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.
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
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 group | Role | What they receive |
|---|---|---|
| High risk critically ill patients | Experimental | Critically 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.
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.
- First posted12 Aug 2020
- Study start1 Sep 2020
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lioudmila Karnatovskaia, Mayo Clinic
- Investigators
- Lioudmila V Karnatovskaia, MD, Principal investigator, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aloud Real-time Reading of ICU Diaries for Prevention of Negative Post-ICU Psychological Outcomes: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04510272
- Acronym / sponsor ID
- 20-002275
- Conditions
- Anxiety, Depression, PTSD
- Keywords
- Critical illness, PTSD, Depression, anxiety, PICS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk critically ill patients | Experimental | Other: Aloud Real-time Reading of ICU DiariesCritically ill patients requiring vasopressor support or mechanical ventilation will receive aloud real time ICU diary reading intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aloud Real-time Reading of ICU DiariesStandard ICU diaries will be read aloud in real time daily to patients by ICU nurses/therapists/family members | Other | High risk critically ill patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 36706496Johnson 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lioudmila V Karnatovskaia, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
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.