The TOTAL trial for weight management participation: A randomized controlled trial protocol.

BACKGROUND: The three types of evidence-based treatment options for adults with overweight and obesity - behavioral weight management, anti-obesity medications (AOM), and bariatric surgery - are underutilized in the Veterans Health Administration (VHA) system. Our objective in this manuscript is to describe the study protocol for an adequately powered randomized controlled trial (RCT) of a behavioral intervention: TOTAL (Teaching Obesity Treatment Options to Adult Learners) to increase patient uptake of obesity treatment. METHODS: In this multi-site, parallel, RCT, eligible Veterans with a body mass index [BMI] ≥ 27 who had not received obesity treatment within the past 12 months were randomly assigned to TOTAL or usual care. TOTAL involves watching an 18-min video that highlights obesity health risks, pros/cons of all three evidence-based obesity treatments, and expected treatment outcomes. It also includes motivational sessions delivered via televideo at 2 weeks, 6 months, and 12 months after the video (target n = 494 participants). The primary outcome is initiation of behavioral weight management treatment within 18 months of randomization. Secondary outcomes include sustained behavioral weight management treatment, initiation of AOM, bariatric surgery referral, and weight change across 18 months. CONCLUSION: TOTAL, which seeks to increase delivery of weight management treatment within the largest integrated health system in the U.S., combines patient education with motivational interviewing components. If efficacious in this trial, further evaluation of intervention effectiveness and implementation throughout the VHA and other healthcare systems would be warranted.

Making Choices: A Multi-institutional, Longitudinal Cohort Study Assessing Changes in Treatment Outcome Valuation for Low-Risk Thyroid Cancer.

OBJECTIVE: To evaluate the relative importance of treatment outcomes to patients with low-risk thyroid cancer (TC). SUMMARY BACKGROUND DATA: Overuse of total thyroidectomy (TT) for low-risk TC is common. Emotions from a cancer diagnosis may lead patients to choose TT resulting in outcomes that do not align with their preferences. METHODS: Adults with clinically low-risk TC enrolled in a prospective, multi-institutional, longitudinal cohort study from 11/2019-6/2021. Participants rated treatment outcomes at the time of their surgical decision and again 9 months later by allocating 100 points amongst 10 outcomes. T-tests and Hotelling's T 2 statistic compared outcome valuation within and between subjects based on chosen extent of surgery (TT vs. lobectomy). RESULTS: Of 177 eligible patients, 125 participated (70.6% response) and 114 completed the 9-month follow-up (91.2% retention). At the time of the treatment decision, patients choosing TT valued the risk of recurrence more than those choosing lobectomy and the need to take thyroid hormone less ( P <0.05). At repeat valuation, all patients assigned fewer points to cancer being removed and the impact of treatment on their voice, and more points to energy levels ( P <0.05). The importance of the risk of recurrence increased for those who chose lobectomy and decreased for those choosing TT ( P <0.05). CONCLUSION: The relative importance of treatment outcomes changes for patients with low-risk TC once the outcome has been experienced to favor quality of life over emotion-related outcomes. Surgeons can use this information to discuss the potential for asthenia or changes in energy levels associated with total thyroidectomy.

Exploring Social Support Dynamics After Bariatric Surgery: Insights From Patients and Providers.

INTRODUCTION: Weight loss after bariatric surgery is impacted by several factors, and social support is one of them. Our objective was to characterize patient and provider perceptions about social support after bariatric surgery. METHODS: We reported a secondary analysis of qualitative data acquired from semi-structured interviews conducted from January-November 2020 with bariatric surgery patients and providers. Participants included primary care providers, health psychologists, registered dietitians, bariatric surgeons, and patients with at least 1 y of follow-up after their bariatric procedure. Interview guides were designed using a hybrid of Andersen's Behavioral Model of Health Services and Torain's Framework for Surgical Disparities. Using directed content analysis, study team members generated codes, which were categorized into themes about social support pertaining to dietary habits, physical activity, and follow-up care. RESULTS: Forty-five participants were interviewed, including 24 patients (83% female; 79% White; mean age 50.6 ± 10.7 y) and 21 providers (six primary care providers, four health psychologists, five registered dieticians, and six bariatric surgeons). We identified four themes relating to social support affecting weight loss after surgery: (1) family involvement in helping patients adjust to the bariatric diet, (2) engagement in activities with partners/friends, (3) help with transportation to appointments, and (4) life stressors experienced by patients within their social relationships. CONCLUSIONS: Continued assessment of interpersonal factors after bariatric surgery is essential for weight loss maintenance. Providers can contribute by reinforcing the facilitators of social support and making referrals that may help patients overcome barriers to social support for sustained weight loss after surgery.

Healthy Outcomes through Peer Educators: Feasibility of a peer support diabetes prevention programme for African-American grandmother caregivers.

AIM: To assess the protocol feasibility and intervention acceptability of a community-based, peer support diabetes prevention programme (DPP) for African-American (AA) grandmother caregivers at risk for diabetes. MATERIALS AND METHODS: Grandmother caregivers were randomized in a 2:1 ratio to DPP (active comparator) or DPP plus HOPE (Healthy Outcomes through Peer Educators; intervention). DPP + HOPE incorporated support from a peer educator who met with participants in person or by telephone every week during the 1-year intervention. Outcomes included: (1) recruitment rates, outcome assessment, and participation adherence rates assessed quantitatively; and (2) acceptability of the programme assessed through end-of-programme focus groups. RESULTS: We successfully consented and enrolled 78% (n = 35) of the 45 AA grandmothers screened for eligibility. Eighty percent of participants (aged 64.4 ± 5.7 years) were retained up to Week 48 (74% for DPP [n = 17] and 92% for DPP + HOPE [n = 11]). All grandmothers identified social support, neighbourhood safety, and access to grocery stores as influences on their health behaviours. At Month 12, the active comparator (DPP) group and the intervention group (DPP + HOPE) had a mean change in body weight from baseline of -3.5 ± 5.5 (-0.68, -6.29) kg and - 4.4 ± 5.7 (-0.59, -8.2) kg, respectively. CONCLUSIONS: This viable study met the aim of educating and equipping AA grandmothers with the practical and sustained support needed to work toward better health for themselves and their grandchildren, who may be at risk for diabetes. The intervention was both feasible and acceptable to participating grandmothers and their organizations.

Primary outcomes from Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.

Background: Partner support is associated with better weight loss outcomes in observational studies, but randomized trials show mixed results for including partners. Unclear is whether teaching communication skills to couples will improve weight loss in index participants. Purpose: To compare the efficacy of a partner-assisted intervention versus participant-only weight management program on long-term weight loss. Methods: This community-based study took place in Madison, WI. Index participants were eligible if they met obesity guideline criteria to receive weight loss counseling, were aged 74 years or younger, lived with a partner, and had no medical contraindications to weight loss; partners were aged 74 years or younger and not underweight. Couples were randomized 1:1 to a partner-assisted or participant-only intervention. Index participants in both arms received an evidence-based weight management program. In the partner-assisted arm, partners attended half of the intervention sessions, and couples were trained in communication skills. The primary outcome was index participant weight at 24 months, assessed by masked personnel; secondary outcomes were 24-month self-reported caloric intake and average daily steps assessed by an activity tracker. General linear mixed models were used to compare group differences in these outcomes following intent-to-treat principles. Results: Among couples assigned to partner-assisted (n=115) or participant-only intervention (n=116), most index participants identified as female (67%) and non-Hispanic White (87%). Average baseline age was 47.27 years (SD 11.51 years) and weight was 106.55 kg (SD 19.41 kg). The estimated mean 24-month weight loss was similar in the partner-assisted (2.66 kg) and participant-only arms (2.89 kg) (estimated mean difference, 0.23 kg [95% CI, -1.58, 2.04 kg]). There were no differences in 24-month average daily caloric intake (50 cal [95% CI: -233, 132 cal]) or steps (806 steps [95% CI: -1675, 64 steps]). The percentage of participants reporting an adverse event with at least possible attribution to the intervention did not differ by arm (partner-assisted: 9%, participant-only, 3%, p=0.11). Conclusions: Partner-assisted and individual weight management interventions led to similar outcomes in index participants. Trial registration: Clinicaltrials.gov NCT03801174.

A low-burden, self-weighing intervention to prevent weight gain in adults with obesity who do not enroll in comprehensive treatment.

Background: For individuals who are eligible but unlikely to join comprehensive weight loss programs, a low burden self-weighing intervention may be a more acceptable approach to weight management. Methods: This was a single-arm feasibility trial of a 12-month self-weighing intervention. Participants were healthcare patients with a BMI ≥25 kg/m2 with a weight-related comorbidity or a BMI >30 kg/m2 who reported lack of interest in joining a comprehensive weight loss program, or did not enroll in a comprehensive program after being provided program information. In the self-weighing intervention, participants were asked to weigh themselves daily on a cellular connected scale and were sent text messages every other week with tailored weight change feedback, including messages encouraging use of comprehensive programs if weight gain occurred. Results: Of 86 eligible patients, 39 enrolled (45.3%) in the self-weighing intervention. Self-weighing occurred on average 4.6 days/week (SD = 1.4). At 12 months, 12 participants (30.8%) lost ≥3% baseline weight, 11 (28.2%) experienced weight stability (±3% baseline), 6 (15.4%) gained ≥3% of baseline weight, and 10 (25.6%) did not have available weight data to evaluate. Three participants reported joining a weight loss program during the intervention (7.7%). Participants reported high intervention satisfaction in quantitative ratings (4.1 of 5), and qualitative interviews identified areas of satisfaction (e.g., timing and content of text messages) and areas for improvement (e.g., increasing personalization of text messages). Conclusion: A low-burden self-weighing intervention can reach adults with overweight/obesity who would be unlikely to engage in comprehensive weight loss programs; the efficacy of this intervention for preventing weight gain should be further evaluated in a randomized trial.

Small Monetary Incentives Lead to Greater Adherence in a Weight Loss Program.

PURPOSE: Understand how weekly monetary incentives for dietary tracking and/or weight loss impact 6-month weight loss behavioral adherence. DESIGN: Secondary analysis of participants randomized to one of four conditions in a behavioral weight loss intervention: incentives for dietary tracking, incentives for weight loss, both, or none. SETTING: Participants were asked to self-weigh at least twice weekly, log food and drink in a mobile application five days weekly, and attend bi-weekly, group-based classes. SAMPLE: Data from (n = 91) adults with obesity who completed a 24-week behavioral weight loss intervention of whom 88% were female and 74% Non-Hispanic White, were analyzed. MEASURES: Non-adherence to weight and dietary self-monitoring was defined as the second week of not meeting criteria. Class attendance was also tracked. ANALYSIS: Kaplan-Meier analyses were used to examine differences across the four conditions. RESULTS: Participants incentivized for dietary self-monitoring had an average 15.8 weeks (SE:1.2) until the first non-adherent week compared to 5.9 weeks (SE:0.8) for those not incentivized for dietary self-monitoring (P < .01). Those incentivized for weight loss had an average 18.0 weeks (SE:1.02) of self-weighing until the first non-adherent week compared to 13.5 weeks (SE:1.3) for those not incentivized for weight loss (P = .02). No difference in class attendance was observed. CONCLUSIONS: Incentivizing behaviors associated with weight loss improved adherence to those behaviors and does not appear to spill over to non-incentivized behaviors.

Patient Perspectives of Barriers and Facilitators for the Uptake of Pharmacogenomic Testing in Veterans Affairs' Pharmacogenomic Testing for the Veterans (PHASER) Program.

We applied implementation science frameworks to identify barriers and facilitators to veterans' acceptance of pharmacogenomic testing (PGx), which was made available as a part of clinical care at 25 VA medical centers. We conducted 30 min interviews with veterans who accepted (n = 14), declined (n = 9), or were contemplating (n = 8) PGx testing. Six team members coded one transcript from each participant group to develop the codebook and finalize definitions. Three team members coded the remaining 28 transcripts and met regularly with the larger team to reach a consensus. The coders generated a matrix of implementation constructs by testing status to identify the similarities and differences between accepters, decliners, and contemplators. All groups understood the PGx testing procedures and possible benefits. In the decision-making, accepters prioritized the potential health benefits of PGx testing, such as reducing side effects or the number of medications. In contrast, decliners prioritized the possibilities of data breach or the negative impact on healthcare insurance or Veterans Affairs benefits. Contemplators desired to speak to a provider to learn more before making a decision. Efforts to improve the clarity of data security and the impact on benefits may improve veterans' abilities to make more informed decisions about whether to undergo PGx testing.

Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method.

Introduction: Obtaining body weights remotely could improve feasibility of pragmatic trials. This investigation examined whether weights collected via cellular scale or electronic health record (EHR) correspond to gold standard in-person study weights. Methods: The agreement of paired weight measurements from cellular scales were compared to study scales from a weight loss intervention and EHR-collected weights were compared to study scales from a weight loss maintenance intervention. Differential weight change estimates between intervention and control groups using both pragmatic methods were compared to study collected weight. In the Log2Lose feasibility weight loss trial, in-person weights were collected bi-weekly and compared to weights collected via cellular scales throughout the study period. In the MAINTAIN weight loss maintenance trial, in-person weights were collected at baseline, 14, 26, 42 and 56 weeks. All available weights from the EHR during the study period were obtained. Results: On average, in Log2Lose cellular scale weights were 0.6 kg (95% CI: -2.9, 2.2) lower than in-person weights; in MAINTAIN, EHR weights were 2.8 kg (SE: -0.5, 6.0) higher than in-person weights. Estimated weight change using pragmatic methods and study scales in both studies were in the same direction and of similar magnitude. Conclusion: Both methods can be used as cost-effective and real-world surrogates within a tolerable variability for the gold-standard. Trial registration: NCT02691260; NCT01357551.

A review of implementation intentions as a tool to benefit high-need patients and healthcare systems: U.S. veterans affairs as an exemplar.

Implementation intentions (if-then plans) are an evidence-based behavior change strategy designed to translate behavioral intentions into habits [1]. Despite extensive evidence of its potential utility, this behavior change strategy is underutilized and under-researched in high-need healthcare contexts within the United States (U.S.) which face high rates of chronic conditions and barriers to care such as rurality, lack of resources, and cognitive strain from mental health and neurological conditions [2,3]. Implementation intentions have demonstrated efficacy in promoting many health behaviors proven to mitigate chronic conditions, namely physical activity, healthy diet, and substance use reduction [4-6]. In addition, the accessible, adaptable, and self-driven nature of implementation intentions allow the technique to meet many of the individual and system-level priorities of these high-need care contexts. By being patient-driven, proactive, and personalized, implementation intentions can help these patients cultivate healthy habits as part of their everyday lives. At the systems-level, implementation intentions' inexpensiveness, scalability, and compatibility with telemedicine platforms allow them to be integrated easily into existing healthcare system infrastructure [7,8]. This review describes these concepts in detail, and uses the Veterans Affairs (VA) healthcare system as an exemplar to provide concrete examples of how and where implementation intentions could be integrated in a healthcare system, within some existing programs, to benefit both the system and individual patients.

Patient and Provider Perceptions About Communication After Bariatric Surgery: A Qualitative Analysis.

INTRODUCTION: Communication between patients and providers can strongly influence patient behavior after surgery. The objective of this study was to assess patient and provider perceptions of how communication affected weight-related behaviors after bariatric surgery. MATERIALS AND METHODS: Semistructured interviews with bariatric surgery patients and providers were conducted from April-November 2020. Patients who had Medicaid within 3 y of surgery were defined as socioeconomically disadvantaged. Interview guides were derived from Andersen's Behavioral Model of Health Services and Torain's Framework for Surgical Disparities. Participants described postoperative experiences regarding diet, physical activity, and follow-up care. A codebook was developed deductively based on the two theories. Directed content analysis identified themes pertaining to patient-provider communication. RESULTS: Forty-five participants were interviewed, including 24 patients (83% female; 79% White), six primary care providers, four health psychologists, five registered dietitians, and six bariatric surgeons. Four themes regarding communication emerged: (1) Patients experiencing weight regain did not want to follow-up with providers to discuss their weight; (2) Patients from socioeconomically disadvantaged backgrounds had less trust and required more rapport-building from providers to enhance trust; (3) Patients felt that providers did not get to know them personally, which was perceived as a lack of personalized communication; and (4) Providers often changed their language to be simpler, so patients could understand them. CONCLUSIONS: Patient-provider communication after bariatric surgery is essential, but perceptions about the elements of communication differ between patients and providers. Reassuring patients who have attained less weight loss than expected and establishing trust with socioeconomically vulnerable patients could strengthen care after bariatric surgery.

Self-reported adherence and reasons for nonadherence among patients with low proportion of days covered for antihypertension medications.

BACKGROUND: Incorporation of pharmacy fill data into the electronic health record has enabled calculations of medication adherence, as measured by proportion of days covered (PDC), to be displayed to clinicians. Although PDC values help identify patients who may be nonadherent to their medications, it does not provide information on the reasons for medication-taking behaviors. OBJECTIVE: To characterize self-reported adherence status to antihypertensive medications among patients with low refill medication adherence. Our secondary objective was to identify the most common reasons for nonadherence and examine the patient sociodemographic characteristics associated with these barriers. METHODS: Participants were adult patients seen in primary care clinics of a large, urban health system and on antihypertensive therapy with a PDC of less than 80% based on 6-month linked electronic health record-pharmacy fill data. We administered a validated medication adherence screener and a survey assessing reasons for antihypertensive medication nonadherence. We used descriptive statistics to characterize these data and logistic and Poisson regression models to assess the relationship between sociodemographic characteristics and adherence barriers. RESULTS: The survey was completed by 242 patients (57% female; 61.2% White; 79.8% not Latino/a or Hispanic). Of these patients, 45% reported missing doses of their medications in the last 7 days. In addition, 48% endorsed having at least 1 barrier to adherence and 38.4% endorsed 2 or more barriers. The most common barriers were being busy and having difficulty remembering to take medications. Compared with White participants, Black participants (incident rate ratio = 2.49; 95% CI = 1.93-3.22) and participants of other races (incident rate ratio = 2.16; 95% CI = 1.62-2.89) experienced a greater number of barriers. CONCLUSIONS: Nearly half of patients with low PDC reported nonadherence in the prior week, suggesting PDC can be used as a screening tool. Augmenting PDC with brief self-report tools can provide insights into the reasons for nonadherence. DISCLOSURES: Dr Kharmats, Ms Martinez, Dr Belli, Ms Zhao, Dr Mann, Dr Schoenthaler, and Dr Blecker received grants from the National Institute of Health/National Heart, Lung, Blood Institute. Dr Voils holds a license by Duke University for the DOSE-Nonadherence measure and is a consultant for New York University Grossman School of Medicine. This research was supported by the NIH (R01HL156355). Dr Kharmats received a postdoctoral training grant from the National Institutes of Health (5T32HL129953-04). Dr Voils was supported by a Research Career Scientist award from the Health Services Research & Development Service of the Department of Veterans Affairs (RCS 14-443). The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the United States Government.

Frontline perspectives of C. difficile infection prevention practice implementation within veterans affairs health care facilities: A qualitative study.

BACKGROUND: In 2012, the veteran's affairs (VA) multidrug-resistant organism (MDRO) Program Office launched a national Clostridioides difficile Infection (CDI) Prevention Initiative to address CDI as the most common cause of healthcare associated infections, mandating use of a VA CDI Bundle of prevention practices in inpatient facilities. We draw upon frontline worker perspectives to explore work system barriers and facilitators to the sustained implementation of the VA CDI Bundle using the systems engineering initiative for patient safety (SEIPS) framework. METHODS: We interviewed 29 key stakeholders at 4 participating sites between October 2019-July 2021. Participants included infection prevention and control (IPC) leaders, nurses, physicians, and environmental management staff. Interviews were analyzed to identify themes and perceptions of facilitators and barriers to CDI prevention. RESULTS: IPC leadership was most likely to know of the specific VA CDI Bundle components. Other participants demonstrated general knowledge of CDI prevention practices, with role-based variation in the depth of awareness of specific practices. Facilitators included leadership support, mandated CDI training and prevention practices, and readily available training from multiple sources. Barriers included limits to communication about facility or unit-level CDI rates, ambiguous communications about CDI prevention practice updates and VA mandates, and role-hierarchies that may limit team members' clinical contributions. DISCUSSION: Recommendations include improving centrally-mandated clarity about and standardization of CDI prevention policies, including testing. Regular IPC training updates for all clinical stakeholders are also recommended. CONCLUSIONS: A work system analysis using SEIPS identified barriers and facilitators to CDI prevention practices that could be addressed both nationally at the system level and locally at the facility level, specifically in the areas of communication and coordination.

Measuring Success in Headache Surgery: A Comparison of Different Outcomes Measures.

BACKGROUND: Studies of migraine surgery have relied on quantitative, patient-reported measures like the Migraine Headache Index (MHI) and validated surveys to study the outcomes and impact of headache surgery. It is unclear whether a single metric or a combination of outcomes assessments is best suited to do so. METHODS: All patients who underwent headache surgery had an MHI calculated and completed the Headache Impact Test, the Migraine Disability Assessment Test, the Migraine-Specific Quality-of-Life Questionnaire, and an institutional ad hoc survey preoperatively and postoperatively. RESULTS: Twenty-seven patients (79%) experienced greater than or equal to 50% MHI reduction. MHI decreased significantly from a median of 210 preoperatively to 12.5 postoperatively (85%; P < 0.0001). Headache Impact Test scores improved from 67 to 61 (14%; P < 0.0001). Migraine Disability Assessment Test scores improved from 57 to 20 (67%; P = 0.0022). The Migraine-Specific Quality-of-Life Questionnaire demonstrated improvement in quality-of-life scores within all three of its domains ( P < 0.0001). The authors' ad hoc survey demonstrated that participants "strongly agreed" that (1) surgery helped their symptoms, (2) they would choose surgery again, and (3) they would recommend headache surgery to others. CONCLUSIONS: Regardless of how one measures it, headache surgery is effective. The authors demonstrate that surgery significantly improves patients' quality of life and decreases the effect of headaches on patients' functioning, but headaches can still be present to a substantial degree. The extent of improvement in migraine burden and quality of life in these patients may exceed the amount of improvement demonstrated by current measures.

Impact of COVID-19 on the Postoperative Bariatric Surgery Patient Experience.

OBJECTIVE: To characterize patient and provider perceptions of the impact of coronavirus disease 2019 (COVID-19) on weight loss following bariatric surgery. BACKGROUND: COVID-19 has disrupted routines and healthcare throughout the United States, but its impact on bariatric surgery patients' postoperative experience is unknown. METHODS: Semistructured interviews with bariatric surgery patients, primary care providers, and health psychologists were conducted from April to November 2020. As part of a secondary analysis, patients and providers described how the COVID-19 pandemic affected the postoperative experience within 3 domains: dietary habits, physical activity, and follow-up care. Interview guides were created from 2 conceptual models: Torain's Surgical Disparities Model and Andersen's Behavioral Model of Health Services Use. Study team members derived codes, which were grouped into themes using conventional content analysis. RESULTS: Thirty-four participants were interviewed: 24 patients (12 Roux-en-Y gastric bypass and 12 sleeve gastrectomy), 6 primary care providers, and 4 health psychologists. Patients were predominately female (83%) and White (79%). Providers were predominately female (90%) and White (100%). COVID-19 affected the postoperative bariatric surgery patient experience via 3 mechanisms: (1) it disrupted dietary and physical activity routines due to facility closures and fear of COVID-19 exposure; (2) it required patients to transition their follow-up care to telemedicine delivery; and (3) it increased stress due to financial and psychosocial challenges. CONCLUSIONS: COVID-19 has exacerbated patient vulnerability. The pandemic is not over, thus bariatric surgery patients need ongoing support to access mental health professionals, develop new physical activity routines, and counteract increased food insecurity.

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial.

BACKGROUND: Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment for insomnia, yet patient access to CBTi is limited. Self-help CBTi could increase patient access. Self-help CBTI with provider sup]port is more effective and is preferred by patients. Self-help CBTi has not been evaluated in veterans; a population with greater medical and mental health morbidity and more severe sleep difficulties than non-veterans. Moreover, those with mental health conditions have been largely excluded from prior CBTi self-help trials. Stablishing the efficacy of provider-supported Self-help CBTi is an important first step for expanding veteran access to CBTi. METHODS: In a 2-armed randomized controlled trial, a provider-supported self-help CBTi (Tele-Self CBTi) is compared to Health Education for improving insomnia severity (primary outcome) among treatment-seeking veterans with insomnia disorder. Tele-Self CBTi is comprised of two treatment components: self-help CBTi via a professionally designed manual developed using an iterative process of expert review and patient input; and 6 telephone-based support sessions lasting >20 min. Outcomes are assessed at baseline, 8 weeks, and 6 months after baseline. The primary outcome, insomnia severity, is measured using the Insomnia Severity Index. Secondary outcomes include self-reported and actigraphy-assessed sleep, fatigue, depression symptoms, and sleep-related quality of life. CONCLUSION: Innovative approaches are essential to improving overall health among veterans; a population with highly prevalent insomnia disorder. If effective, Tele-Self CBTi may bridge the gap between unavailable resources and high demand for CBTi and serve as the entry level intervention in a stepped model of care. GOV IDENTIFIER: NCT03727438.

Gender differences in social support for diabetes self-management: A qualitative study among veterans.

OBJECTIVE: Describe the role of social support in veterans' diabetes self-management and examine gender differences. METHODS: We conducted semi-structured interviews among veterans with diabetes from one Veterans Health Administration Health Care System. Participants described how support persons influenced their diabetes self-management and perspectives on a proposed self-management program incorporating a support person. We used thematic analysis to identify salient themes and examine gender differences. RESULTS: Among 18 women and 18 men, we identified four themes: 1) women felt responsible for their health and the care of others; 2) men shared responsibility for managing their diabetes, with support persons often attempting to correct behaviors (social control); 3) whereas both men and women described receiving instrumental and informational social support, primarily women described emotional support; and 4) some women's self-management efforts were hindered by support persons. Regarding programs incorporating a support person, some participants endorsed including family/friends and some preferred programs including other individuals with diabetes. CONCLUSIONS: Notable gender differences in social support for self-management were observed, with women assuming responsibility for their diabetes and their family's needs and experiencing interpersonal barriers. PRACTICE IMPLICATIONS: Gender differences in the role of support persons in diabetes self-management should inform support-based self-management programs.

A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer.

BACKGROUND: Obtaining comprehensive family health history (FHH) to inform colorectal cancer (CRC) risk management in primary care settings is challenging. OBJECTIVE: To examine the effectiveness of a patient-facing FHH platform to identify and manage patients at increased CRC risk. DESIGN: Two-site, two-arm, cluster-randomized, implementation-effectiveness trial with primary care providers (PCPs) randomized to immediate intervention versus wait-list control. PARTICIPANTS: PCPs treating patients at least one half-day per week; patients aged 40-64 with no medical conditions that increased CRC risk. INTERVENTIONS: Immediate-arm patients entered their FHH into a web-based platform that provided risk assessment and guideline-driven decision support; wait-list control patients did so 12 months later. MAIN MEASURES: McNemar's test examined differences between the platform and electronic medical record (EMR) in rates of increased risk documentation. General estimating equations using logistic regression models compared arms in risk-concordant provider actions and patient screening test completion. Referral for genetic consultation was analyzed descriptively. KEY RESULTS: Seventeen PCPs were randomized to each arm. Patients (n = 252 immediate, n = 253 control) averaged 51.4 (SD = 7.2) years, with 83% assigned male at birth, 58% White persons, and 33% Black persons. The percentage of patients identified as increased risk for CRC was greater with the platform (9.9%) versus EMR (5.2%), difference = 4.8% (95% CI: 2.6%, 6.9%), p < .0001. There was no difference in PCP risk-concordant action [odds ratio (OR) = 0.7, 95% CI (0.4, 1.2; p = 0.16)]. Among 177 patients with a risk-concordant screening test ordered, there was no difference in test completion, OR = 0.8 [0.5,1.3]; p = 0.36. Of 50 patients identified by the platform as increased risk, 78.6% immediate and 68.2% control patients received a recommendation for genetic consultation, of which only one in each arm had a referral placed. CONCLUSIONS: FHH tools could accurately assess and document the clinical needs of patients at increased risk for CRC. Barriers to acting on those recommendations warrant further exploration. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT02247336 https://clinicaltrials.gov/ct2/show/NCT02247336.

What do patients want to know about surgery for low-risk thyroid cancer? A qualitative study.

BACKGROUND: Shared decision-making about treatment for low-risk thyroid cancer requires patients and surgeons to work together to select treatment that best balances risks and expected outcomes with patient preferences and values. To participate, patients must be activated and ask questions. We aimed to characterize what topics patients prioritize during treatment decision-making. METHODS: We identified substantive questions by patients with low-risk (cT1-2, N0) thyroid cancer during audio-recorded consultations with 9 surgeons at 2 unique health care systems. Logistics questions were excluded. Qualitative content analysis was used to identify major themes among patients' questions and surgeon responses. RESULTS: Overall, 28 of 30 patients asked 253 substantive questions, with 2 patients not asking any substantive questions (median 8, range 0-25). Patients were 20 to 71 years old, mostly White (86.7%) and female (80.0%). The questions addressed extent of surgery, hormone supplementation, risk of cancer progression, radioactive iodine, and etiology of thyroid cancer. When patients probed for a recommendation regarding extent of surgery, surgeons often responded indirectly. When patients asked how surgery could impact quality of life, surgeons focused on oncologic benefits and surgical risk. Patients commonly asked about hormone supplementation and radioactive iodine. CONCLUSION: Patient questions focused on the decision regarding extent of surgery, quality of life, and nonsurgical aspects of thyroid cancer care. Surgeon responses do not consistently directly answer patients' questions but focus on the risks, benefits, and conduct of surgery itself. These findings suggest an opportunity to help surgeons with resources to improve shared decision-making by providing information that patients prioritize.