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

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ClinicalTrials.gov Identifier: NCT04510272

Recruitment Status : Completed

First Posted : August 12, 2020

Last Update Posted : April 27, 2021

Sponsor:

Information provided by (Responsible Party):

Lioudmila Karnatovskaia, Mayo Clinic

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Anxiety Depression PTSD	Other: Aloud Real-time Reading of ICU Diaries	Not Applicable

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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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	72 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Aloud Real-time Reading of ICU Diaries for Prevention of Negative Post-ICU Psychological Outcomes: A Feasibility Study
Actual Study Start Date :	September 1, 2020
Actual Primary Completion Date :	March 9, 2021
Actual Study Completion Date :	March 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Depression

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510272

Locations

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

Sponsors and Collaborators

Mayo Clinic

Investigators

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Principal Investigator:	Lioudmila V Karnatovskaia, MD	Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

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Responsible Party:	Lioudmila Karnatovskaia, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT04510272
Other Study ID Numbers:	20-002275
First Posted:	August 12, 2020 Key Record Dates
Last Update Posted:	April 27, 2021
Last Verified:	April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Lioudmila Karnatovskaia, Mayo Clinic:


Critical illness PTSD Depression anxiety PICS

Additional relevant MeSH terms:

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Depression Behavioral Symptoms

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