Family Procedural Presence

NCT03808350 | Unknown

• 1 other identifier: 1050086
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient and Family Engagement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient & Family Member Stress

  Time of ICU procedure to 48 hours afterwards

• Clinician Stress

  Time of ICU procedure to 48 hours afterwards

• Procedural Complication Rate

  Through 7 days after the ICU procedure

• Trainee Satisfaction with Procedure Education

  Time of ICU procedure to 24 hours afterwards

• Patient & Family Member Anxiety & Depression

  3 months after ICU procedure

Study Arms (2)

Families Excluded From Presence at Procedures

PLACEBO COMPARATOR

Families not invited to remain for ICU procedures

Other: Placebo/Control

Families Invited to Be Present at Procedures

ACTIVE COMPARATOR

Families invited to remain for ICU procedures

Procedure: Families Invited to Be Present at Procedures

Interventions

Families Invited to Be Present at Procedures PROCEDURE

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

Families Invited to Be Present at Procedures

Placebo/Control OTHER

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

Families Excluded From Presence at Procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• University of Utah: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Study Officials

• Sarah J Beesley, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Family members and patients will be told the study is being done to understand engagement, but will not be told about the main intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist - Shock Trauma ICU

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: January 17, 2019
• Study Start: September 14, 2016
• Primary Completion: March 31, 2019
• Study Completion: September 30, 2024
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

US (1)