Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Failure
- Sponsor
- Johns Hopkins University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Treatment Satisfaction Questionnaire
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Investigators
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
Outcomes
Primary Outcomes
Treatment Satisfaction Questionnaire
Time Frame: 5 weeks post-enrollment
Treatment Satisfaction Questionnaire (TSQ) ranges from 0-21, with higher scores representing greater satisfaction. Items (e.g., "useful", "liked it," "perceived symptom improvement") are scored based on a Likert scale, ranging from 0= "not at all" to 7= "very much so." Higher scores indicate higher satisfaction
treatment feasibility as assessed by sessions completed
Time Frame: 5 weeks post enrollment
treatment feasibility as assessed by \>70% of intervention sessions completed
treatment feasibility as assessed by drop out rate
Time Frame: 3 years
treatment feasibility as assessed by \<15% drop-out across intervention arm
average accrual rate of 2 patients/month across all patients
Time Frame: 3 years
treatment feasibility objective
Secondary Outcomes
- Self Efficacy for Managing Chronic Disease Rating Scale(at hospital discharge (up to 12 weeks after randomization), 3 month followup)
- Hospital Anxiety and Depression Scale(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)(3 month follow up)
- State Anxiety Inventory(at hospital discharge (up to 12 weeks after randomization), immediately post intervention, 5 weeks post intervention, 3 months)
- Healthcare Utilization as assessed by Healthcare Utilization interview(3 month follow-up)
- Montreal Cognitive Assessment - Blind(3 month follow up)
- Visual Analog Scale - Anxiety(at hospital discharge (up to 12 weeks after randomization), 5 weeks post enrollment, 3 months)
- Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6(3 month follow up)
- Hopkins Rehab Engagement Scale(at hospital discharge (up to 12 weeks after randomization))