Effects of emollient therapy with sunflower seed oil on neonatal growth and morbidity in Uttar Pradesh, India: a cluster-randomized, open-label, controlled trial.

BACKGROUND: Newborn oil massage is a widespread practice. Vigorous massage with potentially harmful products and forced removal of vernix may disrupt skin barrier integrity. Hospitalized, very-preterm infants treated with sunflower seed oil (SSO) have demonstrated improved growth but community-based data on growth and health outcomes are lacking. OBJECTIVES: We aimed to test whether SSO therapy enhances neonatal growth and reduces morbidity at the population level. METHODS: We conducted an open-label, controlled trial in rural Uttar Pradesh, India, randomly allocating 276 village clusters equally to comparison (usual care) and intervention comprised of promotion of improved massage practices exclusively with SSO, using intention-to-treat and per-protocol mixed-effects regression analysis. RESULTS: We enrolled 13,478 and 13,109 newborn infants in demographically similar intervention and comparison arms, respectively. Adherence to exclusive SSO increased from 22.6% of intervention infants enrolled in the first study quartile to 37.2% in the last quartile. Intervention infants gained significantly more weight, by 0.94 g · kg-1 · d-1 (95% CI: 0.07, 1.82 g · kg-1 · d-1, P = 0.03), than comparison infants by intention-to-treat analysis. Restricted cubic spline regression revealed the largest benefits in weight gain (2-4 g · kg-1 · d-1) occurred in infants weighing <2000 g at birth. Weight gain in intervention infants was higher by 1.31 g · kg-1 · d-1 (95% CI: 0.17, 2.46 g · kg-1 · d-1; P = 0.02) by per-protocol analysis. Morbidities were similar by intention-to-treat analysis but in per-protocol analysis rates of hospitalization and of any illness were reduced by 36% (OR: 0.64; 95% CI: 0.44, 0.94; P = 0.02) and 44% (OR: 0.56; 95% CI: 0.40, 0.77; P < 0.001), respectively, in treated infants. CONCLUSIONS: SSO therapy improved neonatal growth, and reduced morbidities when applied exclusively, across the facility-community continuum of care at the population level. Further research is needed to improve demand for recommended therapy inside hospital as well as in community settings, and to confirm these results in other settings.This trial was registered at www.isrctn.com as ISRCTN38965585 and http://ctri.nic.in as CTRI/2014/12/005282.

A randomized controlled trial of a therapeutic relational agent for reducing substance misuse during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic disrupted access to treatment for substance use disorders (SUDs), while alcohol and cannabis retail sales increased. During the pandemic, we tested a tailored digital health solution, Woebot-SUDs (W-SUDs), for reducing substance misuse. METHODS: In a randomized controlled trial, we compared W-SUDs for 8 weeks to a waitlist control. U.S. adults (N = 180) who screened positive for substance misuse (CAGE-AID>1) were enrolled June-August 2020. The primary outcome was the change in past-month substance use occasions from baseline to end-of-treatment (EOT). Study retention was 84%. General linear models tested group differences in baseline-to-EOT change scores, adjusting for baseline differences and attrition. RESULTS: At baseline, the sample (age M = 40, SD = 12, 65% female, 68% non-Hispanic white) averaged 30.2 (SD = 18.6) substance occasions in the past month. Most (77%) reported alcohol problems, 28% cannabis, and 45% multiple substances; 46% reported moderate-to-severe depressive symptoms. Treatment participants averaged 920 in-app text messages (SD = 892, Median = 701); 96% of completed lessons were rated positively; and 88% would recommend W-SUDs. Relative to waitlist, W-SUDs participants significantly reduced past-month substance use occasions (M = -9.1, SE = 2.0 vs. M = -3.3, SE = 1.8; p = .039). Secondary substance use and mood outcomes did not change significantly by group; however, reductions in substance use occasions correlated significantly with increased confidence and fewer substance use problems, cravings, depression and anxiety symptoms, and pandemic-related mental health effects (p-value<.05). CONCLUSIONS: W-SUDs was associated with significant reductions in substance use occasions. Reduction in substance use occasions was associated with better outcomes, including improved mental health. W-SUDs satisfaction was high.

Evaluation of an intervention targeted with predictive analytics to prevent readmissions in an integrated health system: observational study.

OBJECTIVES: To determine the associations between a care coordination intervention (the Transitions Program) targeted to patients after hospital discharge and 30 day readmission and mortality in a large, integrated healthcare system. DESIGN: Observational study. SETTING: 21 hospitals operated by Kaiser Permanente Northern California. PARTICIPANTS: 1 539 285 eligible index hospital admissions corresponding to 739 040 unique patients from June 2010 to December 2018. 411 507 patients were discharged post-implementation of the Transitions Program; 80 424 (19.5%) of these patients were at medium or high predicted risk and were assigned to receive the intervention after discharge. INTERVENTION: Patients admitted to hospital were automatically assigned to be followed by the Transitions Program in the 30 days post-discharge if their predicted risk of 30 day readmission or mortality was greater than 25% on the basis of electronic health record data. MAIN OUTCOME MEASURES: Non-elective hospital readmissions and all cause mortality in the 30 days after hospital discharge. RESULTS: Difference-in-differences estimates indicated that the intervention was associated with significantly reduced odds of 30 day non-elective readmission (adjusted odds ratio 0.91, 95% confidence interval 0.89 to 0.93; absolute risk reduction 95% confidence interval -2.5%, -3.1% to -2.0%) but not with the odds of 30 day post-discharge mortality (1.00, 0.95 to 1.04). Based on the regression discontinuity estimate, the association with readmission was of similar magnitude (absolute risk reduction -2.7%, -3.2% to -2.2%) among patients at medium risk near the risk threshold used for enrollment. However, the regression discontinuity estimate of the association with post-discharge mortality (-0.7% -1.4% to -0.0%) was significant and suggested benefit in this subgroup of patients. CONCLUSIONS: In an integrated health system, the implementation of a comprehensive readmissions prevention intervention was associated with a reduction in 30 day readmission rates. Moreover, there was no association with 30 day post-discharge mortality, except among medium risk patients, where some evidence for benefit was found. Altogether, the study provides evidence to suggest the effectiveness of readmission prevention interventions in community settings, but further research might be required to confirm the findings beyond this setting.

Treating tobacco dependence to aid re-employment among job-seekers: A randomized controlled trial.

INTRODUCTION: U.S. reductions in smoking have not been experienced equally. Smoking prevalence is greater among persons of lower education, lower income, and unemployed. We evaluated whether a cessation intervention for job-seekers would result in significantly fewer cigarettes smoked per day and a greater likelihood of tobacco abstinence and re-employment, compared to the control condition at 6-months follow-up. METHODS: Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018. Intention to quit smoking was not required. Participants were randomized to a brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline. Midstudy, 8-weeks of combination nicotine replacement was added to the intervention. Expired carbon monoxide and cotinine testing verified abstinence. Data were analyzed fall 2019. RESULTS: Participants (N = 360; 70% men; 43% African American, 27% non-Hispanic Caucasian; 19% unhoused) averaged 12 cigarettes/day (SD = 6), 67% smoked within 30 min of wakening; 27% were in preparation stage to quit. During the 6-month study period, intervention participants were more likely to make a quit attempt (71% vs. 58%, p = .021) and reported significantly greater reduction in cigarettes/day than control participants (median reduction: 6.9 vs. 5.0, p = .038); however, bioconfirmed abstinence (3%) and re-employment (36%) did not differ by treatment group. CONCLUSIONS: In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition. A priority group, further research is needed on smoking and re-employment.