CFP-RCTChaplain Family Project Randomized Controlled Trial
Spiritual Care Assessment and Intervention (SCAI) framework
Trauma and Stressor Related Disorders+7
+ Anxiety Disorders
+ Behavior
Supportive Care Study
Summary
Study start date: August 28, 2018
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.192 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
IU Health Methodist Hospital
Indianapolis, United StatesOpen IU Health Methodist Hospital in Google MapsIU Health University Hospital
Indianapolis, United States