Investigating Dyadic Expectations About ARF Survivorship (IDEAS)

Overview

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.

Interventions

• Other Dyadic expectations about the ARF survivor's perceived health 6 months after hospital discharge
  Dyad members' expectations will be collected at baseline and at 3- month follow-up assessments using a visual analogue scale (VAS) ranging from 0 - 100, similar to the EQ-5D-VAS.
• Other Self-efficacy
  Self-efficacy in both dyad members will be assessed at 3- and 6-month follow-up assessments using the Generalized Self-Efficacy Scale (GSE). The GSE has 10 items scored on a 4-point scale. U.S. adult population norms are available.
• Other Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge
  Dyad members' expectations will be collected at baseline and at 3- month follow-up assessments using a visual analogue scale (VAS) ranging from 0 - 100, similar to the EQ-5D-VAS.

Primary outcome measures

• Symptoms of Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS) [Time frame: 3 and 6 months after ARF survivor's ICU discharge]
• Dyadic Coping as Assessed by the Dyadic Coping Inventory (DCI) [Time frame: 3 and 6 months after ARF survivor's ICU discharge]

Secondary outcome measures (4)

• Symptoms of Post Traumatic Stress as Measured by the Impact of Events Scale-Revised (IES-R) [Time frame: 3 and 6 months after ARF survivor's hospital discharge]
• Health-related Quality of Life as Measured by the European Quality of Life 5-Domain 5-level Questionnaire (EQ-5D-5L) [Time frame: 3 and 6 months after ARF survivor's hospital discharge]
• Social Isolation as Measured by Social Isolation Score [Time frame: 3 and 6 months after ARF survivor's hospital discharge]
• Financial Toxicity as Assessed by Qualitative Questions [Time frame: 3 and 6 months after ARF survivor's hospital discharge]

Eligibility criteria

Patient Inclusion Criteria:

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

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

• Mechanical ventilation via an endotracheal tube ≥24 consecutive hours OR
• Non-invasive ventilation (CPAP, BiPAP) ≥24 consecutive hours that is not for obstructive sleep apnea or other stable use OR
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Johns Hopkins Hospital — Baltimore

Publications

• 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 Ja PMID 36682611
• 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/jamanetwork PMID 33052404
• 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. PMID 31464769
• 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. PMID 32590386

Identifiers

NCT: NCT06401239 · IRB00429340 · R01HL163660

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗