CommunicationWRITENCT05636371
Written Communication in the Intensive Care Unit
A study testing Written Communication in people with Communication and Satisfaction, Patient, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Satisfaction, Patient, Burnout
- What is being tested?
- Written Communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as one of the patient's decision makers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: 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
- Conditions
- Communication, Satisfaction, Patient, Burnout
- Being tested
- Written Communication
- Medical subject headings
- Communication, Patient Satisfaction, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written CommunicationOther
Written patient care updates provided to families of ICU patients each day
| Study group | Role | What they receive |
|---|---|---|
| Written Communication | Experimental | ICU care providers will initiate the process for providing written communication to families. Study investigators will facilitate the creation and distribution of written communication Receives: Other: Written Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days after ICU admission
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.
Measured: 10 days after ICU admission
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.
Measured: 3 months before the intervention
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.
Measured: 3 months after the intervention
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."
Measured: 3 months before the intervention
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."
Measured: 3 months after the intervention
Secondary outcomes (3)
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.
Measured: 3 months after the intervention
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.
Measured: 3 months after the intervention
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.
Measured: 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Nov 2022
- Primary completion19 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636371
- Sponsor's protocol ID
- 22092704-IRB01
- Acronym
- WRITE
- Status last verified
- Aug 2023
- First submitted
- 31 Oct 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 35607975Grant 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 25898880Kerlin 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 32204724Wright 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of WRitten Communication on the ICU Team Experience
- ClinicalTrials.gov ID
- NCT05636371
- Acronym / sponsor ID
- WRITE / 22092704-IRB01
- Conditions
- Communication, Satisfaction, Patient, Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Written Communication | Experimental | Other: Written CommunicationICU care providers will initiate the process for providing written communication to families. Study investigators will facilitate the creation and distribution of written communication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-identify as one of the patient's decision makers
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written CommunicationWritten patient care updates provided to families of ICU patients each day | Other | Written Communication |
Primary outcome
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.
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.
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.
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.
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."
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 secondary outcomes
The Acceptability, Appropriateness and Feasibility of Intervention Survey (AIM, IAM and FIM)
Time frame: 3 months after the intervention
The Post Study System Usability Questionnaire (PSSUQ)
Time frame: 3 months after the intervention
The User Experience Questionnaire (UEQ)
Time frame: 3 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 35607975Greenberg 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.
- Background: PubMed 25898880Grant 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.
- Background: PubMed 32204724Kerlin 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.
- Background: PubMed 29365301Wright 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Communication in people with Communication and Satisfaction, Patient, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Inpatient Communication Survey (FICS) (time frame: 5 days after ICU admission). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05636371, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.