A Hybrid Implementation-Effectiveness Study of a Community Health Worker-Delivered Intervention to Reduce Cardiovascular Disease Risk in a Rural, Underserved Non-Hispanic Black Population: The CHANGE Study.

PURPOSE: To evaluate the implementation and effectiveness of the Carolina Heart Alliance Networking for Greater Equity (CHANGE) Program, an adapted evidence-based cardiovascular disease risk reduction intervention delivered by Community Health Workers (CHW) to rural adults. DESIGN: Hybrid implementation-effectiveness study with a pre-post design. SETTING: North Carolina Federally Qualified Health Center and local health department in a rural, medically underserved area. SAMPLE: Participants (n = 255) included 87% Non-Hispanic Black with a mean age of 57 years; 84% had diagnosed hypertension, 55% had diabetes, and 65% had hypercholesterolemia. INTERVENTION: A CHW-delivered, low-intensity, 4-month behavioral lifestyle intervention promoting a southern-style Mediterranean dietary pattern and physical activity. MEASURES: We measured number and representativeness of participants reached and retained, intervention delivery fidelity, weight, blood pressure, and self-reported dietary and physical activity behaviors. ANALYSIS: Pre-post changes at 4 months were analyzed using paired t-tests. RESULTS: Study participants completed 90% of planned intervention contacts; 87% were retained. Intervention delivery fidelity measures showed participants receiving a mean of 3.5 counseling visits, 2.7 booster calls, and on average completing 1.7 modules, setting 1.8 goals, and receiving 1.3 referrals per visit. There were significant mean reductions in systolic (-2.5 mmHg, P < .05) and diastolic blood pressure (-2.1 mmHg, P < .01); the proportion of participants with systolic blood pressure <130 increased by 7 % points (P = .05), and diastolic pressure <80 by 9 percentage points (P < .01). Dietary behaviors improved significantly with average weekly servings of nuts increased by .5 serving (P < .0001), and fruits and vegetables by .8 daily serving (P < .0001). Physical activity also increased on average by 45 min./week (P < .001). Weight did not change significantly. CONCLUSIONS: The CHANGE program showed both implementation and program effectiveness and adds to the evidence supporting CHW-delivered lifestyle interventions to reduce CVD risk among rural, Non-Hispanic Black, and medically underserved populations.

Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study.

BACKGROUND: Community Health Workers (CHW) are recommended for delivery of interventions to prevent cardiovascular disease, but there is insufficient evidence to guide implementation of CHW interventions in rural, medically underserved areas. METHODS: Using a hybrid implementation-effectiveness design, we evaluated the implementation and effectiveness of an adapted, evidence-based cardiovascular disease risk reduction intervention among rural high-risk adults. CHWs at a community health center and local health department recruited, enrolled and counseled participants during 4 monthly home visits and 3 brief phone contacts. Participant data collection included pre- and post-intervention measurements of blood pressure, weight, and dietary and physical activity behaviors. We evaluated implementation with measures of intervention reach and delivery fidelity. Statistical analyses included descriptive statistics and paired t-tests. RESULTS: Study participants (n = 105) had a mean age of 62 years and included 88% Non-Hispanic Blacks and 82% females. Recruitment strategies resulted in the enrollment of 38% of interested and eligible participants who received 80% of the planned intervention visits and phone contacts. Mean differences in pre-/post-intervention measures showed significant mean reductions in blood pressure (- 5.4 mmHg systolic, p = .006; - 2.3 mmHg diastolic, p = .04) and body weight (- 3.8 lb., p = .02). Self-reported dietary and physical activity behaviors also improved significantly. CONCLUSION: This feasibility study demonstrated preliminary implementation and program effectiveness of a CHW-delivered intervention to reduce cardiovascular disease risk factors. Additionally, it identified areas for future refinements to strategies that strengthen community-clinical linkages with an integrated role of CHWs in rural health care delivery. If results from this feasibility study can be enhanced in a larger sample, there would be significant potential to positively impact the excess burden of chronic diseases that adversely impact rural, low-income, and medically underserved populations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03582696.

Patient characteristics associated with favorable perceptions of patient-provider communication in early-stage lung cancer treatment.

Perceived quality of lung cancer communication is strongly associated with receiving potentially curative surgery for early-stage disease. The patient characteristics associated with poor quality communication in the setting of new lung cancer diagnosis are not known, although race may be a contributing factor. Using data from a prospective study of decision making in early-stage non-small cell lung cancer patients in five academic and community medical centers (N = 386), the authors used logistic regression techniques to identify patient-level characteristics correlated with scoring in the lowest quartile of a communication scale and a single-item communication variable describing shared communication. Income, lung cancer diagnostic status, and trust score were significantly associated with the overall communication scale. Lung cancer diagnostic status and trust score were also associated with patient perceptions of the single shared communication item, in addition to participation in a religious organization. Improving patient perceptions of communication with their provider is an important next step in ensuring that eligible patients receive optimal care for this deadly disease. This analysis identifies several modifiable factors that could improve patient perceptions of patient-provider communication. The fact that patient perception of communication is a predictor of the decision to undergo surgery independent of race highlights the need for broad communication interventions to ensure that as many eligible patients as possible are receiving surgery.

Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials.

BACKGROUND: Professional societies recommend shared decision making (SDM) for prostate cancer screening, however, most efforts have promoted informed rather than shared decision making. The objective of this study is to 1) examine the effects of a prostate cancer screening intervention to promote SDM and 2) determine whether framing prostate information in the context of other clearly beneficial men's health services affects decisions. METHODS: We conducted two separate randomized controlled trials of the same prostate cancer intervention (with or without additional information on more clearly beneficial men's health services). For each trial, we enrolled a convenience sample of 2 internal medicine practices, and their interested physicians and male patients with no prior history of prostate cancer (for a total of 4 practices, 28 physicians, and 128 men across trials). Within each practice site, we randomized men to either 1) a video-based decision aid and researcher-led coaching session or 2) a highway safety video. Physicians at each site received a 1-hour educational session on prostate cancer and SDM. To assess intervention effects, we measured key components of SDM, intent to be screened, and actual screening. After finding that results did not vary by trial, we combined data across sites, adjusting for the random effects of both practice and physician. RESULTS: Compared to an attention control, our prostate cancer screening intervention increased men's perceptions that screening is a decision (absolute difference +41%; 95% CI 25 to 57%) and men's knowledge about prostate cancer screening (absolute difference +34%; 95% CI 19% to 50%), but had no effect on men's self-reported participation in shared decisions or their participation at their preferred level. Overall, the intervention decreased screening intent (absolute difference -34%; 95% CI -50% to -18%) and actual screening rates (absolute difference -22%; 95% CI -38 to -7%) with no difference in effect by frame. CONCLUSIONS: SDM interventions can increase men's knowledge, alter their perceptions of prostate cancer screening, and reduce actual screening. However, they may not guarantee an increase in shared decisions. TRIAL REGISTRATION: #NCT00630188.

Partnerships in health disparities research and the roles of pastors of black churches: potential conflict, synergy, and expectations.

BACKGROUND: The black church is a promising site to engage in health disparities research; however, little is understood about the pastors' perspectives. We used role theory to explore their expectations, potential conflicts, and synergy with research. METHODS: Four focus groups (n = 30) were conducted with pastors and analyzed using principles of grounded theory and content analysis. RESULTS: Pastors identified a variety of potential roles in research. They noted potential conflicts due to perceptions of research, the process, and pace of research. Areas of synergy included perceptions of health disparities research as consistent with the healthy mind, body, and spirit ideology, and clear benefits to congregations and communities. Pastors' research expectations included long-term commitments, honest and clear communication, investigator visibility, respect for church traditions/practices, and support in forming collaborations. CONCLUSIONS: Understanding pastors' roles, potential areas of synergy and conflict, and collaboration expectations offers insight in support of successful church-academic partnerships.

Factors associated with decisions to undergo surgery among patients with newly diagnosed early-stage lung cancer.

CONTEXT: Lung cancer is the leading cause of cancer death in the United States. Surgical resection for stage I or II non-small cell cancer remains the only reliable treatment for cure. Patients who do not undergo surgery have a median survival of less than 1 year. Despite the survival disadvantage, many patients with early-stage disease do not receive surgical care and rates are even lower for black patients. OBJECTIVES: To identify potentially modifiable factors regarding surgery in patients newly diagnosed with early-stage lung cancer and to explore why blacks undergo surgery less often than whites. DESIGN, SETTING, AND PATIENTS: Prospective cohort study with patients identified by pulmonary, oncology, thoracic surgery, and generalist practices in 5 communities through study referral or computerized tomography review protocol. A total of 437 patients with biopsy-proven or probable early-stage lung cancer were enrolled between December 2005 and December 2008. Before establishment of treatment plans, patients were administered a survey including questions about trust, patient-physician communication, attitudes toward cancer, and functional status. Information about comorbid illnesses was obtained through chart audits. MAIN OUTCOME MEASURE: Lung cancer surgery within 4 months of diagnosis. RESULTS: A total of 386 patients met full eligibility criteria for lung resection surgery. The median age was 66 years (range, 26-90 years) and 29% of patients were black. The surgical rate was 66% for white patients (n = 179/273) compared with 55% for black patients (n = 62/113; P = .05). Negative perceptions of patient-physician communication manifested by a 5-point decrement on a 25-point communication scale (odds ratio [OR], 0.42; 95% confidence interval [CI], 0.32-0.74) and negative perception of 1-year prognosis postsurgery (OR, 0.27; 95% CI, 0.14-0.50; absolute risk, 34%) were associated with decisions against surgery. Surgical rates for blacks were particularly low when they had 2 or more comorbid illnesses (13% vs 62% for <2 comorbidities; OR, 0.04 [95% CI, 0.01-0.25]; absolute risk, 49%) and when blacks lacked a regular source of care (42% with no regular care vs 57% with regular care; OR, 0.20 [95% CI, 0.10-0.43]; absolute risk, 15%). CONCLUSIONS: A decision not to undergo surgery by patients with newly diagnosed lung cancer was independently associated with perceptions of communication and prognosis, older age, multiple comorbidities, and black race. Interventions to optimize surgery should consider these factors.

Screening and interventions for obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force.

BACKGROUND: Obesity poses a considerable and growing health burden. This review examines evidence for screening and treating obesity in adults. DATA SOURCES: MEDLINE and Cochrane Library (January 1994 through February 2003). STUDY SELECTION: Systematic reviews; randomized, controlled trials; and observational studies of obesity's health outcomes or efficacy of obesity treatment. DATA EXTRACTION: Two reviewers independently abstracted data on study design, sample, sample size, treatment, outcomes, and quality. DATA SYNTHESIS: No trials evaluated mass screening for obesity, so the authors evaluated indirect evidence for efficacy. Pharmacotherapy or counseling interventions produced modest (generally 3 to 5 kg) weight loss over at least 6 or 12 months, respectively. Counseling was most effective when intensive and combined with behavioral therapy. Maintenance strategies helped retain weight loss. Selected surgical patients lost substantial weight (10 to 159 kg over 1 to 5 years). Weight reduction improved blood pressure, lipid levels, and glucose metabolism and decreased diabetes incidence. The internal validity of the treatment trials was fair to good, and external validity was limited by the minimal ethnic or gender diversity of volunteer participants. No data evaluated counseling harms. Primary adverse drug effects included hypertension with sibutramine (mean increase, 0 mm Hg to 3.5 mm Hg) and gastrointestinal distress with orlistat (1% to 37% of patients). Fewer than 1% (pooled samples) of surgical patients died; up to 25% needed surgery again over 5 years. CONCLUSIONS: Counseling and pharmacotherapy can promote modest sustained weight loss, improving clinical outcomes. Pharmacotherapy appears safe in the short term; long-term safety has not been as strongly established. In selected patients, surgery promotes large amounts of weight loss with rare but sometimes severe complications.