Perioperative Family Updates Reduce Anxiety and Improve Satisfaction

NCT04330612 | Completed

• 1 other identifier: CHRMS 16-642
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Family Members; Anxiety; Satisfaction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Spearman correlation between length of procedure and Likert score of anxiety level

  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

  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

  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.

Study Arms (2)

Control

NO INTERVENTION

In the control pathway, the surgeons communicated with the family only once near the completion of the procedure.

Intervention

EXPERIMENTAL

In the intervention group, the families received additional standardized electronic updates via pagers.

Other: Perioperative Updates

Interventions

Perioperative Updates OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vermont Medical Center: lead

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Researcher

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 1, 2020
• Study Start: June 1, 2016
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: April 1, 2020

Record last verified: 2020-03