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EMPOWERWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug1193 Individualised Ayurveda Wiki 1.00
drug850 Enhanced Usual Care Wiki 1.00

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D003147 Communication Disorders NIH 1.00
D016638 Critical Illness NIH 0.14

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients

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).

NCT03276559 Critical Illness Communication Disabilities Behavioral: EMPOWER Other: Enhanced Usual Care
MeSH:Communication Disorders Critical Illness

Primary Outcomes

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)

Secondary Outcomes

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)

Other Outcomes

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 up

Description: 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 up

Description: 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 up

Description: 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)

No related HPO nodes (Using clinical trials)