Covid 19 Research using Clinical Trials (Home Page)
Report for D014652: Vascular Diseases NIH
(Synonyms: Vascular Disea, Vascular Disease, Vascular Diseases)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug9 | 0.9% saline Wiki | 0.71 |
| drug685 | Crizanlizumab Wiki | 0.71 |
| drug762 | Diet tracking and survey Wiki | 0.71 |
| drug809 | EHR-based Clinician Jumpstart Wiki | 0.71 |
Correlated MeSH Terms (13)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D016491 | Peripheral Vascular Diseases NIH | 0.50 |
| D058729 | Peripheral Arterial Disease NIH | 0.41 |
| D009362 | Neoplasm Metastasis NIH | 0.41 |
| D051437 | Renal Insufficiency, NIH | 0.35 |
| D008175 | Lung Neoplasms NIH | 0.35 |
| D008103 | Liver Cirrhosis, NIH | 0.35 |
| D007676 | Kidney Failure, Chronic NIH | 0.29 |
| D006333 | Heart Failure NIH | 0.27 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.25 |
| D017563 | Lung Diseases, Interstitial NIH | 0.22 |
| D002908 | Chronic Disease NIH | 0.22 |
| D008171 | Lung Diseases, NIH | 0.18 |
| D009369 | Neoplasms, NIH | 0.16 |
Correlated HPO Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000083 | Renal insufficiency HPO | 0.35 |
| HP:0001395 | Hepatic fibrosis HPO | 0.35 |
| HP:0100526 | Neoplasm of the lung HPO | 0.35 |
| HP:0004950 | Peripheral arterial stenosis HPO | 0.32 |
| HP:0001635 | Congestive heart failure HPO | 0.27 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.25 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.22 |
| HP:0002088 | Abnormal lung morphology HPO | 0.18 |
| HP:0002664 | Neoplasm HPO | 0.16 |
There are 2 clinical trials
Clinical Trials
1 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness
The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.
NCT04281784 Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failure，Congestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart MeSH:Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease Neoplasms
HPO:Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Left ventricular dysfunction Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure
Primary Outcomes
Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.
Measure: EHR documentation of Goals of Care discussions Time: Assessed for the period between randomization and 30 days following randomization
Secondary Outcomes
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU admissions Time: Assessed for the period between randomization and 30 days following randomization
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU length of stay Time: Assessed for the period between randomization and 30 days following randomization
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/Hospital use: Hospital length of stay Time: Assessed for the period between randomization and 30 days following randomization
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: Hospital Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomization
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: ICU Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomization
Description: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Measure: Intensity of care: Healthcare costs Time: 1 and 3 months after randomization
Description: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomization
Other Outcomes
Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.
Measure: Key Implementation Factors Time: 3 months after randomization
2 Crizanlizumab for Treating COVID-19 Vasculopathy
Primary Outcomes
Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.
Measure: EHR documentation of Goals of Care discussions Time: Assessed for the period between randomization and 30 days following randomizationSecondary Outcomes
Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU admissions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/Hospital use: Hospital length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: Hospital Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: ICU Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Measure: Intensity of care: Healthcare costs Time: 1 and 3 months after randomizationDescription: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomizationOther Outcomes
Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.
Measure: Key Implementation Factors Time: 3 months after randomizationThe purpose of this trial is to test the efficacy and safety of crizanlizumab in patients hospitalized with COVID-19.
NCT04435184 COVID-19 Drug: Crizanlizumab Other: 0.9% saline MeSH:Vascular Diseases
Primary Outcomes
Description: Level of soluble P-selectin in ng/ml.
Measure: Soluble P-selectin level Time: Day 7 after randomizationSecondary Outcomes
Description: Level of soluble P-selectin in ng/ml.
Measure: Soluble P-selectin level Time: Day 14 after randomizationDescription: Level of D-dimer in mg/L.
Measure: D-dimer level Time: Day 7 after randomizationDescription: Level of D-dimer in mg/L.
Measure: D-dimer level Time: Day 14 after randomizationDescription: Level of VWF antigen (percentage).
Measure: VWF level Time: Day 7 after randomizationDescription: Level of VWF antigen in (percentage).
Measure: VWF level Time: Day 14 after randomizationDescription: Level of C-reactive protein (CRP) in mg/dL.
Measure: CRP level Time: Day 7 after randomizationDescription: Level of C-reactive protein (CRP) in mg/dL.
Measure: CRP level Time: Day 14 after randomizationDescription: Change in the clinical status over 14 days as measured by an ordinal scale that is the first assessment of the clinical status on a given study day. The scale is as follows: 0 = Uninfected; no viral RNA detected = Ambulatory; asymptomatic; viral RNA detected = Ambulatory; symptomatic; independent = Ambulatory; symptomatic; assistance needed = Hospitalized; no oxygen therapy = Hospitalized; oxygen by mask or nasal prongs = Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow = Hospitalized; intubation and mechanical ventilation, partial pressure of oxygen / fraction of inspired oxygen (pO2/FIO2) ≥ 150 or oxygen saturation / FIO2 (SpO2/FIO2) ≥ 200 = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 < 150 or SpO2/FIO2 < 200 or vasopressors = Hospitalized; intubation and mechanical ventilation, pO2/FIO2 < 150 or SpO2/FIO2 < 200 and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) = Dead
Measure: Change in clinical status as assessed by the World Health Organization (WHO) Ordinal Scale for COVID-19 Trials Time: Daily up to day 14 after randomizationDescription: Time (days) to hospital discharge
Measure: Time to hospital discharge Time: Up to 30 days after randomizationDescription: Safety of crizanlizumab will by assessed by adverse events, serious adverse events, and suspected unexpected serious adverse reactions.
Measure: Safety of Crizanlizumab as assessed by adverse events Time: Up to day 14 after randomization