scholarly journals Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients (EMPOWER): Study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Holly G. Prigerson ◽  
Martin Viola ◽  
Chris R. Brewin ◽  
Christopher Cox ◽  
Daniel Ouyang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Decision Makers ◽  
Post Intervention ◽  
Icu Patients ◽  
Emotional Resilience ◽  
Life And Death ◽  
Randomized Controlled ◽  
Surrogate Decision Makers ◽  
Surrogate Decision

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 among Surrogate Decision-Makers of ICU Patients) 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 (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 posttraumatic stress disorder (PTSD), prolonged grief disorder (PGD) and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at one-month and three-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 on. Participant exit interviews will be conducted at the three-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.

scholarly journals Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients (EMPOWER): Study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Holly G. Prigerson ◽  
Martin Viola ◽  
Chris R. Brewin ◽  
Christopher Cox ◽  
Daniel Ouyang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Decision Makers ◽  
Icu Patients ◽  
Emotional Resilience ◽  
Life And Death ◽  
Randomized Controlled ◽  
Surrogate Decision Makers ◽  
Surrogate Decision

Abstract Background Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers or 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 among Surrogate Decision-Makers of ICU Patients) 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 administered as a multisite randomized controlled trial (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 posttraumatic stress disorder (PTSD), prolonged grief disorder (PGD) and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at one-month and three-months from baseline. 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 on. Participant exit interviews will be conducted at the three-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 Identifier NCT03276559 (Retrospectively registered September 8th, 2017)

A Qualitative Analysis of Factors Influencing Critical Care Trial Enrollment Among Surrogates

2021 ◽  
pp. 088506662199897
Author(s):  
Dustin C. Krutsinger ◽  
Breanna D. Hetland ◽  
Kelly L. O’Leary ◽  
Scott D. Halpern ◽  
Katherine R. Courtright
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Respiratory Failure ◽  
Acute Respiratory Failure ◽  
Controlled Trial ◽  
Decision Makers ◽  
Free Text ◽  
Randomized Controlled ◽  
Surrogate Decision Makers ◽  
Surrogate Decision

Background: We sought to identify factors that influence surrogate decision makers’ decisions to enroll patients into a critical care randomized controlled trial. Methods: We conducted a qualitative study embedded within a randomized controlled trial testing the effect of a behavioral nudge intervention for surrogate decision makers on enrollment rate in a sham ventilatory weaning trial among patients with acute respiratory failure. Participants were adult surrogate decision makers of patients receiving mechanical ventilation for acute respiratory failure. The study was conducted in 10 ICUs across 2 urban hospitals within an academic medical center in Philadelphia, Pennsylvanaia, United States. Immediately following their trial enrollment decision, surrogate decision makers were asked to enter free-text responses about the factors that influenced their decision. Responses were analyzed using content analysis. Results: Of the 90 (49%) participants who provided free-text responses, the mean age was 54.9 years (SD 14.3), 69 (79%) were Caucasian, and 48 (53%) were the spouse of the eligible patient. We identified 5 themes influencing enrollment decisions: (i) trial characteristics, (ii) patient clinical condition, (iii) decision making processes, (iv) altruism, and (v) enrollment attempt. Among surrogates who enrolled the patient in the trial (n = 40), the most commonly cited factors were helping future patients (n = 24, 60%) and following the patient’s wishes (n = 11, 28%). In contrast, those who declined enrollment (n = 50) most commonly reported that the patient was too sick (n = 27, 54%) and that they feared complicating the patient’s condition (n = 11, 22%). Conclusions: Surrogates who enroll patients into trials most often cite altruistic motivations, while those who decline enrollment are most often concerned with the severity of the patients’ condition.

Does Caregiver Participation in Advance Care Planning Using a Decision Support Tool Together With Patients Reduce Caregiver Strain, Burden and Anxiety Over Time? A Post-Hoc Analysis of a Randomized Controlled Trial

2021 ◽  
pp. 104990912110402
Author(s):  
Bronson R. Kunzler ◽  
Andrew J. Foy ◽  
Benjamin H. Levi ◽  
Lauren J. Van Scoy ◽  
Erik B. Lehman ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Decision Support Tool ◽  
Study Groups ◽  
Decision Makers ◽  
Support Tool ◽  
Randomized Controlled ◽  
Surrogate Decision Makers ◽  
Advance Care ◽  
Surrogate Decision ◽  
Post Hoc

Context: Surrogate decision makers experience significant amounts of anxiety, burden, and strain in their role as caregivers and decision makers for loved ones. Objectives: To investigate longitudinally whether surrogate decision makers engaging in ACP together with their loved one reduces perceived anxiety, burden, and strain felt by surrogate decision makers. Methods: Post-hoc analysis of a randomized controlled trial evaluating caregivers’ perceived self-efficacy to serve as surrogate decision makers. The trial employed a 2×2 study design of patient/caregiver dyads who engaged in advance care planning (ACP) using a standard living will form vs “Making Your Wishes Known” (MYWK), and having the patient engage in ACP alone vs together with the family caregiver. Surrogates completed validated survey instruments surveys longitudinally to compare levels of anxiety, burden, and strain. Results: 246 of 285 dyads completed the measures. No significant reductions in anxiety, burden, or strain were found longitudinally in surrogate decision makers using MYWK together with loved one’s vs other control groups. Increases in strain and anxiety were seen across all study groups and increases in burden across 2/4 study groups. Strain and burden increased most in the MYWK Together arm (▴ = +2.22 and ▴ = +1.91 respectively). Conclusion: Family caregivers who engaged in ACP together with patients using the decision support tool MYWK did not experience less strain, burden, or anxiety longitudinally compared to other study arms. These results may help inform the design of future studies and interventions that promote caregivers’ involvement in ACP interventions.

scholarly journals Development and preliminary evaluation of EMPOWER for surrogate decision-makers of critically ill patients

2021 ◽  
pp. 1-11
Author(s):  
Wendy G. Lichtenthal ◽  
Martin Viola ◽  
Madeline Rogers ◽  
Kailey E. Roberts ◽  
Lindsay Lief ◽  
...  
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Experiential Avoidance ◽  
Decision Makers ◽  
Post Intervention ◽  
Prolonged Grief ◽  
Surrogate Decision Makers ◽  
Surrogate Decision ◽  
Peritraumatic Distress

Abstract Objective The objectives of this study were to develop and refine EMPOWER (Enhancing and Mobilizing the POtential for Wellness and Resilience), a brief manualized cognitive-behavioral, acceptance-based intervention for surrogate decision-makers of critically ill patients and to evaluate its preliminary feasibility, acceptability, and promise in improving surrogates’ mental health and patient outcomes. Method Part 1 involved obtaining qualitative stakeholder feedback from 5 bereaved surrogates and 10 critical care and mental health clinicians. Stakeholders were provided with the manual and prompted for feedback on its content, format, and language. Feedback was organized and incorporated into the manual, which was then re-circulated until consensus. In Part 2, surrogates of critically ill patients admitted to an intensive care unit (ICU) reporting moderate anxiety or close attachment were enrolled in an open trial of EMPOWER. Surrogates completed six, 15–20 min modules, totaling 1.5–2 h. Surrogates were administered measures of peritraumatic distress, experiential avoidance, prolonged grief, distress tolerance, anxiety, and depression at pre-intervention, post-intervention, and at 1-month and 3-month follow-up assessments. Results Part 1 resulted in changes to the EMPOWER manual, including reducing jargon, improving navigability, making EMPOWER applicable for a range of illness scenarios, rearranging the modules, and adding further instructions and psychoeducation. Part 2 findings suggested that EMPOWER is feasible, with 100% of participants completing all modules. The acceptability of EMPOWER appeared strong, with high ratings of effectiveness and helpfulness (M = 8/10). Results showed immediate post-intervention improvements in anxiety (d = −0.41), peritraumatic distress (d = −0.24), and experiential avoidance (d = −0.23). At the 3-month follow-up assessments, surrogates exhibited improvements in prolonged grief symptoms (d = −0.94), depression (d = −0.23), anxiety (d = −0.29), and experiential avoidance (d = −0.30). Significance of results Preliminary data suggest that EMPOWER is feasible, acceptable, and associated with notable improvements in psychological symptoms among surrogates. Future research should examine EMPOWER with a larger sample in a randomized controlled trial.

What CPR means to surrogate decision makers of ICU patients

Resuscitation ◽  
2015 ◽  
Vol 90 ◽  
pp. 73-78 ◽  
Author(s):  
Yuri Shif ◽  
Pratik Doshi ◽  
Khalid F. Almoosa
Keyword(s):  
Decision Makers ◽  
Icu Patients ◽  
Surrogate Decision Makers ◽  
Surrogate Decision

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

scholarly journals A Culturally Adapted Timed-Activity RCT for Latinos With ADRD and Caregivers: Feasibility, Acceptability, and Effects

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 547-547
Author(s):  
Liming Huang ◽  
G Adriana Perez
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Behavioral Symptoms ◽  
Attendance Rate ◽  
Post Intervention ◽  
Spanish Speaking ◽  
Randomized Controlled ◽  
Culturally Adapted ◽  
Trial Participants

Abstract Latinos are twice as likely to develop Alzheimer’s disease (AD) compared to non-Latino whites, yet, account for <2% of clinical trial participants in AD research. This randomized controlled trial examined the feasibility, acceptability and effects of a culturally-adapted timed-activity intervention designed to promote quality of life (QOL) and reduce behavioral symptoms in older Latinos with AD and their caregivers. Healthy Patterns [Pautas Saludables] was implemented among 40 Spanish-speaking dyads. Measures assessed at baseline and 4 weeks post-intervention, indicate improvements in sleep efficiency (p=.06) and QOL (p=.01) among intervention participants. Pautas Saludables was found to be feasible and acceptable. Intervention attendance rate was >90% with low attrition (n=0); no adverse events. Most (74%) rated timed-activity sessions as helpful and appropriate; 58% recommended refreshers. Results provide evidence that Latinos with AD will participate in clinical trials and can improve on key health outcomes, when interventions are adapted to meet their cultural needs.

scholarly journals Quality of life of persons living with HIV and congruence with surrogate decision-makers

2018 ◽  
Vol 28 (1) ◽  
pp. 47-56 ◽  
Author(s):  
Katherine B. Curtin ◽  
◽  
Yao I. Cheng ◽  
Jichuan Wang ◽  
Rachel K. Scott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Decision Makers ◽  
Persons Living With Hiv ◽  
Surrogate Decision Makers ◽  
Surrogate Decision ◽  
Living With Hiv
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