CFP-RCTChaplain Family Project Randomized Controlled Trial
Spiritual Care Assessment and Intervention (SCAI) framework
Troubles liés aux traumatismes et aux facteurs de stress+2
+ Troubles anxieux
+ Troubles Mentaux
Soins de support
Résumé
Date de début de l'étude : 28 août 2018
Date à laquelle le premier participant a commencé l'étude.Unmet spiritual needs may have at least two negative consequences for surrogates. First, they may have high levels of spiritual distress, an important aspect of the surrogate's well-being. Second, surrogates include their religious and spiritual beliefs when making serious medical decisions . Therefore unmet spiritual needs may have a negative effect on the surrogate's ability to make good decisions for the patient, especially when facing extremely distressful decisions such as whether to continue life sustaining treatment or enroll in hospice. The specific aims of this proposed study are: 1. To determine the effect of the spiritual care intervention on psychological well-being for family surrogates at 3 months post discharge, including anxiety (primary outcome: GAD-7), depression (PHQ-9), Posttraumatic stress (IES-R), and overall distress. 2. To determine the effect of the spiritual care intervention on spiritual well-being for family surrogates, (FACIT-SP- non-illness) and on religious coping (Brief RCOPE positive and negative). 3. To determine the effects of the spiritual care intervention on other aspects of the surrogates' experience, including satisfaction with spiritual care (Patient Satisfaction Instrument--Chaplaincy) communication (FICS), overall satisfaction with the hospital stay (Picker single item) and decision conflict (DCS). 4. To determine the effect of the intervention on treatment at the end of life (life sustaining treatments and hospice utilization) for patients who die in the hospital. 5. To determine differences in outcomes between the intervention group, who will receive our intervention, and the control group, who will receive the usual care provided by the hospital chaplaincy service.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.192 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Cognitive Requirements 1. Patient is not decisional due to: * Intubation (other than surgery- see exclusion criteria below) * Sedation * Unresponsive * otherwise unable to communicate (AMS, dementia, delirium, etc.) Decision Support Requirements 2. Patient has a qualified surrogate decision maker Exclusion Criteria: * Intubated for surgery and expected to be extubated within 24 hours * Imminently dying as evidenced by patient notes * Patient and/or family have a care contract or other restriction due to complicated or volatile situation * Patient is a prisoner * Patient is being followed by Adult Protective Services (APS) * Patient meets cognitive criteria but does not have a qualified surrogate decision maker
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
IU Health Methodist Hospital
Indianapolis, United StatesOuvrir IU Health Methodist Hospital dans Google MapsIU Health University Hospital
Indianapolis, United States