Perioperative Family Updates Reduce Anxiety and Improve Satisfaction

Perioperative Family Updates Reduce Anxiety and Improve Satisfaction: A Randomized Controlled Trial

This study was a randomized control trial conducted to determine if frequent, standardized updates affect anxiety and satisfaction of family members. Additionally, the investigators aimed to determine if the length of the surgical procedure effects the satisfaction with updates.

Study Overview

• Status: Completed
• Conditions: Anxiety; Satisfaction; Family Members
• Intervention / Treatment: Other: Perioperative Updates

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient undergoing inpatient arthroplasty, orthopaedic spine, or orthopaedic trauma procedures

Exclusion Criteria:

• Age under 18
• Non-English speaking patients or families
• Patients with families that would not be waiting in the hospital during the perioperative period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; In the control pathway, the surgeons communicated with the family only once near the completion of the procedure.
EXPERIMENTAL: Intervention; In the intervention group, the families received additional standardized electronic updates via pagers.	Other: Perioperative Updates; In the intervention group, the families received additional standardized electronic updates via pagers at three pivotal moments: 1) Initial skin incision has been made; 2) Critical part of the case is completed and closure has begun; and, 3) Closure is complete, and patient will be transferred to the recovery room when ready.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert Score (0-5) of level of overall satisfaction	Likert Score (0-5) of level of overall satisfaction of family members throughout the perioperative period	Overall satisfaction levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.
Likert Score (0-5) of anxiety level	Likert Score (0-5) of anxiety level of family members throughout the perioperative period	Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.
Likert Score (0-5) of level of satisfaction with perioperative updates	Likert Score (0-5) of level of satisfaction of family members with perioperative updates throughout the perioperative period	Satisfaction with perioperative updates measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon-family update. This update occurred at or near the end of the surgical procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spearman correlation between length of procedure and Likert score of anxiety level	Spearman correlation between length of procedure and Likert score (0-5) of anxiety level of family members throughout the perioperative period	Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Anxiety levels measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.
Spearman correlation between length of procedure and Likert score of overall satisfaction	Spearman correlation between length of procedure and Likert score (0-5) of overall satisfaction level of family members throughout the perioperative period	Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.
Spearman correlation between length of procedure and Likert score of satisfaction with perioperative updates	Spearman correlation between length of procedure and Likert score of family member satisfaction with perioperative updates	Procedure time defined as the time the patient enters the operating room to the time the patient exits the operating room. Satisfaction level measured throughout the perioperative period (up to 8.4 hours), reported at the time of final surgeon update.

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): August 30, 2017
• Study Completion (ACTUAL): August 30, 2017

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (ACTUAL): April 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CHRMS 16-642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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