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| Name | Class |
|---|---|
| Regenstrief Institute, Inc. | OTHER |
| Indiana University Health | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Usual Care) | No Intervention | Surrogate will receive usual care in the hospital, which could include visits from the unit chaplain or other staff from the spiritual care department. | |
| Intervention | Experimental | Spiritual Care Assessment and Intervention (SCAI) framework |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiritual Care Assessment and Intervention (SCAI) framework | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety from baseline enrollment interview to 6-8 weeks post patient discharge | GAD-7 (7 item inventory of anxiety) | Assessed at enrollment and again 6-8 weeks after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression from baseline enrollment interview to 6-8 weeks post patient discharge | PHQ-9 (9 item inventory of depression) | Assessed at enrollment and again 6-8 weeks after hospital discharge |
| Presence of post traumatic stress at 6-8 weeks post patient discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spiritual well-being at baseline enrollment interview to 6-8 weeks post patient discharge | FACIT-SP- non-illness scale (a validated scale of spiritual well-being) | Assessed at enrollment and again 6-8 weeks after hospital discharge |
| Change in religious coping from baseline enrollment interview to 608 weeks post patient discharge |
Inclusion Criteria:
Cognitive Requirements
Patient is not decisional due to:
Decision Support Requirements
Patient has a qualified surrogate decision maker
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexia M Torke, MD, MS | Indiana University, IU Health, Regenstrief Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States | ||
| IU Health University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36526251 | Derived | Torke AM, Varner-Perez SE, Burke ES, Taylor TA, Slaven JE, Kozinski KL, Maiko SM, Pfeffer BJ, Banks SK. Effects of Spiritual Care on Well-Being of Intensive Care Family Surrogates: A Clinical Trial. J Pain Symptom Manage. 2023 Apr;65(4):296-307. doi: 10.1016/j.jpainsymman.2022.12.007. Epub 2022 Dec 14. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D003142 | Communication |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Arm 1- Control group Arm 2- Intervention group
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Research staff conducting interviews with study participants will be masked to study group allocation, until all outcome assessments for that participant have been completed.
|
IES-R (Impact of Events scale- inventory for PTSD) |
| Assessed 6-8 weeks after hospital discharge |
| Change in overall distress from baseline enrollment interview to 6-8 weeks post patient discharge | Distress thermometer (a 1-10 scale developed by our team to assess distress) | Assessed at enrollment and again 6-8 weeks after hospital discharge |
Brief RCOPE (a validated scale of religious coping) |
| Assessed at enrollment and again 6-8 weeks after hospital discharge |
| Satisfaction with spiritual care at 6-8 weeks post patient discharge | Patient Satisfaction Instrument- Chaplaincy (an adaptation of a scale of patient satisfaction to be used with surrogates) | Assessed 6-8 weeks after hospital discharge |
| Communication in the hospital at 6-8 weeks post patient discharge | Family Inpatient Communication Survey (FICS) (A validated scale of communication | Assessed 6-8 weeks after hospital discharge |
| Overall satisfaction with the hospital stay at 6-8 weeks post patient discharge | Picker single item (1-10) | Assessed 6-8 weeks after hospital discharge |
| Presence of decision conflict at 6-8 weeks post patient 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) | Assessed 6-8 weeks after hospital discharge |
| Effect of the intervention on end of life care for those who die in the hospital | Will use comparative statistics to determine any correlations between intervention and EOL care (life sustaining treatments received and hospice enrollment) | Chart abstraction to review from the date of admission to the hospital up to one year after admission |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| D001519 | Behavior |