Acute Respiratory Failure, Critical Illness, Hypercapnia, Hypoxia, Sepsis
Conditions
Keywords
Acute Respiratory Failure, Family-Centered Intervention, Critical illness, Sepsis, Septic shock
Brief summary
This study will investigate whether a family-centered intervention that has been adapted for patients with critical illness and their caregivers is possible, acceptable, and helpful
Detailed description
Participants will be randomized to receive written handouts or to the ICU-SUCCEED intervention. The intervention includes one inpatient (in-person) and 4 outpatient (Zoom or telephone) sessions that take 30-45 minutes. Dyads will complete questionnaires at baseline and at a Day 90 Follow-Up.
Interventions
BEHAVIORALICU-SUCCEED
Includes one inpatient (in-person) session followed by four outpatient (Zoom or telephone) sessions. Dyads will receive one session every 1-2 weeks. Each session will have a different focus, which may incorporate one of the following: communication, self-management, emotion management, stress management, lifestyle and hobbies, and interpersonal relationship building. This intervention has been adapted to meet the needs of patients with acute respiratory failure and their caregivers
OTHERAugmented Usual Care
Usual care will continue unchanged and will include any services, counseling, monitoring, or referrals that are coordinated by the clinical team prior to discharge. Handouts include a hospital discharge preparation checklist and information about the long-term complications of and recovery from critical illness.
Sponsors
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria * Admitted to the medical ICU at UNC with acute respiratory failure (functional lung impairment resulting in hypoxia, hypercapnia, or both) and/or sepsis with significant end organ dysfunction. * At least 18 years old * Survives to hospital discharge * Is expected to be discharged home or to an acute inpatient rehabilitation center with a clear plan to be subsequently discharged home * Capable of providing written informed consent * Has English language proficiency Caregiver Inclusion Criteria * Provides emotional, physical, and/or financial support to the patient in a non-professional, unpaid capacity * Must be related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling * At least 18 years of age * Has English language proficiency * Must be the caregiver of a patient that meets the patient eligibility criteria listed above Patient
Exclusion criteria
* No available family caregiver * Lacks decision-making capacity * Under 18 years of age * Living at a location other than home prior to admission * Unhoused prior to admission * Receives extracorporeal membrane oxygenation (ECMO) during hospital stay * Expected to discharge to any location other than home or an acute inpatient rehabilitation center * Does not have English language proficiency Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of intervention completion | From enrollment through intervention completion, average of 8 weeks | The number of dyads that complete all five sessions relative to the number of dyads randomized. Expressed as a percentage. |
| Feasibility of retention | From enrollment to day 90 follow-up | The number of dyads who remained in the study through the Day 90 Follow-up relative to the number of dyads that are consented. Expressed as a percentage. |
| Intervention acceptability | Day 90 | Defined as the mean score on three Likert-scale items assessed at 90 days post index discharge for participants in the intervention group |
| Feasibility of ICU-SUCCEED inpatient session | From recruitment start to inpatient session completion | The number of dyads who complete inpatient session relative to the number of participants randomized to the intervention arm. Expressed as a percentage. |
| Feasibility of enrollment | From the start to end of recruitment | The number of enrolled dyads who provide consent relative to the number of dyads that are approached. Expressed as a percentage |
| Feasibility of participant eligibility | From the start to the end of recruitment | Defined as the number of patients who met the inclusion criteria relative to the number of patients screened. Expressed as a percentage. |
| Feasibility of recruitment | From the start to the end of recruitment | The number of eligible patient-caregiver dyads that are approached by the study team relative to the number of dyads that are eligible for the study. Expressed as a percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregivers' change in self-efficacy | Baseline to Day 90 | The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale which measures a caregiver's confidence in supporting a patient in completing activities related to the patient's self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy. |
| Patients' Hospital Anxiety and Depression scores at Day 90 | Day 90 | Defined as the difference between the intervention and control arms on the Hospital Anxiety and Depression scale, which is designed to measure severity of anxiety and depression over the past week. Scores range from 0 to 21 where higher scores indicate greater anxiety and depression) |
| Caregivers' Hospital Anxiety and Depression scores at Day 90 | Day 90 | Defined as the difference between the intervention and control arms on the Hospital Anxiety and Depression scale which is designed to measure severity of anxiety and depression over the past week. Scores range from 0 to 21 where higher scores indicate greater anxiety and depression) |
| Caregivers' Couples' Illness Communication Scale scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Couples' Illness Communication Scale which measures a couple's illness-related communication. Scores range from 4 to 20 where higher scores indicate greater communication. |
| Caregivers' Impact of Events Scale-6 scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Impact of Events Scale-6 which is designed to measure symptoms of post-traumatic stress disorder. Scores range from 0 to 24 where higher scores indicate greater impairment |
| Patients' return to work status at Day 90 | Day 90 | The difference between arms in the proportion of patients who have returned to work as defined by a Y/N item on a revised Employment Questionnaire |
| Caregivers' return to work status at Day 90 | Day 90 | The difference between arms in the proportion of caregivers who have returned to work as defined by a Y/N item on a revised Employment Questionnaire |
| Patients' EQ-5D scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the EQ-5D, which measures health-related quality of life. Scores range from 5 to 25 where higher scores indicate worse health status. |
| Caregivers' EQ-5D scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the EQ-5D which measures health-related quality of life. Scores range from 5 to 25 where higher scores indicate worse health status. |
| Patients' Care Transition Measure scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Care Transition Measure, which measures an individual's preparation for hospital discharge. Scores range from 3 to 13 where higher scores indicate greater preparation for hospital discharge. |
| Caregivers' Care Transition Measure scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Care Transition Measure which measures an individual's preparation for hospital discharge. Scores range from 3 to 13 where higher scores indicate greater preparation for hospital discharge. |
| Patients' Multidimensional Scale of Perceived Social Support scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Multidimensional Scale of Perceived Social Support, which measures perceived social support. Scores range from 12 to 84 where higher scores indicate greater perceived support. |
| Caregivers' Multidimensional Scale of Perceived Social Support scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Multidimensional Scale of Perceived Social Support which measures perceived social support. Scores range from 12 to 84 where higher scores indicate greater perceived support. |
| Patients' Couples' Illness Communication Scale scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Couples' Illness Communication Scale, which measures a couple's illness-related communication. Scores range from 4 to 20 where higher scores indicate greater communication. |
| Patients' Impact of Events Scale-6 scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Impact of Events Scale-6, which is designed to measure symptoms of post-traumatic stress disorder. Scores range from 0 to 24 where higher scores indicate greater impairment |
| Patients' Self-Care Self Efficacy Scale scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale, which measures a patient's confidence in completing activities related to their self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy. |
| Caregivers' Self-Care Self Efficacy Scale scores at Day 90 | Day 90 | The difference in scores between the intervention and control arms on the Caregiver Self-Efficacy in Contribution to Self-Care Scale, which measures a caregiver's confidence in supporting a patient in completing activities related to the patient's self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy. |
| Days alive and out of hospital (DAOH) | From enrollment to day 90 follow-up | Defined as the number of days spent alive and outside of an acute care hospital (including acute care at home), long-term acute care hospital (LTACH), or emergency department (ED) over the 90 days following index hospital discharge. |
| Patients' Self-Care Self Efficacy Scale scores at Baseline | Baseline | The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale, which measures a patient's confidence in completing activities related to their self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy. |
| Caregivers' Self-Care Self Efficacy Scale scores at Baseline | Baseline | The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale which measures a caregiver's confidence in supporting a patient in completing activities related to the patient's self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy. |
| Patients' change in self-efficacy | Baseline to Day 90 | The difference in scores between the intervention and control arms on the Self-Care Self Efficacy Scale, which measures a patient's confidence in completing activities related to their self-care. Scores range from 10 to 50 where higher scores indicate greater self-efficacy. |
Countries
United States
Contacts
CONTACTBlair Wendlandt, MD, MSCR
PRINCIPAL_INVESTIGATORBlair Wendlandt, MD, MSCR
University of North Carolina, Chapel Hill
Outcome results
None listed