- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636371
Written Communication in the Intensive Care Unit (WRITE)
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
- 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jared A Greenberg, MD, MSc
- Phone Number: 312-942-6744
- Email: jared_greenberg@rush.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22092704-IRB01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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