Evaluating the impact of a standardised intervention for announcing decisions of withholding and withdrawing life-sustaining treatments on the stress of relatives in emergency departments (DISCUSS): protocol for a stepped-wedge randomised controlled trial
Karim Tazarourte,
Marion Douplat,
Laurent Jacquin,
Delphine Douillet,
Fabien Subtil,
Julie Haesebaert,
Xavier Dubucs,
Anne-Marie Schott-Pethelaz,
Damien Viglino,
Mathilde Marchal,
Manon Verroul,
Anne Termoz,
Pauline Drouin,
Estelle Bravant,
Carole Langlois,
Bénédicte Clément,
Daniel Roux-Boniface,
Frédéric Verbois,
Marine Demarquet
Affiliations
Karim Tazarourte
Hôpital Edouard Herriot, Service d’Accueil des Urgences, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France
Marion Douplat
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1—Domaine de Rockefeller, Lyon, Rhône-Alpes, France
Laurent Jacquin
Hôpital Edouard Herriot, Service d’Accueil des Urgences, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France
Delphine Douillet
Hôpital Larrey, Service d’Accueil des Urgences, Centre Hospitalier Universitaire d`Angers, Angers, Pays de la Loire, France
Fabien Subtil
Pôle Santé Publique, Service de Biostatistique et Bio-informatique, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France
Julie Haesebaert
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1—Domaine de Rockefeller, Lyon, Rhône-Alpes, France
Xavier Dubucs
Hôpital Larrey, Service d’Accueil des Urgences, Centre Hospitalier Universitaire de Toulouse, Toulouse, Occitanie, France
Anne-Marie Schott-Pethelaz
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1—Domaine de Rockefeller, Lyon, Rhône-Alpes, France
Damien Viglino
Hôpital Nord, Service d’Accueil des Urgences, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France
Mathilde Marchal
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1—Domaine de Rockefeller, Lyon, Rhône-Alpes, France
Manon Verroul
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1—Domaine de Rockefeller, Lyon, Rhône-Alpes, France
Anne Termoz
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1—Domaine de Rockefeller, Lyon, Rhône-Alpes, France
Pauline Drouin
Pôle Santé Publique, Service Recherche et Epidémiologie Cliniques, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France
Estelle Bravant
Research on Healthcare Performance (RESHAPE), INSERM U1290, Université Claude Bernard Lyon 1—Domaine de Rockefeller, Lyon, Rhône-Alpes, France
Carole Langlois
Pôle Santé Publique, Service de Biostatistique et Bio-informatique, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France
Bénédicte Clément
Hôpital de la Croix-Rousse, Service d’Accueil des Urgences, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France
Daniel Roux-Boniface
Hôpital Gabriel Montpied, Service d’Accueil des Urgences, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
Frédéric Verbois
Centre Hospitalier Nord Ouest, Service d’Accueil des Urgences, Hopital de Villefranche-sur-Saone, Villefranche-sur-Saone, Auvergne-Rhône-Alpes, France
Marine Demarquet
Centre Hospitalier Fleyriat, Service d’Accueil des Urgences, Centre Hospitalier de Bourg-en-Bresse, Bourg-en-Bresse, Rhône-Alpes, France
Introduction The decisions of withholding or withdrawing life-sustaining treatments are difficult to make in the context of emergency departments (EDs) because most patients are unable to communicate. Relatives are thus asked to participate in the decision‐making process, although they are unprepared to face such situations. We therefore aimed to develop a standardised intervention for announcing decisions of withholding or withdrawing life-sustaining treatments in EDs and assess the efficacy of the intervention on the stress of relatives.Methods and analysis The DISCUSS trial is a multicentre stepped-wedge cluster randomised study and will be conducted at nine EDs in France. A standardised intervention based on human simulation will be codesigned with partner families and implemented at three levels: the relatives, the healthcare professionals (HCP) and the EDs. The intervention will be compared with a control based on treatment as usual. A total of 538 families are planned to be included: 269 in the intervention group and 269 in the control group. The primary endpoint will be the symptoms of post-traumatic stress disorder (PTSD) at 90 days. The secondary endpoints will be symptoms of PTSD at 7 and 30 days, diagnosis of PTSD at 90 days and anxiety and depression scores at 7, 30 and 90 days. Satisfaction regarding the training, the assertiveness in communication and real-life stress of HCPs will be measured at 90 days.Ethics and dissemination This study was approved by the ethics committee Est III from Nancy and the French national data protection authority. All relatives and HCPs will be informed regarding the study objectives and data confidentiality. Written informed consent will be obtained from participants, as required by French law for this study type. The results from this study will be disseminated at conferences and in a peer-reviewed journal.Trial registration number NCT06071078.
