Multisite Randomized Clinical Trial Research Articles

Effect of a Multicomponent Sepsis Transition and Recovery Program on Mortality and Readmissions After Sepsis: The Improving Morbidity During Post-Acute Care Transitions for Sepsis Randomized Clinical Trial.

To evaluate whether a nurse navigator-led, multicomponent Sepsis Transition And Recovery program improves 30-day mortality and readmission outcomes after sepsis hospitalization. n: Multisite pragmatic randomized clinical trial. Three hospitals in North Carolina from January 2019 to March 2020. Eligible patients hospitalized for suspected sepsis and deemed high-risk for mortality or readmission by validated internal risk models. Patients were randomized to receive usual care alone (i.e., routine transition support, outpatient care; n = 342) or additional Sepsis Transition And Recovery support (n = 349). The 30-day intervention involved a multicomponent transition service led by a nurse navigator through telephone and electronic health record communication to facilitate best practice postsepsis care strategies during and after hospitalization including: postdischarge medication review, evaluation for new impairments or symptoms, monitoring comorbidities, and palliative care approach when appropriate. Clinical oversight was provided by a Hospital Medicine Transition Services team. The primary outcome was a composite of mortality or hospital readmission at 30 days. Logistic regression models were constructed to evaluate marginal and conditional odds ratios (adjusted for prognostic covariates: age, comorbidity, and organ dysfunction at enrollment). Among 691 randomized patients (mean age = 63.7 ± 15.1 yr; 52% female), a lower percentage of patients in the Sepsis Transition And Recovery group experienced the primary outcome compared with the usual care group (28.7% vs 33.3%; risk difference, 4.7%; odds ratio, 0.80; 95% CI, 0.58-1.11; adjusted odds ratio, 0.80; 95% CI, 0.64-0.98). There were 74 deaths (Sepsis Transition And Recovery: 33 [9.5%] vs usual care: 41 [12.0%]) and 155 rehospitalizations (Sepsis Transition And Recovery: 71 [20.3%] vs usual care: 84 [24.6%]). In a multisite randomized clinical trial of patients hospitalized with sepsis, patients provided with a 30-day program using a nurse navigator to provide best practices for postsepsis care experienced a lower proportion of either mortality or rehospitalization within 30 days after discharge. Further research is needed to understand the contextual factors associated with successful implementation.

The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain

Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients.Clinical Trials.gov: NCT 04129450.

Expressions of conflict following postoperative complications in older adults having major surgery

BackgroundAfter serious postoperative complications, patients and families may experience conflict about goals of care. MethodsWe performed a multisite randomized clinical trial to test the effect of a question prompt list on postoperative conflict. We interviewed family members and patients age ≥60 who experienced serious complications. We used qualitative content analysis to analyze conflict and characterize patient experiences with complications. ResultsFifty-six of 446 patients suffered a serious complication. Participants generally did not report conflict relating to postoperative treatments and expressed support for the care they received. We did not appreciate a difference in conflict between intervention and usual care. Respondents reported feeling unprepared for complications, witnessing heated interactions among team members, and a failure to develop trust for their surgeon preoperatively. ConclusionPostoperative conflict following serious complications is well described but its incidence may be low. Nonetheless, patient and family observations reveal opportunities for improvement.

Problem-solving skills training in adult cancer survivors: Bright IDEAS-AC.

e24109 Background: Cancer patients experience significant distress throughout treatment and especially during transition back to normal life with greater burden on socially disadvantaged patients and those with medical comorbidities. Patient stressors can interfere with their ability to make reasoned and timely decisions about survivorship care and lead to poor quality of life and low physical and social functioning. This pilot effectiveness-implementation study examined the impact and feasibility of offering the Bright IDEAS system of Problem-Solving Skills Training (PSST) to adult cancer survivors to help them and their caregivers cope more successfully with decision making and distress. Methods: Patients with breast (21), prostate (9) or colorectal (20) cancer who completed their definitive cancer treatment within the last 6 months and had their cancer survivorship visit were recruited from two regional cancer centers and affiliated community oncology clinics. Patients with an NCCN distress level > 2 were randomly assigned to either care as usual (CAU) or 8 weekly PSST sessions provided by a trained therapist in person or remotely. Patients were invited but not required to include a supportive other (n = 17). Patient and caregiver assessments at baseline (T1), end of intervention/3 months (T2), and 3 months post intervention/6 months (T3) focused on problem-solving skills (SPSI-25), distress (HADS) and quality of life (FACT). We also collected healthcare utilization data. We compared outcome changes T1-T2 and T1-T3, by study arm, using t-tests. Multivariate regression analysis identified subgroups of patients with positive and negative responses to skills training. Results: Average age of the participants was 63 years (45 to 87) with racial and ethnic distributions representative of the local population (88% white). Two thirds were women (n = 32), one third of the patients were recruited and received therapy fully remotely due to COVID-19-related protocol changes. Patients who received PSST reported a reduction in dysfunctional problem-solving style and improvement in constructive style while problem-solving skills of CAU patients trended in the opposite direction. Patients in the PSST arm also reported significant reduction in anxiety and depression and improvement in cancer-specific quality of life (p < 0.05) that was sustained at 6 months. Patients in the PSST arm reported lower use of hospital and ED services compared to CAU patients (p = 0.07). Better improvement in outcomes was driven by lower problem-solving skills at baseline. Conclusions: Despite the logistical complexity of running a clinical trial during quarantine, patients and caregivers in the PSST arm demonstrated meaningful improvement in distress and quality of life. The evidence from this pilot study will help guide development of a future multi-site randomized clinical trial of the effect of PSST on cancer survivorship care and outcomes. Clinical trial information: NCT03567850.

Frequency of Preoperative Advance Care Planning for Older Adults Undergoing High-risk Surgery

For patients facing major surgery, surgeons believe preoperative advance care planning (ACP) is valuable and routinely performed. How often preoperative ACP occurs is unknown. To quantify the frequency of preoperative ACP discussion and documentation for older adults undergoing major surgery. This secondary analysis of data from a multisite randomized clinical trial testing the effects of a question prompt list intervention on preoperative communication for older adults considering major surgery was performed at 5 US academic medical centers. Participants included surgeons who routinely perform high-risk surgery and patients 60 years or older with at least 1 comorbidity and an oncological or vascular (cardiac, peripheral, or neurovascular) problem. Data were collected from June 1, 2016, to November 30, 2018. Patients received a question prompt list brochure with 11 questions that they might ask their surgeon. For patients who had major surgery, any statement related to ACP from the surgeon, patient, or family member during the audiorecorded preoperative consultation was counted. The presence of a written advance directive (AD) in the medical record at the time of the initial consultation or added preoperatively was recorded. Open-ended interviews with patients who experienced postoperative complications and family members were conducted. Among preoperative consultations with 213 patients (122 men [57%]; mean [SD] age, 72 [7] years), only 13 conversations had any discussion of ACP. In this cohort of older patients with at least 1 comorbid condition, 141 (66%) did not have an AD on file before major surgery; there was no significant association between the presence of an AD and patient age (60-69 years, 26 [31%]; 70-79 years, 31 [33%]; ≥80 years, 15 [42%]; P = .55), number of comorbidities (1, 35 [32%]; 2, 18 [33%]; ≥3, 19 [40%]; P = .62), or type of procedure (oncological, 53 [32%]; vascular, 19 [42%]; P = .22). There was no difference in preoperative communication about ACP or documentation of an AD for patients who were mailed a question prompt list brochure (intervention, 38 [35%]; usual care, 34 [33%]; P = .77). Patients with complications were enthusiastic about ACP but did not think it was important to discuss their preferences for life-sustaining treatments with their surgeon preoperatively. Although surgeons believe that preoperative discussion of patient preferences for postoperative life-sustaining treatments is important, these preferences are infrequently explored, addressed, or documented preoperatively. ClinicalTrials.gov Identifier: NCT02623335.

Association of Race with End-of-Life Treatment Preferences in Older Adults with Cancer Receiving Outpatient Palliative Care.

Background: End-of-life discussions and documentation of preferences are especially important for older cancer patients who are at high risk of morbidity and mortality. Objective: To evaluate influence of demographic factors such as religiosity, education, income, race, and ethnicity on treatment preferences for end-of-life care. Methods: A retrospective observational study was performed on baseline data from a multisite randomized clinical trial of Dignity Therapy in 308 older cancer patients who were receiving outpatient palliative care (PC). Interviews addressed end-of-life treatment preferences, religion, religiosity and spirituality, and awareness of prognosis. End-of-life treatment preferences for care were examined, including preferences for general treatment, cardiopulmonary resuscitation (CPR), and mechanical ventilation (MV). Bivariate associations and multiple logistic regression analysis of treatment preferences with demographic and other baseline variables were conducted. Results: Our regression models demonstrated that race was a significant predictor for CPR preference and preferences for MV, although not for general treatment goals. Minority patients were more likely to want CPR and MV than whites. Men were more likely to opt for MV, although not for CPR or overall aggressive treatment, than women. Higher level of education was a significant predictor for preferences for less aggressive care at the end-of-life but not for CPR or MV. Higher level of terminal illness awareness was also a significant predictor for preferences for CPR, but not MV or aggressive care at the end-of-life. Discussion: Race was significantly associated with all three markers for aggressive care in bivariate analysis and with two out of three markers in multiple regression analysis, with minorities preferring aggressive care and whites preferring less aggressive care. Contrary to our hypothesis, income was not significantly associated with treatment preferences, whereas religion was significantly associated with all markers for aggressive care in bivariate models, but not in multiple regression models. Clinical Trial Registration Number NCT03209440.

A Brief Home-Based Parenting Intervention to Reduce Behavior Problems in Young Children

Behavior problems are one of the most common mental health disorders in childhood and can undermine children's health, education, and employment outcomes into adulthood. There are few effective interventions for early childhood. To test the clinical effectiveness of a brief parenting intervention, the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD), in reducing behavior problems in children aged 12 to 36 months. The Healthy Start, Happy Start study was a 2-group, parallel-group, researcher-blind, multisite randomized clinical trial conducted via health visiting services in 6 National Health Service trusts in England. Baseline and 5-month follow-up data were collected between July 30, 2015, and April 27, 2018. Of 818 eligible families, 227 declined to participate, and 300 were randomized into the trial. Target participants were caregivers of children who scored in the top 20% for behavior problems on the Strengths and Difficulties Questionnaire. Participants were randomly allocated on a 1:1 basis to receive either VIPP-SD (n = 151) or usual care (n = 149), stratified by site and number of participating caregivers. Analysis was performed on an intention-to-treat basis. Statistical analysis was performed from September 5, 2019, to January 17, 2020. All families continued to access usual care. Families allocated to VIPP-SD were offered 6 home-based video-feedback sessions of 1 to 2 hours' duration every 2 weeks. The primary outcome was the score on an early childhood version of the Preschool Parental Account of Children's Symptoms, a semistructured interview of behavior symptoms, at 5 months after randomization. Secondary outcomes included caregiver-reported behavior problems on the Child Behavior Checklist and the Strengths and Difficulties Questionnaire. Among 300 participating children (163 boys [54%]; mean [SD] age, 23.0 [6.7] months), primary outcome data were available for 140 of 151 VIPP-SD participants (93%) and 146 of 149 usual care participants (98%). There was a mean difference in the total Preschool Parental Account of Children's Symptoms score of 2.03 (95% CI, 0.06-4.01; P = .04; Cohen d = 0.20 [95% CI, 0.01-0.40]) between trial groups, with fewer behavior problems in the VIPP-SD group, particularly conduct symptoms (mean difference, 1.61 [95% CI, 0.44-2.78]; P = .007; d = 0.30 [95% CI, 0.08-0.51]). Other child behavior outcomes showed similar evidence favoring VIPP-SD. No treatment or trial-related adverse events were reported. This study found that VIPP-SD was effective in reducing symptoms of early behavior problems in young children when delivered in a routine health service context. isrctn.org Identifier: ISRCTN58327365.

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial

Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. Our objective was to compare the efficacy and adverse events of these 2 procedures. At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of-18% (95% confidence interval,-33% to-3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

Effect of Incentives for Alcohol Abstinence in Partnership With 3 American Indian and Alaska Native Communities

Many American Indian and Alaska Native communities are disproportionately affected by problems with alcohol use and seek culturally appropriate and effective interventions for individuals with alcohol use disorders. To determine whether a culturally tailored contingency management intervention, in which incentives were offered for biologically verified alcohol abstinence, resulted in increased abstinence among American Indian and Alaska Native adults. This study hypothesized that adults assigned to receive a contingency management intervention would have higher levels of alcohol abstinence than those assigned to the control condition. This multisite randomized clinical trial, the Helping Our Native Ongoing Recovery (HONOR) study, included a 1-month observation period before randomization and a 3-month intervention period. The study was conducted at 3 American Indian and Alaska Native health care organizations located in Alaska, the Pacific Northwest, and the Northern Plains from October 10, 2014, to September 2, 2019. Recruitment occurred between October 10, 2014, and February 20, 2019. Eligible participants were American Indian or Alaska Native adults who had 1 or more days of high alcohol-use episodes within the last 30 days and a current diagnosis of alcohol dependence. Data were analyzed from February 1 to April 29, 2020. Participants received treatment as usual and were randomized to either the contingency management group, in which individuals received 12 weeks of incentives for submitting a urine sample indicating alcohol abstinence, or the control group, in which individuals received 12 weeks of incentives for submitting a urine sample without the requirement of alcohol abstinence. Regression models fit with generalized estimating equations were used to assess differences in abstinence during the intervention period. Alcohol-negative ethyl glucuronide (EtG) urine test result (defined as EtG<150 ng/mL). Among 1003 adults screened for eligibility, 400 individuals met the initial criteria. Of those, 158 individuals (39.5%; mean [SD] age, 42.1 [11.4] years; 83 men [52.5%]) met the criteria for randomization, which required submission of 4 or more urine samples and 1 alcohol-positive urine test result during the observation period before randomization. A total of 75 participants (47.5%) were randomized to the contingency management group, and 83 participants (52.5%) were randomized to the control group. At 16 weeks, the number who submitted an alcohol-negative urine sample was 19 (59.4%) in the intervention group vs 18 (38.3%) in the control group. Participants randomized to the contingency management group had a higher likelihood of submitting an alcohol-negative urine sample (averaged over time) compared with those randomized to the control group (odds ratio, 1.70; 95% CI, 1.05-2.76; P = .03). The study's findings indicate that contingency management may be an effective strategy for increasing alcohol abstinence and a tool that can be used by American Indian and Alaska Native communities for the treatment of individuals with alcohol use disorders. ClinicalTrials.gov Identifier: NCT02174315.

Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial.

Objective: To conduct an interim analysis of data collected from an ongoing multisite randomized clinical trial (RCT) assessing the effectiveness of Trauma Center Trauma-Sensitive Yoga (TCTSY) for post-traumatic stress disorder (PTSD) among women veterans with PTSD related to military sexual trauma (MST). The purpose of the interim analysis was to assess outcomes from the primary site, which is geographically, demographically, culturally, and procedurally distinct from the second site. Design: RCT was conducted within a Veterans Administration Health Care System. Data collection included preintervention through 3 months postintervention. Participants: Enrollment for the main site was 152 women. The sample size for the intent-to-treat analysis was 104. The majority were African American (91.3%) with a mean age of 48.46 years. Intervention: The TCTSY intervention (n = 58) was conducted by TCTSY-certified yoga facilitators and consisted of 10 weekly 60-min group sessions. The control intervention, cognitive processing therapy (CPT; n = 46), consisted of 12 90-min weekly group sessions conducted per Veterans Administration protocol by clinicians in the PTSD Clinic. Outcome measures: The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) was used to assess current PTSD diagnosis and symptom severity, including overall PTSD and four symptom clusters. The PTSD checklist for DSM-5 (PCL-5) was used to obtain self-report of PTSD symptom severity, including total score and four symptom clusters. Results: The findings reported here are interim results from one clinical site. For both the CAPS-5 and PCL-5, total scores and all four criterion scores decreased significantly (p < 0.01) over time in all five multilevel linear models within both TCTSY and CPT groups, without significant differences between groups. There were clinically meaningful improvements seen for both TCTSY and CPT with 51.1%-64.3% of TCTSY subjects and 43.5%-73.7% of CPT decreasing their CAPS-5 scores by 10 points or more. Effect sizes for total symptom severity were large for TCTSY (Cohen's d = 1.10-1.18) and CPT (Cohen's d = 0.90-1.40). Intervention completion was higher in TCTSY (60.3%) than in CPT (34.8%). Symptom improvement occurred earlier for TCTSY (midintervention) than for CPT (2 weeks postintervention). Safety: There were no unanticipated adverse events in this study. Conclusion: The results of this study demonstrate that TCTSY may be an effective treatment for PTSD that yields symptom improvement more quickly, has higher retention than CPT, and has a sustained effect. TCTSY may be an effective alternative to trauma-focused therapy for women veterans with PTSD related to MST. The study is registered in ClinicalTrials.gov (CTR no.: NCT02640690).

Correlates of oral health fatalism in caregivers of children with autism spectrum disorder.

To study correlates of oral health fatalism (OHF) in caregivers of children with autism spectrum disorder (ASD). This exploratory analysis used baseline data from 118 Medicaid-eligible families of children with ASD in a multi-site randomized clinical trial of a parent training intervention supporting home oral hygiene and dental visits. About half (46%) of caregivers agreed with the statement "most children eventually develop dental cavities," endorsing OHF. Hispanic caregivers more strongly endorsed OHF than non-Hispanics (cumulative odds ratio=2.4, 95% confidence interval [CI]: 1.2-4.7, P=.014). Caregivers living alone with children less strongly endorsed OHF than caregivers cohabitating with other adults (cumulative odds ratio=0.39, 95% CI 0.17-0.86, P=.019). Multivariable analysis maintained significance of ethnicity (P=.030) but not living situation (P=.052). Additional analyses included demographics, parenting beliefs, and children's oral hygiene and oral health status. About half the caregivers endorsed OHF, with Hispanic caregivers more strongly endorsing OHF. OHF was not significantly associated with oral health behaviors or status, consistent with emerging literature suggesting fatalism is not necessarily linked to health behavior. Further exploration of OHF correlates in families of children with ASD is needed; ethnicity, living situation, child age, and caries status are of interest.

Effectiveness of Integrated Palliative and Oncology Care for Patients With Acute Myeloid Leukemia

Patients with acute myeloid leukemia (AML) receiving intensive chemotherapy experience substantial decline in their quality of life (QOL) and mood during their hospitalization for induction chemotherapy and often receive aggressive care at the end of life (EOL). However, the role of specialty palliative care for improving the QOL and care for this population is currently unknown. To assess the effect of integrated palliative and oncology care (IPC) on patient-reported and EOL outcomes in patients with AML. We conducted a multisite randomized clinical trial of IPC (n = 86) vs usual care (UC) (n = 74) for patients with AML undergoing intensive chemotherapy. Data were collected from January 2017 through July 2019 at 4 tertiary care academic hospitals in the United States. Patients assigned to IPC were seen by palliative care clinicians at least twice per week during their initial and subsequent hospitalizations. Patients completed the 44-item Functional Assessment of Cancer Therapy-Leukemia scale (score range, 0-176) to assess QOL; the 14-item Hospital Anxiety and Depression Scale (HADS), with subscales assessing symptoms of anxiety and depression (score range, 0-21); and the PTSD Checklist-Civilian version to assess posttraumatic stress disorder (PTSD) symptoms (score range, 17-85) at baseline and weeks 2, 4, 12, and 24. The primary end point was QOL at week 2. We used analysis of covariance adjusting and mixed linear effect models to evaluate patient-reported outcomes. We used Fisher exact test to compare patient-reported discussion of EOL care preferences and receipt of chemotherapy in the last 30 days of life. Of 235 eligible patients, 160 (68.1%) were enrolled; of the 160 participants, the median (range) age was 64.4 (19.7-80.1) years, and 64 (40.0%) were women. Compared with those receiving UC, IPC participants reported better QOL (adjusted mean score, 107.59 vs 116.45; P = .04), and lower depression (adjusted mean score, 7.20 vs 5.68; P = .02), anxiety (adjusted mean score, 5.94 vs 4.53; P = .02), and PTSD symptoms (adjusted mean score, 31.69 vs 27.79; P = .01) at week 2. Intervention effects were sustained to week 24 for QOL (β, 2.35; 95% CI, 0.02-4.68; P = .048), depression (β, -0.42; 95% CI, -0.82 to -0.02; P = .04), anxiety (β, -0.38; 95% CI, -0.75 to -0.01; P = .04), and PTSD symptoms (β, -1.43; 95% CI, -2.34 to -0.54; P = .002). Among patients who died, those receiving IPC were more likely than those receiving UC to report discussing EOL care preferences (21 of 28 [75.0%] vs 12 of 30 [40.0%]; P = .01) and less likely to receive chemotherapy near EOL (15 of 43 [34.9%] vs 27 of 41 [65.9%]; P = .01). In this randomized clinical trial of patients with AML, IPC led to substantial improvements in QOL, psychological distress, and EOL care. Palliative care should be considered a new standard of care for patients with AML. ClinicalTrials.gov Identifier: NCT02975869.

Screening, Brief Intervention, and Referral to Treatment for Pain Management for Veterans Seeking Service-Connection Payments for Musculoskeletal Disorders: SBIRT-PM Study Protocol.

BackgroundVeterans with significant chronic pain from musculoskeletal disorders are at risk of substance misuse. Veterans whose condition is the result of military service may be eligible for a disability pension. Department of Veterans Affairs compensation examinations, which determine the degree of disability and whether it was connected to military service, represent an opportunity to engage Veterans in pain management and substance use treatments. A multisite randomized clinical trial is testing the effectiveness and cost-effectiveness of Screening, Brief Intervention, and Referral to Treatment for Pain Management (SBIRT-PM) for Veterans seeking compensation for musculoskeletal disorders. This telephone-based intervention is delivered through a hub-and-spoke configuration.DesignThis study is a two-arm, parallel-group, 36-week, multisite randomized controlled single-blind trial. It will randomize 1,100 Veterans experiencing pain and seeking service-connection for musculoskeletal disorders to either SBIRT-PM or usual care across eight New England VA medical centers. The study balances pragmatic with explanatory methodological features. Primary outcomes are pain severity and number of substances misused. Nonpharmacological pain management and substance use services utilization are tracked in the trial.SummaryEarly trial enrollment targets were met across sites. SBIRT-PM could help Veterans, at the time of their compensation claims, use multimodal pain treatments and reduce existing substance misuse. Strategies to address COVID-19 pandemic impacts on the SBIRT-PM protocol have been developed to maintain its pragmatic and exploratory integrity.

Individual-Level Predictors of the Working Relationship between Probation Officers and Probationers

The working relationship between probation officers and probationers is an important area of research given recent studies illustrate a strong relationship reduces recidivism. In this study, the perceptions of the working relationship between officers and probationers were examined among a group of substance-using probationers who participated in a multi-site randomized clinical trial. After 6 months, probationers who reported greater alcohol use and greater family and peer drug use on a baseline Addiction Severity Index were less likely to perceive their probation officer as being caring/fair/trustworthy, and older probationers were less likely to perceive their PO as being tough. Important policy implications are discussed.

Perfectionism, anorexia nervosa, and family treatment: How perfectionism changes throughout treatment and predicts outcomes.

This study uses data from a multisite randomized clinical trial to study the role of perfectionism in family-based treatment (FBT) for adolescent anorexia nervosa (AN). The main aim is to examine the role of baseline perfectionism in treatment response. Adolescents (N = 158; ages 12-18; 89.2% female) and their families were randomized to receive either FBT or systemic family treatment for AN. Eating disorder (ED) pathology, obsessive-compulsive symptoms, and perfectionism were assessed at baseline, end of treatment, and 6- and 12-month follow-up. Linear regression analyses were used to test whether perfectionism and obsessive-compulsive symptoms at baseline predict ED pathology at all timepoints. An independent samples t test was used to test whether there was a significant difference in the change in perfectionism in either treatment group. Baseline maladaptive perfectionism significantly predicted ED pathology but not ideal body weight at all timepoints. The model that included obsessive-compulsive symptoms also predicted ED pathology at all timepoints except 12-month follow-up. Perfectionism scores did not change during treatment regardless of treatment type. Baseline perfectionism predicted treatment response in this study. Interventions might target perfectionism to improve treatment response in AN.

Utility of an Observational Social Skill Assessment as a Measure of Social Cognition in Autism.

Models of impaired social competence in autism spectrum disorder (ASD) highlight deficits in social cognition and social behavior. The Contextual Assessment of Social Skills (CASS) is a laboratory-based assessment of conversation ability in which participants interact with trained confederates who act interested (CASS-I) and bored (CASS-B), sequentially. The increased ecological validity of the CASS allows for better generalization to real-world social situations. Participants' perceptions of confederate behavior, assessed by the CASS Conversation Rating Scale (CRS), might offer additional utility as a metric of social cognition. The current study examined CASS confederate behavior (adherence to interested or bored condition) and both internal validity and convergent validity of the CASS as a measure of social behavior and social cognition. Fifty adolescents with ASD participated as part of a multisite randomized clinical trial. Adherence ratings were consistent across gender and site, with interested confederates significantly out-performing bored confederates. The ability to distinguish between interested and bored confederates was positively associated with CASS social behavior and social cognition tasks, although social behavior during the CASS was not consistently associated with parent-rated social behavior. Controlling for confederate behavior did not significantly alter these associations. Findings demonstrate strong internal validity of the CASS and, partially, external validity of the CASS as a measure of social cognition. Findings highlight nuanced differences in social behavior and social cognition. The CASS shows promise as an outcome measure for clinical interventions and should be incorporated into a multimethod battery to assess social competence in individuals with ASD. LAY SUMMARY: Social cognition and social behavior should be studied together to examine social competence in youth with autism. The Contextual Assessment of Social Skills (CASS), a behavioral observation measure, shows promise toward this end; findings suggest the CASS taps social cognition and social behavior when administered alongside a participant rating scale of their conversation partner's engagement. Continued research, including examination of the CASS, may inform best practices in comprehensive assessment of social competence in autism. Autism Res 2021, 14: 709-719. © 2020 International Society for Autism Research and Wiley Periodicals LLC.

Short-term Psychological Outcomes of Disclosing Amyloid Imaging Results to Research Participants Who Do Not Have Cognitive Impairment

The goal of preclinical Alzheimer disease (AD) clinical trials is to move diagnosis and treatment to presymptomatic stages, which will require biomarker testing and disclosure. To assess the short-term psychological outcomes of disclosing amyloid positron emission tomography results to older adults who did not have cognitive impairment. This observational study included participants who were screening for a multisite randomized clinical trial that began on February 28, 2014, and is anticipated to be completed in 2022. Participants aged 65 to 85 years who had no known cognitive impairments underwent an amyloid positron emission tomography scan and learned their result from an investigator who used a protocol-specified process that included prescan education and psychological assessments. This report compares participants with elevated amyloid levels with at least 1 available outcome measure with participants who did not have elevated amyloid levels who enrolled in an observational cohort study and received further evaluations. Data were collected from April 2014 to December 2017 and analyzed from March 2019 to October 2019. A personal biomarker result described as either an elevated or not elevated amyloid level. To assess the immediate and short-term psychological outcome of disclosure, the following validated measures were used: the Geriatric Depression Scale, the state items from the State-Trait Anxiety Inventory, and the Columbia Suicide Severity Rating Scale, as well as the Concerns About AD Scale and the Future Time Perspective Scale to assess changes in participants' perceived risk for AD and perceived remaining life span, respectively. A total of 1167 participants with elevated amyloid levels and 538 participants with not elevated amyloid levels were included. Participants had a mean (SD) age of 71.5 (4.7) years, 1025 (60.1%) were women, and most were white (1611 [94.5%]) and non-Latino (1638 [96.1%]). Compared with participants who learned that they had a not elevated amyloid result, individuals who learned of an elevated amyloid result were no more likely to experience short-term increases in depression (mean [SD] change in the Geriatric Depression Scale score, 0.02 [1.3] vs 0.04 [1.3]; P = .90), anxiety (mean [SD] change in State-Trait Anxiety Inventory score, -0.02 [3.2] vs -0.15 [3.0]; P = .65), or suicidality (mean [SD] change in the Columbia Suicide Severity Rating Scale score, 0.0 [0.4] vs -0.01 [0.5]; P = .67). Participants with elevated amyloid levels had increased Concern About AD scores (raw change in scores: elevated amyloid group, 0.8 [3.9]; not elevated amyloid group, -0.4 [3.8]; P < .001). Participants with not elevated amyloid levels experienced a slight increase in Future Time Perspective score(mean [SD] score, 1.15 [7.4] points; P < .001); there was no change in time perspective among those receiving an elevated amyloid result (mean [SD] score, 0.33 [7.8] points). In this observational preclinical AD study, participants who learned they had elevated amyloid levels did not experience short-term negative psychological sequelae compared with persons who learned they did not have elevated amyloid levels.

The Effect of Business Internships Model and Employment on Enhancing the Independence of Young Adults With Significant Impact From Autism.

This article presents findings from a multisite randomized clinical trial measuring the impact of employment on independence in 18 to 22 year old youth with significant impact from autism spectrum disorder (ASD). The treatment condition was Project SEARCH plus ASD Supports (PS+ASD) where 73.4% of participants gained competitive integrated employment (CIE) within 1 year of graduation compared to control participants who acquired CIE at 17%. Within group analysis revealed that PS+ASD participants demonstrated improvement in all domains whereas control group participants demonstrated improvement in one domain only. Between groups analysis indicated that participants in PS+ASD demonstrated nominally better rates of improvement than control group participants at graduation and 1-year follow-up. Results provide evidence that employment provides therapeutic benefits to individuals with ASD.

Extended-release naltrexone versus buprenorphine-naloxone to treat opioid use disorder among black adults

Few studies examine the effectiveness of treatments for opioid use disorder (OUD) among Black individuals despite recent evidence suggesting opioid overdose death rates are, in some cases, highest and increasing at a faster rate among Black people compared to other racial/ethnic groups. This secondary analysis study investigated treatment preference, retention, and relapse rates amongst a subgroup of 73 Black participants with OUD (81% male, mean age 39.05, SD = 11.80) participating in a 24-week multisite randomized clinical trial (“X:BOT”) comparing the effectiveness of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) between 2014 and 2017. Chi-square analyses were used to investigate treatment preference assessed at baseline, and logistic regression analyses were used to investigate differences in the odds of retention and relapse assessed over the 24-week course of treatment between treatment groups. Our findings suggest no differences in preference for XR-NTX versus BUP-NX. However, similar to the parent trial, there was an induction hurdle such that only 59.5% of those randomized to XR-NTX successfully initiated medication compared to 91.6% of those randomized to BUP-NX (OR = 0.13, 95% CI = 0.04, 0.52). No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol [i.e., those who initiated medication]: OR = 0.60, 95% CI = 0.20, 1.82) or relapse rates between treatment groups (intention-to-treat: OR = 1.53, 95% CI = 0.57, 4.13; per-protocol: OR = 0.69, 95% CI = 0.23, 2.06). Although there is a significant initiation hurdle with XR-NTX, once inducted, both medications appear similar in effectiveness, but as in the main study, dropout rates were high. Future research is needed on how to improve adherence.

Dosage of booster phone calls following an SBIRT intervention in the emergency department for reducing substance use

Brief Interventions (BIs) for problematic drug use in general medical settings, including in Emergency Departments (EDs), have shown disappointing results compared to those that target problematic alcohol use. Telephone booster calls may augment the impact of a BI delivered in the ED. The current study uses data from the National Drug Abuse Treatment Clinical Trials Network (CTN) Protocol 0047, “Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED)”, a multisite randomized clinical trial conducted in six EDs in the U.S. We examine dose effects of telephone boosters (0, 1, or 2 calls completed) with non–treatment seeking patients who we randomized to the BI-Booster condition and who endorsed problematic drug use during their ED visit (N = 427). We assessed primary outcomes at 3-, 6-, and 12-month follow-ups, which included past month use of the primary drug of choice, use of any drug, and heavy drinking. There were no significant differences among those completing 0, 1, or 2 booster calls on any of the three main outcomes at 3-, 6-, and 12-months post-BI in the ED. Patients who were older were significantly more likely to complete booster calls. Taken together, these findings raise questions about the clinical utility of booster phone calls following screening and BIs targeting heterogeneous drug use in the ED.