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Improving Sleep Quality in Flap Patients in the SICU

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ClinicalTrials.gov Identifier: NCT03957317
Recruitment Status : Completed
First Posted : May 21, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Bryan Romito, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE February 6, 2018
Actual Primary Completion Date October 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Improvement in Richards-Campbell Sleep Questionnaire (RCSQ) scores [ Time Frame: 2 days from ICU admission ]
The Richards-Campbell Sleep Questionnaire (RCSQ) is a 5-item questionnaire used to evaluate perceived sleep depth, sleep latency, number of awakenings, efficiency, and sleep quality. Each RCSQ question is measured on a 0 (minimum) to 100 (maximum) visual-analogue scale, with higher scores representing better sleep. The primary outcome measure is a 25% increase in median RCSQ scores from the control group.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
Improvement in RCSQ scores [ Time Frame: 2 days ]
Assess a 25% increase in global RCSQ scores from control group.
Change History Complete list of historical versions of study NCT03957317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Improvement in overall modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey scores [ Time Frame: 2 days from ICU admission ]
    The Family Satisfaction in the Intensive Care Unit (FS-ICU) questionnaire is a reliable and valid 34-item tool used to measure family satisfaction with care and decision-making in the ICU. Each question is completed using a 5-point Likert scale where 1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor, and 6 = not applicable. A modified version of the FS-ICU survey used in the present study includes 14 questions and contains only questions directed toward the patient and not family members. Overall satisfaction score is calculated as the mean of the 14 items, with lower scores indicating greater satisfaction. A secondary outcome measure is to determine the difference in overall modified FS-ICU scores between control and intervention groups.
  • Improvement in positive Confusion Assessment Method for the ICU (CAM-ICU) scores [ Time Frame: 2 days from ICU admission ]
    The Confusion Assessment Method for the ICU (CAM-ICU) is a valid and reliable delirium monitoring instrument for ICU patients. It tests for the presence of alteration in mental status, inattention, altered level of consciousness, and disorganized thinking. The presence of both altered mental status and inattention along with either altered consciousness or disorganized thinking corresponds to a positive CAM-ICU result, and delirium is present. If these criteria are not met, then CAM-ICU is considered negative, and delirium is absent. A secondary outcome measure is to determine the difference in positive CAM-ICU results between control and intervention groups.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • Improvement in modified Family Satisfaction in the Intensive Care Unit survey [ Time Frame: 2 days ]
    Assess difference between control and intervention in modified FS-ICU scores
  • Improvement in Confusion Assessment Method for the ICU [ Time Frame: 2 days ]
    Determine difference in CAM-ICU scores between control and intervention groups
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Sleep Quality in Flap Patients in the SICU
Official Title  ICMJE Improving Sleep Quality and Satisfaction for Postoperative Plastic Surgery Flap Patients in the CUH SICU
Brief Summary This investigation will be a randomized interventional prospective quality improvement study. Patients undergoing plastic surgery with flap procedures (n =123) will be randomized to evaluate the effect of the implementation bundle for sleep quality improvement in the surgical intensive care unit (SICU). Roughly one half of the patients (n =62) will be randomized to the intervention group. This group will receive the intervention bundle which consists of providing ear plugs and eye masks to patients and their family members. Roughly one half of the patients (n =62) will be randomized to the control group. This group will receive "usual care", which does not include ear plugs or eye masks and lacks specified times for laboratory draws and imaging studies. For each of the two groups, the investigators will collect Richards-Campbell Sleep Questionnaire (RCSQ) scores, Confusion Assessment Method for the ICU (CAM-ICU) scores, and modified Family Satisfaction in the Intensive Care Unit (FS-ICU) scores. The investigators will administer the RCSQ to these patients following every night they spend in the SICU and the FS-ICU questionnaire immediately prior to their discharge from the ICU.
Detailed Description

Patients will be identified during their presurgical clinic visit or anesthesia preoperative clinic visit for eligibility. The electronic medical record (Epic) will also be used for prescreening of potential study participants by reviewing the clinic visit daily schedule or operating room schedule. Then patient charts will be reviewed for initial data collection to determine the eligibility of potential subjects with the use of a HIPAA waiver form.

A discussion of risks, benefits, and alternatives will be performed. Following the discussion, informed written consent for clinical care and participation in the study will be obtained.

Roughly one half of the patients (n =62) will be randomized to the intervention group. This group will receive the intervention bundle which consists of providing ear plugs and eye masks to patients and their family members. Roughly one half of the patients (n =62) will be randomized to the control group. This group will receive "usual care", which does not include ear plugs or eye masks and lacks specified times for laboratory draws and imaging studies. For each of the two groups, the investigators will collect RCSQ scores, CAM-ICU scores, and modified FS-ICU scores. The investigators will administer the RCSQ to these patients following every night they spend in the SICU and the modified FS-ICU questionnaire immediately prior to their discharge from the ICU. The RCSQ is a short, 5-question, validated survey instrument for measuring sleep quality in ICU patients. The FS-ICU is a short, validated survey instrument for measuring family satisfaction with care and decision making in the ICU. The modified version is more focused on satisfaction of the patient rather than their family member(s). The CAM-ICU is a validated screening test for delirium, and scores are currently charted in the electronic medical record (EMR) as a part of routine monitoring in the SICU. The anticipated length of time for the project is 28 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, controlled study comparing effects of wearing eye masks and ear plugs for sensory deprivation against the standard-of-care (no treatment). Primary outcome is measuring difference between RCSQ scores (sleep quality survey).
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sleep Deprivation
Intervention  ICMJE Other: Eye mask and ear plugs
Subjects receive one pair of eye mask and ear plugs during their stay in the surgical ICU.
Study Arms  ICMJE
  • No Intervention: Control
    Subjects in this group do not receive an eye mask or ear plugs, and receive standard of care (including pain control modalities). The subjects will receive a Richards-Campbell Sleep Questionnaire (RCSQ) survey for each night they spend in the Surgical ICU, as well as a modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey upon discharge from the ICU.
  • Experimental: Intervention
    Subjects in this group receive an eye mask and ear plugs in addition to standard of care for pain control. The subjects will receive a Richards-Campbell Sleep Questionnaire (RCSQ) survey for each night they spend in the Surgical ICU, as well as a modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey upon discharge from the ICU.
    Intervention: Other: Eye mask and ear plugs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2019)
123
Actual Study Completion Date  ICMJE October 5, 2019
Actual Primary Completion Date October 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients age ≥ 18 years
  • Individuals undergoing plastic surgery flap procedures requiring hourly monitoring

Exclusion Criteria:

  • Pregnancy
  • Incarceration
  • Diagnosis of obstructive sleep apnea
  • Diagnosis of insomnia or other sleep disturbance
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957317
Other Study ID Numbers  ICMJE STU082017-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Only deidentified aggregate data can be shared with other researchers at this time.
Responsible Party Bryan Romito, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bryan T Romito, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP