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AnxietyNCT04510272

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

A study testing Aloud Real-time Reading of ICU Diaries in people with Anxiety and Depression, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Depression, PTSD
What is being tested?
Aloud Real-time Reading of ICU Diaries
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 9 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions
Anxiety, Depression, PTSD
Being tested
Aloud Real-time Reading of ICU Diaries
Keywords
Critical illness, PTSD, Depression, anxiety, PICS
Medical subject headings
Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aloud Real-time Reading of ICU DiariesOther

    Standard ICU diaries will be read aloud in real time daily to patients by ICU nurses/therapists/family members

Study groups in NCT04510272
Study groupRoleWhat they receive
High risk critically ill patientsExperimentalCritically ill patients requiring vasopressor support or mechanical ventilation will receive aloud real time ICU diary reading intervention
Receives: Other: Aloud Real-time Reading of ICU Diaries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Length of ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start1 Sep 2020
  3. Primary completion9 Mar 2021
  4. Study completion9 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04510272
Sponsor's protocol ID
20-002275
Status last verified
Feb 2023
First submitted
10 Aug 2020
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 Jun;76:103400. doi: 10.1016/j.iccn.2023.103400. Epub 2023 Jan 25.

    PubMed 36706496

Questions about this trial

What is this clinical trial studying?

A study testing Aloud Real-time Reading of ICU Diaries in people with Anxiety and Depression, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of days patients successfully receive the intervention (time frame: Length of ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04510272, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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