Chaplain Family Project Trial



Status:Recruiting
Conditions:Anxiety, Anxiety, Depression, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:August 28, 2018
End Date:August 28, 2019
Contact:Emily Burke, BA
Email:esburke@iupui.edu
Phone:317-274-9047

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Chaplain Family Project Randomized Controlled Trial

Our research team has designed a chaplain delivered intervention focused on surrogate
decision makers for hospitalized adults in the ICU. In this study, surrogates will complete
an enrollment interview with research staff, including the completion of anxiety screening
(GAD-7). Based on their score the surrogate will be put into one of two groups, and then
randomized to either the control or intervention group. Control group members will receive
usual care, while intervention group members will meet with our study chaplain, who will
provide the SCAI (Spiritual Care Assessment and Intervention) framework.

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.

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
We found this trial at
2
sites
Indianapolis, Indiana 46202
Principal Investigator: Alexia M Torke, MD, MS
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mi
from
Indianapolis, IN
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Indianapolis, Indiana 46202
Principal Investigator: Alexia M Torke, MD, MS
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials