Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23HL153310-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
The purpose of this study is to test a multi-faceted anemia treatment plan to reduce the severity of anemia and to promote hemoglobin and functional recovery in adults who have been in the intensive care unit (ICU).
Anemia is common during critical illness and is associated with impaired outcomes during and after hospitalization. The goal of this investigation is to test a multi-faceted anemia prevention and targeted treatment bundle to attenuate anemia development and promote functional recovery in the setting of critical illness. Specifically, this will be a pragmatic phase II clinical trial of a multi-faceted anemia prevention and treatment bundle with 3 aspects (optimized phlebotomy practice, clinical decision support, targeted pharmacologic anemia treatment) assessing the impact of the intervention on hemoglobin concentrations (primary aim), transfusion utilization, and functional outcomes through 3 months after hospitalization.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Standard of Care) Group | No Intervention | Subjects will receive standard clinical care for the treatment of anemia while in the ICU. | |
| Anemia Treatment Bundle | Experimental | The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Dextran | Drug | 1000 mg IV |
| |
| Erythropoietin (EPO) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Concentrations | Hemoglobin is a protein that cares oxygen through the body | 1 month post-hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Concentrations | Hemoglobin is a protein that cares oxygen through the body | Hospital discharge (approximately 1 month), 3 months post-hospitalization |
| Phlebotomy Practice-Blood Draws |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Warner, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40152861 | Derived | Warner MA, Johnson ML, Hanson AC, Fortune E, Flaby GW, Schulte PJ, Hazelton VM, Go RS, Beam WB, Charnin JE, Anderson BK, Karon B, Cheville AL, Gajic O, Kor DJ. Practical Anemia Bundle and Hemoglobin Recovery in Critical Illness: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e252353. doi: 10.1001/jamanetworkopen.2025.2353. | |
| 36460332 | Derived | Warner MA, Go RS, Schulte PJ, Beam WB, Charnin JE, Meade L, Droege KA, Anderson BK, Johnson ML, Karon B, Cheville A, Gajic O, Kor DJ. Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) in critical illness: a protocol for a randomised controlled trial. BMJ Open. 2022 Dec 2;12(12):e064017. doi: 10.1136/bmjopen-2022-064017. |
Not provided
Not provided
Study data will be shared through the NHLBI Data Repository, which is managed by thenBiologic Specimen and Data Repository Information Coordinating Center (BioLINCC). In addition to study data (e.g. information recorded for each study participant including demographics, clinical characteristics, laboratory assessments, and outcomes / follow-up assessments), study documentation information will also be provided in order to facilitate secondary use of data by investigators not familiar with the original data set. This includes a summary documentation file, manuals of procedures, detailed statistical code, and data dictionary information, among other important documentation. The timing and manner of research data uploading to the Data Repository will be in full compliance with NHLBI guidelines.
Not provided
We commit to providing data immediately upon acceptance of the data for scientific publication or within one year of completion of the award period (whichever comes first).
All published scientific manuscripts will contain information regarding how to request and access study data.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control (Standard of Care) Group | Subjects received standard clinical care for the treatment of anemia while in the ICU. |
| FG001 | Anemia Treatment Bundle | The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease). Iron Dextran: 1000 mg IV Erythropoietin (EPO): 40,000 units subcutaneous |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control (Standard of Care) Group | Subjects received standard clinical care for the treatment of anemia while in the ICU. |
| BG001 | Anemia Treatment Bundle | The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease). Iron Dextran: 1000 mg IV Erythropoietin (EPO): 40,000 units subcutaneous |
| 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 | Hemoglobin Concentrations | Hemoglobin is a protein that cares oxygen through the body | Data was not collected nor analyzed for four subjects in the Control (Standard of Care) Group and eight subjects in the Anemia Treatment Bundle arm | Posted | Median | Inter-Quartile Range | g/dL | 1 month post-hospitalization |
|
Adverse events were collected from baseline through approximately 3-months after hospitalization.
Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (Standard of Care) Group | Subjects received standard clinical care for the treatment of anemia while in the ICU. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloodstream Infection | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venous thromboembolism | Vascular disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Warner, M.D. | Mayo Clinic | 507-422-1714 | Warner.Matthew@mayo.edu |
Not provided
| 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 | Oct 11, 2022 | Feb 4, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2023 | Oct 14, 2024 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| D004921 | Erythropoietin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
40,000 units subcutaneous |
|
|
Number of times subjects have blood drawn
| Hospital discharge (approximately 1 month) |
| Phlebotomy Practice-Volume | Total volume of phlebotomy blood draws | Hospital discharge (approximately 1 month) |
| Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | The EuroQol (EQ-5D) is a 5-item questionnaire that assess health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total score ranges from 0 to 100, with higher scores indicating improved health. | Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization |
| Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale is a 13-item questionnaire used to measure the severity of fatigue and its impact on daily activities. Each question is rated on a 4-point scale where 0 represents "very much" fatigued and 4 represents "not at all" fatigued. Total scores range from 0 to 52 with lower scores indicating greater fatigue. | Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization |
| 6 Minute Walk Distance | Distance walked in 6 minutes used to assess physical function after critical illness. | 1 and 3-months post-hospitalization |
| Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) | The Montreal Cognitive Assessment (MoCA-BLIND) score assesses cognitive impairment by a 30-item questionnaire that includes tests of orientation, attention, memory, language and visual-spatial skills. Possible scores range from 0 to 30, with higher scores indicating higher cognitive function. A final total score of 26 and above is considered normal. | 1 and 3-months post-hospitalization |
| Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) assesses a patient's anxiety and depression levels. Subject's answer 14 questions (7 for anxiety and 7 for depression). Each question is scored from 0-3. Total scores can range from 0 to 21 for either anxiety or depression, with higher scores indicating a presence of anxiety or depression. | 1 and 3-months post-hospitalization |
| Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) | The Impact of Events Scale-Revised (IES-R) is a self-reported questionnaire that measures the distress caused by traumatic events. Subjects respond to 22 questions using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total scores range from 0 to 88, with a higher score indicting the likely presence of post-traumatic stress disorder (PTSD). | 1 and 3-months post-hospitalization |
| Number of Participants With Allogeneic Red Blood Cell Transfusions | Number (percentage) of patients transfused with allogeneic red blood cells | 3-months post-hospitalization |
| Number of Transfused Units of Allogeneic Red Blood Cells | Number of transfused units from hospital discharge through 3-months post-hospitalization | 3 months post hospitalization |
| Unplanned Hospital Readmissions | Number of subjects to experience an unplanned hospital readmission | 3 months and 12-months post-hospitalization |
| Mortality | Mortality from any cause | 3 months and 12-months post-hospitalization |
| Adverse Events Post-enrollment | Venous thromboembolism, bloodstream infection, myocardial infarction, stroke | Hospital discharge (approximately 1 month), 3-months post-hospitalization |
| Accelerometry-measured Number of Steps Taken Per Day | Home-based activity monitor daily step counts (optional, exploratory study component) | 1 and 3-months post-hospitalization |
| Accelerometry-measured Daily Maximum Step Cadence | Actigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint) | 1 month and 3 month post hospitalization |
| BG002 | 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Hemoglobin Concentrations | Hemoglobin is a protein that cares oxygen through the body | Data was not collected or analyzed for 8 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at 3-months post hospitalization. | Posted | Median | Inter-Quartile Range | g/dL | Hospital discharge (approximately 1 month), 3 months post-hospitalization |
|
|
|
|
| Secondary | Phlebotomy Practice-Blood Draws | Number of times subjects have blood drawn | Posted | Median | Inter-Quartile Range | Number of blood draws | Hospital discharge (approximately 1 month) |
|
|
|
|
| Secondary | Phlebotomy Practice-Volume | Total volume of phlebotomy blood draws | Posted | Median | Inter-Quartile Range | mL | Hospital discharge (approximately 1 month) |
|
|
|
|
| Secondary | Patient-Reported Quality of Life Measured by EuroQol (EQ-5D) | The EuroQol (EQ-5D) is a 5-item questionnaire that assess health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total score ranges from 0 to 100, with higher scores indicating improved health. | Data was not collected nor analyzed for 1 subject in the Control (Standard of Care) arm and 1 subject in the Anemia Treatment Bundle arm at hospital discharge. No data was collected or analyzed for 6 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 subjects in the control standard of care arm and 8 subjects in the anemia treatment bundle arm at 3-months post hospitalization. | Posted | Median | Inter-Quartile Range | score on a scale | Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization |
|
|
|
|
| Secondary | Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale is a 13-item questionnaire used to measure the severity of fatigue and its impact on daily activities. Each question is rated on a 4-point scale where 0 represents "very much" fatigued and 4 represents "not at all" fatigued. Total scores range from 0 to 52 with lower scores indicating greater fatigue. | Data was not collected or analyzed for 1 subject in the Control Standard of Care arm and 1 subject in the Anemia Treatment Bundle arm at hospital discharge. No data was collected or analyzed for 6 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at the 1-month post hospitalization. No data was collected or analyzed for 10 subject in the control standard of care arm and 8 subject in the anemia treatment bundle arm at the 3-months post hospitalization. | Posted | Median | Inter-Quartile Range | score on a scale | Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization |
|
|
|
|
| Secondary | 6 Minute Walk Distance | Distance walked in 6 minutes used to assess physical function after critical illness. | No data was collected or analyzed for 33 participants in the control standard of care arm and 32 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 39 participants in the control standard of care arm and 41 participants in the anemia treatment bundle arm at 3-months post hospitalization. | Posted | Median | Inter-Quartile Range | Feet | 1 and 3-months post-hospitalization |
|
|
|
|
| Secondary | Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND) | The Montreal Cognitive Assessment (MoCA-BLIND) score assesses cognitive impairment by a 30-item questionnaire that includes tests of orientation, attention, memory, language and visual-spatial skills. Possible scores range from 0 to 30, with higher scores indicating higher cognitive function. A final total score of 26 and above is considered normal. | No data was collected or analyzed for 11 participants in the control standard of care arm and 10 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 14 participants in the control standard of care arm and 13 participants in the in the anemia treatment bundle arm at 3-months post hospitalization. | Posted | Median | Inter-Quartile Range | score on a scale | 1 and 3-months post-hospitalization |
|
|
|
|
| Secondary | Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) assesses a patient's anxiety and depression levels. Subject's answer 14 questions (7 for anxiety and 7 for depression). Each question is scored from 0-3. Total scores can range from 0 to 21 for either anxiety or depression, with higher scores indicating a presence of anxiety or depression. | No data was collected or analyzed for 6 participants in the control standard of care arm and 7 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 participants in the control standard of care arm and 8 in the anemia treatment bundle arm at 3-months post hospitalization. | Posted | Median | Inter-Quartile Range | score on a scale | 1 and 3-months post-hospitalization |
|
|
|
|
| Secondary | Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R) | The Impact of Events Scale-Revised (IES-R) is a self-reported questionnaire that measures the distress caused by traumatic events. Subjects respond to 22 questions using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total scores range from 0 to 88, with a higher score indicting the likely presence of post-traumatic stress disorder (PTSD). | No data was collected or analyzed for 6 participants in the control standard of care arm and 7 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 participants in the control standard of care arm and 8 in the anemia treatment bundle arm at 3-months post hospitalization. | Posted | Median | Inter-Quartile Range | score on a scale | 1 and 3-months post-hospitalization |
|
|
|
|
| Secondary | Number of Participants With Allogeneic Red Blood Cell Transfusions | Number (percentage) of patients transfused with allogeneic red blood cells | No data was collected or analyzed for 1 participant in the anemia treatment bundle arm. | Posted | Count of Participants | Participants | 3-months post-hospitalization |
|
|
|
|
| Secondary | Number of Transfused Units of Allogeneic Red Blood Cells | Number of transfused units from hospital discharge through 3-months post-hospitalization | No data was collected or analyzed for 1 participant in the anemia treatment bundle arm. | Posted | Median | Inter-Quartile Range | Transfused units | 3 months post hospitalization |
|
|
|
| Secondary | Unplanned Hospital Readmissions | Number of subjects to experience an unplanned hospital readmission | No data was collected or analyzed for 1 participant in the anemia treatment bundle arm at 3-months post hospitalization. No data was collected or analyzed for 1 participant in the anemia treatment bundle arm at 12-months post hospitalization. | Posted | Count of Participants | Participants | 3 months and 12-months post-hospitalization |
|
|
|
|
| Secondary | Mortality | Mortality from any cause | Posted | Count of Participants | Participants | 3 months and 12-months post-hospitalization |
|
|
|
|
| Secondary | Adverse Events Post-enrollment | Venous thromboembolism, bloodstream infection, myocardial infarction, stroke | Posted | Count of Participants | Participants | Hospital discharge (approximately 1 month), 3-months post-hospitalization |
|
|
|
| Secondary | Accelerometry-measured Number of Steps Taken Per Day | Home-based activity monitor daily step counts (optional, exploratory study component) | No data was collected or analyzed for 33 participants in the control standard of care arm and 27 participants in the anemia treatment bundle arm. | Posted | Median | Full Range | Number of steps per day | 1 and 3-months post-hospitalization |
|
|
|
| Secondary | Accelerometry-measured Daily Maximum Step Cadence | Actigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint) | No data was collected or analyzed for 33 participants in the control standard of care arm and 27 participants in the anemia treatment bundle arm. | Posted | Median | Full Range | Steps per Minute | 1 month and 3 month post hospitalization |
|
|
|
| 2 |
| 51 |
| 3 |
| 51 |
| 5 |
| 51 |
| EG001 | Anemia Treatment Bundle | The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease). Iron Dextran: 1000 mg IV Erythropoietin (EPO): 40,000 units subcutaneous | 3 | 49 | 1 | 49 | 4 | 49 |
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Venous Thromboembolism | Vascular disorders | Systematic Assessment |
|
| Myocardial ischemia | Cardiac disorders | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| 3-months post hospitalization |
|
|
Hospital Discharge |
| Mixed Models Analysis |
linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission |
| 0.42 |
| Mean Difference (Net) |
| 0.2 |
| 2-Sided |
| 95 |
| -0.3 |
| 0.7 |
| Superiority |
| 1 month post hospitalization |
|
|
| 3 months post hospitalization |
|
|
|
1-month post hospitalization |
| proportional odds |
proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission |
| 0.18 |
| Odds Ratio (OR) |
| 1.79 |
| 2-Sided |
| 95 |
| 0.76 |
| 4.20 |
Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention |
| Superiority |
| 3-months post hospitalization | proportional odds | proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission | 0.64 | Odds Ratio (OR) | 1.23 | 2-Sided | 95 | 0.51 | 3.00 | Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention | Superiority |
| 1 month post hospitalization |
|
|
| 3 months post hospitalization |
|
|
|
1-month post hospitalization |
| proportional odds |
proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission |
| 0.09 |
| Odds Ratio (OR) |
| 2.43 |
| 2-Sided |
| 95 |
| 0.87 |
| 6.80 |
Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention |
| Superiority |
| 3-months post hospitalization | proportional odds | proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission | 0.084 | Odds Ratio (OR) | 2.52 | 2-Sided | 95 | 0.88 | 7.20 | Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention | Superiority |
| 3 months post hospitalization |
|
|
3-months post hospitalization |
| Mixed Models Analysis |
adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, baseline ADLs |
| 0.27 |
| Median Difference (Net) |
| 178 |
| 2-Sided |
| 95 |
| -154 |
| 510 |
| Superiority |
| 3 months post hospitalization |
|
|
|
3-months post hospitalization |
| proportional odds |
proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission |
| 0.07 |
| Odds Ratio (OR) |
| 3.10 |
| 2-Sided |
| 95 |
| 0.91 |
| 10.5 |
Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention |
| Superiority |
| Anxiety Score-3 months post hospitalization |
|
|
| Depression Score-1 month post hospitalization |
|
|
| Depression Score-3 months post hospitalization |
|
|
| 3-months post hospitalization for anxiety score | proportional odds | proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission | 0.57 | Odds Ratio (OR) | 0.68 | 2-Sided | 95 | 0.18 | 2.60 | Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention | Superiority |
| 1-month post hospitalization for depression score | proportional odds | proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission | 0.12 | Odds Ratio (OR) | 0.36 | 2-Sided | 95 | 0.10 | 1.30 | Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention | Superiority |
| 3-months post hospitalization for depression score | proportional odds | proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission | 0.48 | Odds Ratio (OR) | 0.62 | 2-Sided | 95 | 0.16 | 2.40 | Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention | Superiority |
| 3 months post hospitalization |
|
|
|
3-months post hospitalization |
| proportional odds |
proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission |
| 0.02 |
| Odds Ratio (OR) |
| 9.16 |
| 2-Sided |
| 95 |
| 1.40 |
| 59.9 |
Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention |
| Superiority |
| Myocardial Infarction |
|
| Stroke |
|