ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers

N/ANot Yet RecruitingNCT07778004

University of North Carolina, Chapel Hill144 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

144

Conditions

Acute Respiratory Failure Critical Illness Sepsis Hypoxia Hypercapnia

Interventions

ICU-SUCCEEDBEHAVIORAL

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

Augmented Usual CareOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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 Exclusion Criteria * Does not provide emotional, physical, and/or financial support to the patient in a non-profession, unpaid capacity * Is not related to the patient in one of the following ways: a spouse or domestic partner, an adult child, a parent, or a sibling * Cannot complete surveys or engage in other study activities due to physical or cognitive limitations * Unhoused prior to admission * Is under 18 years of age * Does not have English language proficiency * Is not the caregiver of a patient that meets the patient eligibility criteria listed above

Locations (1)

UNC Hospitals

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Feasibility of participant eligibility

Defined as the number of patients who met the inclusion criteria relative to the number of patients screened. Expressed as a percentage.

Time frame: From the start to the end of recruitment

Feasibility 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

Time frame: From the start to the end of recruitment

Feasibility of enrollment

The number of enrolled dyads who provide consent relative to the number of dyads that are approached. Expressed as a percentage

Time frame: From the start to end of recruitment

Feasibility of ICU-SUCCEED inpatient session

The number of dyads who complete inpatient session relative to the number of participants randomized to the intervention arm. Expressed as a percentage.

Time frame: From recruitment start to inpatient session completion

Feasibility of intervention completion

The number of dyads that complete all five sessions relative to the number of dyads randomized. Expressed as a percentage.

Time frame: From enrollment through intervention completion, average of 8 weeks

Feasibility of retention

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.

Time frame: From enrollment to day 90 follow-up

Intervention acceptability

Defined as the mean score on three Likert-scale items assessed at 90 days post index discharge for participants in the intervention group

Central Contacts

Blair Wendlandt, MD, MSCR

CONTACT

(984)542-7702 succeed_icu@med.unc.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Patients' Hospital Anxiety and Depression scores at 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)

Time frame: Day 90

Caregivers' Hospital Anxiety and Depression scores at 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)

Time frame: Day 90

Patients' Impact of Events Scale-6 scores at 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

Time frame: Day 90

Caregivers' Impact of Events Scale-6 scores at 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

Time frame: Day 90

Patients' return to work status at 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

Time frame: Day 90

Caregivers' return to work status at 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

Time frame: Day 90

Patients' EQ-5D scores at 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.

Time frame: Day 90

Caregivers' EQ-5D scores at 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.

Time frame: Day 90

Patients' Care Transition Measure scores at 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.

Time frame: Day 90

Caregivers' Care Transition Measure scores at 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.

Time frame: Day 90

Patients' Multidimensional Scale of Perceived Social Support scores at 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.

Time frame: Day 90

Caregivers' Multidimensional Scale of Perceived Social Support scores at 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.

Time frame: Day 90

Patients' Couples' Illness Communication Scale scores at 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.

Time frame: Day 90

Caregivers' Couples' Illness Communication Scale scores at 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.

Time frame: Day 90

Patients' Self-Care Self Efficacy Scale scores at 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.

Time frame: Day 90

Caregivers' Self-Care Self Efficacy Scale scores at 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.

Time frame: Day 90

Days alive and out of hospital (DAOH)

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.

Time frame: From enrollment to day 90 follow-up

Patients' Self-Care Self Efficacy Scale scores at Baseline

Time frame: Baseline

Caregivers' Self-Care Self Efficacy Scale scores at 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.

Time frame: Baseline

Patients' change in self-efficacy

Time frame: Baseline to Day 90

Caregivers' change in self-efficacy

Time frame: Baseline to Day 90