Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03276559
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2017-08-15
Brief Title:
Enhancing Mobilizing the POtential for Wellness Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Enhancing Mobilizing the POtential for Wellness Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER
Brief Summary:
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 patients 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 surrogates 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 ones potential impending death and adjust following the patients 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 n10 All 10 participants in the open trial phase received EMPOWER 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 we then launched a second single arm open trial and paused recruitment for the RCT All participants recruited during the open trial COVID-19 phase received EMPOWER Beginning in August 2021 we resumed the RCT portion of the trial to meet the initial recruitment goals of the study total n of RCT COVID-19 open trial60
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 surrogates 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 ones potential impending death and adjust following the patients 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 n10 All 10 participants in the open trial phase received EMPOWER 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 we then launched a second single arm open trial and paused recruitment for the RCT All participants recruited during the open trial COVID-19 phase received EMPOWER Beginning in August 2021 we resumed the RCT portion of the trial to meet the initial recruitment goals of the study total n of RCT COVID-19 open trial60
Detailed Description:
Aggressive care in Intensive Care Units ICUs has been shown to impair the quality of life of patients with advanced cancer and to increase the risk of Posttraumatic Stress Disorder PTSD among the family and friends who serve as informal caregivers Although ICU stays are established indicators of low quality end-of-life EoL cancer care a large growing number of cancer patients - over 1 in 4 -- are being admitted to the ICU in the last month of life Even within the ICU investigators find that as the number of life-prolonging procedures administered to the patient rises the patients quality of life falls Thus interventions to reduce the suffering and to improve the quality of life and care of ICU cancer patients are needed
As described above suffering is not confined to the patient Informal caregivers of cancer patients in the ICU also suffer In our Severity of Suffering SoS study which examined dying cancer patients quality of life in the ICU nurses indicated that 53 of the patients caregivers were acutely distressed The nurses also reported that 43 of the patients caregivers had unrealistic expectations for the patients recovery and that 41 insisted that the patient receive futile burdensome care eg resuscitation Over 85 of these patients were unable to communicate which resulted in the need for grieving potentially traumatized caregivers to serve as the patients surrogate decision-maker and make life-and-death decisions for a critically ill uncommunicative patient Additionally caregivers of patients who die in the ICU are also at elevated risk of posttraumatic stress disorder PTSD in the months that follow the potentially traumatic ICU exposures These findings indicate a compelling need to address the varying mental health needs of informal caregivers and surrogate decision-makers of patients in the ICU from admission to after discharge as well as to provide them with resources to clarify and inform the decision-making process regarding care for patients who are unable to communicate
To address these needs we have developed and will refine and evaluate EMPOWER a mental health intervention for surrogate decision-makers of ICU patients who are at risk of becoming incapacitated or are currently unable to make medical decisions Delivered by a trained mental health professional in the ICU setting EMPOWER is a cognitive-behavioral acceptance-based intervention designed to reduce experiential avoidance of unpleasant thoughts and feelings related to thinking about the patients death and to provide active strategies for coping with peritraumatic distress and anticipatory grief Additionally by reducing surrogates experiential avoidance EMPOWER removes a barrier to advanced care planning and promotes the receipt of EoL care consistent with patient values In this way EMPOWER aims to facilitate EoL care that enhances patient quality of life while also empowering surrogates to cope with a loved ones potential impending death and adjust following the patients ICU death or discharge
This study is designed to obtain information on its feasibility tolerability acceptability and preliminary effect size estimates to inform the planning of a larger efficacy randomized controlled trial RCT In order to develop the RCT the first 10 surrogate decision-makers were enrolled in an open trial to receive EMPOWER In addition during the manual refinement phase up to 15 stakeholders bereaved caregivers of ICU patients were interviewed after reviewing the EMPOWER intervention manual We then began a pilot RCT randomizing surrogate decision-makers to receive either EMPOWER or enhanced usual care using a block-randomization strategy to determine condition assignment In light of restrictions on recruitment and increased needs of surrogates during the COVID-19 pandemic we paused the RCT portion of this trial and we recruited for a second open trial only administering EMPOWER 60 surrogate-patient dyads were enrolled between the RCT and COVID-19 open trial In August 2021 we resumed the RCT trial of the study We resumed in person recruitment and randomization of participants to EMPOWER or EUC Including the first open trial we will enroll a total of 70 surrogate decision-makers of 70 current patients from the intensive care units at New York Presbyterian-Weill Cornell New York Presbyterian-Queens and Memorial Sloan Kettering Cancer Center Research staff will regularly contact ICU physicians in person or by email andor screen patient charts to identify eligible candidates based on the inclusion criteria
Surrogates will be consented and screened Those who score above 5 on either item measuring anxiety in the McGill Quality of Life Scale or with a summed score of at least 8 on the first two items of the Partner Dependency Scale PDS will be randomized to receive EMPOWER or usual care in the RCT or solely assigned to receive the intervention in the pilot trials Surrogates will be assessed pre-interventionbaseline Time point 1 T1 post-intervention within a week of the surrogates completion of the baseline assessment Time point 2 T2 1-month post-T2 Time point 3 T3 and 3-months post-T2Time point 4 T4 Surrogates will be assigned to either control usual care or intervention group using block randomization in the RCT and solely to EMPOWER in open trials
EMPOWER is based on well-established cognitive-behavioral techniques that aim to promote the expression and understanding of a persons emotional reactions The EMPOWER interventionist will be compassionate and attempt to teach subjects tools for remaining present-focused validate participants experience explore participants loved ones and participants own wishes values and decision challenges increase subjects acceptance and sense of permission to experience challenging emotions and prepare participants for future distressing situations Enhanced usual care will consist of a surrogates interactions with social support services in the ICU as documented in the patients medical chart referrals for current site-specific resources for informal caregivers and a packet providing general information and tips on serving as an informal caregiver
HLM modeling will determine differences between surrogates and patients assigned to EMPOWER vs enhanced usual care The primary outcome is post-intervention T2 differences on a measure of peritraumatic distress Secondary outcomes are differences on measures of prolonged grief disorder PTSD and experiential avoidance at one-month T3 and three-month T4 follow up from T2 Exploratory outcomes for surrogates are differences in reported symptoms of anxiety depression and decision regret at one-month T3 and three-month T4 follow up from T2 Exploratory outcomes for patients are differences in surrogate-reported quality of life quality of death and value concordant care HLM models will include covariates either as fixed-effect or time-varying if those variables are found to be significantly statistically associated with both intervention assignment and the outcome examined
Following a review of the open trial pilot data and stakeholder feedback to evaluate our intervention targets assessments and the primary outcome in the RCT were revised to target the effects of the EMPOWER intervention on peri rather than post traumatic stress
As described above suffering is not confined to the patient Informal caregivers of cancer patients in the ICU also suffer In our Severity of Suffering SoS study which examined dying cancer patients quality of life in the ICU nurses indicated that 53 of the patients caregivers were acutely distressed The nurses also reported that 43 of the patients caregivers had unrealistic expectations for the patients recovery and that 41 insisted that the patient receive futile burdensome care eg resuscitation Over 85 of these patients were unable to communicate which resulted in the need for grieving potentially traumatized caregivers to serve as the patients surrogate decision-maker and make life-and-death decisions for a critically ill uncommunicative patient Additionally caregivers of patients who die in the ICU are also at elevated risk of posttraumatic stress disorder PTSD in the months that follow the potentially traumatic ICU exposures These findings indicate a compelling need to address the varying mental health needs of informal caregivers and surrogate decision-makers of patients in the ICU from admission to after discharge as well as to provide them with resources to clarify and inform the decision-making process regarding care for patients who are unable to communicate
To address these needs we have developed and will refine and evaluate EMPOWER a mental health intervention for surrogate decision-makers of ICU patients who are at risk of becoming incapacitated or are currently unable to make medical decisions Delivered by a trained mental health professional in the ICU setting EMPOWER is a cognitive-behavioral acceptance-based intervention designed to reduce experiential avoidance of unpleasant thoughts and feelings related to thinking about the patients death and to provide active strategies for coping with peritraumatic distress and anticipatory grief Additionally by reducing surrogates experiential avoidance EMPOWER removes a barrier to advanced care planning and promotes the receipt of EoL care consistent with patient values In this way EMPOWER aims to facilitate EoL care that enhances patient quality of life while also empowering surrogates to cope with a loved ones potential impending death and adjust following the patients ICU death or discharge
This study is designed to obtain information on its feasibility tolerability acceptability and preliminary effect size estimates to inform the planning of a larger efficacy randomized controlled trial RCT In order to develop the RCT the first 10 surrogate decision-makers were enrolled in an open trial to receive EMPOWER In addition during the manual refinement phase up to 15 stakeholders bereaved caregivers of ICU patients were interviewed after reviewing the EMPOWER intervention manual We then began a pilot RCT randomizing surrogate decision-makers to receive either EMPOWER or enhanced usual care using a block-randomization strategy to determine condition assignment In light of restrictions on recruitment and increased needs of surrogates during the COVID-19 pandemic we paused the RCT portion of this trial and we recruited for a second open trial only administering EMPOWER 60 surrogate-patient dyads were enrolled between the RCT and COVID-19 open trial In August 2021 we resumed the RCT trial of the study We resumed in person recruitment and randomization of participants to EMPOWER or EUC Including the first open trial we will enroll a total of 70 surrogate decision-makers of 70 current patients from the intensive care units at New York Presbyterian-Weill Cornell New York Presbyterian-Queens and Memorial Sloan Kettering Cancer Center Research staff will regularly contact ICU physicians in person or by email andor screen patient charts to identify eligible candidates based on the inclusion criteria
Surrogates will be consented and screened Those who score above 5 on either item measuring anxiety in the McGill Quality of Life Scale or with a summed score of at least 8 on the first two items of the Partner Dependency Scale PDS will be randomized to receive EMPOWER or usual care in the RCT or solely assigned to receive the intervention in the pilot trials Surrogates will be assessed pre-interventionbaseline Time point 1 T1 post-intervention within a week of the surrogates completion of the baseline assessment Time point 2 T2 1-month post-T2 Time point 3 T3 and 3-months post-T2Time point 4 T4 Surrogates will be assigned to either control usual care or intervention group using block randomization in the RCT and solely to EMPOWER in open trials
EMPOWER is based on well-established cognitive-behavioral techniques that aim to promote the expression and understanding of a persons emotional reactions The EMPOWER interventionist will be compassionate and attempt to teach subjects tools for remaining present-focused validate participants experience explore participants loved ones and participants own wishes values and decision challenges increase subjects acceptance and sense of permission to experience challenging emotions and prepare participants for future distressing situations Enhanced usual care will consist of a surrogates interactions with social support services in the ICU as documented in the patients medical chart referrals for current site-specific resources for informal caregivers and a packet providing general information and tips on serving as an informal caregiver
HLM modeling will determine differences between surrogates and patients assigned to EMPOWER vs enhanced usual care The primary outcome is post-intervention T2 differences on a measure of peritraumatic distress Secondary outcomes are differences on measures of prolonged grief disorder PTSD and experiential avoidance at one-month T3 and three-month T4 follow up from T2 Exploratory outcomes for surrogates are differences in reported symptoms of anxiety depression and decision regret at one-month T3 and three-month T4 follow up from T2 Exploratory outcomes for patients are differences in surrogate-reported quality of life quality of death and value concordant care HLM models will include covariates either as fixed-effect or time-varying if those variables are found to be significantly statistically associated with both intervention assignment and the outcome examined
Following a review of the open trial pilot data and stakeholder feedback to evaluate our intervention targets assessments and the primary outcome in the RCT were revised to target the effects of the EMPOWER intervention on peri rather than post traumatic stress
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA218313 | NIH | None | httpsreporternihgovquickSearchR21CA218313 |