Clinical trial NCT04708002: Interventional Research With Mixed Methods on an Early Integrated Palliative Approach in Nursing Home
Official title: How to Improve the Care of Elderly People From Nursing Home: Interventional Research With Mixed Methods on an Early Integrated Palliative Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Maison Médicale Jeanne Garnier
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Regional Agency for Health PACA
name: Groupement Interrégional de Recherche Clinique et d'Innovation
name: Versailles Saint-Quentin-en-Yvelines University
name: Centre hospitalier de l'Université de Montréal (CHUM)
name: École de santé publique Université de Montréal
name: Centre Hospitalier Henri Duffaut - Avignon
name: Maison de santé Marie Galène
name: Agence Regionale de Sante d'Ile de France
First posted: 2021-01-13
Enrollment: 3500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: stepped-wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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. 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.

A mixed methods research, with qualitative and quantitative approach, will be carried out in at least 20 NH in three different health territories. These NH will benefit from a EIPCA-NH intervention which consists of 1) implementing a mechanism for sharing and co-producing knowledge, 2) integrating this approach as early as possible in the care of residents. This study is based on a multicenter, randomized crossover cluster-type stepped-wedge study, running on 4 years in order to measure the sustainability of EIPCA-NH; the quantitative analysis of the effectiveness of EIPCA-NH will focus on an open cohort of 3,500 residents receiving the intervention. The qualitative component will consist of a multiple case study to analyse the process of implementation and production of the EIPCA-NH. The integrative analysis of qualitative and quantitative data will allow a better understanding of the causal mechanisms of the observed phenomena.

This project will provide evidence on the value of EIPCA and the conditions for its implementation and transferability. The proposed intervention will help improve care practices for all NH residents (600,000 people). The approach by co-construction between actors of the thousands of care structures (NH, cities, hospitals) and researchers should promote a better representation of PC, promote the culture of anticipation, evaluation and collaboration between actors of in- and out- NH, contributing to a better synergy of intersectoral and territorial actions of the supply of health services.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: 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:
measure: 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.
timeFrame: Qualitative data collections will be carry out continuously throughout study completion (up to 2 years)
measure: Median score of quality of life of nursing home resident using InterRAI Self-Report Nursing Home Quality of Life Survey instrument (interRAI-QoL)
timeFrame: 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
measure: Median score of quality of life of informal caregiver using the Caregiver's Burden Scale in End-of-Life Care (CBS-EOLC) self-questionnaire
timeFrame: 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
measure: Median score of quality of life of professional caregiver using the professional quality of life scale (ProQoL)
timeFrame: 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
Other outcomes:
Locations:
city: Avignon
country: France
facility: Ch Avignon
city: Bordeaux
country: France
facility: Maison de Santé Marie Galène
city: Paris
country: France
facility: Maison Médicale Jeanne Garnier
Study officials:
affiliation: SPES, Maison médicale Jeanne Garnier
name: Emmanuel Bagaragaza, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SPES, Maison médicale Jeanne Garnier
name: Frédéric Guirimand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: GIRCI IDF
name: Philippe Aegerter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: