Clinical trial NCT06401239: Investigating Dyadic Expectations About ARF Survivorship (IDEAS)
Official title: Investigating Dyadic Expectations About ARF Survivorship (IDEAS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Failure
Caregiving Stress
Mental Health Issue
Keywords: ARF survivor
Caregiver
ICU recovery
Dyadic coping
Dyadic self-efficacy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-05-06
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study team will enroll adults who were treated for ARF in ICUs at Johns Hopkins Hospital and Bayview Medical Center in Baltimore, Maryland.

Brief summary: The purpose of this observational study is to understand how adults who survive acute respiratory failure (ARF) and the people (usually family) who support ARF survivors after returning home think about the first 6 months of recovery. The study aims to find out if expectations about the recovery process after ARF are associated with mental health symptoms in both survivors and the survivor's care partners. Study participants will complete 3 surveys over 6 months. These surveys ask questions about participants' future expectations, feelings, and mood. Surveys can be completed online, over the phone, or on paper.

Detailed description: The overarching objectives of the Investigating Dyadic Expectations about ARF Survivorship (IDEAS) cohort study are to learn how expectations about ARF survivorship are related to dyadic mental health symptoms and dyadic coping. Specifically, the study aims are:

* Aim 1: To determine whether health expectations and self-efficacy after acute respiratory failure (ARF) are associated with mental health outcomes in survivor-care partner dyads.
* Aim 2: To assess whether concordant expectations within survivor-care partner dyads are associated with better dyadic coping (primary outcome) and exploratory secondary outcomes.

The term dyadic coping refers to the ways two people interact as the pair manage illness-related stressors. Concordant expectations within dyads, also called shared appraisal, refers to both members of a dyad being "on the same page", and is hypothesized to lead to better dyadic coping behaviors.

Eligibility criteria: Patient Inclusion Criteria:

* ≥18 years old
* Meets study definition of ARF:

  * The study defines ARF as meeting 1 of the following 3:

    1. Mechanical ventilation via an endotracheal tube ≥24 consecutive hours OR
    2. Non-invasive ventilation (CPAP, BiPAP) ≥24 consecutive hours that is not for obstructive sleep apnea or other stable use OR
    3. High flow nasal cannula with fraction of inspired oxygen (FIO2)≥.5 and flow rate ≥ litres per minute (LPM) for ≥24 consecutive hours.
  * Occasional rest periods of ≤1 hour are not deducted from the calculation of consecutive hours. Patients who are intubated for mental status or airway obstruction are not eligible unless they have simultaneous ARF.
* Survival to hospital discharge to home
* Speaks or reads English or Spanish
* Identifies an adult who is expected to act as a primary care partner for at least the next 6 months.

Patient Exclusion Criteria:

* Pre-existing cognitive impairment (IQ-CODE \>3.6)
* Residing in a medical institution at hospital discharge
* Receiving hospice care or life expectancy \<6 months
* Homelessness or recent history of psychosis

Care Partner Inclusion Criteria:

* ≥18 years old
* Speaks or reads English or Spanish

Care Partner Exclusion Criteria:

* Pre-existing cognitive impairment (IQ-CODE \>3.6)

Primary outcomes:
measure: Symptoms of Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 and 6 months after ARF survivor's ICU discharge
measure: Dyadic Coping as Assessed by the Dyadic Coping Inventory (DCI)
timeFrame: 3 and 6 months after ARF survivor's ICU discharge
Secondary outcomes:
measure: Symptoms of Post Traumatic Stress as Measured by the Impact of Events Scale-Revised (IES-R)
timeFrame: 3 and 6 months after ARF survivor's hospital discharge
measure: Health-related Quality of Life as Measured by the European Quality of Life 5-Domain 5-level Questionnaire (EQ-5D-5L)
timeFrame: 3 and 6 months after ARF survivor's hospital discharge
measure: Social Isolation as Measured by Social Isolation Score
timeFrame: 3 and 6 months after ARF survivor's hospital discharge
measure: Financial Toxicity as Assessed by Qualitative Questions
timeFrame: 3 and 6 months after ARF survivor's hospital discharge
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Alison E Turnbull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turnbull AE, Lee EM, Dinglas VD, Beesley S, Bose S, Banner-Goodspeed V, Hopkins RO, Jackson JC, Mir-Kasimov M, Sevin CM, Brown SM, Needham DM; Addressing Post-Intensive Care Syndrome-01 (APICS-01) Study Team. Health Expectations and Quality of Life After Acute Respiratory Failure: A Multicenter Prospective Cohort Study. Chest. 2023 Jul;164(1):114-123. doi: 10.1016/j.chest.2023.01.016. Epub 2023 Jan 19.
citation: Vranceanu AM, Bannon S, Mace R, Lester E, Meyers E, Gates M, Popok P, Lin A, Salgueiro D, Tehan T, Macklin E, Rosand J. Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020807. doi: 10.1001/jamanetworkopen.2020.20807.
citation: Geense WW, van den Boogaard M, van der Hoeven JG, Vermeulen H, Hannink G, Zegers M. Nonpharmacologic Interventions to Prevent or Mitigate Adverse Long-Term Outcomes Among ICU Survivors: A Systematic Review and Meta-Analysis. Crit Care Med. 2019 Nov;47(11):1607-1618. doi: 10.1097/CCM.0000000000003974.
citation: Zante B, Camenisch SA, Schefold JC. Interventions in Post-Intensive Care Syndrome-Family: A Systematic Literature Review. Crit Care Med. 2020 Sep;48(9):e835-e840. doi: 10.1097/CCM.0000000000004450.