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Researching Efficient Approaches to Delirium Identification-Sustaining Effective Translation

Study acronym: READI-SET-GO
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Jul 2027 to Dec 2027 Completion date: Dec 2027 to May 2028 · Study description revised · Site contacts updated at 1 of 2 sitesv6 Show 3 more changesShow less
    • Completion date: Dec 2027 to May 2028
    • Study description revised
    • Site contacts updated at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Phase: Not specified to Not applicable Interventions: READI-SET GO UB-CAM delirium screening into EHR (Other) · Site contacts updated at 1 of 2 sites · Study description shortened, about 3 wordsv5 Show 3 more changesShow less
    • Interventions: READI-SET GO UB-CAM delirium screening into EHR (Other)
    • Site contacts updated at 1 of 2 sites
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study description revised Site contacts updated at 1 of 2 sitesv4 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study description expanded, about 18 wordsv3 See this version in full on ClinicalTrials.gov ↗
  5. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 2023 to Apr 3, 2024 · Study sites: 0 to 2v2 Show 2 more changesShow less
    • Start date changed from estimate of Nov 2023 to Apr 3, 2024
    • Study sites: 0 to 2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this step-wedge trial is to test the implementation of daily nurse screening for delirium in routine care and its impact on outcomes and complications in hospitalized older adults admitted to 6 general medicine/surgery units at 3 hospitals in Pennsylvania and Massachusetts. The main question\[s\] it aims to answer are: * 1\. To test the fidelity, accuracy, and durability of implementing daily nurse screening for delirium using the UB-CAM in routine care. * 2\. To evaluate the impact of UB-CAM delirium screening on patient and care partner centered outcomes assessed at one month follow-up interviews 3. To evaluate the impact of UB-CAM screening on rates of delirium complications (falls, pressure injury, aspiration) and adverse delirium management (psychoactive medication use, restraint use). Participants (patients) will be assessed for delirium on study days 1, 2 and 3 (or until hospital discharge) and will be asked basic demographics. These patients will be contacted by phone 1 month after enrollment to collect information about inpatient facility use and to administer the Delirium Burden Patient Scale. Participants (care partners) will be interviewed at the patient's discharge to complete the Alzheimer's Disease-8 scale. These care partners will be contacted by phone 1 month after enrollment to complete the Delirium Burden Caregiver Scale and to complete a Qualitative Interview which includes questions about communication and collaboration.
Trial Details
NCT Number NCT05915377
Lead Sponsor Penn State University
Collaborators: Mount Nittany Medical Center, Beth Israel Deaconess Medical Center, Penn State Health Milton S Hershey Medical Center
Conditions Delirium, Delirium in Old Age, Delirium With Dementia, Delirium Superimposed on Dementia
Enrollment 1,050 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov