Interventional Research With Mixed Methods on an Early Integrated Palliative Approach in Nursing Home

NCT04708002 | Unknown

• 1 other identifier: 2020-A01832-37
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 3

Brief Summary

The national context of the end of life of elderly people living in Nursing Home (NH) is concerning. A quarter of NH residents die each year representing a quarter of annual deaths in France of all ages. The number of resident deaths arises (148,300 deaths in 2015 versus 124,500 in 2011). In fact, the age of residents welcomed in NH increase, 82% of residents are 80 years old and over, suffering from several chronic pathologies, some of which are serious and incurable. These are the main cause of death for residents. The advancing age of NH residents and the interweaving of multiple chronic conditions and disabling pathologies generate complex care needs, the complexity of which undermines the current system of care organization. In 2016, 59% of NH residents were severely dependent in their activities of daily living (ADL) and instrumental activities of daily living (IADL) according to the French scale Autonomie, Gérontologie Groupe Iso Ressources, (1 the most dependant to 6 the less dependent); the majority of these most dependent NH residents (80% of Groupe Iso-Ressource 1-2 in 2011) had at least one unstable chronic pathology and 73% of deceased residents (in 2015) come from this group whose level of dependence is very high. Palliative care (PC), which is care focused on maintaining quality of life in a context of incurable and complex pathology, therefore appears to be indicated in the context of NH. However, residents' access to PC remains limited, uneven and late. The number of residents requiring this support is estimated at more than 100,000 residents per year. The consequences of such situation are serious, first with regard to the quality of life of NH residents and their family caregivers, but also the inappropriate use of health services (as shown by the excessive use of emergency department and unscheduled hospitalizations) and work life for care providers in NH is affected (care providers suffer from a lack of support when faced with the difficulties of caring for NH residents at the end of their life). However, these consequences are potentially avoidable by means of adapted organizational solutions. The implementation of an integrated and early palliative approach (IEPA) in care pathway of patient is one of the solutions recommended by the World Health Organization and the French National Authority for Health. Several studies have shown the benefit of such approach in the management of cancer patients. However, the transferability and effectiveness of this approach in other organizational and population contexts are poorly documented, particularly in NH settings. The main objective is to evaluate, through a pragmatic controlled trial the effectiveness of an Early Integrated Palliative Care Approach in usual NH context (EIPCA-NH) on the quality of care in NH for elderly in need of PC. The secondary objectives concern:

1. 1.the implementation process of the EIPCA-NH: i) measure the degree of implementation of the EIPCA-NH in each site, ii) identify and understand the factors (individual and organizational) facilitating or limiting the success of the implementation process of an IEPA according to NH contexts (inter-site comparison).
2. 2.the effects of the EIPCA-NH in the NH : i) on the quality of life of residents requiring PC and ii) that of their family caregivers, iii) on the quality work life of professional caregivers and iv) on the care pathway of NH residents.

Conditions

Palliative Care; Nursing Homes; Aged

Keywords

Integrated and early palliative care approach; care pathway; quality of care; intervention research; resident; nursing home caregiver; health services research; mixed method

Outcome Measures

Primary Outcomes (1)

• Change in the number of resident with access to palliative care assessed by the proactive identification guidance and by the InterRAI Palliative Care assessment system

  stepped-wedge with 4 clusters

  Quantitative data will be collected throughout study completion (up to 2 years), each nursing home will have evaluations following a stepped-wedge design with 4 time periods: Pre-implantation, Implantation, Post implantation, Sustainability

Secondary Outcomes (4)

• Median score of the degree of implementation using a scale based on Proctor et al indicators, with a minimum score of 6 and a maximum score of 30.

  Qualitative data collections will be carry out continuously throughout study completion (up to 2 years)

• Median score of quality of life of nursing home resident using InterRAI Self-Report Nursing Home Quality of Life Survey instrument (interRAI-QoL)

  Quantitative data collections will be done throughout study completion (up to 2 years), each nursing home will have one evaluation following a stepped-wedge design with 2 time periods: Pre-implantation, Post implantation

• Median score of quality of life of informal caregiver using the Caregiver's Burden Scale in End-of-Life Care (CBS-EOLC) self-questionnaire

  Quantitative data collections will be done throughout study completion (up to 2 years), each nursing home will have one evaluation following a stepped-wedge design with 2 time periods: Pre-implantation, Post implantation

• Median score of quality of life of professional caregiver using the professional quality of life scale (ProQoL)

  Quantitative data collections will be done throughout study completion (up to 2 years), each nursing home will have one evaluation following a stepped-wedge design with 2 time periods: Pre-implantation, Post implantation

Study Arms (4)

First EIPCA-NH group

OTHER

There are 5 nursing home in each arm (cluster), randomly selected from 3 French areas.

Other: early integrated palliative approach model

Early intermediate EIPCA-NH group

OTHER

There are 5 nursing home in each arm (cluster), randomly selected from 3 French areas.

Other: early integrated palliative approach model

Late intermediate EIPCA-NH group

OTHER

There are 5 nursing home in each arm (cluster), randomly selected from 3 French areas.

Other: early integrated palliative approach model

Last EIPCA-NH group

OTHER

There are 5 nursing home in each arm (cluster), randomly selected from 3 French areas.

Other: early integrated palliative approach model

Interventions

early integrated palliative approach model OTHER

From the construction of a common vision of palliative care between actors inside and outside the nursing home to the sustainability of palliative care in nursing home.

Early intermediate EIPCA-NH group; First EIPCA-NH group; Last EIPCA-NH group; Late intermediate EIPCA-NH group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a resident of a nursing home.
• Be 60 years of age or older.
• Be a resident who has been identified by the Proactive identification Guidance

You may not qualify if:

• Be under 60 years of age.
• Resident living temporarily in the nursing home.
• Refusing to participate

Sponsors & Collaborators

• Maison Médicale Jeanne Garnier: lead
• Ministry of Health, France: collaborator
• Regional Agency for Health PACA: collaborator
• Groupement Interrégional de Recherche Clinique et d'Innovation: collaborator
• Versailles Saint-Quentin-en-Yvelines University: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• École de santé publique Université de Montréal: collaborator
• Centre Hospitalier Henri Duffaut - Avignon: collaborator
• Maison de santé Marie Galène: collaborator
• Agence Regionale de Sante d'Ile de France: collaborator

Study Sites (3)

Ch Avignon

Avignon, France

RECRUITING

Maison de Santé Marie Galène

Bordeaux, France

RECRUITING

Maison Médicale Jeanne Garnier

Paris, France

RECRUITING

Related Publications (2)

• Umubyeyi B, Leboul D, Bagaragaza E. "You close the door, wipe your sadness and put on a smiling face": a qualitative study of the emotional labour of healthcare professionals providing palliative care in nursing homes in France. BMC Health Serv Res. 2024 Sep 16;24(1):1070. doi: 10.1186/s12913-024-11550-7.

  PMID: 39278920 DERIVED

• Bagaragaza E, Colombet I, Perineau M, Aegerter P, Guirimand F. Assessing the implementation and effectiveness of early integrated palliative care in long-term care facilities in France: an interventional mixed-methods study protocol. BMC Palliat Care. 2023 Apr 6;22(1):35. doi: 10.1186/s12904-023-01157-w.

  PMID: 37024830 DERIVED

Study Officials

• Emmanuel Bagaragaza, MPH, PhD

  SPES, Maison médicale Jeanne Garnier

  PRINCIPAL INVESTIGATOR

• Frédéric Guirimand, MD, PhD

  SPES, Maison médicale Jeanne Garnier

  PRINCIPAL INVESTIGATOR

• Philippe Aegerter, MD, PhD

  GIRCI IDF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Bouscaren, PhD

CONTACT

003314922189; nbouscaren@adc.asso.fr

Célia Broussard, PhD

CONTACT

003314922189; cbroussard@adc.asso.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: stepped-wedge design

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 13, 2021
• Study Start: March 30, 2021
• Primary Completion: March 30, 2021
• Study Completion: August 31, 2023
• Last Updated: June 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study protocole: july 2021

Locations

FR (3)