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

NCT07778004 | Not Yet Recruiting DMC

• 2 other identifiers: 24-30101K23HL171951-01A1
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Respiratory Failure; Critical Illness; Sepsis; Hypoxia; Hypercapnia

Keywords

Acute Respiratory Failure; Family-Centered Intervention; Critical illness; Sepsis; Septic shock

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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

  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.

  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.

  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.

  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

  Day 90

Secondary Outcomes (21)

• Patients' Hospital Anxiety and Depression scores at Day 90

  Day 90

• Caregivers' Hospital Anxiety and Depression scores at Day 90

  Day 90

• Patients' Impact of Events Scale-6 scores at Day 90

  Day 90

• Caregivers' Impact of Events Scale-6 scores at Day 90

  Day 90

• Patients' return to work status at Day 90

  Day 90

Study Arms (2)

ICU-SUCCEED

EXPERIMENTAL

This arm will receive ICU-SUCCEED intervention.

Behavioral: ICU-SUCCEED

Augmented Usual Care

PLACEBO COMPARATOR

This arm will receive standard care routinely available plus written handouts prior to hospital discharge.

Other: Augmented Usual Care

Interventions

ICU-SUCCEED BEHAVIORAL

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

ICU-SUCCEED

Augmented Usual Care OTHER

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.

Augmented Usual Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Critical Illness; Sepsis; Hypoxia; Hypercapnia; Shock, Septic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Signs and Symptoms, Respiratory; Signs and Symptoms; Shock

Study Officials

• Blair Wendlandt, MD, MSCR

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blair Wendlandt, MD, MSCR

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: The investigator who proposes to use the data must have an approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)