Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire

The investigators are interested in measuring the influence of addressing sleep in the orthopedic setting. This includes assessing patient experience measures (satisfaction with the visit, perceived empathy, communication effectiveness) as well as greater engagement in their healthcare (patient activation). The investigators will also see what factors might be associated with sleep disturbance and if addressing sleep leads to an intervention such as cognitive behavioral therapy.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance
• Intervention / Treatment: Other: Sleep assessment score; Other: No Score

Detailed Description

All adult (18+ years old) new patients seeing a musculoskeletal specialist will be invited to enroll. For the purposes of this trial, The investigators will include people with lesser degrees of sleep disturbance including anyone with a score greater than 3. For people that are enrolled in the trial, the researcher will record the PSQI score and enter at the first page of survey filled out by the patient after meeting. P The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit. The control group will include patients whose clinicians do not view the results, simulating usual care. Patients in both groups will fill out a survey entailing demographics, sleep quality, JSPPPE.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sina Ramtin; Phone Number: 5124955067; Email: sina.ramtin@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78701
      • Recruiting
      • University of Texas Health Austin (UTHA)
      • Contact: David Ring, M.D; Phone Number: 512-495-5067; Email: David.Ring@austin.utexas.edu
    • Austin, Texas, United States, 78701
      • Recruiting
      • University of Texas Health Austin
      • Contact: Sina Ramtin; Phone Number: 512-495-5067; Email: sina.ramtin@austin.utexas.edu
      • Principal Investigator: David Ring, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Adult patients (18+)
2. Orthopedic new visit
3. Sleep disturbance score > 3

Exclusion criteria:

1. Inability to read.
2. Diminished cognition preventing completion of the questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinician with Scores; The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit.	Other: Sleep assessment score; The patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit.
Active Comparator: Clinician without Scores; The control group will include patients whose clinicians do not view the results, simulating usual care.	Other: No Score; The patients in the control group will include those for whom their clinician was not given their sleep questionnaire result before the visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jefferson Scale of Patient's Perceptions of Physician Empathy	The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: David Ring, MD, Professor of orthopedic surgery at The university of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 2020-05-0067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No