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Family Procedural Presence

Stress and Engagement Surrounding ICU Procedures Among Patients, Families and Clinicians

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03808350
Enrollment
120
Registered
2019-01-17
Start date
2016-09-14
Completion date
2024-09-30
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient and Family Engagement

Brief 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 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.

Interventions

PROCEDUREFamilies Invited to Be Present at Procedures

Family members will be invited (but not required) to remain in the ICU room during procedures, if patients agree

Family members will not be invited to remain in the ICU room

Sponsors

University of Utah
CollaboratorOTHER
Intermountain Health Care, Inc.
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Family members and patients will be told the study is being done to understand engagement, but will not be told about the main intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Patient & Family Member EngagementTime of ICU procedure to 48 hours afterwardsEngagement, as measured by the collaboRATE survey, administered to patients & family members within 48 hours after a procedure in the ICU

Secondary

MeasureTime frameDescription
Clinician StressTime of ICU procedure to 48 hours afterwardsClinician 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.
Procedural Complication RateThrough 7 days after the ICU procedureComplications associated with procedures, including infections associated with central lines
Patient & Family Member StressTime of ICU procedure to 48 hours afterwardsPerceived 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.
Patient & Family Member Anxiety & Depression3 months after ICU procedureAnxiety 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.
Patient & Family Member PTSD3 months after ICU procedurePTSD 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.
Trainee Satisfaction with Procedure EducationTime of ICU procedure to 24 hours afterwardsSatisfaction 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026