Back to resultsPerioperative Family Updates Reduce Anxiety and Improve Satisfaction
Primary Purpose
Family Members, Anxiety, Satisfaction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perioperative Updates
Sponsored by
About this trial
This is an interventional other trial for Family Members
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
In the control pathway, the surgeons communicated with the family only once near the completion of the procedure.
In the intervention group, the families received additional standardized electronic updates via pagers.
Outcomes
Primary Outcome Measures
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
Likert Score (0-5) of anxiety level
Likert Score (0-5) of anxiety level of family members throughout the perioperative period
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT04330612
First Posted
March 29, 2020
Last Updated
March 30, 2020
Sponsor
University of Vermont Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04330612
Brief Title
Perioperative Family Updates Reduce Anxiety and Improve Satisfaction
Official Title
Perioperative Family Updates Reduce Anxiety and Improve Satisfaction: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Members, Anxiety, Satisfaction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
In the control pathway, the surgeons communicated with the family only once near the completion of the procedure.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
In the intervention group, the families received additional standardized electronic updates via pagers.
Intervention Type
Other
Intervention Name(s)
Perioperative Updates
Intervention Description
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.
Primary Outcome Measure Information:
Title
Likert Score (0-5) of level of overall satisfaction
Description
Likert Score (0-5) of level of overall satisfaction of family members throughout the perioperative period
Time Frame
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.
Title
Likert Score (0-5) of anxiety level
Description
Likert Score (0-5) of anxiety level of family members throughout the perioperative period
Time Frame
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.
Title
Likert Score (0-5) of level of satisfaction with perioperative updates
Description
Likert Score (0-5) of level of satisfaction of family members with perioperative updates throughout the perioperative period
Time Frame
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 Measure Information:
Title
Spearman correlation between length of procedure and Likert score of anxiety level
Description
Spearman correlation between length of procedure and Likert score (0-5) of anxiety level of family members throughout the perioperative period
Time Frame
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.
Title
Spearman correlation between length of procedure and Likert score of overall satisfaction
Description
Spearman correlation between length of procedure and Likert score (0-5) of overall satisfaction level of family members throughout the perioperative period
Time Frame
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.
Title
Spearman correlation between length of procedure and Likert score of satisfaction with perioperative updates
Description
Spearman correlation between length of procedure and Likert score of family member satisfaction with perioperative updates
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Perioperative Family Updates Reduce Anxiety and Improve Satisfaction
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