Anxiety, Communication, Depression, PTSD, Satisfaction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
The study chaplain will work with the surrogate, using questions in four domains of spiritual care, to assess them and tailor the visit to their specific needs. The study chaplain will then utilize a pre-determined list of spiritual care interventions, and also document observable outcomes that occur at each visit (which are also listed within the SCAI framework).
Sponsors
Regenstrief Institute, Inc.
Indiana University Health
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Research staff conducting interviews with study participants will be masked to study group allocation, until all outcome assessments for that participant have been completed.
Intervention model description
Arm 1- Control group Arm 2- Intervention group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge | Assessed at enrollment and again 6-8 weeks after hospital discharge | GAD-7 (7 item inventory of anxiety) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge | Assessed at enrollment and again 6-8 weeks after hospital discharge | PHQ-9 (9 item inventory of depression) |
| Presence of post traumatic stress at 6-8 weeks post patient discharge | Assessed 6-8 weeks after hospital discharge | IES-R (Impact of Events scale- inventory for PTSD) |
| Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge | Assessed at enrollment and again 6-8 weeks after hospital discharge | Distress thermometer (a 1-10 scale developed by our team to assess distress) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall satisfaction with the hospital stay at 6-8 weeks post patient discharge | Assessed 6-8 weeks after hospital discharge | Picker single item (1-10) |
| Change in spiritual well-being at baseline enrollment interview to 6-8 weeks post patient discharge | Assessed at enrollment and again 6-8 weeks after hospital discharge | FACIT-SP- non-illness scale (a validated scale of spiritual well-being) |
| Effect of the intervention on end of life care for those who die in the hospital | Chart abstraction to review from the date of admission to the hospital up to one year after admission | Will use comparative statistics to determine any correlations between intervention and EOL care (life sustaining treatments received and hospice enrollment) |
| Presence of decision conflict at 6-8 weeks post patient discharge | Assessed 6-8 weeks after hospital discharge | Decision Conflict Scale (DCS) (a validated scale of decision conflict that is used to assess decision conflict when a person has made 1 or more major decisions for a patient in the hospital setting) |
| Change in religious coping from baseline enrollment interview to 608 weeks post patient discharge | Assessed at enrollment and again 6-8 weeks after hospital discharge | Brief RCOPE (a validated scale of religious coping) |
| Satisfaction with spiritual care at 6-8 weeks post patient discharge | Assessed 6-8 weeks after hospital discharge | Patient Satisfaction Instrument- Chaplaincy (an adaptation of a scale of patient satisfaction to be used with surrogates) |
| Communication in the hospital at 6-8 weeks post patient discharge | Assessed 6-8 weeks after hospital discharge | Family Inpatient Communication Survey (FICS) (A validated scale of communication |
Countries
United States
Outcome results
None listed