This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older UES delirium survivors will be improved through the use of the DANE Recovery Model. Participants can expect to be on the study for 18 months.
This is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the DANE Recovery Model to improve the cognitive, physical and psychological recovery of older UES delirium survivors. At or near the time of discharge, enrolled participants will be randomized to receive the DANE Recovery Model or usual care. The hypothesis is that, after 18 months, older UES delirium survivors who are randomized to the DANE Recovery Model will experience more favorable cognitive, physical and psychological recovery in comparison to those randomized to usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
528
Virtual visits with care coordinator to carry out an individualized recovery plan
Physical, cognitive, and psychological assessments
SwedishAmerican Hospital
Rockford, Illinois, United States
NOT_YET_RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGUniversity of Wisconsin
Madison, Wisconsin, United States
Change in overall cognitive recovery
Change in score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive screening assessment. The measure consists of 12 subtests that contribute to a total score and Index scores across five domains: Immediate Memory, Visuospatial-Constructional, Language, Attention, and Delayed Memory. Index scores are converted to age-based standard scores (Mean = 100, Standard Deviation = 15)
Time frame: Baseline, 6 months, 12 months, and 18 months
Short Physical Performance Battery (SPPB)
Change in overall physical recovery will be assessed using Short Physical Performance Battery (SPPB). SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests, and yields a performance score of 0-12; 0-4 poor, 5-7 intermediate, 8-12 good.
Time frame: Baseline, 6 months, 12 months, and 18 months
Change in overall physical recovery
Change in overall physical recovery will be assessed using 36-Item Short Form Survey (SF-36). SF-36 scale has eight components (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health).
Time frame: Baseline, 6 months, 12 months, and 18 months
Patient Health Questionnaire-9 (PHQ-9)
Change in overall psychological recovery will be assessed using Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a nine-item depression scale with a total score from 0 to 27, with higher scores indicating greater depression.
Time frame: Baseline, 6 months, 12 months, and 18 months
General Anxiety Disorder-7 (GAD-7) .
Change in overall psychological recovery will be assessed using General Anxiety Disorder-7 (GAD-7) to determine the impact of the intervention on participant's mood and anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 27, with higher scores indicating greater anxiety.
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Meriter Hospital
Madison, Wisconsin, United States
RECRUITINGEast Madison Hospital
Madison, Wisconsin, United States
RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGTime frame: Baseline, 6 months, 12 months, and 18 months