Family MembersNCT04330612
Perioperative Family Updates Reduce Anxiety and Improve Satisfaction
A study testing Perioperative Updates in people with Family Members and Anxiety, run by University of Vermont Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Members, Anxiety, Satisfaction
- What is being tested?
- Perioperative Updates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing inpatient arthroplasty, orthopaedic spine, or orthopaedic trauma procedures
Who cannot join
- Age under 18
- Non-English speaking patients or families
- Patients with families that would not be waiting in the hospital during the perioperative period
About this study
Official title: 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.
- Conditions
- Family Members, Anxiety, Satisfaction
- Being tested
- Perioperative Updates
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative UpdatesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Perioperative Updates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Spearman correlation between length of procedure and Likert score (0-5) of anxiety level of family members throughout the perioperative period
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Jun 2016
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family MembersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Howe, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330612
- Sponsor's protocol ID
- CHRMS 16-642
- Status last verified
- Mar 2020
- First submitted
- 29 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Family Updates Reduce Anxiety and Improve Satisfaction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04330612
- Acronym / sponsor ID
- CHRMS 16-642
- Conditions
- Family Members, Anxiety, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In the control pathway, the surgeons communicated with the family only once near the completion of the procedure. |
| Intervention | Experimental | Other: Perioperative UpdatesIn the intervention group, the families received additional standardized electronic updates via pagers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing inpatient arthroplasty, orthopaedic spine, or orthopaedic trauma procedures
Key exclusion criteria (3 listed)
- Age under 18
- Non-English speaking patients or families
- Patients with families that would not be waiting in the hospital during the perioperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative UpdatesIn 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. | Other | Intervention |
Primary outcome
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
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
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
3 secondary outcomes
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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Updates in people with Family Members and Anxiety, run by University of Vermont Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.