Adoption of IMPACT program by advanced practice nurse
    Description
    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
    Time Frame
    3 years
    Title
    Participation in IMPACT program
    Description
    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
    Time Frame
    3 years
    Title
    IMPACT program satisfaction for advanced practice nurse
    Description
    IMPACT program satisfaction will be assessed by semi-structured interview with advanced practice nurse
    Time Frame
    3 years
    Title
    effectiveness of IMPACT program
    Description
    Effectiveness of IMPACT program will be assessed by proportion of patients completing the proposed follow-up package
    Time Frame
    3 years
    Title
    Context of IMPACT program
    Description
    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
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Franck CHAUVIN, PhD
    Phone
    (0)664816586
    Ext
    +33
    Email
    franck.chauvin@univ-st-etienne.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amandine BAUDOT, CRA
    Phone
    (0)477829450
    Ext
    +33
    Email
    Amandine.Baudot@chu-st-etienne.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Franck CHAUVIN, PhD
    Organizational Affiliation
    CHUSE
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Elise VEROT, MD
    Organizational Affiliation
    CHUSE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

    We'll reach out to this number within 24 hrs