Family Procedural Presence

NCT ID: NCT03808350

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-14

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Patient and Family Engagement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Family members and patients will be told the study is being done to understand engagement, but will not be told about the main intervention

Study Groups

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Families Excluded From Presence at Procedures

Families not invited to remain for ICU procedures

Group Type PLACEBO_COMPARATOR

Placebo/Control

Intervention Type OTHER

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

Families Invited to Be Present at Procedures

Families invited to remain for ICU procedures

Group Type ACTIVE_COMPARATOR

Families Invited to Be Present at Procedures

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Placebo/Control

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Sarah Beesley

Pulmonologist - Shock Trauma ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah J Beesley, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

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Intermountain Medical Center

Murray, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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1050086

Identifier Type: -

Identifier Source: org_study_id

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