Family Procedural Presence

Patient and Family Engagement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03808350
• Other study ID #: 1050086
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2016
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2022
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient and Family Engagement

Intervention

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

Other:
• Placebo/Control
Family members will not be invited to remain in the ICU room

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Procedural Complication Rate	Complications associated with procedures, including infections associated with central lines	Through 7 days after the ICU procedure
Secondary	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
Secondary	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
Secondary	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