EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in Surrogate Decision-Makers in the ICU.

CONTEXT: Efforts to reduce the psychological distress of surrogate decision-makers of critically ill patients have had limited success, and some have even exacerbated distress. OBJECTIVES: The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of EMPOWER (Enhancing and Mobilizing the POtential for Wellness and Resilience), an ultra-brief (∼2-hour), 6-module manualized psychological intervention for surrogates. METHODS: Surrogates who reported significant anxiety and/or an emotionally close relationship with the patient (n=60) were randomized to receive EMPOWER or enhanced usual care (EUC) at one of three metropolitan hospitals. Participants completed evaluations of EMPOWER's acceptability and measures of psychological distress pre-intervention, immediately post-intervention, and at 1- and 3-month follow-up assessments. RESULTS: Delivery of EMPOWER appeared feasible, with 89% of participants completing all 6 modules, and acceptable, with high ratings of satisfaction (mean=4.5/5, SD = .90). Compared to EUC, intent-to-treat analyses showed EMPOWER was superior at reducing peritraumatic distress (Cohen's d = -0.21, small effect) immediately post-intervention and grief intensity (d = -0.70, medium-large effect), posttraumatic stress (d = -0.74, medium-large effect), experiential avoidance (d = -0.46, medium effect), and depression (d = -0.34, small effect) 3 months post-intervention. Surrogate satisfaction with overall critical care (d = 0.27, small effect) was higher among surrogates randomized to EMPOWER. CONCLUSIONS: EMPOWER appeared feasible and acceptable, increased surrogates' satisfaction with critical care, and prevented escalation of posttraumatic stress, grief, and depression 3 months later.

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

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.

Beyond Progression: Devising a New Training Model for Candidate Assessment, Advancement, and Advising at Columbia.

Research over several decades has identified significant problems with the progression model-the traditional approach to assessment and advancement of psychoanalytic candidates-including candidates' anxiety and uncertainty about the methods and fairness of their assessment, avoidance of conflictual issues with patients in order to keep cases, and reluctance to share their challenges with supervisors and advisors. In light of these findings, the Columbia Center for Psychoanalytic Training and Research restructured its psychoanalytic training programs. The progression committee, the progression advisor role, candidate application to advance through the program, and routine committee discussion of candidates were eliminated and replaced by confidential mentorship and a clear and predictable system of trainee advancement. Analytic competency-a requirement for graduation-is now determined solely from detailed written feedback regarding the candidate's achievement of the Center's learning objectives. The number of months of supervised analysis required for graduation has been reduced, as has the required length of the candidate's longest case; in addition, three-times-weekly analyses are now accepted for credit. These changes are meant to increase the transparency, objectivity, and predictability of the training experience and reduce the pressure on clinical decision making and communication between trainees and faculty. An extensive evaluation of the impact of these innovations is currently under way.

Emergency Remote Training in Psychoanalysis and Psychotherapy: An Initial Assessment from Columbia.

The Covid-19 pandemic and the social distancing required to combat it have set in motion an experiment in psychoanalytic education of unprecedented scope. Following an abrupt shift from in-person study to remote classes, supervision, clinical work, and training analyses, the Columbia University Center for Psychoanalytic Training and Research polled its psychotherapy and psychoanalysis trainees to assess their initial experience of remote training. Most candidates found the technical aspects of online learning easy and were satisfied with remote training overall. Across all programs, most trainees considered class length and reading load about right and felt their class participation was unaffected, though they found it harder to concentrate. Most found it no harder to start a training case, felt the shift to remote supervision had no negative effect, and were satisfied with seeing their training analyst remotely. Most trainees preferred in-person classes, clinical work, and training analyses to those offered remotely, yet in light of the health risks they said they were less likely to continue training in fall 2020 if in-person work resumed. Trainees suggested several modifications of teaching techniques to improve their participation and concentration in class. These findings' implications for the debate regarding remote training in psychoanalysis are explored.

Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial.

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.

Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial.

BACKGROUND: Functional Strength Training (FST) could enhance recovery late after stroke. The aim of this study was to evaluate the feasibility of a subsequent fully powered, randomized controlled trial. METHODS: The study was designed as a randomized, observer-blind trial. Both interventions were provided for up to one hour a day, four days a week, for six weeks. Evaluation points were before randomization (baseline), after six weeks intervention (outcome), and six weeks thereafter (follow-up). The study took place in participants' own homes. Participants (n = 52) were a mean of 24.4 months after stroke with a mean age of 68.3 years with 67.3% male. All had difficulty using their paretic upper (UL) and lower limb (LL). Participants were allocated to FST-UL or FST-LL by an independent randomization service. The outcome measures were recruitment rate, attrition rate, practicality of recruitment strategies, occurrence of adverse reactions, acceptability of FST, and estimation of sample size for a subsequent trial. Primary clinical efficacy outcomes were the Action Research Arm Test (ARAT) and the Functional Ambulation Categories (FAC). Analysis was conducted using descriptive statistics and thematic analysis of participants' views of FST. A power calculation used estimates of clinical efficacy variance to estimate sample size for a subsequent trial. RESULTS: The screening process identified 1,127 stroke survivors of whom 52 (4.6%) were recruited. The recruitment rate was higher for referral from community therapists than for systematic identification of people discharged from an acute stroke unit. The attrition rate was 15.5% at the outcome and follow-up time-points. None of the participants experienced an adverse reaction. The participants who remained in the study at outcome had received 68% of the total possible amount of therapy. Participants reported that their experience of FST provided a sense of purpose and involvement and increased their confidence in performing activities. The power calculation provides estimation that 150 participants in each group will be required for a subsequent clinical trial. CONCLUSIONS: This study found that a subsequent clinical trial was feasible with modifications to the recruitment strategy to be used. TRIAL REGISTRATION: Controlled-trials.com ISCTN71632550, 30 January 2009.

Service contacts prior to death in people dying by suicide in the Scottish Highlands.

INTRODUCTION: Many people who die by suicide have been in contact with health services prior to their death. This study examined service contacts in people in urban and rural areas of the Scottish Highlands. METHODS: Highland residents dying by suicide or undetermined intent in 2001-2004 were identified using routine death records. Health service databases were searched to identify general hospital, mental health and general practice notes. RESULTS: 177 residents died in the time period (136 males). At least one type of record was identified on 175 people, including general practice records (167 people, 94.4%), psychiatric hospital records (n=87, 49.2%) and general hospital records (n=142, 80.2%). Of these, 52.5% had been in contact with at least one health service in the month before their death, including 18.6% with mental health services, and 46.4% with general practice. In total, 68.9% had a previous diagnosis of mental illness, 52.5% of substance misuse problems, and 40.1% of self-harm. The commonest mental illness diagnosis was depression (n=97, 54.8%). There was no difference in rates of GP contact in rural and urban areas. Of those dying in urban areas, 32% had been in contact with mental health services in the previous month, compared with 21% in Accessible Rural/Accessible Small Towns, and 11% in Remote Rural/Remote Small Towns (p<0.01). People in rural areas were less likely to have had contact with mental health services in the year before their death (p<0.01), and to have had lower recorded lifetime rates of mental health service contact (p<0.001), deliberate self-harm (p<0.005) and mental illness (p<0.001). CONCLUSIONS: Overall service contact rates prior to death by suicide were very similar to the results of a previous meta-analysis. Rates of contact with specialist mental health services were significantly lower in rural than urban areas, and this finding increased with greater rurality.

Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren's contracture: a pragmatic, multi-centre, randomised controlled trial.

BACKGROUND: Dupuytren's disease is a progressive fibroproliferative disorder which can result in fixed flexion contractures of digits and impaired hand function. Standard treatment involves surgical release or excision followed by post-operative hand therapy and splinting, however the evidence supporting night splinting is of low quality and equivocal. METHODS: A multi-centre, pragmatic, open, randomised controlled trial was conducted to evaluate the effect of night splinting on self-reported function, finger extension and satisfaction in patients undergoing fasciectomy or dermofasciectomy. 154 patients from 5 regional hospitals were randomised after surgery to receive hand therapy only (n = 77) or hand therapy with night-splinting (n = 77). Primary outcome was self-reported function using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcomes were finger range of motion and patient satisfaction. Primary analysis was by intention to treat. RESULTS: 148 (96%) patients completed follow-up at 12 months. No statistically significant differences were observed on the DASH questionnaire (0-100 scale: adjusted mean diff. 0.66, 95%CI - 2.79 to 4.11, p = 0.703), total extension deficit of operated digits (degrees: adjusted mean diff 5.11, 95%CI -2.33 to 12.55, p = 0.172) or patient satisfaction (0-10 numerical rating scale: adjusted mean diff -0.35, 95%CI -1.04 to 0.34, p = 0.315) at 1 year post surgery. Similarly, in a secondary per protocol analysis no statistically significant differences were observed between the groups in any of the outcomes. CONCLUSIONS: No differences were observed in self-reported upper limb disability or active range of motion between a group of patients who were all routinely splinted after surgery and a group of patients receiving hand therapy and only splinted if and when contractures occurred. Given the added expense of therapists' time, thermoplastic materials and the potential inconvenience to patients having to wear a device, the routine addition of night-time splinting for all patients after fasciectomy or dermofasciectomy is not recommended except where extension deficits reoccur. TRIAL REGISTRATION: The trial was registered as an International Standard Randomised Controlled Trial ISRCTN57079614.

A questionnaire-based survey of participants' decisions regarding recruitment and retention in a randomised controlled trial - lessons learnt from the SCoRD trial.

Successful recruitment and retention on trials is critical to ensuring that adequate power is conferred, results are generalisable and trials are completed within the allocated time and resources. Nested within an existing pragmatic randomised controlled trial a process evaluation was conducted to explore the reasons for a much higher than anticipated recruitment (120% of required sample size) and retention rate (96% completed follow-up). A questionnaire was designed to ascertain patient's views on reasons affecting consent and retention. 148 patients still enrolled in the trial at their final follow-up were either given or mailed a questionnaire of which 102 were returned (69%). 96% rated the written information as very or somewhat important in their decision to consent. Verbal information given to them by the operating surgeon was considered very or somewhat important by 86% and the relative inconvenience was rated as important by 79% of patients. Reasons for consenting for a large proportion of patents were the wish to help in research which may benefit others in the future and the perception that this was an important and relevant study. There was also some evidence that patients weighed up the demands with the potential benefits to them. High levels of satisfaction were expressed with trial personnel and trial procedures. The inclusion of a trial process evaluation such as the one presented here is an efficient method for gathering information of participants' decisions regarding recruitment and retention in a trial and can help to inform the successful planning of future trials.