Aloud Real-time Reading of ICU Diaries for Prevention of Negative Post-ICU Psychological Outcomes

Aloud Real-time Reading of ICU Diaries for Prevention of Negative Post-ICU Psychological Outcomes: A Feasibility Study

This study will evaluate whether a systematically delivered, patient-oriented real time communication via aloud real time readings of ICU diary entries during patient's ICU stay is feasible

Study Overview

• Status: Completed
• Conditions: Depression; PTSD; Anxiety
• Intervention / Treatment: Other: Aloud Real-time Reading of ICU Diaries

Detailed Description

Survivors of sepsis and acute respiratory failure suffer from long-term impairment in the domains of physical, cognitive, and psychological functioning collectively known as post intensive care syndrome (PICS) associated with increased re-hospitalization rates, higher health care costs and impaired quality of life. Pioneering work in the field of early physical rehabilitation of intensive care unit (ICU) patients and in identification of strategies for delirium reduction demonstrated improvement in physical and cognitive outcomes. Prevention of psychological complications, however, has not been adequately addressed. Anxiety, depression and post-traumatic stress disorder (PTSD) affect over a third of all critical illness survivors post discharge, which is more than double of what has been reported in combat veterans. Despite the staggering rates of mental health morbidity, research on targeting preventive measures to be employed in the ICU before development of psychological symptoms has earned sparse attention. Memories of frightening and delusional experiences appear to be the strongest potentially modifiable risk factor, with higher rates of PTSD reported in those who had delusional memories without recall of factual events. Indeed, psychiatric symptoms such as anxiety, depression, and PTSD can be conceptualized as disorders of memory content, whereby the neural representation of the emotional component of the memory of a traumatic experience persists beyond any adaptive purpose. This causes dysregulation in the fear memory system, resulting in pathology associated with impaired cognitive, affective, and volitional functions. Research on the formation of fear memories demonstrates that one can interfere with the initial process of fear conditioning during the temporal windows when memory consolidation and reconsolidation occur.

Therefore, a potential approach to treatment may be to introduce mitigating/factual information during the time period when the consolidation of the initial memory occurs and also following its initial recall, because at this time memories are labile and susceptible to alteration; however, the longer a memory has been stored in the brain, the more difficult it is to destabilize and alter it, explaining the lack of effectiveness of outpatient interventions. For the critically ill this would mean introducing some form of communication as soon as feasible following admission and providing communication in parallel with medical care in the ICU. Even though semantic processing continues in an altered states of consciousness, very little verbal communication systematically takes place with sedated and/or cognitively altered patients during the time window when the negative memories are being formed. How can such communication be introduced?

A lot of patients receive ICU diaries following hospital discharge. The original design that has remained unchanged on over 30 years has care team and family members write entries of the patient's daily events, written in a non-medical language. Despite decades of research, ICU diaries failed to demonstrate consistent benefit for mental health outcomes. What if the reason is simply due to the timing of the information provided? What is reading the entries in real time, as the events unfold, can provide that protective factual information to mitigate formation of traumatic memories?

The investigators hypothesize that reading ICU diary entries aloud in real time (in addition to providing them to patients following hospital discharge as has been the standard previously) is feasible and may translate into improved mental health outcomes including symptoms of anxiety, depression, and PTSD as well as more delirium free days. Doing so systematically may mitigate formation of false negative memories, provide reorientation and factual information, and thus help patients understand what is happening to them in real time.

This will be accomplished via the following aim:

Specific Aim #1: To conduct a feasibility trial of reading ICU diaries aloud daily and to refine the intervention based on stakeholder feedback Objective 1: ICU diaries will be read aloud in real time daily to 30 enrolled patients by ICU nurses/therapists. The approach will subsequently be refined based on semi-structured interviews of all involved stakeholders (patients, families, nurses, therapists). Patients will also complete anxiety, depression, acute stress/PTSD and cognitive function evaluation as measured by validated instruments.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• High risk critically ill patients: adults (age ≥ 18) in acute respiratory failure and/or requiring vasopressors admitted to the ICU and expected to stay >48 hours. adults (age ≥ 18) in acute respiratory failure and/or requiring vasopressors admitted to the ICU and expected to stay >48 hours
• Enrolled patient's family members.
• Critical care nurses.
• Physical/Occupational therapists writing ICU diary entries.

Exclusion Criteria:

• History of dementia, mental retardation, suicide attempt, psychotic disorders such as schizophrenia, acute alcohol/substance intoxication or withdrawal, severe metabolic encephalopathy; patients on comfort care; patients not expected to survive the hospital stay or non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High risk critically ill patients; Critically ill patients requiring vasopressor support or mechanical ventilation will receive aloud real time ICU diary reading intervention	Other: Aloud Real-time Reading of ICU Diaries; Standard ICU diaries will be read aloud in real time daily to patients by ICU nurses/therapists/family members

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days patients successfully receive the intervention	Feasibility of the intervention as defined by ICU diary entries being read aloud on >80% of days they were entered	Length of ICU admission

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

General Publications

• Johnson KR, Temeyer JP, Schulte PJ, Nydahl P, Philbrick KL, Karnatovskaia LV. Aloud real- time reading of intensive care unit diaries: A feasibility study. Intensive Crit Care Nurs. 2023 Jan 25;76:103400. doi: 10.1016/j.iccn.2023.103400. Online ahead of print.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 9, 2021
• Study Completion (Actual): March 9, 2021

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: PTSD; Depression; anxiety; Critical illness; PICS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 20-002275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No