Improving Sleep Quality in Flap Patients in the SICU

Sleep Deprivation Clinical Trial

Official title:

Improving Sleep Quality and Satisfaction for Postoperative Plastic Surgery Flap Patients in the CUH SICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957317
• Other study ID #: STU082017-007
• Status: Completed
• Phase: N/A
• Start date: February 6, 2018
• Est. completion date: October 5, 2019

Study information

• Verified date: October 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 5, 2019
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• Eye mask and ear plugs
Subjects receive one pair of eye mask and ear plugs during their stay in the surgical ICU.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Richards-Campbell Sleep Questionnaire (RCSQ) scores	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.	2 days from ICU admission
Secondary	Improvement in overall modified Family Satisfaction in the Intensive Care Unit (FS-ICU) survey scores	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.	2 days from ICU admission
Secondary	Improvement in positive Confusion Assessment Method for the ICU (CAM-ICU) scores	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.	2 days from ICU admission