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

How to Improve the Care of Elderly People From Nursing Home: Interventional Research With Mixed Methods on an Early Integrated Palliative Approach

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.

Study Overview

• Status: Recruiting
• Conditions: Palliative Care; Aged; Nursing Homes
• Intervention / Treatment: Other: early integrated palliative approach model

• Study Type: Interventional
• Enrollment (Anticipated): 3500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie Bouscaren, PhD; Phone Number: 003314922189; Email: nbouscaren@adc.asso.fr
• Study Contact Backup: Name: Célia Broussard, PhD; Phone Number: 003314922189; Email: cbroussard@adc.asso.fr

Study Locations

• France
  • Avignon, France
    • Recruiting
    • CH Avignon
    • Contact: Sylvie Barois; Phone Number: 0033 1 43 92 21 89; Email: sbarois@adc.asso.fr
  • Bordeaux, France
    • Recruiting
    • Maison de santé Marie Galène
    • Contact: Morgan Brunet; Phone Number: 0033 1 43 92 21 89; Email: mbrunet@adc.asso.fr
  • Paris, France
    • Recruiting
    • Maison Médicale Jeanne Garnier
    • Contact: Simon Martine; Phone Number: 0033 1 43 92 21 89; Email: smartine@adc.asso.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: First EIPCA-NH group; There are 5 nursing home in each arm (cluster), randomly selected from 3 French areas.	Other: early integrated palliative approach model; 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.
OTHER: Early intermediate EIPCA-NH group; There are 5 nursing home in each arm (cluster), randomly selected from 3 French areas.	Other: early integrated palliative approach model; 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.
OTHER: Late intermediate EIPCA-NH group; There are 5 nursing home in each arm (cluster), randomly selected from 3 French areas.	Other: early integrated palliative approach model; 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.
OTHER: Last EIPCA-NH group; There are 5 nursing home in each arm (cluster), randomly selected from 3 French areas.	Other: early integrated palliative approach model; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	stepped-wedge with 4 clusters : The minimum score is 6 which means that the degree of implementation is very low. The maximum score is 30 which means that the degree of implementation is very high.	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)	stepped-wedge with 4 clusters : InterRAI quality of life has ten subscales with minimum score of 0 and a maximum score ranging between 16 to 24. The minimum score (0) is the best outcome for quality of life and, the maximum (16-24) is the worse outcome.	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	stepped-wedge with 4 clusters : The minimum score is 16 meaning that it is the best outcome for the quality of life of informal caregivers and, the maximum score is 54 meaning that it is the worst outcome.	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)	stepped-wedge with 4 clusters : The minimum score is 30, the average score is around 50 and the highest score is 57 or over. The highest score means a good quality of life of professional caregiver and the lowest score means a poor professional caregiver's quality of life	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2021
• Primary Completion (ACTUAL): March 30, 2021
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (ACTUAL): January 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: quality of care; care pathway; health services research; mixed method; resident; Integrated and early palliative care approach; intervention research; nursing home caregiver
• Other Study ID Numbers: 2020-A01832-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Study protocole: july 2021
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No