Patient and Family EngagementNCT03808350
Family Procedural Presence
A study testing Families Invited to Be Present at Procedures in people with Patient and Family Engagement, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
This study seeks to determine the effect of a quality improvement policy regarding allowing family members to remain in a patient's room during ICU procedures. The investigators hypothesized that our change in policy to invite family members to remain during procedures will improve patient \& family engagement and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient and Family Engagement
- What is being tested?
- Families Invited to Be Present at Procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2016to 30 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Able to read \& speak English
- Family member of a patient or a patient that has undergone one of these procedures at any point during the ICU stay (if the procedure occurs from Sunday at 8 am to Friday at 12 pm): intubation, central line placement, arterial line placement, bronchoscopy, thoracentesis, chest tube placement, paracentesis and lumbar puncture
- Physician (both attending physicians and trainees) and nurses who work in the ICU during the study period.
Who cannot join
- Patients for whom no family member can be identified
- Non-English speaking individuals
- Children (<18 years of age)
- Participants with dementia, psychiatric disorder with psychosis, schizophrenia or known cognitive dysfunction (established from chart review, report and/or score greater than or equal to 3 on IQ Code screening).
- Provider who does not want to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress and Engagement Surrounding ICU Procedures Among Patients, Families and Clinicians
This study seeks to determine the effect of a quality improvement policy regarding allowing family members to remain in a patient's room during ICU procedures. The investigators hypothesized that our change in policy to invite family members to remain during procedures will improve patient \& family engagement and improve long term psychological outcomes after an ICU admission. The study also seeks to determine if inviting family members to remain in a patient's room during ICU procedures will not increase clinician stress.
Read the detailed description
This is a research study about the effect of a quality improvement policy change regarding family presence at ICU procedures on family and patient engagement, psychological outcomes and stress levels in clinicians. In the study, ICU patients, their family members and ICU clinicians will be surveyed regarding these outcomes, with some surveys obtained prior to a policy change and a second set during a second time period after policy change. The patients and family members will be asked survey questions after the procedure and 3 months later. This study will also evaluate the change in clinician stress related to this policy change, and clinicians will also answer survey questions.
- Conditions
- Patient and Family Engagement
- Being tested
- Families Invited to Be Present at Procedures, Placebo/Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families Invited to Be Present at ProceduresProcedure or surgery
Family members will be invited (but not required) to remain in the ICU room during procedures, if patients agree
Placebo/ControlOther
Family members will not be invited to remain in the ICU room
| Study group | Role | What they receive |
|---|---|---|
| Families Excluded From Presence at Procedures | Placebo comparator | Families not invited to remain for ICU procedures Receives: Other: Placebo/Control |
| Families Invited to Be Present at Procedures | Active comparator | Families invited to remain for ICU procedures Receives: Procedure: Families Invited to Be Present at Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient & Family Member Engagement
Engagement, as measured by the collaboRATE survey, administered to patients \& family members within 48 hours after a procedure in the ICU
Measured: Time of ICU procedure to 48 hours afterwards
Secondary outcomes (6)
Patient & Family Member Stress
Perceived stress of patient \& family members, assessed within 48 hours after a procedure in the ICU by the Perceived Stress Scale-4 (PSS-4), measured on a scale from 0 to 16 with high numbers indicating increased level of perceived stress.
Measured: Time of ICU procedure to 48 hours afterwards
Clinician Stress
Clinician stress, as assessed within 48 hours after a procedure in ICU by the visual analog scale, measured on a scale from 1-100 with 100 indicating higher levels of clinician stress.
Measured: Time of ICU procedure to 48 hours afterwards
Procedural Complication Rate
Complications associated with procedures, including infections associated with central lines
Measured: Through 7 days after the ICU procedure
Trainee Satisfaction with Procedure Education
Satisfaction with the education experience among trainees performing procedures, as assessed within 24 hours by a Likert scale from 1-5 with 5 indicating increased satisfaction with education experience and 1 indicating dissatisfaction with education experience.
Measured: Time of ICU procedure to 24 hours afterwards
Patient & Family Member Anxiety & Depression
Anxiety and depression for patients \& family members, assessed at 3 months after the ICU procedure by the Hospital Anxiety and Depression Scale (HADS), measured from 0 to 42 with higher scores indicating more likelihood of anxiety or depression.
Measured: 3 months after ICU procedure
Patient & Family Member PTSD
PTSD for patients \& family members, assessed at 3 months after the ICU procedure by the Impact of Event Scale Revised (IES-R), measured from 4 to 88 with a score over 33 indicating likely presence of PTSD.
Measured: 3 months after ICU procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start14 Sep 2016
- Primary completion31 Mar 2019
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient and Family EngagementStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Sarah Beesley, Intermountain Health Care, Inc.
- Investigators
- Sarah J Beesley, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808350
- Sponsor's protocol ID
- 1050086
- Status last verified
- Apr 2022
- First submitted
- 26 Dec 2018
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Completely deidentified data may potentially be available to other researchers upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Engagement Surrounding ICU Procedures Among Patients, Families and Clinicians
- ClinicalTrials.gov ID
- NCT03808350
- Acronym / sponsor ID
- 1050086
- Conditions
- Patient and Family Engagement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- University of Utah
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 17 Jan 2019 (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 seeks to determine the effect of a quality improvement policy regarding allowing family members to remain in a patient's room during ICU procedures. The investigators hypothesized that our change in policy to invite family members to remain during procedures will improve patient \& family engagement and improve long term psychological outcomes after an ICU admission. The study also seeks to determine if inviting family members to remain in a patient's room during ICU procedures will not increase clinician stress.
Detailed description
This is a research study about the effect of a quality improvement policy change regarding family presence at ICU procedures on family and patient engagement, psychological outcomes and stress levels in clinicians. In the study, ICU patients, their family members and ICU clinicians will be surveyed regarding these outcomes, with some surveys obtained prior to a policy change and a second set during a second time period after policy change. The patients and family members will be asked survey questions after the procedure and 3 months later. This study will also evaluate the change in clinician stress related to this policy change, and clinicians will also answer survey questions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Families Excluded From Presence at Procedures | Placebo comparator | Other: Placebo/ControlFamilies not invited to remain for ICU procedures |
| Families Invited to Be Present at Procedures | Active comparator | Procedure: Families Invited to Be Present at ProceduresFamilies invited to remain for ICU procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- Able to read \& speak English
- Family member of a patient or a patient that has undergone one of these procedures at any point during the ICU stay (if the procedure occurs from Sunday at 8 am to Friday at 12 pm): intubation, central line placement, arterial line placement, bronchoscopy, thoracentesis, chest tube placement, paracentesis and lumbar puncture
- Physician (both attending physicians and trainees) and nurses who work in the ICU during the study period.
Key exclusion criteria (5 listed)
- Patients for whom no family member can be identified
- Non-English speaking individuals
- Children (<18 years of age)
- Participants with dementia, psychiatric disorder with psychosis, schizophrenia or known cognitive dysfunction (established from chart review, report and/or score greater than or equal to 3 on IQ Code screening).
- Provider who does not want to participate
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 |
|---|---|---|
| Families Invited to Be Present at ProceduresFamily members will be invited (but not required) to remain in the ICU room during procedures, if patients agree | Procedure or surgery | Families Invited to Be Present at Procedures |
| Placebo/ControlFamily members will not be invited to remain in the ICU room | Other | Families Excluded From Presence at Procedures |
Primary outcome
Patient & Family Member Engagement
Time frame: Time of ICU procedure to 48 hours afterwards
Engagement, as measured by the collaboRATE survey, administered to patients \& family members within 48 hours after a procedure in the ICU
6 secondary outcomes
Patient & Family Member Stress
Time frame: Time of ICU procedure to 48 hours afterwards
Clinician Stress
Time frame: Time of ICU procedure to 48 hours afterwards
Procedural Complication Rate
Time frame: Through 7 days after the ICU procedure
Trainee Satisfaction with Procedure Education
Time frame: Time of ICU procedure to 24 hours afterwards
Patient & Family Member Anxiety & Depression
Time frame: 3 months after ICU procedure
Patient & Family Member PTSD
Time frame: 3 months after ICU procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Undecided. Completely deidentified data may potentially be available to other researchers upon request
Related trials for Patient and Family Engagement
Recruiting
The Family-ICU Trial
Family Engagement, Patient and Family Engagement
Enrolling by invitation
The Effect of Family Member Voices on Dopamine, Serotonin Levels, and Pain in Patients in Intensive Care Units
Patient Engagement, Intensive Care (ICU)
Not yet recruiting
The Family Cares Trial
Family Engagement, Critical Care, Intensive Care
Recruiting
Increasing Family Engagement in Critical Care
Family Engagement, Critical Care, Intensive Care
RecruitingObservational study
Measuring Family Engagement in Care (The FAME Study)
Family Engagement, Patient-centered Care
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.
Sarah J Beesley, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families Invited to Be Present at Procedures in people with Patient and Family Engagement, run by Intermountain Health Care, Inc. at 1 site in United States.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Patient & Family Member Engagement (time frame: Time of ICU procedure to 48 hours afterwards). 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 13 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.