Clinical trial NCT03808350: Family Procedural Presence
Official title: Stress and Engagement Surrounding ICU Procedures Among Patients, Families and Clinicians
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient and Family Engagement
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2019-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient & Family Member Engagement
timeFrame: Time of ICU procedure to 48 hours afterwards
Secondary outcomes:
measure: Patient & Family Member Stress
timeFrame: Time of ICU procedure to 48 hours afterwards
measure: Clinician Stress
timeFrame: Time of ICU procedure to 48 hours afterwards
measure: Procedural Complication Rate
timeFrame: Through 7 days after the ICU procedure
measure: Trainee Satisfaction with Procedure Education
timeFrame: Time of ICU procedure to 24 hours afterwards
measure: Patient & Family Member Anxiety & Depression
timeFrame: 3 months after ICU procedure
measure: Patient & Family Member PTSD
timeFrame: 3 months after ICU procedure
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Sarah J Beesley, MD
role: PRINCIPAL_INVESTIGATOR
References: