The Patient's Point of View: Characterizing Patient-Level Factors Associated with Perceptions of Health Care.

Purpose: We explored the association between perception of care, as measured by the Interpersonal Processes of Care (IPC) survey, and patient-level factors, including (1) Trust in physicians; (2) Perceived empathy; (3) Stereotype threat; (4) Perceived everyday discrimination; and (5) Self-Reported Health. Methods: Fifty participants from diverse racial backgrounds and education levels were surveyed. We examined the associations between the five patient-level factors and each subdomain of the IPC using multiple linear regression. We added a race interaction term to assess whether associations between IPC subdomains and predictors differed by race. We tested for correlation among factors found to be significantly associated with the IPC. Results: In adjusted analyses, trust in the physician, perceived empathy from the provider, and perceived everyday discrimination were significantly associated with most subdomains of the IPC. There was no significant race interaction. Conclusion: This exploratory study suggests that empathy, trust, and perceived everyday discrimination are significantly linked to patient perception of quality care, which are linked to clinical outcomes. Results present modifiable factors that may potentially improve patient care. Practice Implications: Increased efforts to improve clinician communication of empathy and general communication skill may have a positive effect on quality of care.

Optimizing an Obesity Treatment Using the Multiphase Optimization Strategy Framework: Protocol for a Randomized Factorial Trial.

BACKGROUND: Effective weight loss interventions exist, yet few can be scaled up for wide dissemination. Further, none has been fully delivered via text message. We used the multiphase optimization strategy (MOST) to develop multicomponent interventions that consist only of active components, those that have been experimentally determined to impact the chosen outcome. OBJECTIVE: The goal of this study is to optimize a standalone text messaging obesity intervention, Charge, using the MOST framework to experimentally determine which text messaging components produce a meaningful contribution to weight change at 6 months. METHODS: We designed a 6-month, weight loss texting intervention based on our interactive obesity treatment approach (iOTA). Participants are randomized to one of 32 experimental conditions to test which standalone text messaging intervention components produce a meaningful contribution to weight change at 6 months. RESULTS: The project was funded in February 2017; enrollment began in January 2018 and data collection was completed in June 2019. Data analysis is in progress and first results are expected to be submitted for publication in 2021. CONCLUSIONS: Full factorial trials are particularly efficient in terms of cost and logistics when leveraged for standalone digital treatments. Accordingly, MOST has the potential to promote the rapid advancement of digital health treatments. Subject to positive findings, the intervention will be low cost, immediately scalable, and ready for dissemination. This will be of great potential use to the millions of Americans with obesity and the providers who treat them. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254940; https://clinicaltrials.gov/ct2/show/NCT03254940. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/19506.

Strategies for Successful Survivorship Care Plan Implementation: Results From a Qualitative Study.

INTRODUCTION: Care for US cancer survivors is often fragmented, contributing to poor health outcomes. Care and outcomes may improve when survivors and follow-up care providers receive survivorship care plans (SCPs), written documents containing information regarding cancer diagnosis, treatment, surveillance plans, and health promotion. However, implementing SCPs is challenging. As such, we sought to identify strategies for successfully implementing SCPs. METHODS: We measured SCP implementation using performance data from cancer programs participating in the American Society of Clinical Oncology Quality Oncology Practice Initiative, an oncologist-led quality assessment and improvement program. We used semistructured interviews with cancer program employees (eg, physicians) to identify strategies for successfully implementing SCPs by comparing approaches in cancer programs that, according to Quality Oncology Practice Initiative performance indicators, developed and delivered SCPs to a relatively small proportion of eligible survivors and their follow-up care providers (ie, low performers; n = 6 participants in five programs) with approaches among programs with better performance (ie, moderate performers; n = 15 participants in nine programs). RESULTS: Ten of 14 cancer programs developed SCPs for ≥ 50% of eligible survivors; two of 14 delivered SCPs to any survivors; and eight of 14 delivered SCPs to ≥ 25% of follow-up care providers. We found that moderate performers proactively addressed SCP requirements, leveraged requirements to improve survivorship care, set internal targets, automated implementation, had active leaders and champions, and tasked appropriate employees with SCP implementation. CONCLUSION: SCP implementation remains challenging. We identified strategies for successfully implementing SCPs. Future research should examine how cancer programs have achieved these strategies; findings could contribute to an understanding of the changes needed to implement comprehensive survivorship care.

Maintenance of Weight Loss After Initiation of Nutrition Training: A Randomized Trial.

BACKGROUND: Weight regain after successful weight loss interventions is common. OBJECTIVE: To establish the efficacy of a weight loss maintenance program compared with usual care in obese adults. DESIGN: 2-group, parallel, randomized trial stratified by initial weight loss (<10 kg vs. ≥10 kg), conducted from 20 August 2012 to 18 December 2015. Outcome assessors were blinded to treatment assignment. (ClinicalTrials.gov: NCT01357551). SETTING: 3 primary care clinics at the Veterans Affairs Medical Center in Durham and Raleigh, North Carolina. PATIENTS: Obese outpatients (body mass index ≥30 kg/m2) who lost 4 kg or more of body weight during a 16-week, group-based weight loss program. INTERVENTION: The maintenance intervention, delivered primarily by telephone, addressed satisfaction with outcomes, relapse-prevention planning, self-monitoring, and social support. Usual care involved no contact except for study measurements. MEASUREMENTS: Primary outcome was mean weight regain at week 56. Secondary outcomes included self-reported caloric intake, walking, and moderate physical activity. RESULTS: Of 504 patients in the initial program, 222 lost at least 4 kg of body weight and were randomly assigned to maintenance (n = 110) or usual care (n = 112). Retention was 85%. Most patients were middle-aged white men. Mean weight loss during initiation was 7.2 kg (SD, 3.1); mean weight at randomization was 103.6 kg (SD, 20.4). Estimated mean weight regain was statistically significantly lower in the intervention (0.75 kg) than the usual care (2.36 kg) group (estimated mean difference, 1.60 kg [95% CI, 0.07 to 3.13 kg]; P = 0.040). No statistically significant differences in secondary outcomes were seen at 56 weeks. No adverse events directly attributable to the intervention were observed. LIMITATIONS: Results may not generalize to other settings or populations. Dietary intake and physical activity were self-reported. Duration was limited to 56 weeks. CONCLUSION: An intervention focused on maintenance-specific strategies and delivered in a resource-conserving way modestly slowed the rate of weight regain in obese adults. PRIMARY FUNDING SOURCE: Veterans Affairs Health Services Research and Development Service.

Does Type 2 Diabetes Genetic Testing and Counseling Reduce Modifiable Risk Factors? A Randomized Controlled Trial of Veterans.

OBJECTIVE: We examined the clinical utility of supplementing type 2 diabetes mellitus (DM) risk counseling with DM genetic test results and counseling. RESEARCH DESIGN AND METHODS: In this randomized controlled trial, non-diabetic overweight/obese veteran outpatients aged 21 to 65 years received DM risk estimates for lifetime risk, family history, and fasting plasma glucose, followed by either genetic test results (CR+G; N = 303) or control eye disease counseling (CR+EYE; N = 298). All participants received brief lifestyle counseling encouraging weight loss to reduce the risk of DM. RESULTS: The mean age was 54 years, 53% of participants were black, and 80% were men. There was no difference between arms in weight (estimated mean difference between CR+G vs. CR+EYE at 3 months = 0.2 kg, 95% CI: -0.3 to 0.7; at 6 months = 0.4 kg, 95 % CI: -0.3 to 1.1), insulin resistance, perceived risk, or physical activity at 3 or 6 months. Calorie and fat intake were lower in the CR+G arm at 3 months (p's ≤ 0.05) but not at 6 months (p's > 0.20). CONCLUSIONS: Providing patients with genetic test results was not more effective in changing patient behavior to reduce the risk of DM compared to conventional risk counseling. TRIAL REGISTRATION: ClinicalTrials.gov NCT01060540 http://clinicaltrials.gov/show/NCT01060540.

Study design and protocol for a theory-based behavioral intervention focusing on maintenance of weight loss: the Maintenance After Initiation of Nutrition TrAINing (MAINTAIN) study.

BACKGROUND: Obesity is a significant public health problem. Although various lifestyle approaches are effective for inducing significant weight loss, few effective behavioral weight maintenance strategies have been identified. It has been proposed that behavior maintenance is a distinct state that involves different psychological processes and behavioral skills than initial behavior change. Previously, we created a conceptual model that distinguishes behavior initiation from maintenance. This model was used to generate Maintenance After Initiation of Nutrition TrAINing (MAINTAIN), an intervention to enhance weight loss maintenance following initiation. The effectiveness of MAINTAIN is being evaluated in an ongoing trial, the rationale and procedures of which are reported herein. METHODS/DESIGN: Veterans aged ≤ 75 with body mass index ≥ 30 kg/m(2) participate in a 16-week, group-based weight loss program. Participants who lose ≥ 4 kg by the end of 16 weeks (target n = 230) are randomized 1:1 to receive (a) usual care for 56 weeks or (b) MAINTAIN, a theoretically-informed weight loss maintenance intervention for 40 weeks, followed by 16 weeks of no intervention contact. MAINTAIN involves 3 in-person group visits that transition to 8 individualized telephone calls with decreasing contact frequency. MAINTAIN focuses on satisfaction with outcomes, weight self-monitoring, relapse prevention, and social support. We hypothesize that, compared to usual care, MAINTAIN will result in at least 3.5 kg less regain and better relative levels of caloric intake and physical activity over 56 weeks, and that it will be cost-effective. DISCUSSION: If effective, MAINTAIN could serve as a model for redesigning existing weight loss programs. CLINICALTRIALSGOV IDENTIFIER: NCT01357551.

Differentiating Behavior Initiation and Maintenance: Theoretical Framework and Proof of Concept.

Although many interventions are effective for health behavior initiation, maintenance has proven elusive. Interventions targeting maintenance often extend the duration with which initiation content is delivered or the duration of follow-up without intervention. We posit that health behavior initiation and maintenance require separate psychological processes and skills. To determine the value of operationalizing maintenance as a process separate from initiation, we conducted a pilot study of a telephone-delivered intervention to assist people in transitioning from behavior initiation to maintenance. Participants were 20 veterans who had initiated lifestyle changes during a randomized controlled trial of a cholesterol reduction intervention. After completing the randomized controlled trial, these participants were enrolled in the pilot maintenance intervention, which involved three monthly telephone calls from a nurse interventionist focusing on behavioral maintenance skills. To evaluate the feasibility and acceptability of this intervention, we assessed recruitment and retention rates as well as 4-month pre-post changes in health behaviors and associated psychological processes. We also conducted individual interviews with participants after study completion. Although not powered to detect significant changes, there was evidence of improvement in dietary intake and of maintenance of physical activity and low-density lipoprotein cholesterol during the 4-month maintenance study. Participants found it helpful to plan for relapses, self-monitor, and obtain social support, but they had mixed reactions about reflecting on satisfaction with outcomes. Participants accepted the intervention and desired ongoing contact to maintain accountability. This pilot maintenance intervention warrants further evaluation in a randomized controlled trial.

The trials and tribulations of enrolling couples in a randomized, controlled trial: a self-management program for hyperlipidemia as a model.

OBJECTIVE: Capitalizing on spousal support may enhance the effectiveness of interventions for chronic disease management. However, couples-based interventions present logistical challenges. We describe our experience and lessons learned while recruiting couples into the Couples Partnering for Lipid-Enhancing Strategies (CouPLES) trial. METHODS: This trial seeks to reduce serum low-density lipoprotein cholesterol levels using a couples-based intervention designed to help patients engage in self-management behaviors. We proposed enrolling 250 couples over 13 months. RESULTS: Due to practical challenges that we encountered, recruitment and enrollment lasted 21 months. Those challenges included: travel to study site; effectively marketing the study; participant burden; and establishing eligibility criteria. By modifying our protocol to address these challenges, the recruitment rate increased from 12 to 33%. CONCLUSION: In the absence of trials identifying the most effective recruitment strategies, investigators may need to experiment, amending their protocol intermittently until target enrollment numbers are reached. The lessons we present may help researchers conducting couples-based interventions develop more effective protocols. PRACTICE IMPLICATIONS: To achieve target enrollment numbers, researchers conducting couples-based interventions should consider minimizing travel to the study site; carefully crafting recruitment materials; budgeting more for participant incentives and staff effort; and limiting exclusion criteria. These practices may also enhance retention.

A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss.

BACKGROUND: Two potent weight loss therapies, a low-carbohydrate, ketogenic diet (LCKD) and orlistat therapy combined with a low-fat diet (O + LFD), are available to the public but, to our knowledge, have never been compared. METHODS: Overweight or obese outpatients (n = 146) from the Department of Veterans Affairs primary care clinics in Durham, North Carolina, were randomized to either LCKD instruction (initially, <20 g of carbohydrate daily) or orlistat therapy, 120 mg orally 3 times daily, plus low-fat diet instruction (<30% energy from fat, 500-1000 kcal/d deficit) delivered at group meetings over 48 weeks. Main outcome measures were body weight, blood pressure, fasting serum lipid, and glycemic parameters. RESULTS: The mean age was 52 years and mean body mass index was 39.3 (calculated as weight in kilograms divided by height in meters squared); 72% were men, 55% were black, and 32% had type 2 diabetes mellitus. Of the study participants, 57 of the LCKD group (79%) and 65 of the O + LFD group (88%) completed measurements at 48 weeks. Weight loss was similar for the LCKD (expected mean change, -9.5%) and the O + LFD (-8.5%) (P = .60 for comparison) groups. The LCKD had a more beneficial impact than O + LFD on systolic (-5.9 vs 1.5 mm Hg) and diastolic (-4.5 vs 0.4 mm Hg) blood pressures (P < .001 for both comparisons). High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups. Low-density lipoprotein cholesterol levels improved within the O + LFD group only, whereas glucose, insulin, and hemoglobin A(1c) levels improved within the LCKD group only; comparisons between groups, however, were not statistically significant. CONCLUSION: In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00108524.