Anxiety, Satisfaction, Well-Being
Conditions
Keywords
spirituality, religion, surrogate decision making, proxy decision making, chaplain
Brief summary
The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.
Detailed description
To prepare for a fully powered, multi-center study, we propose a 2-arm, attention controlled, randomized pilot trial of high-quality spiritual care for 64 surrogates at 2 additional US medical centers. Specific Aims are: 1. To determine the feasibility and acceptability of all aspects of the study, including enrollment, randomization, delivery of the SCAI framework (e.g., chaplain intervention) and attention control conditions, acceptability, and outcome assessments, in preparation for a larger, Stage III effectiveness trial. 2. To test the effects of spiritual care on the primary outcome of anxiety (GAD-7) and the secondary outcomes of surrogate spiritual well-being and satisfaction with spiritual care (FACIT-Sp-non-illness version, Satisfaction with Care-Chaplain), and decision making for the patient, including the process of decision making and the medical care received by the patient. 3. To study the experience of spiritual care from the perspective of surrogates who are religious and those who are not, those of different faiths, and those who describe themselves as spiritual but not religious. Because chaplains are common in the ICU this intervention is highly scalable. Results will guide hospital leaders, policy makers and the healthcare team regarding how to deploy chaplains to improve surrogates' psychological and spiritual health and the quality of decisions for critically ill patients.
Interventions
The SCAI intervention includes three visits generally scheduled 48-72 hours apart. After three visits, the chaplain will contact the surrogate at least weekly for the remainder of the hospitalization. If the patient dies, the chaplain will conduct a bereavement visit. The SCAI framework addresses four dimensions of spirituality. If all four dimensions are not addressed, they may be assessed during follow-up visits. If all four dimensions are addressed during the initial visit, other visits include at least one question from any dimension. The SCAI framework includes a list of common spiritual care interventions developed based on clinical experience and literature review.. Based on our conceptual framework, interventions are either are emotionally supportive, address spiritual or religious dimensions of care, or address information support such as exploring the meaning of medical events. Consistent with chaplain standards, the chaplain selects and tailors these interventions.
BEHAVIORALICU Guide
The ICU Guide intervention will include three visits with the site RA that are similar in duration to the chaplain visits (based on the single center study, first visit median of 23 minutes, follow-up visit median 12 minutes), with review of a brochure introducing the family member to the ICU including staff, policies and procedures that will be helpful to the family member.
Sponsors
Indiana University
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Regenstrief Institute, Inc.
University of California, San Francisco
Wake Forest University
Rush University
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We will enroll patient/surrogate dyads. Patients will be eligible if: * They are age 18 or older at the time of screening. * They are judged to lack decisional capacity based on either: a Glasgow Coma Scale (GCS) score of 8 or less; or a GCS of 9-13 with at least one secondary criterion (intubation, sedation, delirium, or noted by clinicians to be unresponsive, comatose or unable to follow commands). \* They have an eligible surrogate willing to participate. Surrogates will be eligible if: * They are age 18 or older, * They are considered the legally authorized representative (LAR) based on prior appointment by the patient or each state's medical consent law. Patient/surrogate dyads will be ineligible if: \* They are unable to complete enrollment activities within 96 hours of admission to the ICU. Patients will be ineligible if: * They are being discharged from the ICU within 24 hours. * They are intubated for surgery but expected to be extubated soon (typically within 24 hours). * They are imminently dying or have a planned terminal wean. Surrogates will be ineligible if: \*They are unable to complete study procedures in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the intervention on surrogate anxiety (GAD-7) | Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital | Generalized Anxiety Disorder- 7 (GAD-7) (7 item inventory of anxiety)- assesses subject's self-reported anxiety for the last two weeks. Scores range from 0-21 0= 'Not at all'; 1= 'Several Days'; 2= 'More than half the days'; 3= 'Nearly every day' Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the intervention on surrogate spiritual well-being (FACIT-Sp) | Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital | Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT- Sp) Scale, a 12-item questionnaire used to measure spiritual well-being in people with chronic illnesses. It assesses aspects like meaning, peace, and faith, and is widely used in research and clinical settings, particularly for patients with cancer and other serious health conditions. |
| Decision making quality (FS-ICU) | Assessed 6-8 weeks after the patient has discharged from the hospital | Family Satisfaction with the ICU Process of Decision Making Subscale, a 4 item inventory of decision making quality |
| Satisfaction with Spiritual Care (PSI-C) | Assessed 6-8 weeks after the patient has discharged from the hospital | Patient Satisfaction Instrument- Chaplaincy includes 23 clinical statements which are rated on a 4 (strongly agree) to 1 (strongly disagree) scale. |
Countries
United States
Contacts
CONTACTEmily S Burke, BA
CONTACTAlexia M Torke, MD, MS
Outcome results
None listed