NCT06969196

Brief Summary

Our research group has developed an approach for providing families of ICU patients with daily written summaries of care as a supplement to traditional verbal communication. Written summaries describe the patient's main ICU problems and management plan and are delivered to families each day. Despite the benefits of written communication to both the family and clinician experience, the main barrier to implementing this communication approach is the time required for clinicians to create a written summary. For the proposed pilot study, the investgators will ask ICU clinicians to identify patients and respective families for whom there has been a challenge with communication. The investigators will ask ICU clinicians to edit AI-generated written summaries for content and clarity before they are delivered to families. The investigators hypothesize that this process will acceptable and feasible for ICU clinicians and families.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

April 18, 2025

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Communication Quality (Clinicians)

    Clinician participants will ratings of quality of AI-generated written summaries and whether written summaries address family-specific communication challenges (5-point Likert scale, 1-5 points with higher scores indicating better quality)

    Through study completion, an average of one week

  • Communication Quality (Families/Surrogates)

    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 (30-150 points with higher scores indicating better quality communication)

    Average one week after enrollment

  • Acceptability of intervention

    Acceptability of the intervention will reflected in adequate enrollment and an average score of at least 3.5 on surveys with 5-point Likert scale measures including the Acceptability of Intervention (AIM), Appropriateness of Intervention (IAM), and Feasibility of Intervention Survey (FIM) (1-5 point with higher scores being better)

    Average one week after enrollment

  • Feasibility of intervention

    Feasibility will be determined by written communication being created for at least 80% of all ICU days and less than 5 minutes on average being spent editing each AI-generated summary.

    Through study completion, an average of one week

Other Outcomes (1)

  • Analysis of Individual Interviews

    Average one week after enrollment

Study Arms (1)

Written Communication

EXPERIMENTAL

AI-edited, ICU clinician edited written communication

Other: Written Communicatoin

Interventions

ICU clinicians will be asked to edit AI-generated written summaries for content and clarity before they are delivered to families

Written Communication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Surrogate Inclusion * One self-identified adult decision maker for an adult medical ICU patient cared for on the 10W ICU * Member of the primary ICU team believes the respective patient will require at least three additional days of ICU care * Member of the primary ICU team has identified at least one communication challenge with the patient's surrogate(s) including but not limited to: 1. Complex medical issues requiring frequent updates to families 2. Complex family dynamics (i.e., multiple involved family members) 3. Increased anxiety/stress of surrogate(s) 4. Difficult to provide updates to family members because they do not visit ICU regularly or are hard to reach by phone Surrogate Exclusion * Surrogate cannot read or understand English * Surrogate is unwilling or unable to participate in study procedures * Patient is decisional and refuses to allow surrogate participation Clinician Inclusion • Advanced practice provider (APP) on the medical ICU team on the 10W ICU Clinician Exclusion • None

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • Lee JJ, Mathur S, Gerhart J, Glover CM, Ritz E, Basapur S, Greenberg JA. Written communication and the ICU team experience (WRITE): A pre-post intervention study. Intensive Crit Care Nurs. 2024 Oct;84:103753. doi: 10.1016/j.iccn.2024.103753. Epub 2024 Jun 25.

    PMID: 38924848BACKGROUND
  • 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.

    PMID: 35607975BACKGROUND
  • Bulger JL, Quinn TV, Glover CM, Basapur S, Shah RC, Greenberg JA. Written Care Summaries Facilitate Communication Between Families and Providers of ICU Patients: A Pilot Study. Crit Care Explor. 2021 Jul 13;3(7):e0473. doi: 10.1097/CCE.0000000000000473. eCollection 2021 Jul.

    PMID: 34278309BACKGROUND

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2025

First Posted

May 13, 2025

Study Start

July 7, 2025

Primary Completion

September 20, 2025

Study Completion

October 20, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations