The feasibility and promise of mobile technology with community health worker reinforcement to reduce rural preterm birth.

OBJECTIVES: (1) Assess feasibility of a smartphone platform intervention combined with Community Health Worker (CHW) reinforcement in rural pregnant women; (2) Obtain data on the promise of the intervention on birth outcomes, patient activation, and medical care adherence; and (3) Explore financial implications of the intervention using return on investment (ROI). SAMPLE: A total of 98 rural pregnant women were enrolled and assigned to intervention or control groups in this two-group experimental design. INTERVENTION: The intervention group received usual prenatal care plus a smartphone preloaded with a tailored prenatal platform with automated texting, chat function, and hyperlinks and weekly contact from the CHW. The control group received usual prenatal care and printed educational materials. MEASUREMENTS: Demographics, health risk data, interaction with platform, medical records, hospital billing charges, Client Satisfaction Questionnaire-8, satisfaction comments, and the Patient Activation Measure. RESULTS: A total of 77 women completed the study. The intervention was well-received, showed promise for improving birth outcomes, patient activation, and medical care adherence. Financial analysis showed a positive ROI under two scenarios. CONCLUSIONS: Despite several practical issues, the study appears feasible. The intervention shows promise for extending prenatal care and improving birth outcomes in rural communities. Further research is needed with a larger and more at-risk population to appreciate the impact of the intervention.

Identification of populations at risk: Stillbirth toolkit for health care providers.

BACKGROUND: Maternity care and women's health are measured, in part, by the stillbirth rate of a country. The purposes of this pilot project were to: a) establish a baseline of health care provider knowledge regarding stillbirth risk factors based on geographic distribution (urban/rural) and provider licensure (MD, APRN, PA, CNM) and b) evaluate the utility of a Stillbirth Risk Factor Toolkit and its effects on provider knowledge. METHODS: Evaluative research using a retrospective pre-posttest survey design was completed. The study setting included primary care clinics (urban [n=25] and rural [n=25]) in Nebraska. Health care providers from N=50 clinics were surveyed about their knowledge of stillbirth risk factors (modifiable and non-modifiable) before and after reading the Toolkit. RESULTS: Providers were least knowledgeable regarding the definition of stillbirth and the number of weeks' gestation that constitute a stillbirth. Overall, there was no significant difference in baseline knowledge between rural and urban providers. Nearly half (43.8%) found the Toolkit to be very helpful and applicable to their patient population, and 34.8% said they would be very likely to utilize it with their patients. There was a statistically significant increase in knowledge of stillbirth risk factors among all health care providers after reviewing the Toolkit (p<0.001). CONCLUSIONS: Health providers had varied baseline knowledge about stillbirth. The Toolkit improved provider knowledge, but further research is needed to assess its impact on clinical practice.

Community Advisory Board Members' Perspectives Regarding Opportunities and Challenges of Research Collaboration.

This case study examines the perspectives of rural community advisory board (CAB) members regarding the opportunities and challenges of partnering with academic investigators on funded research. We used a sequential exploratory design to evaluate the phenomena. Qualitative and quantitative data from CAB members were integrated to gain better understanding. Results showed that CAB members valued professional networking and gaining new evidence-based knowledge to enhance their professional practices. They identified rurality, the academic research process, and fulfilling research roles as the most significant challenges. CAB members also believed that strong community-based leaders had been essential in promoting and sustaining a shared vision for evidence-based research solutions to their community problem. Self-evaluation is essential for effective CAB research partnerships, and nurse researchers can strengthen these collaborations by (a) providing continuing education on research and evidence-based practices, (b) assuring that perceived benefits of CAB participation outweigh perceived challenges, and (c) supporting community-based leadership.

Enrolling research subjects from clinical practice: ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial.

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial is a multi-site effectiveness study funded by the National Institute of Mental Health (NIMH) with the aim of identifying successful, acceptable and cost-effective treatment strategies for outpatients with unremitted depression. With enrollment of 4,041 adults with major depressive disorder (MDD), it is the largest controlled psychiatric treatment study ever undertaken. In the course of developing procedures to ensure that ambitious enrollment goals were met, a number of ethical and practical issues became apparent that underscore the conflicts between effectiveness research and human subject protections. These are delineated as they relate to study design; eligibility criteria; incentives to subjects; investigators and clinical sites; the complementary roles of clinical research coordinators (CRCs) and study clinicians; and recruitment and consent procedures. The STAR*D trial exemplifies the interplay and tension between those strategies that integrate research and clinical aims and roles in the service of enhancing external validity, site participation, and recruitment and retention versus those strategies that differentiate research and clinical treatment in the service of research integrity and human subject protections. We hope that a discussion of these key challenges and dilemmas and how they have been addressed will help inform future discussions concerning design and conduct of ethical effectiveness trials designed to optimize care in real world clinical settings.

Trajectory and Predictors of Depression and Anxiety Disorders in Mothers With the FMR1 Premutation.

BACKGROUND: Although the FMR1 premutation is associated with elevated prevalence of psychiatric disorders, the longitudinal course of symptoms has not been established. The present study followed a sample of women with the FMR1 premutation to characterize the incidence, stability, and predictors of mood and anxiety disorders across a 3-year period. METHODS: Participants included 83 women with the FMR1 premutation (mean age = 38.35) who completed the Structured Clinical Interview for DSM-IV Axis I Disorders at two time points, 3 years apart. Additional information was obtained regarding demographic, child, and biomedical (e.g., medication, menopause, CGG repeats) factors. RESULTS: We found increased prevalence of major depressive disorder (MDD) and anxiety disorders over time, with adverse outcomes predicted by complex interactions among biological, behavioral, and environmental risk factors. Lifetime MDD increased from 46% to 54% and lifetime anxiety disorders increased from 28% to 35%. Midrange CGG repeats, elevated child problem behaviors, and divorced marital status conveyed elevated risk for psychiatric diagnoses. Primary ovarian insufficiency was highly prevalent (41%) but did not account for elevated rates of psychiatric diagnoses. Medication use was highly reported (41%), particularly in women with MDD or anxiety, with selective serotonin reuptake inhibitors reported as the most commonly used medication across diagnostic groups. CONCLUSIONS: The elevated prevalence of depression and anxiety in women with the FMR1 premutation is a clear and pressing concern given the frequent occurrence of the FMR1 premutation in the general community and the adverse outcomes-at both individual and systems levels-associated with psychiatric disorders in this population.

The effects of mirtazapine on plasma lipid profiles in healthy subjects.

BACKGROUND: The novel antidepressant mirtazapine has been linked to elevated random plasma total cholesterol (TC) levels. The purpose of this study was to evaluate in a more controlled and precise approach the putative effects of mirtazapine on plasma lipids. METHOD: In a double-blind design, 50 healthy subjects (30 women and 20 men) were randomized to receive either mirtazapine (N = 28) or placebo (N = 22) for a 4-week period. The study was conducted from June 1997 to September 1998. The initial dose for the mirtazapine group was 15 mg daily, which was increased to 30 mg daily at the beginning of the second week. Body weight and plasma lipoprotein profiles, including TC, low-density lipoproteins (LDL), high-density lipoproteins (HDL), and triglycerides, were determined at baseline and at weekly intervals throughout the study period. RESULTS: At baseline, there were no group differences in any of the measures. There was a statistically significant increase of 2.5% in mean body weight over the course of the study in the mirtazapine group that appeared to reach a plateau at 3 weeks, while no increase was observed in the placebo group. Mirtazapine subjects also showed significantly increased TC at week 4 (p =.016) and a transient rise in triglycerides that normalized by week 4. No significant changes in any of the other lipid parameters, including HDL, LDL, and TC/HDL ratios, were observed within either group. Changes in TC were significantly and positively correlated with changes in weight (p <.01). CONCLUSION: These results suggest that while mirtazapine may be associated with increased TC, it does not increase LDL levels or affect the ratio of TC to HDL.