Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug1314 | EMPOWER Wiki | 0.71 |
drug3029 | Positive Minds Strong Bodies Enhanced Wiki | 0.71 |
drug1809 | Hydroxychloroquine and Azithromycin Wiki | 0.50 |
Name (Synonyms) | Correlation | |
---|---|---|
D003147 | Communication Disorders NIH | 0.71 |
D016638 | Critical Illness NIH | 0.09 |
D003863 | Depression, NIH | 0.08 |
Name (Synonyms) | Correlation |
---|
Navigate: Correlations HPO
There are 2 clinical trials
Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are made and patients' surrogate decision-makers are exposed to potentially traumatic experiences. As the number of life-prolonging procedures administered to the patient rises, the patient's quality of life falls. Thus, interventions to improve the quality of life and care of ICU patients are needed. EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate decision-makers to reduce experiential avoidance of unpleasant thoughts and feelings related to thinking about patient death. By reducing surrogate's experiential avoidance, EMPOWER removes a barrier to advance care planning. EMPOWER aims to improve patient quality of life through enhancing value-directed end-of-life care while also empowering surrogates to cope with a loved one's potential impending death and adjust following the patient's ICU death or discharge. Specifically, investigators aim to: - 1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at risk of becoming incapacitated or are currently unable to communicate in the ICU. Key informants, including bereaved ICU patient caregivers and clinicians, will be asked to evaluate the EMPOWER intervention manual to increase its potential tolerability, acceptability and efficacy. - 2: Determine feasibility, tolerability, acceptability, and preliminary effects of EMPOWER on surrogate mental health. - 3: Estimate the effects of EMPOWER on patient outcomes in the months following the ICU admission. Hypothesis 1: Surrogate decision-makers who receive EMPOWER will have significantly lower levels of peritraumatic distress when compared to usual care condition at post intervention assessment (T2). Hypothesis 2: Patients whose surrogates receive EMPOWER will have more value-concordant care, better quality of life, and better quality of death. EMPOWER was first evaluated though a single site open trial (n=10). Feedback from clinicians, bereaved stakeholders and results from the open trial were then used to refine the intervention and launch a multi-center randomized controlled trial to examine clinical superiority of EMPOWER to enhanced usual care. In order to adapt to restrictions in ICU visitation and meet the needs of family caregivers impacted by the COVID-19 pandemic, a second single arm open trial is now occurring while the RCT recruitment is paused (total n of RCT & COVID-19 open trial=60).
Description: Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Peritraumatic Distress Inventory Time: In the week following the intervention (T2)Description: Anticipatory grief for patients who are not deceased, as measured by the Prolonged Grief-12, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The PG-12 consists of 12 items and total score can range from 0 to 57. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Anticipatory Grief Time: One month and three months from baseline (T3 and T4)Description: Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PG-13 consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Prolonged Grief Disorder Time: One month and three months from baseline (T3 and T4)Description: Symptoms of experiential avoidance, as measured by the Brief Experiential Avoidance Questionnaire, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The BEAQ consists of 15 items and total score can range from 15 to 90. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Experiential Avoidance Time: One month and three months from baseline (T3 and T4)Description: Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Post-Traumatic Stress Disorder Time: One month and three months from baseline (T3 and T4)Description: Logistic regression models will regress patient quality of life for EMPOWER vs. the enhanced usual care condition. Patient quality of life will be assessed using three previously validated items. Total score can range from 0 to 30. Higher total scores represent better caregiver-assessed patient quality of life. Higher scores represent better outcomes.
Measure: Patient Quality of Life Time: From baseline assessment to three-month follow upDescription: For patients who die during the study period, logistic regression models will regress patient quality of death for EMPOWER vs. the enhanced usual care condition. Quality of Death will be measured using the Caregiver Evaluation of the Quality of End-of-Life Care (CEQUEL). Total score can range from 13 to 26. Higher total scores represent better caregiver-assessed patient quality of death. Higher total scores represent better outcomes.
Measure: Patient Quality of Death Time: From baseline assessment to three-month follow upDescription: Intensity of care (measured through indication of cardiopulmonary resuscitation, dialysis, mechanical ventilation, chemotherapy, parenteral nutrition, and palliative care in the medical record) will be matched with surrogate perceptions of patient treatment preferences to create a measure of value-concordant care. Logistic regression analyses will then model the effects of EMPOWER on the odds of patients' receipt of value-concordant care. Higher odds equal better outcomes.
Measure: Value-Concordant Care Time: From baseline assessment to three-month follow upDescription: Symptoms of anxiety, as measured by the state scale of the State-Trait Anxiety Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The STAI-Y state scale consists of 20 items and total score can range from 20 to 80. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Anxiety Time: One month and three months from baseline (T3 and T4)Description: Symptoms of anxiety, as measured by the Patient Health Questionnaire - 9 , will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PHQ-9 consists of 9 items and total score can range from 0 to 27. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Depression Time: One month and three months from baseline (T3 and T4)Description: Decision regret, as measured by the Decision Regret Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The decision regret scale is a one-item likert-style measure. Total score can range from 1 to 10. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Measure: Decision Regret Time: One month and three months from baseline (T3 and T4)This study aims to address treatment and service disparities and prevent disability among racial/ethnic and linguistic minority elders. It tests the effectiveness and implementation readiness of the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), a combined mental and physical health intervention designed to be implemented in low-resource community settings. This renewal grant project includes a streamlined intervention with new components designed to improve and maintain participant outcomes.
Description: >/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment.
Measure: Acceptability Time: 6 months at end of treatmentDescription: Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.
Measure: Hopkins Symptom Checklist-25 (change) Time: Baseline and 3, 6, and 12 months after baselineDescription: Assessment of standing balance, timed 4-m walk, and timed test of five chair-rise repetitions, to assess functional limitations. A virtual option will be used while in person assessment is not possible due to COVID-19.
Measure: Short Physical Performance Battery (change) Time: Baseline and 3, 6, and 12 months after baselineDescription: Self-report instrument designed to measure both functional capacity and components of disability.
Measure: Late-Life Function and Disability Instrument (LLFDI) - functional component (change) Time: Baseline and 3, 6, and 12 months after baselineAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports