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| ID | Type | Description | Link |
|---|---|---|---|
| A539714 | Other Identifier | UW Madison | |
| Protocol Version 4/20/2025 | Other Identifier | UW Madison | |
| SMPH/SURGERY/TRAUMA | Other Identifier | UW Madison | |
| 1R01AG076489-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DANE Recovery Model | Experimental | The delivery of the model will occur in five phases that correspond to the known stages of recovery after surgery. During the acute stage (0 - 1 month after surgery), participants will undergo the initial case review and two initial virtual visits, and the development of the recovery care plan. During the recovery (2 - 6 months after surgery) and maintenance (7-12 months after surgery) stages, the participants will undergo the interaction phase of the DANE Recovery Model. |
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| Usual Care | Other | Participants will receive the usual rehabilitation and post-operative care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DANE Recovery Program | Other | Virtual visits with care coordinator to carry out an individualized recovery plan |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 6 months, 12 months, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 months, 12 months, and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Zarzaur, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SwedishAmerican Hospital | Rockford | Illinois | 61104 | United States | ||
| Indiana University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39609928 | Derived | Gardner L, Bylund P, Robbins S, Holler E, Shojaei F, Shojaei F, Seidman M, Holden RJ, Fowler NR, Zarzaur B, Barboi C, Boustani M. Agile monitoring dashboard for clinical research studies. Trials. 2024 Nov 29;25(1):802. doi: 10.1186/s13063-024-08646-0. | |
| 37789461 | Derived | Mohanty S, Holler E, Ortiz D, Meagher A, Perkins A, Bylund P, Khan B, Unverzagt F, Xu H, Ingraham A, Boustani M, Zarzaur B. Delirium and neuropsychological recovery among emergency general surgery survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention. Trials. 2023 Oct 3;24(1):634. doi: 10.1186/s13063-023-07670-w. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 14, 2025 | Jul 2, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Questionnaires | Other | Physical, cognitive, and psychological assessments |
|
| 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). | 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. | 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. | Baseline, 6 months, 12 months, and 18 months |
| Indianapolis |
| Indiana |
| 47405 |
| United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Meriter Hospital | Madison | Wisconsin | 53715 | United States |
| East Madison Hospital | Madison | Wisconsin | 53718 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 37720054 | Derived | Mohanty S, Holler E, Ortiz D, Meagher A, Perkins A, Bylund P, Khan B, Unverzagt F, Xu H, Ingraham A, Boustani M, Zarzaur B. Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention. Res Sq [Preprint]. 2023 Sep 7:rs.3.rs-3185716. doi: 10.21203/rs.3.rs-3185716/v1. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |