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

NCT04510272 | Completed

• 1 other identifier: 20-002275
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety; Depression; PTSD

Keywords

Critical illness; PTSD; Depression; anxiety; PICS

Outcome Measures

Primary Outcomes (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

  Length of ICU admission

Study Arms (1)

High risk critically ill patients

EXPERIMENTAL

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

Interventions

Aloud Real-time Reading of ICU Diaries OTHER

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

High risk critically ill patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 36706496 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Critical Illness

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lioudmila V Karnatovskaia, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: September 1, 2020
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)