Family Procedural Presence

Not Applicable

Active, not recruiting

• Conditions: Patient and Family Engagement
• Interventions: Other: Placebo/Control; Procedure: Families Invited to Be Present at Procedures

• Registration Number: NCT03808350
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Study Timeline

• Study Start: 2016-09-14
• Study First Submitted: 2018-12-26
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-17
• Primary Completion: 2019-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-13
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Families Excluded From Presence at Procedures	Placebo/Control	Families not invited to remain for ICU procedures
Families Invited to Be Present at Procedures	Families Invited to Be Present at Procedures	Families invited to remain for ICU procedures

Primary Outcome Measures

Name	Time	Method
Patient & Family Member Engagement	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

Secondary Outcome Measures

Name	Time	Method
Trainee Satisfaction with Procedure Education	Time of ICU procedure to 24 hours afterwards	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.
Procedural Complication Rate	Through 7 days after the ICU procedure	Complications associated with procedures, including infections associated with central lines
Patient & Family Member Anxiety & Depression	3 months after ICU procedure	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.
Patient & Family Member PTSD	3 months after ICU procedure	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.
Patient & Family Member Stress	Time of ICU procedure to 48 hours afterwards	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.
Clinician Stress	Time of ICU procedure to 48 hours afterwards	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.

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States