Perioperative Family Updates Reduce Anxiety and Improve Satisfaction

March 30, 2020 updated by: Lindsay Howe, University of Vermont Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Likert Score (0-5) of level of overall satisfaction
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.
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
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.
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spearman correlation between length of procedure and Likert score of anxiety level
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.
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
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.
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
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Vermont Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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