ClinicalTrials.gg
CompletedNCT05636371WRITEUpdated Aug 31, 2023

Written Communication in the Intensive Care Unit

An interventional study of Written Communication in Communication, Satisfaction, Patient and Burnout, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-31.

Sponsored by Rush University Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

  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

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Conditions studied

  • Communication
  • Satisfaction, Patient
  • Burnout
03

In context

Communication

198 studies on the registry are indexed under Communication; 85 are open to participants now.

This study's enrollment of 166 is close to the median of 161 across 170 interventional studies indexed under Communication.

Browse Communication studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 26 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
166 participants (actual)

Study arms

  • 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

    Other: Written Communication

Interventions

  • OtherWritten Communication

    Written patient care updates provided to families of ICU patients each day

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 days after ICU admission

  2. 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.

    Time frame: 10 days after ICU admission

  3. 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.

    Time frame: 3 months before the intervention

  4. 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.

    Time frame: 3 months after the intervention

  5. 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."

    Time frame: 3 months before the intervention

  6. 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."

    Time frame: 3 months after the intervention

Secondary outcomes

  1. 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.

    Time frame: 3 months after the intervention

  2. 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.

    Time frame: 3 months after the intervention

  3. 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.

    Time frame: 3 months after the intervention

Other outcomes

  1. Qualitative analysis

    Semi-structured interviews with participants will be coded and examined using thematic content analysis.

    Time frame: 3 months after the intervention

07

Study locations

1 site
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
08

References and documents

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. PubMed 35607975 ↗
  • 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. PubMed 25898880 ↗
  • 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. PubMed 32204724 ↗
  • 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. PubMed 29365301 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05636371
Responsible party
Sponsor
First posted
Dec 5, 2022
Start date
Nov 1, 2022
Primary completion
May 19, 2023
Completion
Jul 1, 2023
Last update
Aug 31, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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