Family Procedural Presence

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Patient and Family Engagement
• Intervention / Treatment: Other: Placebo/Control; Procedure: Families Invited to Be Present at Procedures

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Families Excluded From Presence at Procedures; Families not invited to remain for ICU procedures	Other: Placebo/Control; Family members will not be invited to remain in the ICU room
Active Comparator: Families Invited to Be Present at Procedures; Families invited to remain for ICU procedures	Procedure: Families 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time of ICU procedure to 48 hours afterwards

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Time of ICU procedure to 48 hours afterwards
Procedural Complication Rate	Complications associated with procedures, including infections associated with central lines	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.	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.	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.	3 months after ICU procedure

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: University of Utah
• Investigators: Principal Investigator: Sarah J Beesley, MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2016
• Primary Completion (Actual): March 31, 2019
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: December 26, 2018
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1050086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Completely deidentified data may potentially be available to other researchers upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No