Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial
Abstract Background Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience addition...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-07-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3515-0 |
| _version_ | 1828475337457008640 |
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| author | Holly G. Prigerson Martin Viola Chris R. Brewin Christopher Cox Daniel Ouyang Madeline Rogers Cynthia X. Pan Shayna Rabin Jiehui Xu Susan Vaughan Janna S. Gordon-Elliot David Berlin Lindsay Lief Wendy G. Lichtenthal |
| author_facet | Holly G. Prigerson Martin Viola Chris R. Brewin Christopher Cox Daniel Ouyang Madeline Rogers Cynthia X. Pan Shayna Rabin Jiehui Xu Susan Vaughan Janna S. Gordon-Elliot David Berlin Lindsay Lief Wendy G. Lichtenthal |
| author_sort | Holly G. Prigerson |
| collection | DOAJ |
| description | Abstract Background Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients’ quality of life and death and dying as well as surrogates’ mental health. Methods Clinician stakeholder and surrogate participant feedback (n = 15), as well as results from an open trial (n = 10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (RCT) (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at 1 and 3 months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment. Participant exit interviews will be conducted at the 3-month assessment time point and will be analyzed using qualitative thematic data analysis methods. Discussion The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application. Trial registration ClinicalTrials.gov, NCT03276559. Retrospectively registered on 8 September 2017. |
| first_indexed | 2024-12-11T06:11:16Z |
| format | Article |
| id | doaj.art-1e5bed3a9a434258a883b77bb2380011 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T06:11:16Z |
| publishDate | 2019-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-1e5bed3a9a434258a883b77bb23800112022-12-22T01:18:06ZengBMCTrials1745-62152019-07-0120111310.1186/s13063-019-3515-0Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trialHolly G. Prigerson0Martin Viola1Chris R. Brewin2Christopher Cox3Daniel Ouyang4Madeline Rogers5Cynthia X. Pan6Shayna Rabin7Jiehui Xu8Susan Vaughan9Janna S. Gordon-Elliot10David Berlin11Lindsay Lief12Wendy G. Lichtenthal13Center for Research on End-of-Life Care, Weill Cornell MedicineCenter for Research on End-of-Life Care, Weill Cornell MedicineDepartment of Clinical, Educational and Health Psychology, University College LondonDepartment of Medicine, Division of Pulmonary & Critical Care Medicine, Duke UniversityCenter for Research on End-of-Life Care, Weill Cornell MedicineCenter for Research on End-of-Life Care, Weill Cornell MedicineNewYork-Presbyterian QueensCenter for Research on End-of-Life Care, Weill Cornell MedicineCenter for Research on End-of-Life Care, Weill Cornell MedicineDepartment of Psychiatry, Columbia College of Physicians and SurgeonsDepartment of Psychiatry, Weill Cornell MedicineDepartment of Medicine, Weill Cornell MedicineDepartment of Medicine, Weill Cornell MedicineDepartment of Psychiatry, Weill Cornell MedicineAbstract Background Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients’ quality of life and death and dying as well as surrogates’ mental health. Methods Clinician stakeholder and surrogate participant feedback (n = 15), as well as results from an open trial (n = 10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (RCT) (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at 1 and 3 months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment. Participant exit interviews will be conducted at the 3-month assessment time point and will be analyzed using qualitative thematic data analysis methods. Discussion The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application. Trial registration ClinicalTrials.gov, NCT03276559. Retrospectively registered on 8 September 2017.http://link.springer.com/article/10.1186/s13063-019-3515-0Critical illnessPsychological distressPeritraumatic distressMedical decision-makingCommunicationSurrogate decision-makers |
| spellingShingle | Holly G. Prigerson Martin Viola Chris R. Brewin Christopher Cox Daniel Ouyang Madeline Rogers Cynthia X. Pan Shayna Rabin Jiehui Xu Susan Vaughan Janna S. Gordon-Elliot David Berlin Lindsay Lief Wendy G. Lichtenthal Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial Trials Critical illness Psychological distress Peritraumatic distress Medical decision-making Communication Surrogate decision-makers |
| title | Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial |
| title_full | Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial |
| title_fullStr | Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial |
| title_full_unstemmed | Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial |
| title_short | Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial |
| title_sort | enhancing mobilizing the potential for wellness emotional resilience empower among surrogate decision makers of icu patients study protocol for a randomized controlled trial |
| topic | Critical illness Psychological distress Peritraumatic distress Medical decision-making Communication Surrogate decision-makers |
| url | http://link.springer.com/article/10.1186/s13063-019-3515-0 |
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