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

Chronic Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780762
• Other study ID #: 21GI262
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Franck CHAUVIN, PhD
• Phone: (0)664816586
• Email: franck.chauvin[@]univ-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: November 30, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Other:
• IMPACT Program
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
usual management with a Nurse in Advanced Practice.

Locations

Country	Name	City	State
France	Direction de la Prévention et de la Santé des Populations	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At month 9
Secondary	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.	baseline, 3 and 6 months
Secondary	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"	At inclusion, 3, 6 and 9 months.
Secondary	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".	at inclusion, 3, 6 and 9 months
Secondary	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"	At baseline, 3, 6 and 9 months
Secondary	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	3 years
Secondary	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	3 years
Secondary	IMPACT program satisfaction for advanced practice nurse	IMPACT program satisfaction will be assessed by semi-structured interview with advanced practice nurse	3 years
Secondary	effectiveness of IMPACT program	Effectiveness of IMPACT program will be assessed by proportion of patients completing the proposed follow-up package	3 years
Secondary	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	3 years