Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention

Overview

A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant. The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients. The main question\[s\] it aims to answer are: * Is this intervention feasible and acceptable in ARF patients? * Is this intervention in the ICU and hospital associated with reduced anxiety symptoms? Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up.

Detailed description

Statement of the Problem. An increasing number of adults develop acute respiratory failure (ARF) requiring mechanical ventilation in an intensive care unit (ICU). To improve patient outcomes, evidence-based guidelines recommend titrating sedatives to allow for patient wakefulness while in the ICU. However, among awake acute respiratory failure patients, anxiety can be a common and long-lasting problem. Outside of the ICU setting, cognitive behavioral therapy based self-management is an established, evidence-based, first-line treatment for patients with anxiety. However, there is limited evidence about the feasibility and benefit of cognitive behavioral therapy interventions for acute respiratory failure patients with anxiety during hospitalization.

Specific Aims. This award proposal seeks to conduct a pilot randomized controlled trial of a tailored self-management protocol vs. usual care in the ICU and subsequent hospital ward to establish its feasibility, acceptability (primary outcome; Aim 1a), and potential efficacy in reducing anxiety symptoms and associated outcomes at hospital discharge (Aim 1b) and at 3-month follow-up (secondary outcomes; Aim 2). Experimental Approach. Pilot randomized controlled trial with blinded outcome assessment and 3-month phone-based follow-up.

Significance of the results. ARF patients experience significant anxiety during ICU stay, reporting feelings of terror, fear of death, and loss of control. Up to 50% of ARF patients report clinically significant anxiety at ICU discharge, and up to 40% report persistent symptoms up to 5 years after ICU. This project provides an essential foundation for evaluating a novel intervention, with a strong evidence-base outside of the ICU, to reduce anxiety in acute respiratory failure patients.

Interventions

• Behavioral Cognitive behavioral therapy based self-management for anxiety
  Evidenced based approach for educating patients about how to manage anxiety after respiratory failure.

Primary outcome measures

• Treatment Satisfaction Questionnaire [Time frame: 5 weeks post-enrollment]
• average accrual rate of 2 patients/month across all patients [Time frame: 3 years]
• treatment feasibility as assessed by sessions completed [Time frame: 5 weeks post enrollment]
• treatment feasibility as assessed by drop out rate [Time frame: 3 years]

Secondary outcome measures (9)

• Visual Analog Scale - Anxiety [Time frame: at hospital discharge (up to 12 weeks after randomization), 5 weeks post enrollment, 3 months]
• State Anxiety Inventory [Time frame: at hospital discharge (up to 12 weeks after randomization), immediately post intervention, 5 weeks post intervention, 3 months]
• Hopkins Rehab Engagement Scale [Time frame: at hospital discharge (up to 12 weeks after randomization)]
• Self Efficacy for Managing Chronic Disease Rating Scale [Time frame: at hospital discharge (up to 12 weeks after randomization), 3 month followup]
• Hospital Anxiety and Depression Scale [Time frame: at hospital discharge (up to 12 weeks after randomization), 3 month followup]
• Quality of Life as assessed by the European Quality of Life Scale (EQ-5D) [Time frame: 3 month follow up]
• Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6 [Time frame: 3 month follow up]
• Healthcare Utilization as assessed by Healthcare Utilization interview [Time frame: 3 month follow-up]
• Montreal Cognitive Assessment - Blind [Time frame: 3 month follow up]

Eligibility criteria

Inclusion criteria

• ≥18 years old
• English speaking and not aphasic
• ARF with mechanical ventilation via endotracheal tube > 24 hours
• Expected hospital stay of >7 days at time of eligibility
• Alert (ie, Richmond Agitation Sedation Scale sedation score = -1, 0, or 1)
• Not delirious (ie, negative Confusion Assessment Method -ICU score)
• Presence of anxiety symptoms (Visual Analog Scale-Anxiety score ≥50)\*\*

Exclusion criteria

• Pre-existing cognitive impairment (AD-8 score ≥2)
• History of major psychiatric illness (i.e., psychotic disorder, bi-polar disorder, suicide attempt in past 24 months, pervasive developmental disorder, active substance use disorder)
• Declines or incapable of informed consent
• Anticipated discharge to hospice, primary focus on palliative care, or >90% probability of in-hospital death

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

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Johns Hopkins Hospital — Baltimore

Publications

• May AD, Parker AM, Caldwell ES, Hough CL, Jutte JE, Gonzalez MS, Needham DM, Hosey MM. Provider-Documented Anxiety in the ICU: Prevalence, Risk Factors, and Associated Patient Outcomes. J Intensive Care Med. 2021 Dec;36(12):1424-1430. doi: 10.1177/0885066620956564. Epub 2020 Oct 9. PMID 33034254
• Hosey MM, Wegener ST, Hinkle C, Needham DM. A Cognitive Behavioral Therapy-Informed Self-Management Program for Acute Respiratory Failure Survivors: A Feasibility Study. J Clin Med. 2021 Feb 20;10(4):872. doi: 10.3390/jcm10040872. PMID 33672672
• Chlan L, Savik K. Patterns of anxiety in critically ill patients receiving mechanical ventilatory support. Nurs Res. 2011 May-Jun;60(3 Suppl):S50-7. doi: 10.1097/NNR.0b013e318216009c. PMID 21543962

Identifiers

NCT: NCT06341972 · IRB00247005 · K23HL155735

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗