Perioperative Family Updates Reduce Anxiety and Improve Satisfaction

• Sponsor: University of Vermont Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04330612
• Collaborator: (none)
• Enrollment: 115
• Arms: 2
• Actual Duration (Months): 14.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Family Members; Anxiety; Satisfaction	Other: Perioperative Updates	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Perioperative Family Updates Reduce Anxiety and Improve Satisfaction: A Randomized Controlled Trial
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Aug 30, 2017
• Actual Study Completion Date: Aug 30, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Likert Score (0-5) of level of overall satisfaction [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 level of overall satisfaction of family members throughout the perioperative period

2. Likert Score (0-5) of anxiety level [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 anxiety level of family members throughout the perioperative period

3. Likert Score (0-5) of level of satisfaction with perioperative updates [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.]

   Likert Score (0-5) of level of satisfaction of family members with perioperative updates throughout the perioperative period

Secondary Outcome Measures

1. 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 (0-5) of anxiety level of family members throughout the perioperative period

2. 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 (0-5) of overall satisfaction level of family members throughout the perioperative period

3. 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.]

   Spearman correlation between length of procedure and Likert score of family member satisfaction with perioperative updates

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Vermont Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 20, 2016

More Information

Publications

None provided.

• Responsible Party: Lindsay Howe, Primary Researcher, University of Vermont Medical Center
• ClinicalTrials.gov Identifier: NCT04330612
• Other Study ID Numbers: CHRMS 16-642
• First Posted: Apr 1, 2020
• Last Update Posted: Apr 1, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Apr 1, 2020