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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG024824-15 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Claude D. Pepper Older Americans Independence Centers | OTHER |
| National Institute on Aging (NIA) | NIH |
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This is a pilot randomized controlled trial that will test whether a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Decision support systems will be tested that provide targeted alerts and recommendations to the Hospital Elder Life Program and family members for delirium prevention.
Delirium is a distressing and common surgical complication, affecting approximately 20-50% of older surgical patients. Postoperative delirium is associated with increased mortality, cognitive and functional decline, and healthcare resource utilization. Prevention programs have been tested with variable success, but the Hospital Elder Life Program (HELP) has consistently been demonstrated to reduce the incidence and impact of delirium. However, substantial resources are needed for program operations, and complementary support systems may help with patient triage and assessment. Family members and caretakers may be able to provide supplementary support with delirium screening and prevention via targeted, therapeutic activities. Thus, an automated postoperative paging system, which elicits additional, focused support from HELP and family members, may augment delirium prevention activities and reduce associated risk.
The primary objectives of this study are to determine whether pager-based clinical decision support systems bolster HELP- and family-based therapeutic activities. A secondary objective will be to identify facilitators and barriers to delivering therapeutic interventions for both HELP and family members. Overall, this pilot trial will test the hypothesis that a multicomponent decision support system will improve the postoperative environment for neurocognitive and clinical recovery in older, high-risk surgical patients. Patients (n=60) will be randomized to one of four groups in a factorial design: usual care (n=15), HELP-based paging system (n=15), family-based paging system (n=15), or both HELP- and family-based paging system (n=15). The support systems will consist of automated pager alerts to the HELP program and/or family members and caretakers, depending on group allocation, for providing additional delirium evaluation and therapeutic prevention activities. Outcomes will include various clinical, neurocognitive, and functional measures, and performance metrics will be collected regarding HELP- and family-based interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | No Intervention | Usual care per surgical ward standards | |
| HELP Support System | Experimental | This arm will receive the HELP Support System intervention only |
|
| Family Support System | Experimental | This arm will receive the Family Support system intervention only |
|
| Combined Support Systems | Experimental | Participants randomized to this arm will receive both HELP- and family-based support system interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Support System | Behavioral | Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19) | morning postoperative day one through afternoon of postoperative day three |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium Severity | For any patient with a completed delirium assessment, the associated severity score will be recorded using the Confusion Assessment Method Long Form Severity Score (n, 0-19, with higher number indicating more severe delirium) | morning postoperative day one through afternoon of postoperative day three |
| Measure | Description | Time Frame |
|---|---|---|
| HELP - Duration of Time | Cumulative length of time spent with HELP team members | postoperative day one through postoperative day three |
| HELP - Visitation | Proportion of patients successfully visited by the program |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip E Vlisides, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Medical School | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39696755 | Derived | Vlisides PE, Runstadler N, Martinez S, Ragheb JW, Mentz G, Leis A, Schoettinger A, Hickey K, McKinney A, Brooks J, Zierau M, Norcott A, Mody L, Inouye SK, Avidan MS, Min L. Feasibility of Alerting Systems and Family Care Partner Support for Postoperative Delirium Prevention. J Neurosurg Anesthesiol. 2025 Oct 1;37(4):361-370. doi: 10.1097/ANA.0000000000001016. Epub 2024 Dec 19. | |
| 32934794 | Derived | Vlisides PE, Ragheb JW, Leis A, Schoettinger A, Hickey K, McKinney A, Brooks J, Zierau M, Norcott A, Yang S, Avidan MS, Min L. Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial. F1000Res. 2019 Sep 24;8:1683. doi: 10.12688/f1000research.20597.2. eCollection 2019. |
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Withdrawn (n=3); surgery cancelled (n=2), staff availability (n=1)
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Group | Usual care per surgical ward standards |
| FG001 | HELP Support System | This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention. |
| FG002 | Family Support System | This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. |
| FG003 | Combined Support Systems | Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Group | Usual care per surgical ward standards |
| BG001 | HELP Support System | This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delirium | Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (n, 0-19) | Posted | Count of Participants | Participants | morning postoperative day one through afternoon of postoperative day three |
|
Adverse events were monitored for up to 30 days after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Group | Usual care per surgical ward standards | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough, Shortness of Breath, Penile Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Phillip Vlisides | Michigan Medicine | 734-936-4280 | pvliside@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2020 | Nov 27, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2022 | Aug 24, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D060825 | Cognitive Dysfunction |
| D003221 | Confusion |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| HELP Support System | Behavioral | A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention. |
|
| Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D) |
Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-D) (n, 0-21, 0 = normal, 21 = presence of severe depression symptoms) |
| baseline through postoperative day 2 |
| Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A) | Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-A) (n, 0-21, 0 = normal, 21 = presence of severe anxiety symptoms) | baseline through postoperative day 3 |
| Falls | Proportion of patients in each group (%) experiencing at least one fall | morning postoperative day one through afternoon of postoperative day three |
| Length of Hospital Stay | Total number of days (n) spent in the hospital, up to 30 days | morning of surgery until day of hospital discharge, up to 30 days |
| Discharge Disposition | Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days | day of hospital discharge, up to 30 days |
| Delayed Discharge - Cognitive Impairment | Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment | day of hospital discharge, up to 30 days |
| New Non-surgical Site Infection | Incidence (%) of any new non-surgical site infection while hospitalized | morning of surgery until day of hospital discharge, up to 30 days |
| Multidrug Resistant Organism Colonization | Incidence (%) of any new multidrug resistant organism colonization | morning postoperative day one through 30 days after surgery |
| Mortality | Incidence (%) | within 30 days after surgery |
| postoperative day one through postoperative day three |
| HELP - Time to Evaluation | Time until initial HELP evaluation | postoperative day one through postoperative day three |
| Family Intervention - Duration of Time | Cumulative duration of time spent with family members/caretakers at the bedside | postoperative day one through postoperative day three |
| Family Intervention - Proportion of Daily Tasks Completed | The proportion of family-based daily tasks successfully completed will be reported | postoperative day one through postoperative day three |
| Family Intervention - Length of Time, Stimulating Activity | Cumulative length of time spent on prescribed stimulating activities | postoperative day one through postoperative day three |
| Agreement - FAM-CAM and Research-based CAM Assessments | Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments. | postoperative day one through postoperative day three |
| 30-Day FAM-CAM Assessments | Incidence (%) of positive FAM-CAM assessments post-discharge | day after discharge through 30 days postoperatively |
| 36-Item Short Form Survey | Comprehensive survey that reports on overall health, functional status, physical/mental well-being, and pains (score range, for both overall scale and domain subscales: n, 0-100, 0 = worst score and 100 = best score in relation to the general state of health and quality of life) | 30 days after hospital discharge |
| PROMIS Cognitive Abilities (Short Form 4a) | Subjective reporting of cognitive function | 30 days postoperatively |
| Hospital Readmission | Incidence (%) of hospital readmission | within 30 days after discharge |
| ICU Transfer |
|
| COVID hospital closure |
|
| Surgery cancelled |
|
| BG002 | Family Support System | This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. |
| BG003 | Combined Support Systems | Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 |
| Family Support System |
This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. |
| OG003 | Combined Support Systems | Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention. |
|
|
|
| Secondary | Delirium Severity | For any patient with a completed delirium assessment, the associated severity score will be recorded using the Confusion Assessment Method Long Form Severity Score (n, 0-19, with higher number indicating more severe delirium) | Delirium severity data are derived from all available, completed delirium assessments within each group. | Posted | Median | Inter-Quartile Range | score on a scale | morning postoperative day one through afternoon of postoperative day three |
|
|
|
| Secondary | Depressive Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-D) | Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-D) (n, 0-21, 0 = normal, 21 = presence of severe depression symptoms) | Posted | Count of Participants | Participants | baseline through postoperative day 2 |
|
|
|
| Secondary | Anxiety Symptoms as Assessed by Hospitalized Anxiety and Depression Scale (HADS-A) | Incidence (%) of positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-A) (n, 0-21, 0 = normal, 21 = presence of severe anxiety symptoms) | Posted | Count of Participants | Participants | baseline through postoperative day 3 |
|
|
|
| Secondary | Falls | Proportion of patients in each group (%) experiencing at least one fall | Posted | Count of Participants | Participants | morning postoperative day one through afternoon of postoperative day three |
|
|
|
| Secondary | Length of Hospital Stay | Total number of days (n) spent in the hospital, up to 30 days | Posted | Median | Inter-Quartile Range | Days | morning of surgery until day of hospital discharge, up to 30 days |
|
|
|
| Secondary | Discharge Disposition | Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days | Posted | Count of Participants | Participants | day of hospital discharge, up to 30 days |
|
|
|
| Secondary | Delayed Discharge - Cognitive Impairment | Proportion of patients in each group (%) experiencing delayed discharge, with the documented reason as cognitive impairment | Posted | Count of Participants | Participants | day of hospital discharge, up to 30 days |
|
|
|
| Secondary | New Non-surgical Site Infection | Incidence (%) of any new non-surgical site infection while hospitalized | Posted | Count of Participants | Participants | morning of surgery until day of hospital discharge, up to 30 days |
|
|
|
| Secondary | Multidrug Resistant Organism Colonization | Incidence (%) of any new multidrug resistant organism colonization | Posted | Count of Participants | Participants | morning postoperative day one through 30 days after surgery |
|
|
|
| Secondary | Mortality | Incidence (%) | Posted | Count of Participants | Participants | within 30 days after surgery |
|
|
|
| Other Pre-specified | HELP - Duration of Time | Cumulative length of time spent with HELP team members | Not Posted | postoperative day one through postoperative day three | Participants |
| Other Pre-specified | HELP - Visitation | Proportion of patients successfully visited by the program | Not Posted | postoperative day one through postoperative day three | Participants |
| Other Pre-specified | HELP - Time to Evaluation | Time until initial HELP evaluation | Not Posted | postoperative day one through postoperative day three | Participants |
| Other Pre-specified | Family Intervention - Duration of Time | Cumulative duration of time spent with family members/caretakers at the bedside | Not Posted | postoperative day one through postoperative day three | Participants |
| Other Pre-specified | Family Intervention - Proportion of Daily Tasks Completed | The proportion of family-based daily tasks successfully completed will be reported | Not Posted | postoperative day one through postoperative day three | Participants |
| Other Pre-specified | Family Intervention - Length of Time, Stimulating Activity | Cumulative length of time spent on prescribed stimulating activities | Not Posted | postoperative day one through postoperative day three | Participants |
| Other Pre-specified | Agreement - FAM-CAM and Research-based CAM Assessments | Agreement will be assessed, via Cohen's kappa, between FAM-CAM and research-based CAM assessments. | Not Posted | postoperative day one through postoperative day three | Participants |
| Other Pre-specified | 30-Day FAM-CAM Assessments | Incidence (%) of positive FAM-CAM assessments post-discharge | Not Posted | day after discharge through 30 days postoperatively | Participants |
| Other Pre-specified | 36-Item Short Form Survey | Comprehensive survey that reports on overall health, functional status, physical/mental well-being, and pains (score range, for both overall scale and domain subscales: n, 0-100, 0 = worst score and 100 = best score in relation to the general state of health and quality of life) | Not Posted | 30 days after hospital discharge | Participants |
| Other Pre-specified | PROMIS Cognitive Abilities (Short Form 4a) | Subjective reporting of cognitive function | Not Posted | 30 days postoperatively | Participants |
| Other Pre-specified | Hospital Readmission | Incidence (%) of hospital readmission | Not Posted | within 30 days after discharge | Participants |
| 15 |
| 3 |
| 15 |
| 3 |
| 15 |
| EG001 | HELP Support System | This arm will receive the HELP Support System intervention only HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention. | 0 | 12 | 6 | 12 | 2 | 12 |
| EG002 | Family Support System | This arm will receive the Family Support system intervention only Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. | 0 | 14 | 2 | 14 | 3 | 14 |
| EG003 | Combined Support Systems | Participants randomized to this arm will receive both HELP- and family-based support system interventions Family Support System: Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members. HELP Support System: A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention. | 0 | 16 | 1 | 16 | 3 | 16 |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Bowel Injury | Surgical and medical procedures | Systematic Assessment |
|
| C. Difficile | Infections and infestations | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Difficulty Swallowing | General disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Unresponsive | General disorders | Systematic Assessment |
|
| Wound dehiscence | Surgical and medical procedures | Systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Mental Status Change | Psychiatric disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Concern for healthcare associated pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Left-sided facial droop | General disorders | Systematic Assessment |
|
| Cellulitis of left lower leg | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Back discomfort | General disorders | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |