Written Communication in the Intensive Care Unit (WRITE)

August 29, 2023 updated by: Rush University Medical Center

Impact of WRitten Communication on the ICU Team Experience

The goal of this study is to compare the experience of intensive care unit (ICU) families and care providers before and after the implementation of an approach whereby clinicians initiate written communication with families

The main questions it aims to answer are

  1. Is ICU care-provider initiated written communication feasible and acceptable to participants?
  2. Does ICU care-provider initiated written communication affect the experience of families and care providers?

Participants will complete surveys and participate in interviews during a 3 month pre-implementation phase and a 3 month post-implementation phase

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria (family members or surrogates)

• Self-identify as one of the patient's decision makers

Exclusion criteria (family members or surrogates)

  • Cannot read or understand English
  • Unwilling to participate in study procedures

Inclusion criteria for care providers (physicians, physician assistants, and nurses)

• Work during the day shift

Exclusion criteria for care providers (physicians, physician assistants, and nurses)

• None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Written Communication
ICU care providers will initiate the process for providing written communication to families. Study investigators will facilitate the creation and distribution of written communication
Written patient care updates provided to families of ICU patients each day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Inpatient Communication Survey (FICS)
Time Frame: 5 days after ICU admission
The Family Inpatient Communication Survey (FICS) is a 30-item survey measuring of the quality of communication with the treatment team from the perspective of families of hospitalized patients. Items on this survey measure the informational and emotional aspects of communication, and each item of this survey is rated on a 5-point Likert scale from strongly agree to strongly disagree. The FICS has been validated in a study of 350 surrogates of hospitalized adults demonstrating the high internal reliability, predictive validity, and high item completion rates of this survey.
5 days after ICU admission
Family Inpatient Communication Survey (FICS)
Time Frame: 10 days after ICU admission
The Family Inpatient Communication Survey (FICS) is a 30-item survey measuring of the quality of communication with the treatment team from the perspective of families of hospitalized patients. Items on this survey measure the informational and emotional aspects of communication, and each item of this survey is rated on a 5-point Likert scale from strongly agree to strongly disagree. The FICS has been validated in a study of 350 surrogates of hospitalized adults demonstrating the high internal reliability, predictive validity, and high item completion rates of this survey.
10 days after ICU admission
Nurse-Physician Collaboration Scale (NPCS)
Time Frame: 3 months before the intervention
The Nurse-Physician Collaboration Scale (NPCS) is a 27-item survey measuring the level of collaboration between nurses and physicians based on three categories: joint participation in the decision-making process, the sharing of patient information, and cooperativeness.Items on this survey are rated on a 5-point scale with responses ranging from always to never. The NPCS has been validated in a study of 446 physicians and 1217 nurses at 27 hospitals.
3 months before the intervention
Nurse-Physician Collaboration Scale (NPCS)
Time Frame: 3 months after the intervention
The Nurse-Physician Collaboration Scale (NPCS) is a 27-item survey measuring the level of collaboration between nurses and physicians based on three categories: joint participation in the decision-making process, the sharing of patient information, and cooperativeness.Items on this survey are rated on a 5-point scale with responses ranging from always to never. The NPCS has been validated in a study of 446 physicians and 1217 nurses at 27 hospitals.
3 months after the intervention
Maslach Burnout Inventory (MBI)
Time Frame: 3 months before the intervention
The Maslach Burnout Inventory (MBI) is a 22-item survey measuring symptoms of burnout. The MBI has been validated for a variety of professions. The MBI has been used in past studies in the ICU to evaluate the level of burnout present among critical care clinicians and to assess for the effectiveness of interventions attempting to alleviate the degree of burnout syndrome. This survey examines the participant's perception of their work, physical and emotional exhaustion, sense of personal accomplishment, and degree of depersonalization. Items are presented as single statements, such as "I feel worn out at the end of a working day," and are rated on a scale of 0 to 6 with 0 being "never" and 6 being "every day."
3 months before the intervention
Maslach Burnout Inventory (MBI)
Time Frame: 3 months after the intervention
The Maslach Burnout Inventory (MBI) is a 22-item survey measuring symptoms of burnout. The MBI has been validated for a variety of professions. The MBI has been used in past studies in the ICU to evaluate the level of burnout present among critical care clinicians and to assess for the effectiveness of interventions attempting to alleviate the degree of burnout syndrome. This survey examines the participant's perception of their work, physical and emotional exhaustion, sense of personal accomplishment, and degree of depersonalization. Items are presented as single statements, such as "I feel worn out at the end of a working day," and are rated on a scale of 0 to 6 with 0 being "never" and 6 being "every day."
3 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Acceptability, Appropriateness and Feasibility of Intervention Survey (AIM, IAM and FIM)
Time Frame: 3 months after the intervention
Care providers will complete this 12-item psychometric assessment. Implementation science researchers have established the benchmarks and acceptance of this scale.
3 months after the intervention
The Post Study System Usability Questionnaire (PSSUQ)
Time Frame: 3 months after the intervention
The Post Study System Usability Questionnaire (PSSUQ) is a 16-item PSSUQ survey that measures the acceptance of new technology. PSSUQ measures perception of information quality, interface quality, and overall intervention usefulness. Lewis et al have published on the high internal validity and sensitivity of this scale since 1992.
3 months after the intervention
The User Experience Questionnaire (UEQ)
Time Frame: 3 months after the intervention
The User Experience Questionnaire (UEQ) is a 8-item scale to measure the overall user experience of the family member(s) who used the communication intervention. The UEQ measures user experience on items including attractiveness, perspicuity, efficiency, dependability, stimulation, and novelty. UEQ has high internal validity and has been benchmarked across numerous usability and user experience evaluation studies.
3 months after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative analysis
Time Frame: 3 months after the intervention
Semi-structured interviews with participants will be coded and examined using thematic content analysis.
3 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

May 19, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22092704-IRB01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burnout

Clinical Trials on Written Communication

3
Subscribe