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Written Communication in the Intensive Care Unit (WRITE)

Primary Purpose

Communication, Satisfaction, Patient, Burnout

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Communication
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Communication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Written Communication

Arm Description

ICU care providers will initiate the process for providing written communication to families. Study investigators will facilitate the creation and distribution of written communication

Outcomes

Primary Outcome Measures

Family Inpatient Communication Survey (FICS)
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.
Family Inpatient Communication Survey (FICS)
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.
Nurse-Physician Collaboration Scale (NPCS)
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.
Nurse-Physician Collaboration Scale (NPCS)
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.
Maslach Burnout Inventory (MBI)
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."
Maslach Burnout Inventory (MBI)
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."

Secondary Outcome Measures

The Acceptability, Appropriateness and Feasibility of Intervention Survey (AIM, IAM and FIM)
Care providers will complete this 12-item psychometric assessment. Implementation science researchers have established the benchmarks and acceptance of this scale.
The Post Study System Usability Questionnaire (PSSUQ)
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.
The User Experience Questionnaire (UEQ)
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.

Full Information

First Posted
October 31, 2022
Last Updated
August 29, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05636371
Brief Title
Written Communication in the Intensive Care Unit
Acronym
WRITE
Official Title
Impact of WRitten Communication on the ICU Team Experience
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 Is ICU care-provider initiated written communication feasible and acceptable to participants? 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communication, Satisfaction, Patient, Burnout

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Written Communication
Arm Type
Experimental
Arm Description
ICU care providers will initiate the process for providing written communication to families. Study investigators will facilitate the creation and distribution of written communication
Intervention Type
Other
Intervention Name(s)
Written Communication
Intervention Description
Written patient care updates provided to families of ICU patients each day
Primary Outcome Measure Information:
Title
Family Inpatient Communication Survey (FICS)
Description
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.
Time Frame
5 days after ICU admission
Title
Family Inpatient Communication Survey (FICS)
Description
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.
Time Frame
10 days after ICU admission
Title
Nurse-Physician Collaboration Scale (NPCS)
Description
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.
Time Frame
3 months before the intervention
Title
Nurse-Physician Collaboration Scale (NPCS)
Description
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.
Time Frame
3 months after the intervention
Title
Maslach Burnout Inventory (MBI)
Description
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."
Time Frame
3 months before the intervention
Title
Maslach Burnout Inventory (MBI)
Description
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."
Time Frame
3 months after the intervention
Secondary Outcome Measure Information:
Title
The Acceptability, Appropriateness and Feasibility of Intervention Survey (AIM, IAM and FIM)
Description
Care providers will complete this 12-item psychometric assessment. Implementation science researchers have established the benchmarks and acceptance of this scale.
Time Frame
3 months after the intervention
Title
The Post Study System Usability Questionnaire (PSSUQ)
Description
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.
Time Frame
3 months after the intervention
Title
The User Experience Questionnaire (UEQ)
Description
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.
Time Frame
3 months after the intervention
Other Pre-specified Outcome Measures:
Title
Qualitative analysis
Description
Semi-structured interviews with participants will be coded and examined using thematic content analysis.
Time Frame
3 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35607975
Citation
Greenberg JA, Basapur S, Quinn TV, Bulger JL, Schwartz NH, Oh SK, Ritz EM, Glover CM, Shah RC. Daily Written Care Summaries for Families of Critically Ill Patients: A Randomized Controlled Trial. Crit Care Med. 2022 Sep 1;50(9):1296-1305. doi: 10.1097/CCM.0000000000005583. Epub 2022 May 23.
Results Reference
background
PubMed Identifier
25898880
Citation
Grant M. Resolving communication challenges in the intensive care unit. AACN Adv Crit Care. 2015 Apr-Jun;26(2):123-30. doi: 10.1097/NCI.0000000000000076.
Results Reference
background
PubMed Identifier
32204724
Citation
Kerlin MP, McPeake J, Mikkelsen ME. Burnout and Joy in the Profession of Critical Care Medicine. Crit Care. 2020 Mar 24;24(1):98. doi: 10.1186/s13054-020-2784-z.
Results Reference
background
PubMed Identifier
29365301
Citation
Wright AA, Katz IT. Beyond Burnout - Redesigning Care to Restore Meaning and Sanity for Physicians. N Engl J Med. 2018 Jan 25;378(4):309-311. doi: 10.1056/NEJMp1716845. No abstract available.
Results Reference
background

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Written Communication in the Intensive Care Unit

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