A pragmatic randomized trial of mailed fecal immunochemical testing to increase colorectal cancer screening among low-income and minoritized populations.

BACKGROUND: Colorectal cancer (CRC) screening is underused, particularly among low-income and minoritized populations, for whom the coronavirus disease 2019 (COVID-19) pandemic has challenged progress in achieving equity. METHODS: A hub-and-spoke model was used. The hub was a nonacademic organization and the spokes were three community health center (CHC) systems overseeing numerous clinic sites. Via a cluster-randomized trial design, nine clinic sites were randomized to intervention and 16 clinic sites were randomized to usual care. Patient-level interventions included invitation letters, mailed fecal immunochemical tests (FITs), and call/text-based reminders. Year 1 intervention impact, which took place during the COVID-19 pandemic, was assessed as the proportion completing screening among individuals not up to date at baseline, which compared intervention and nonintervention clinics accounting for intraclinic cluster variation; confidence intervals (CIs) around differences not including 0 were interpreted as statistically significant. RESULTS: Among 26,736 patients who met eligibility criteria, approximately 58% were female, 55% were Hispanic individuals, and 44% were Spanish speaking. The proportion completing screening was 11.5 percentage points (ppts) (95% CI, 6.1-16.9 ppts) higher in intervention versus usual care clinics. Variation in differences between intervention and usual care clinics was observed by sex (12.6 ppts [95% CI, 7.2-18.0 ppts] for females; 8.8 ppts [95% CI, 4.7-13.9 ppts] for males) and by racial and ethnic group (13.8 ppts [95% CI, 7.0-20.6 ppts] for Hispanic individuals; 13.0 ppts [95% CI, 3.6-22.4 ppts] for Asian individuals; 11.3 ppts [95% CI, 5.8-16.8 ppts] for non-Hispanic White individuals; 6.1 ppts [95% CI, 0.8-10.4 ppts] for Black individuals). CONCLUSIONS: A regional mailed FIT intervention was effective for increasing CRC screening rates across CHC systems serving diverse, low-income populations.

Planned care for obesity and cardiovascular risk reduction using a stepped-down approach: A randomized-controlled trial.

Primary care-based approaches to address concurrent obesity and cardiovascular disease risk factors (CVDRFs) that begin with a high intensity intervention that is subsequently decreased (i.e., stepped-down) if weight loss is achieved have not been rigorously examined. Our study is a 20-month, single-blind randomized controlled trial at five primary care clinics in San Diego, CA, in 2013, where 262 obese adults (aged 25-70 years; 32.1% male; 59.2% white) with at least one CVDRF were enrolled into planned care for obesity and risk reduction (PCORR) using a stepped-down approach or enhanced usual care (EUC). All patients received physician recommendations for weight loss and CVDRFs. EUC patients (n = 132) received an individual session with a health educator every 4 months. PCORR patients (n = 130) received individual and group sessions (in-person, mail, telephone, and email) in three steps, characterized by less contact if success was achieved. At 20 months, 40.7%, 23.8%, and 15.4% of PCORR patients were in steps 1, 2, and 3, respectively (25.2% were lost to follow-up). PCORR resulted in a between-group difference in reduction in body weight of 6.1% [95% CI, 5.3 to 6.9] compared to EUC 2.8% [95% CI, 2.0 to 3.6] p = 0.007, with a greater reduction in BMI (35.2 [95% CI, 34.4 to 35.9] to 33.7 [95% CI, 32.9 to 34.5] kg/m2) than EUC (36.0 [95% CI, 35.3 to 36.8] to 35.1 [95% CI, 34.3 to 35.9] kg/m2), as indicated by a significant treatment by time interaction (p = 0.009). PCORR resulted in greater weight loss over 20 months than EUC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01134029.

Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol.

BACKGROUND: Guidelines recommend screening for colorectal cancer (CRC), but participation and abnormal test follow up rates are suboptimal, with disparities by demography. Evidence-based interventions exist to promote screening, but community adoption and implementation are limited. METHODS: The San Diego Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science (ACCSIS) program is an academic-community partnership testing regional implementation of a Hub-and-Spoke model for increasing CRC screening and follow-up. The "hub" is a non-academic, non-profit organization that includes 17 community health center (CHC) systems, serving over 190 rural and urban clinic sites. The "spokes" are 3 CHC systems that oversee 11-28 clinics each, totaling over 60 clinics. Using a cluster-randomized trial design, 9 clinics were randomized to intervention and 16 to usual care. Within intervention clinics, approximately 5000 eligible patients not up-to-date with CRC screening per year were identified for intervention. Interventions include an invitation primer, a mailed fecal immunochemical test with completion instructions, and phone and text-based reminders (hub) and patient navigation protocol to promote colonoscopy completion after abnormal FIT (spoke). Outcomes include: 1) proportion of patients up-to-date with screening after three years in intervention versus non-intervention clinics; 2) proportion of patients with abnormal FIT completing colonoscopy within six months of the abnormal result. Implementation science measures are collected to assess acceptability, intervention and usual care adaptations, and sustainability of the intervention strategies. CONCLUSION: This large-scale, regional cluster randomized trial among CHCs serving diverse populations is anticipated to accelerate progress in CRC prevention in underserved populations. TRIAL REGISTRATION: NCT04941300.

A randomized trial of a multicomponent intervention for adolescent sun protection behaviors.

OBJECTIVE: To evaluate a multicomponent primary care-based intervention to increase sun protection behaviors among adolescents. Excessive sun exposure in childhood increases the lifetime risk of melanomas and other forms of skin cancer. Interventions to improve sun protection behaviors in childhood have been based primarily in school and community settings, with little attention to the role of primary care physicians. DESIGN: A 2-year randomized controlled trial. SETTING: Primary care physician offices and participant homes. PARTICIPANTS: Eight hundred nineteen adolescents aged 11 to 15 years. INTERVENTIONS: At the study onset and the 12-month follow-up, the adolescents engaged in an office-based expert system assessment of sun protection behaviors followed by brief stage-based counseling from the primary care provider. Participants also received up to 6 expert system-generated feedback reports, a brief printed manual, and periodic mailed tip sheets. Participants randomized to the comparison condition received a physical activity and nutrition intervention. MAIN OUTCOME MEASURE: A self-reported composite measure of sun protection behavior. RESULTS: A random-effects repeated-measures model indicated a greater adoption of sun protection behaviors over time in the intervention group compared with the control group. The intervention effect corresponded to between-group differences at 24 months in avoiding the sun and limiting exposure during midday hours and using sunscreen with a sun protection factor of at least 15. Secondary analysis indicated that, by 24 months, more adolescents in the intervention group had moved to the action or the maintenance stage of change than those in the control group (25.1% vs 14.9%; odds ratio, 1.74; 95% confidence interval, 1.13-2.68). Sun protection behavior was also found to be positively associated with the completion of more intervention sessions (P = .002). CONCLUSION: Primary care counseling coupled with a minimal-intensity expert system intervention can improve adolescents' sun protection behaviors.

Randomized controlled trial of a primary care and home-based intervention for physical activity and nutrition behaviors: PACE+ for adolescents.

OBJECTIVE: Many adolescents do not meet national guidelines for participation in regular moderate or vigorous physical activity (PA); limitations on sedentary behaviors; or dietary intake of fruits and vegetables, fiber, or total dietary fat. This study evaluated a health care-based intervention to improve these behaviors. DESIGN: Randomized controlled trial. SETTING: Primary care with follow-up at home. PARTICIPANTS: Eight hundred seventy-eight adolescent girls and boys aged 11 to 15 years. INTERVENTIONS: Two experimental conditions: (1) Primary care, office-based, computer-assisted diet and PA assessment and stage-based goal setting followed by brief health care provider counseling and 12 months of monthly mail and telephone counseling and (2) a comparison condition addressing sun exposure protection. MAIN OUTCOME MEASURES: Minutes per week of moderate plus vigorous PA measured by self-report and accelerometer; self-report of days per week of PA and sedentary behaviors; and percentage of energy from fat and servings per day of fruits and vegetables measured by three 24-hour diet recalls. Body mass index (calculated as weight in kilograms divided by the square of height in meters) was a secondary outcome. RESULTS: Compared with adolescents in the sun protection condition, girls and boys in the diet and PA intervention significantly reduced sedentary behaviors (intervention vs control change, 4.3 to 3.4 h/d vs 4.2 to 4.4 h/d for girls, respectively [P = .001]; 4.2 to 3.2 h/d vs 4.2 to 4.3 h/d for boys, respectively [P = .001]). Boys reported more active days per week (intervention vs control change: 4.1 to 4.4 d/wk vs 3.8 to 3.8 d/w, respectively [P = .01]), and the number of servings of fruits and vegetables for girls approached significance (intervention vs control change, 3.5 to 4.2 servings/d vs 3.5 to 3.9 servings/d, respectively [P = .07]). No intervention effects were seen with percentage of calories from fat or minutes of PA per week. Percentage of adolescents meeting recommended health guidelines was significantly improved for girls for consumption of saturated fat (intervention vs control change, 23.4% to 41.0% vs 18.5% to 31%, respectively [relative risk, 1.33; 95% confidence interval, 1.01-1.68]) and for boys' participation in d/wk of PA (intervention vs control change, 45.3% to 55.4% vs 41.9% to 38.0%, respectively [relative risk, 1.47; 95% confidence interval, 1.19-1.75]). No between-group differences were seen in body mass index. CONCLUSIONS: Improvements in some diet, PA, and sedentary behaviors in adolescents can be enabled through the use of a 1-year, integrated intervention using the computer, health provider counseling, mail, and telephone. The amount of intervention received may contribute to its efficacy.

Outcomes of a 12-month technology-based intervention to promote weight loss in adolescents at risk for type 2 diabetes.

BACKGROUND: Obese adolescents are at risk for type 2 diabetes mellitus (T2DM). Obesity interventions delivered through media, such as the web and text messages [short message service (SMS)] may be beneficial when targeting obese adolescents.. METHODS: A randomized controlled trial, Pace-Internet for Diabetes Prevention Intervention (PACEi-DP), compared three forms of an obesity intervention to usual care (UC): (a) website only (W); (b) website, monthly group sessions, and follow-up calls (WG); and (c) website and SMS (WSMS). Participants were overweight or obese adolescents at risk for T2DM (n = 101; age 12-16 years; mean body mass index (BMI) percentile = 97.6; 74.3% Hispanic). In addition to the website, WSMS participants received SMS supporting intervention goals and behavioral strategies and communicated via SMS with a case manager. WG participants had additional group activities related to weight loss and received follow-up calls from a health coach. UC participants were given printed materials and encouraged to attend three initial group sessions. Repeated measures mixed model regression analyses tested treatment effects for anthropometric, behavioral, and behavioral change strategy outcomes. RESULTS: There were no treatment effects for BMI, adiposity, physical activity, or diet at 12 months. Treatment effects were observed for sedentary behavior, with the W arm having a greater decrease in sedentary behavior (4.9 to 2.8 h/day) than the UC arm (p = .006). CONCLUSION: Although not sufficient to produce weight loss, the combination of web intervention and group sessions with telephone follow-up yielded improvements in sedentary behavior and in the use of behavior change strategies expected to lead to behavior change.