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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05636371
Other study ID # 22092704-IRB01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date July 1, 2023

Study information

Verified date August 2023
Source Rush University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date July 1, 2023
Est. primary completion date May 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Qualitative analysis Semi-structured interviews with participants will be coded and examined using thematic content analysis. 3 months after the intervention
Primary 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. 5 days after ICU admission
Primary 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. 10 days after ICU admission
Primary 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. 3 months before the intervention
Primary 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. 3 months after the intervention
Primary 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." 3 months before the intervention
Primary 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." 3 months after the intervention
Secondary 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. 3 months after the intervention
Secondary 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. 3 months after the intervention
Secondary 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. 3 months after the intervention
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