Change in posttraumatic stress disorder-related thoughts during treatment: Do thoughts drive change when pills are involved?

Posttraumatic negative thoughts about one's self and the world are related to posttraumatic stress disorder (PTSD) symptom severity and change in cognitive behavioral treatment (CBT), but little is known about this association when CBT is delivered with medication. The current study presents a planned comparison of changes in negative posttraumatic thoughts during (a) prolonged exposure (PE) plus pill placebo (PE+PLB), (b) sertraline plus enhanced medication management (SERT+EMM), and (c) PE plus sertraline (PE+SERT) as part of a randomized clinical trial in a sample of 176 veterans. Lagged regression modeling revealed that change in posttraumatic negative thoughts was associated with PTSD symptom change in the conditions in which participants received sertraline, ds = 0.14-0.25, ps = 0.04-.001). However, contrary to previous research, the models that started with symptom change were also statistically significant, d = 0.23, p < .001, for the lagged effect of symptoms on negative thoughts about self in the SERT+EMM condition, indicating a bidirectional association between such thoughts and PTSD symptoms. In the PE+PLB condition, no significant association between posttraumatic thoughts and PTSD symptoms emerged in either direction. These results suggest that the previously demonstrated role of change in posttraumatic thoughts leading to PTSD symptom reduction in PE may be altered when combined with pill administration, either active or placebo.

Benzodiazepine Prescribing from VA and Medicare to Dually Enrolled Older Veterans: A Retrospective Cohort Study.

BACKGROUND: There has been a reduction in BZD prescribing in the Veterans Affairs (VA) health care system since 2013. It is unknown whether the decline in VA-dispensed BZDs has been offset by Medicare Part D prescriptions. OBJECTIVES: To examine (1) whether, accounting for Part D, declines in BZD prescribing to older Veterans remain; (2) patient characteristics associated with obtaining BZDs outside VA and facility variation in BZD source (VA only, VA and Part D, Part D only). DESIGN: Retrospective cohort study with mixed effects multinomial logistic model examining characteristics associated with BZD source. PATIENTS: A total of 1,746,278 Veterans aged ≥65 enrolled in VA and Part D, 2013-2017. MAIN MEASURES: BZD prescription prevalence and source. KEY RESULTS: From January 2013 to June 2017, the quarterly prevalence of older Veterans with Part D filling BZD prescriptions through the VA declined from 5.2 to 3.1% (p<0.001) or, accounting for Part D, from 10.0 to 7.7% (p<0.001). Among those prescribed BZDs between July 2016 and June 2017, 37.0%, 10.2%, and 52.8% received prescriptions from VA only, both VA and Part D, or Part D only, respectively. Older age was associated with higher odds of obtaining BZDs through Part D (e.g., compared to those 65-74, Veterans ≥85 had adjusted odds ratio [AOR] for Part D vs. VA only of 1.8 [95% highest posterior density interval (HPDI), 1.69, 1.86]). Veterans with substance use disorders accounted for few BZD prescriptions from any source but were associated with higher odds of prescriptions through Part D (e.g., alcohol use disorder AOR for Part D vs. VA alone: 1.9 [95% HPDI, 1.63, 2.11]) CONCLUSIONS: The decline in BZD use by older Veterans with Part D coverage remained after accounting for Part D, but the majority of BZD prescriptions came from Medicare. Further reducing BZD prescribing to older Veterans should consider prescriptions from community sources.

Prevalence of Central Nervous System-Active Polypharmacy Among Older Adults With Dementia in the US.

Importance: Community-dwelling older adults with dementia have a high prevalence of psychotropic and opioid use. In these patients, central nervous system (CNS)-active polypharmacy may increase the risk for impaired cognition, fall-related injury, and death. Objective: To determine the extent of CNS-active polypharmacy among community-dwelling older adults with dementia in the US. Design, Setting, and Participants: Cross-sectional analysis of all community-dwelling older adults with dementia (identified by International Classification of Diseases, Ninth Revision, Clinical Modification or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnosis codes; N = 1 159 968) and traditional Medicare coverage from 2015 to 2017. Medication exposure was estimated using prescription fills between October 1, 2017, and December 31, 2018. Exposures: Part D coverage during the observation year (January 1-December 31, 2018). Main Outcomes and Measures: The primary outcome was the prevalence of CNS-active polypharmacy in 2018, defined as exposure to 3 or more medications for longer than 30 days consecutively from the following classes: antidepressants, antipsychotics, antiepileptics, benzodiazepines, nonbenzodiazepine benzodiazepine receptor agonist hypnotics, and opioids. Among those who met the criterion for polypharmacy, duration of exposure, number of distinct medications and classes prescribed, common class combinations, and the most commonly used CNS-active medications also were determined. Results: The study included 1 159 968 older adults with dementia (median age, 83.0 years [interquartile range {IQR}, 77.0-88.6 years]; 65.2% were female), of whom 13.9% (n = 161 412) met the criterion for CNS-active polypharmacy (32 139 610 polypharmacy-days of exposure). Those with CNS-active polypharmacy had a median age of 79.4 years (IQR, 74.0-85.5 years) and 71.2% were female. Among those who met the criterion for CNS-active polypharmacy, the median number of polypharmacy-days was 193 (IQR, 88-315 polypharmacy-days). Of those with CNS-active polypharmacy, 57.8% were exposed for longer than 180 days and 6.8% for 365 days; 29.4% were exposed to 5 or more medications and 5.2% were exposed to 5 or more medication classes. Ninety-two percent of polypharmacy-days included an antidepressant, 47.1% included an antipsychotic, and 40.7% included a benzodiazepine. The most common medication class combination included an antidepressant, an antiepileptic, and an antipsychotic (12.9% of polypharmacy-days). Gabapentin was the most common medication and was associated with 33.0% of polypharmacy-days. Conclusions and Relevance: In this cross-sectional analysis of Medicare claims data, 13.9% of older adults with dementia in 2018 filled prescriptions consistent with CNS-active polypharmacy. The lack of information on prescribing indications limits judgments about clinical appropriateness of medication combinations for individual patients.

Moving Evidence-Informed Assessment and Management of Behavioral and Psychological Symptoms of Dementia into the Real World: Training Family and Staff Caregivers in the DICE Approach.

OBJECTIVE: To investigate the impact of a one-day training program on caregivers' confidence and knowledge in managing aspects of dementia care. DESIGN: One-day caregiver training program featuring: 1) an interactive, multi-media format; 2) a companion manual; and 3) a "brain-storming" session at the end of the day that utilized attendees' real-world cases where the use of the DICE (Describe, Investigate, Create, and Evaluate) approach was illustrated "live." SETTING: Three different geographical sites in Michigan. PARTICIPANTS: Family (n = 40) and professional (paid; n = 140) caregivers (total n = 180) for people with dementia. MEASURES: Pre- and post self-ratings related to confidence in aspects of dementia care management before and directly after the training. RESULTS: Comparing self-ratings pre- and post-training, more than 50% of family caregivers showed improvement in confidence post-training on 11 of 12 items with significant improvement in 4 items. Among professionals, more than 50% of caregivers showed improved confidence on 3 of 12 items, with 4 items showing significant improvement. Family caregivers were significantly more likely than professionals to show improved confidence on 6 of 12 items. CONCLUSIONS: The number of people with dementia and their family caregivers is large and growing every day with the aging of the population. Living well with dementia is the goal. Current care systems are inadequate and lead to multiple poor outcomes. Innovative solutions like the DICE Approach with delivery methods including a manual and interactive training can put the key components of good dementia care at the fingertips of the people who need it most.

Understanding the impact of complicated grief on combat related posttraumatic stress disorder, guilt, suicide, and functional impairment in a clinical trial of post-9/11 service members and veterans.

BACKGROUND: Complicated grief (CG) is a bereavement-specific syndrome distinct from but commonly comorbid with posttraumatic stress disorder (PTSD). While bereavement is common among military personnel (Simon et al., 2018), there is little research on the impact of CG comorbidity on PTSD treatment outcomes. METHODS: To evaluate the impact of comorbid CG on PTSD treatment outcomes we analyzed data from a randomized trial comparing prolonged exposure, sertraline, and their combination in veterans with a primary diagnosis of combat-related PTSD (n = 194). Assessment of PTSD, trauma-related guilt, functional impairment, and suicidal ideation and behavior occurred at baseline and weeks 6, 12, and 24 during the 24-week trial. RESULTS: CG was associated with lower PTSD treatment response (odds ratio (OR) = 0.29, 95% confidence interval (CI) [0.12, 0.69], p = 0.005) and remission (OR = 0.28, 95% CI [0.11, 0.71], p = 0.007). Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint. In addition, those with CG were more likely to experience suicidal ideation during the study (CG: 35%, 14/40 vs. no CG 15%, 20/130; OR = 3.01, 95% CI [1.29, 7.02], p = 0.011). CONCLUSIONS: Comorbid CG is associated with elevated PTSD severity and independently associated with poorer endpoint treatment outcomes in veterans with combat-related PTSD, suggesting that screening and additional intervention for CG may be needed.

Predicting Outcomes After Distal Radius Fracture: A 24-Center International Clinical Trial of Older Adults.

PURPOSE: Current evidence on predictors of outcomes after distal radius fracture is often based on retrospective analyses or may be confounded by fracture type. Using data from the Wrist and Radius Injury Surgical Trial (WRIST), a 24-site randomized study of distal radius fracture treatment, in which all fractures are severe enough to warrant surgery, we set out to perform a secondary data analysis to explore predictors of better or worse hand outcomes. METHODS: The primary outcome measure was the Michigan Hand Outcomes Questionnaire (MHQ) summary score 12 months after treatment. We used a regression tree analysis with recursive partitioning to identify subgroups of participants who experienced similar outcomes (ie, MHQ score) and to determine which baseline or treatment factors they had in common. RESULTS: Factors most predictive of 12-month MHQ score were pain at enrollment, education, age, and number of comorbidities. Specifically, participants who had a high school education or less and also reported severe pain had the lowest MHQ scores. Conversely, participants with less pain and more education and who were age 87 years or younger with one or no comorbid condition had the highest MHQ scores. Treatment type or radiographic measurements assessed on post-reduction films did not affect 12-month outcomes. CONCLUSIONS: These results identified patient characteristics that can be used by surgeons to identify subgroups of patients who may experience similar hand outcomes. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic III.

Antidepressant Medication Treatment and Risk of Death.

OBJECTIVE: Although previous studies have assessed whether depression is a mortality risk factor, few have examined whether antidepressant medications (ADMs) influence mortality risk. METHODS: We estimated hazards of 1-year all-cause mortality associated with ADMs, with use occurring within 90 days of depression diagnosis among 720 821 patients who received treatment in a Veterans Health Administration facility during fiscal year 2006. We addressed treatment selection biases using conventional Cox regression, propensity-stratified Cox regression (propensity score), and 2 forms of marginal structural models. Models accounted for multiple potential clinical and demographic confounders, and sensitivity analyses compared findings by antidepressant class. RESULTS: Antidepressant medication use compared with no use was associated with significantly lower hazards of 1-year mortality risk in Cox (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.90-0.97) and propensity score estimates (HR, 0.94; 95% CI, 0.91-0.98), whereas marginal structural model-based estimates showed no difference in mortality risk when the exposure was specified as "as-treated" in every 90-day intervals of the 1-year follow-up (HR, 0.91; 95% CI, 0.66-1.26) but showed increased risk when specified as "intent-to-treat" (HR, 1.07; 95% CI, 1.02-1.13). CONCLUSIONS: Among patients treated with ADMs belonging to a single class in the first 90 days, there were no significant differences in 1-year all-cause mortality risks. When accounting for clinical and demographic characteristics and treatment selection bias, ADM use was associated with no excess harm.

"It is not guaranteed that you will benefit": True but misleading?

BACKGROUND: Participants of early-phase intervention trials for serious conditions provide high estimates of likelihood of benefit, even when informed consent forms do not promise such benefits. However, some technically correct, negatively stated benefits statements­such as "it is not guaranteed that you will benefit"­could play a role in raising expectations of benefit because in ordinary English usage such statements denote a likely but not a certain-to-occur event. METHODS: An experimental online survey of 584 English-speaking adults recruited online. They were randomized to receive one of two benefit statements ("not guaranteed" vs "some but very small chance"), using a hypothetical scenario of an early-phase clinical trial testing an intervention to treat amyotrophic lateral sclerosis. We assessed respondents' willingness to consider participating in the amyotrophic lateral sclerosis trial, their estimates of likelihood of benefit, and their explanations for those estimates. RESULTS: The two arms did not differ in willingness to consider participation in the amyotrophic lateral sclerosis trial. Those receiving "not guaranteed" benefit statement had higher estimates of benefit than those receiving "some but very small chance" statement (35.7% (standard deviation 20.2) vs 28.3% (standard deviation 22.0), p < 0.0001). A total of 43% of all respondents chose expressions of positive sentiment (hope and need to stay positive) as explanations of their estimates; these respondents' estimates of benefit were higher than others but similar between the two arms. The effect of benefit statements was greatest among those who chose "Those are just the facts" as the explanation for their estimate (31.0% (standard deviation 22.4%) in "not guaranteed" arm vs 18.9% (standard deviation 21.0%) in comparison arm, p = 0.008). CONCLUSION: The use of "not guaranteed" language in benefit statements, when compared to "small but very small chance" language, appeared to increase the perception of likelihood of benefit of entering an early-phase trial, especially among those who view their estimates of benefits as "facts." Such "no guarantee" benefit statements may be misleading and should not be used in informed consent forms.

Are therapeutic motivation and having one's own doctor as researcher sources of therapeutic misconception?

BACKGROUND: Desire for improvement in one's illness and having one's own doctor functioning as a researcher are thought to promote therapeutic misconception (TM), a phenomenon in which research subjects are said to conflate research with treatment. PURPOSE: To examine whether subjects' therapeutic motivation and own doctor functioning as researcher are associated with TM. METHODS: We interviewed 90 persons with advanced Parkinson's disease (PD) enrolled or intending to enrol in sham surgery controlled neurosurgical trials, using qualitative interviews. Subjects were compared by motivation (primarily therapeutic vs primarily altruistic or dually motivated by altruistic and therapeutic motivation), and by doctor status (own doctor as site investigator vs not) on the following: understanding of purpose of study; understanding of research procedures; perception of chance of direct benefit; and recollection and perceptions concerning the risks. RESULTS: 60% had primarily therapeutic motivation and 44% had their own doctor as the site investigator, but neither were generally associated with increased TM responses. Overall level of understanding of purpose and procedures of research were high. Subjects responded with generally high estimates of probability of direct benefit, but their rationales were personal and complex. The therapeutic-motivation group was more sensitive to risks. Five (5.6%) subjects provided incorrect answers to the question about purpose of research, and yet, showed excellent understanding of research procedures. CONCLUSIONS: In persons with PD involved in sham surgery clinical trials, being primarily motivated by desire for direct benefit to one's illness or having one's own doctor as the site investigator were not associated with greater TM responses.

Patient compliance and suboptimal bowel preparation with split-dose bowel regimen in average-risk screening colonoscopy.

BACKGROUND: Although split-dose bowel regimen is recommended in colon cancer screening and surveillance guidelines, implementation in clinical practice has seemingly lagged because of concerns of patient compliance. OBJECTIVES: To assess patient compliance with the split-dose bowel regimen and assess patient- and preparation process-related factors associated with compliance and bowel preparation adequacy. DESIGN: Prospective survey cohort. SETTING: Tertiary care setting. PATIENTS: Average-risk patients undergoing colonoscopy for colorectal cancer screening between August 2011 and January 2013. MAIN OUTCOME MEASUREMENTS: Split-dose bowel regimen patient-reported compliance and bowel preparation adequacy with the Boston Bowel Preparation Scale score. RESULTS: Surveys and Boston Bowel Preparation Scale score data were completed in 462 participants; 15.4% were noncompliant with the split-dose bowel regimen, and suboptimal bowel preparation (score <5) was reported in 16% of all procedures. White (P = .009) and married (P = .01) subjects were least likely to be noncompliant, whereas Hispanic subjects and those who reported incomes of US$75,000 or less were most likely to be noncompliant (P = .004). Participants who were noncompliant with split-dosing were less likely to follow the other laxative instructions and more likely to have their colonoscopy appointment before 10:30 am. Compliance differed by bowel preparation type (P = .003, χ(2) test), with those who used MiraLAX showing the highest compliance, followed by polyethylene glycol electrolyte solution and other bowel preparations. Noncompliance with split-dose bowel preparation (odds ratio 6.7; 95% confidence interval, 3.2-14.2) was the strongest predictor of suboptimal bowel preparation. LIMITATIONS: Patient self-report, performed at tertiary care center. CONCLUSIONS: Overall, 1 in 7 patients do not comply with a split-dose bowel regimen. Ensuring compliance with the split-dose bowel regimen will reduce the risk of a suboptimal bowel preparation.

The association between race and gender, treatment attitudes, and antidepressant treatment adherence.

OBJECTIVES: We examined the associations between treatment attitudes and beliefs with race-gender differences in antidepressant adherence. METHODS: Subjects (n = 186) were African-American and White subjects aged ≥60 years, diagnosed with clinically significant depression, and had a new outpatient primary care recommendation for antidepressant treatment. Antidepressant adherence was assessed using the Brief Medication Questionnaire. Attitudes and beliefs were assessed using the Patients Attitudes Toward and Ratings of Care for Depression, two items rating perceived medication importance, and a modified version of the Stigma Scale for Receiving Psychological Help. RESULTS: African-American men and women had significantly greater concerns about antidepressants and significantly less understanding about treatment than White women. African-American men had significantly more negative attitudes toward healthcare providers than African-American and White women. African-American women were more likely than White men and women to endorse a medication other than their antidepressant as most important. Whereas some race-gender differences were found in personal spirituality, no group differences were found in perceived stigma. In a logistic regression model adjusted for key baseline variables, White women were significantly more adherent to antidepressants than African-American women (OR = 3.05, 95% CI = 1.06-8.81). Fewer concerns about antidepressants and indicating the antidepressant as the most important medication were both significantly associated with adherence. After including either of these two variables, the adherence difference between White women and African-American women was no longer significant (OR = 2.56, 95% CI = 0.84-7.80). CONCLUSIONS: Concerns about antidepressants and the importance of antidepressant medication are associated with adherence and are potentially modifiable through improved patient-provider communication, psycho-education, and therapeutic interventions.

Predictors of functional outcomes after simple decompression for ulnar neuropathy at the elbow: a multicenter study by the SUN study group.

OBJECTIVE: To identify predictors of surgical outcome for ulnar neuropathy at the elbow (UNE). DESIGN: Prospective cohort followed for 1 year. SETTING: Clinics. PARTICIPANTS: Patients diagnosed with UNE (N=55). INTERVENTION: All subjects had simple decompression surgery. MAIN OUTCOME MEASURES: The primary outcome measure was patient-reported outcomes, such as overall hand function through the Michigan Hand Outcomes Questionnaire (MHQ). Predictors included age, duration of symptoms, disease severity, and motor conduction velocity across the elbow. RESULTS: Multiple regression models with change in the overall MHQ score as the dependent variable showed that at 3 months postoperative time, patients with <3 months duration of symptoms showed 12 points (95% confidence interval [CI], 0.9-23.5) greater improvement in MHQ scores than those with ≥3 months symptom duration. Less than 3 months of symptoms was again associated with 13 points (95% CI, 2.9-24) greater improvement in MHQ scores at 6 months postoperative, but it was no longer associated with better outcomes at 12 months. A worse baseline MHQ score was associated with significant improvement in MHQ scores at 3 months (coefficient, -0.38; 95% CI, -.67 to -.09), and baseline MHQ score was the only significant predictor of 12 month MHQ scores (coefficient, -.40; 95% CI, -.79 to -.01). CONCLUSIONS: Subjects with <3 months of symptoms and worse baseline MHQ scores showed significantly greater improvement in functional outcomes as reported by the MHQ. However, duration of symptoms was only predictive at 3 or 6 months because most patients recovered within 3 to 6 months after surgery.

Reported barriers to mental health care in three samples of U.S. Army National Guard soldiers at three time points.

The military community and its partners have made vigorous efforts to address treatment barriers and increase appropriate mental health services use among returning National Guard soldiers. We assessed whether there were differences in reports of treatment barriers in 3 categories (stigma, logistics, or negative beliefs about treatment) in sequential cross-sectional samples of U.S. soldiers from a Midwestern Army National Guard Organization who were returning from overseas deployments. Data were collected during 3 time periods: September 2007-August 2008 (n = 333), March 2009-March 2010 (n = 884), and August 2011-August 2012 (n = 737). In analyses using discretized time periods and in trend analyses, the percentages of soldiers endorsing negative beliefs about treatment declined significantly across the 3 sequential samples (19.1%, 13.9%, and 11.1%). The percentages endorsing stigma barriers (37.8%, 35.2%, 31.8%) decreased significantly only in trend analyses. Within the stigma category, endorsement of individual barriers regarding negative reactions to a soldier seeking treatment declined, but barriers related to concerns about career advancement did not. Negative treatment beliefs were associated with reduced services use (OR = 0.57; 95% CI [0.33, 0.97]).

Non-inferiority Study Design: Application to Clinical Trials.

SUMMARY: Non-inferiority trials, a distinct category within randomized controlled trials, are garnering increased attention in medical research. Their unique and evolving role comes to the forefront in scenarios where new treatments, despite not surpassing the efficacy of an existing standard, bring additional benefits like reduced side effects, enhanced compliance, or cost savings. As the field of surgery witnesses a growing number of published non-inferiority trials, it becomes imperative for surgeons to grasp the intricacies of this trial type to accurately decipher and interpret their outcomes.

Role of Institutional Support for Evidence-Based Psychotherapy in Satisfaction and Burnout Among Veterans Affairs Therapists.

OBJECTIVE: Burnout is widespread among psychotherapists and leads to negative mental and other health outcomes, absenteeism, and turnover. Job resources, including institutional support for evidence-based practices, can buffer against burnout and may improve satisfaction among therapists. The Veterans Health Administration (VHA) is the nation's largest integrated health system and employs 23,000 therapists, including psychologists, social workers, and counselors. The authors assessed associations between perceived institutional support for evidence-based treatment and satisfaction and burnout among VHA therapists. METHODS: This analysis used data from the VHA's national 2018 Mental Health Provider Survey. Responding therapists (N=5,341) answered questions about the quality of mental health care and job satisfaction. Multilevel logistic regression models were used to predict burnout and satisfaction. The authors tested availability of evidence-based treatment and measurement-based care (MBC) as predictors; analyses were adjusted for therapist workload, demographic characteristics, and potential clustering by facility. RESULTS: VHA therapists had less burnout and more job satisfaction when they perceived receiving institutional support for evidence-based psychotherapy (EBP) and MBC, irrespective of whether the analyses were adjusted for workload. Less difficulty in scheduling EBP was significantly associated with decreased likelihood of burnout (OR=0.83, p<0.001) and increased satisfaction (OR=1.09, p=0.008). Less difficulty ending psychotherapy was significantly associated with decreased likelihood of burnout (OR=0.89, p=0.002) and increased satisfaction (OR=1.12, p=0.004). CONCLUSIONS: Support for evidence-based practices, including EBP and MBC, was closely linked to VHA therapists' satisfaction and burnout. Expanding support for therapists to provide evidence-based treatment may benefit therapists, patients, and the health care system.

Effectiveness of a virtual quality improvement training program to improve reach of weight management programs within a large health system.

OBJECTIVE: To test effectiveness of the LEAP (Learn Engage Act Process) Program on engaging frontline Veteran Health Administration (VHA) medical center teams in continuous quality improvement (QI), a core capability for learning health systems. DATA SOURCES AND STUDY SETTING: Data sources included VHA electronic health record (EHR) data, surveys, and LEAP coaching field notes. STUDY DESIGN: A staggered difference-in-differences study was conducted. Fifty-five facilities participated in LEAP across eight randomly assigned clusters of 6-8 facilities per cluster over 2 years. Non-participating facilities were used as controls. A MOVE! weight management program team completed a Plan-Do-Study-Act cycle of change supported by learning curriculum, coaching, and virtual collaboratives in LEAP facilities. Primary outcome was program reach to Veterans. A mixed-effects model compared pre- versus post-LEAP periods for LEAP versus control facilities. LEAP adherence, satisfaction, and cost to deliver LEAP were evaluated. DATA COLLECTION/EXTRACTION METHODS: Thirty months of facility-level EHR MOVE! enrollment data were included in analyses. LEAP Satisfaction and QI skills were elicited via surveys at baseline and 6-month post-LEAP. PRINCIPAL FINDINGS: Fifty-five facilities were randomly assigned to eight time-period-based clusters to receive LEAP (71% completed LEAP) and 82 non-participating facilities were randomly assigned as controls. Reach in LEAP and control facilities was comparable in the 12-month pre-LEAP period (p = 0.07). Though LEAP facilities experienced slower decline in reach in the 12-month post-LEAP period compared with controls (p < 0.001), this is likely due to unexplained fluctuations in controls. For LEAP facilities, satisfaction was high (all mean ratings >4 on a 5-point scale), self-reported use of QI methods increased significantly (p-values <0.05) 6 months post-LEAP, and delivery cost was $4024 per facility-based team. CONCLUSION: Control facilities experienced declining reach in the 12-month post-LEAP period, but LEAP facilities did not, plus they reported higher engagement in QI, an essential capability for learning health systems.

Impact of PTSD treatment on postconcussive symptoms in veterans: A comparison of sertraline, prolonged exposure, and their combination.

Many Veterans who served in Iraq and Afghanistan struggle with posttraumatic stress disorder (PTSD) and the effects of traumatic brain injuries (TBI). Some people with a history of TBI report a constellation of somatic, cognitive, and emotional complaints that are often referred to as postconcussive symptoms (PCS). Research suggests these symptoms may not be specific to TBI. This study examined the impact of PTSD treatment on PCS in combat Veterans seeking treatment for PTSD. As part of a larger randomized control trial, 198 Operation Iraqi Freedom, Operation Enduring Freedom, Operation New Dawn (OIF/OEF/OND) Veterans with PTSD received Prolonged Exposure Therapy, sertraline, or the combination. Potential deployment related TBI, PCS, PTSD and depression symptoms were assessed throughout treatment. Linear mixed models were used to predict PCS change over time across the full sample and treatment arms, and the association of change in PTSD and depression symptoms on PCS was also examined. Patterns of change for the full sample and the subsample of those who reported a head injury were examined. Results showed that PCS decreased with treatment. There were no significant differences across treatments. No significant differences were found in the pattern of symptom change based on TBI screening status. Shifts in PCS were predicted by change PTSD and depression. Results suggest that PCS reduced with PTSD treatment in this population and are related to shift in depression and PTSD severity, further supporting that reported PCS symptoms may be better understood as non-specific symptoms.

Using Behavioral Economics to Reduce Low-Value Care Among Older Adults: A Cluster Randomized Clinical Trial.

Importance: Use of low-value care is common among older adults. It is unclear how to best engage clinicians and older patients to decrease use of low-value services. Objective: To test whether the Committing to Choose Wisely behavioral economic intervention could engage primary care clinicians and older patients to reduce low-value care. Design, Setting, and Participants: Stepped-wedge cluster randomized clinical trial conducted at 8 primary care clinics of an academic health system and a private group practice between December 12, 2017, and September 4, 2019. Participants were primary care clinicians and older adult patients who had diabetes, insomnia, or anxiety or were eligible for prostate cancer screening. Data analysis was performed from October 2019 to November 2023. Intervention: Clinicians were invited to commit in writing to Choosing Wisely recommendations for older patients to avoid use of hypoglycemic medications to achieve tight glycemic control, sedative-hypnotic medications for insomnia or anxiety, and prostate-specific antigen tests to screen for prostate cancer. Committed clinicians had their photographs displayed on clinic posters and received weekly emails with alternatives to these low-value services. Educational handouts were mailed to applicable patients before scheduled visits and available at the point of care. Main Outcomes and Measures: Patient-months with a low-value service across conditions (primary outcome) and separately for each condition (secondary outcomes). For patients with diabetes, or insomnia or anxiety, secondary outcomes were patient-months in which targeted medications were decreased or stopped (ie, deintensified). Results: The study included 81 primary care clinicians and 8030 older adult patients (mean [SD] age, 75.1 [7.2] years; 4076 men [50.8%] and 3954 women [49.2%]). Across conditions, a low-value service was used in 7627 of the 37 116 control patient-months (20.5%) and 7416 of the 46 381 intervention patient-months (16.0%) (adjusted odds ratio, 0.79; 95% CI, 0.65-0.97). For each individual condition, there were no significant differences between the control and intervention periods in the odds of patient-months with a low-value service. The intervention increased the odds of deintensification of hypoglycemic medications for diabetes (adjusted odds ratio, 1.85; 95% CI, 1.06-3.24) but not sedative-hypnotic medications for insomnia or anxiety. Conclusions and Relevance: In this stepped-wedge cluster randomized clinical trial, the Committing to Choose Wisely behavioral economic intervention reduced low-value care across 3 common clinical situations and increased deintensification of hypoglycemic medications for diabetes. Use of scalable interventions that nudge patients and clinicians to achieve greater value while preserving autonomy in decision-making should be explored more broadly. Trial Registration: ClinicalTrials.gov Identifier: NCT03411525.

The impact of fair colonoscopy preparation on colonoscopy use and adenoma miss rates in patients undergoing outpatient colonoscopy.

BACKGROUND: The impact of fair bowel preparation on endoscopists' recommendations and adenoma miss rates in average-risk patients undergoing colonoscopy is unknown. OBJECTIVE: To assess the impact of fair bowel preparation on endoscopists' interval colonoscopy recommendations and miss rates in colonoscopies performed within 3 years of the index colonoscopy in average-risk patients undergoing colorectal cancer screening. DESIGN: Retrospective chart review. SETTING: Tertiary-care center. PATIENTS: Average-risk patients undergoing index colonoscopy for colorectal cancer screening between 2004 and 2006. INTERVENTION: Colonoscopy. MAIN OUTCOME MEASUREMENTS: Endoscopists' interval recommendations, adenoma miss rates. RESULTS: A total of 16,251 colonoscopy records were reviewed over a 2-year period. Of these cases, 1943 colonoscopies were performed for the sole indication of average risk or screening. Of these, fair bowel preparation was reported in 619 patients (31.9%). A repeat colonoscopy within 5 years was recommended in 70.4% of patients. The follow-up colonoscopy compliance rate within 3 years was 55.9%. Adenoma detection rates at index and follow-up colonoscopy were 20.5% and 28.2%, respectively. Of the 39 patients with follow-up colonoscopy within 3 years, the overall adenoma miss rate was 28%. Of the patients with an adenoma identified on follow-up colonoscopy, 13.6% had normal colonoscopy results on index examination. LIMITATIONS: Retrospective design. CONCLUSION: Fair bowel preparation led to a deviation from national guidelines with early repeat colonoscopy follow-up recommendations in nearly 60% of average-risk patients with normal colonoscopy results. In patients who returned for repeat colonoscopy within 3 years, the overall adenoma miss rate was 28%. Further guidelines on timing for repeat colonoscopy for fair bowel preparation are needed.

Neuropsychological correlates of capacity determinations in Alzheimer disease: implications for assessment.

OBJECTIVES: To explore the neuropsychological correlates of the capacity to consent to research and to appoint a research proxy among persons with Alzheimer disease. DESIGN, SETTING, AND PARTICIPANTS: Interview study of 77 persons with Alzheimer disease recruited through an Alzheimer disease research center and a memory disorder clinic. MEASUREMENTS: The capacity to consent to two research scenarios (a drug randomized clinical trial and a neurosurgical clinical trial) and the capacity to appoint a research proxy were determined by five experienced consultation psychiatrists who rendered categorical judgments based on videotaped interviews of the MacArthur Competence Assessment Tool-Clinical Research and the Capacity to Appoint a Proxy Assessment. Mattis Dementia Rating Scale-Second Edition was used to assess neuropsychological functioning. RESULTS: The capacity to appoint a proxy and to consent to the drug randomized clinical trial, as determined by a majority or greater opinion of the five-psychiatrist panel, was predicted by Conceptualization and Initiation/Perseveration subscales, whereas the capacity to consent to a neurosurgical randomized clinical trial was predicted by the Memory subscale. Furthermore, the more lenient individual psychiatrists' judgments were predicted by the Conceptualization subscale, whereas the stricter psychiatrists' judgments were predicted by the Memory subscale. CONCLUSIONS: How experienced psychiatrists view the capacity of patients with Alzheimer disease for consenting to research and for appointing a proxy may be related to the patients' conceptualization and memory functioning. More explicit and standardized guidance on the role of short-term memory in capacity determinations may be useful.