Facilitators and Barriers to Implementing a Digital Informed Decision Making Tool in Primary Care: A Qualitative Study.

BACKGROUND: Informed decision aids provide information in the context of the patient's values and improve informed decision making (IDM). To overcome barriers that interfere with IDM, our team developed an innovative iPad-based application (aka "app") to help patients make informed decisions about colorectal cancer screening. The app assesses patients' eligibility for screening, educates them about their options, and empowers them to request a test via the interactive decision aid. OBJECTIVE: The aim of the study is to explore how informed decision aids can be implemented successfully in primary care clinics, including the facilitators and barriers to implementation; strategies for minimizing barriers; adequacy of draft training materials; and any additional support or training desired by clinics. DESIGN: This work deals with a multicenter qualitative study in rural and urban settings. PARTICIPANTS: A total of 48 individuals participated including primary care practice managers, clinicians, nurses, and front desk staff. APPROACH: Focus groups and semi-structured interviews, with data analysis were guided by thematic analysis. KEY RESULTS: Salient emergent themes were time, workflow, patient age, literacy, and electronic health record (EHR) integration. Saving time was important to most participants. Patient flow was a concern for all clinic staff, and they expressed that any slowdown due to patients using the iPad module or perceived additional work to clinic staff would make staff less motivated to use the program. Participants voiced concern about older patients being unwilling or unable to utilize the iPad and patients with low literacy ability being able to read or comprehend the information. CONCLUSION: Integrating new IDM apps into the current clinic workflow with minimal disruptions would increase the probability of long-term adoption and ultimate sustainability. NIH TRIAL REGISTRY NUMBER: R01CA218416-A1.

A randomized trial to reduce smoking among American Indians in South Dakota: The walking forward study.

BACKGROUND: Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, "Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?" METHODS: Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Adult AIs, age 18 years or older and currently smoking, were enrolled. Eligible subjects were randomized to one of 15 groups and exposed to either a MINIMAL or an INTENSE level of 4 intervention components. The intervention was delivered face-to-face or via telephone by Patient Navigators (PN). The primary outcome was self-reported abstinence from smoking verified by carbon monoxide measurement. RESULTS: At 18 months post-quit date, 88% of those who were still in the study were abstinent. This included 6% of all participants who enrolled in the study (14/254) and 13% of those who made it to the quit date (14/108). No intervention groups were found to have significant proportions of participants who were abstinent from smoking at the quit date (visit 5) or primary outcome visit (18 months post-quit date, visit 11), but use of pharmacologic support for abstinence was found to be an effective strategy for individuals who continued participation throughout the study. Those who remained in the study received more visits and were more likely to be abstinent. CONCLUSIONS: Use of NRT increased the odds of not smoking, as assessed at the 18-month follow-up visit, but no other interventions were found to significantly contribute to abstinence from smoking. Although the intervention protocol included numerous points of contact between CRRs and participants (11 visits) loss to follow-up was extensive with only 16/254 remaining enrolled. Additional research is needed to improve understanding of factors that influence enrollment and retention in smoking cessation interventions for AI and other populations.

A Group Randomized Trial to Reduce Obesity among Appalachian Church Members: The Walk by Faith Study.

Background: Appalachia is a rural, socioeconomically disadvantaged region with high rates of cancer and obesity. Using community-based participatory research principles, the Appalachia Community Cancer Network tested an initiative to reduce weight among overweight and obese participants by partnering with churches, an important community-based institution in Appalachia.Methods: A group randomized trial was conducted with counties or groups of counties in five Appalachian states. These groups were randomly assigned to receive either monthly diet and exercise education sessions ("Walk by Faith"; WbF) or an educational program focused on cancer screening and education ("Ribbons of Faith"; RoF) to examine effects on weight change. Participants completed questionnaires and biometric measurements at baseline and 12 months. The primary outcome of the study was weight change from baseline to 12 months.Results: The relative difference in weight loss from baseline to 12 months for WbF compared with RoF was 1.4% but was not statistically significant (P = 0.13). However, results varied by sex and marital status. WbF men experienced a significant 2.8% decrease in body weight, married WbF women a 1.5% decrease, and unmarried WbF women a 1.5% increase compared with their respective RoF subgroups (interaction P = 0.016). Among WbF participants, greater participation in monthly educational sessions was associated with greater weight loss (P = 0.002).Conclusions: WbF facilitated weight loss mainly in male participants. Level of participation in WbF activities correlated with weight loss.Impact: Findings suggest that additional research is needed to better understand factors associated with participation in health promotion programs for underserved rural communities. Cancer Epidemiol Biomarkers Prev; 27(11); 1289-97. ©2018 AACR.

Predictors of Willingness to Participate in Biospecimen Donation and Biobanking among Appalachian Adults.

BACKGROUND: Rural residents in the U.S., particularly residents of Appalachia, are underrepresented in biomedical research, limiting the generalizability of research findings. OBJECTIVE: To examine factors associated with Appalachian adults' willingness to participate in biospecimen donation and banking. METHODS: A survey assessing willingness to donate blood, saliva, and buccal specimens and to have these biospecimens stored for future use in genetic studies was conducted among 493 Appalachian adults. RESULTS: Most participants 73% (358/493) were willing to donate one or more biospecimen type; among them, 75% (268/358) were willing to donate blood, saliva, and buccal specimens. Approximately 61% (300/493) were willing to have their biospecimens banked and 97% (290/300) of these were willing to have their samples used for genetic studies. Appalachian self-identity predicted willingness to donate biospecimens, to have them stored, and used in genetic studies (OR1.52, 95% CI 1.03-2.24). CONCLUSIONS: Appalachian adults were generally willing to participate in biobanking research.

Reality Versus Grant Application Research "Plans".

This article describes the implementation of the American Indian mHealth Smoking Dependence Study focusing on the differences between what was written in the grant application compared to what happened in reality. The study was designed to evaluate a multicomponent intervention involving 256 participants randomly assigned to one of 15 groups. Participants received either a minimal or an intense level of four intervention components: (1) nicotine replacement therapy, (2) precessation counseling, (3) cessation counseling, and (4) mHealth text messaging. The project team met via biweekly webinars as well as one to two in-person meetings per year throughout the study. The project team openly shared progress and challenges and collaborated to find proactive solutions to address challenges as compared to what was planned in the original grant application. The project team used multiple strategies to overcome unanticipated intervention issues: (1) cell phone challenges, (2) making difficult staffing decisions, (3) survey lessons, (4) nicotine replacement therapy, (5) mHealth text messages, (6) motivational interviewing counseling sessions, and (7) use of e-cigarettes. Smoking cessation studies should be designed based on the grant plans. However, on the ground reality issues needed to be addressed to assure the scientific rigor and innovativeness of this study.

Modeling the Influence of Early Skin-to-Skin Contact on Exclusive Breastfeeding in a Sample of Hispanic Immigrant Women.

Using data from a longitudinal study of breastfeeding in Hispanics, this study evaluated the influence of early skin-to-skin contact (SSC) on initiation and sustained exclusive breastfeeding (EBF) at 1 month postpartum. Two-thirds of the women in the sample participated in early SSC. At discharge, over half of the women were EBF; this proportion decreased to one-third at 1 month postpartum. Controlling for demographic and clinical variables in the model, participation in early SSC was associated with a greater than sevenfold increase in the odds of EBF at discharge (p = .005) but was not predictive of EBF at 1 month post-discharge (p = .7). Younger maternal age and increased prenatal infant feeding intention were associated with an increased likelihood of EBF across both timepoints. Promoting early SSC may help with initiation of EBF, while further breastfeeding support may be needed to maintain EBF following discharge for this vulnerable population.

The Effect of Changes in Health Beliefs Among African-American and Rural White Church Congregants Enrolled in an Obesity Intervention: A Qualitative Evaluation.

Church interventions can reduce obesity disparities by empowering participants with knowledge and skills within an established community. The purpose of this study was to evaluate the Biomedical/Obesity Reduction Trial (BMORe) and investigate changes in health beliefs among obese adult participants. Ten pre-/post-intervention focus groups applying the Health Belief Model conducted in two African-American churches in Tennessee (n = 20) and South Carolina (n = 20), and one rural Appalachian church in Kentucky (n = 21). Two independent coders using NVivo analyzed transcribed audio data and notes. Participants' health status of being overweight/obese and having comorbidities of diabetes and high blood pressure motivated enrollment in BMORe. Initially participants voiced low self-efficacy in cooking healthy and reading food labels. BMORe made participants feel "empowered" after 12 weeks compared to initially feeling "out of control" with their weight. Participants reported improvements in emotional health, quality of life, and fewer medications. During post-intervention focus groups, participants reported increased self-efficacy through family support, sharing healthy eating strategies, and having accountability partners. Solidarity and common understanding among BMORe participants led focus group attendees to comment how their peers motivated them to stay in the program for 12 weeks. Long-term barriers include keeping the weight off by maintaining habits of exercise and healthy eating. Implementation of pre-/post-intervention focus groups is an innovative approach to evaluate an obesity intervention and track how changes in health beliefs facilitated behavior change. This novel approach shows promise for behavioral interventions that rely on participant engagement for sustained effectiveness.

Research Partnerships with Healthcare Providers in Rural Community Health Centers: Needs and Challenges in Diabetes Research.

Kentucky has among the highest rates of diabetes and obesity in the United States. The Kentucky Diabetes and Obesity Collaborative (KDOC) was designed to develop a novel research infrastructure that can be used by researchers focusing on obesity and diabetes among patients cared for by Federally Qualified Health Centers (FQHC) serving rural Kentucky. Focus groups were carried out to develop an understanding of the needs and interests of FQHC practitioners and staff regarding participation in KDOC. Focus groups were conducted with 6 FQHCs and included a total of 41 individuals including health care providers, administrative staff and clinical staff. The discussions ranged in time from 30 to 70 minutes and averaged 45 minutes. Analysis of the transcripts of the focus groups revealed 4 themes: 1) contextual factors, 2) infrastructure, 3) interpersonal relationships, and 4) clinical features. The participants also noted four requirements that should be met for a research project to be successful in rural primary care settings: 1) there must be a shared understanding of health priorities of rural communities between the researcher and the practices/providers; 2) the proposed research must be relevant to clinics and their communities; 3) research and recommendations for evidence-based interventions need to reflect the day-to-day challenges of rural primary care providers; and 4) there needs to be an understanding of community norms and resources. Although research-clinic partnerships were viewed favourably overall, challenges in data integration to support both research and clinical outcomes were identified.

Study design, intervention, and baseline characteristics of a group randomized trial involving a faith-based healthy eating and physical activity intervention (Walk by Faith) to reduce weight and cancer risk among overweight and obese Appalachian adults.

BACKGROUND: Increased prevalence of overweight and obesity among Appalachian residents may contribute to increased cancer rates in this region. This manuscript describes the design, components, and participant baseline characteristics of a faith-based study to decrease overweight and obesity among Appalachian residents. METHODS: A group randomized study design was used to assign 13 churches to an intervention to reduce overweight and obesity (Walk by Faith) and 15 churches to a cancer screening intervention (Ribbons of Faith). Church members with a body mass index (BMI) ?25 were recruited from these churches in Appalachian counties in five states to participate in the study. A standard protocol was used to measure participant characteristics at baseline. The same protocol will be followed to obtain measurements after completion of the active intervention phase (12months) and the sustainability phase (24months). Primary outcome is change in BMI from baseline to 12months. Secondary outcomes include changes in blood pressure, waist-to-hip ratio, and fruit and vegetable consumption, as well as intervention sustainability. RESULTS: Church members (n=664) from 28 churches enrolled in the study. At baseline 64.3% of the participants were obese (BMI?30), less than half (41.6%) reported regular exercise, and 85.5% reported consuming less than 5 servings of fruits and vegetables per day. CONCLUSIONS: Church members recruited to participate in a faith-based study across the Appalachian region reported high rates of unhealthy behaviors. We have demonstrated the feasibility of developing and recruiting participants to a faith-based intervention aimed at improving diet and increasing exercise among underserved populations.

Factors influencing exclusive breastfeeding at 4 months postpartum in a sample of urban Hispanic mothers in Kentucky.

BACKGROUND: Although Hispanic mothers in the United States have slightly higher rates of breastfeeding initiation than the national average, they are more likely to supplement with formula. OBJECTIVES: To describe infant feeding decisions in a sample of 72 urban Hispanic mothers and assess whether demographic and personal factors influence exclusive breastfeeding (EBF) status at 4 months postpartum. METHODS: The study was longitudinal and included assessments during pregnancy, in the hospital following childbirth, and monthly up to 4 months following birth. RESULTS: Nearly all of the 72 mothers were breastfeeding at discharge after the birth of their infant (94%); half of these were EBF. By 2 months postpartum, the rate of EBF had declined to 26%, dropping to 22% by 4 months. Significant predictors of EBF status at 4 months included the baseline indicator for mother's partner as the most important person in life (adjusted odds ratio [AOR], 5.42; 95% confidence interval [CI], 1.03-28.66) and breastfeeding self-efficacy score at 1 month (AOR, 1.20; 95% CI, 1.07-1.34). CONCLUSION: These findings have particular relevance in this population, given the high rate of breastfeeding initiation coupled with breastfeeding self-efficacy being a modifiable factor. Support during pregnancy and postpartum, including consultation with a lactation consultant, may increase the self-efficacy of EBF in this low-income population, leading to higher rates of extended EBF among Hispanics.

Intention to Breastfeed as a Predictor of Initiation of Exclusive Breastfeeding in Hispanic Women.

Exclusive breastfeeding (EBF) is the most efficacious form of infant feeding and nutrition. Hispanic mothers in the US are more likely than mothers of other racial/ethnic groups to supplement with formula in the first 2 days of life. The purpose of this study was to explore infant feeding intentions during the prenatal period as a predictor of EBF at postpartum discharge in a sample of Hispanic women (n = 99). At discharge, 51 % of the women were EBF, 44 % were breastfeeding and supplementing with formula, and 5 % were feeding only formula. Intention to breastfeed was found to be a strong and potentially modifiable predictor of breastfeeding behavior, showing a significant association with EBF upon discharge from the hospital after birth when linked with acceptance of pregnancy and method of delivery. Prenatal care offers a unique opportunity to enhance intentions to breastfeed that may lead to improved EBF in this health vulnerable population.

Findings from the native navigators and the Cancer Continuum (NNACC) study.

Native Navigators and the Cancer Continuum (NNACC) was a community based participatory research study among Native American Cancer Research Corporation, CO; Inter-Tribal Council of Michigan, MI; Rapid City Regional Hospital's Walking Forward, SD; Great Plains Tribal Chairman's' Health Board, SD; and Muscogee (Creek) Nation, OK. The project goal was to collaborate, refine, expand, and adapt navigator/community education programs to address American Indian communities' and patients' needs across the continuum of cancer care (prevention through end-of-life). The intervention consisted of four to six site-specific education workshop series at all five sites. Each series encompassed 24 h of community education. The Social Ecology Theory guided intervention development; community members from each site helped refine education materials. Following extensive education, Native Patient Navigators (NPNs) implemented the workshops, referred participants to cancer screenings, helped participants access local programs and resources, and assisted those with cancer to access quality cancer care in a timely manner. The intervention was highly successful; 1,964 community participants took part. Participants were primarily American Indians (83 %), female (70 %) and between 18 and 95 years of age. The education programs increased community knowledge by 28 %, facilitated referral to local services, and, through site-specific navigation services, improved access to care for 77 participants diagnosed with cancer during the intervention. Approximately, 90 % of participants evaluated workshop content as useful and 92.3 % said they would recommend the workshop to others. The intervention successfully increased community members' knowledge and raised the visibility of the NPNs in all five sites.

Dissemination of go sun smart in outdoor recreation: effect of program exposure on sun protection of guests at high-altitude ski areas.

Go Sun Smart is a theory-based health communication program designed to influence sun-protection behaviors of employees and guests at high-altitude ski areas to reduce skin cancer risk. The effects of Go Sun Smart, in a Phase IV dissemination randomized posttest-only trial, on sun-protection behaviors of ski area guests are reported. Program use was assessed by on-site observation and guest message exposure, and sun protection was measured in intercept surveys at ski areas. Dissemination strategy-enhanced versus basic-was not significantly related to sun safety practices. Additional analyses examined the relation between message exposure and guests' sun safety practices. Ski areas displaying at least 6 Go Sun Smart materials in guest-only areas and 9 Go Sun Smart materials throughout the area increased guests' message exposure. Higher message exposure within the high-use ski areas was associated with improved sun protection by guests but not within the low-use ski areas. The authors underscore the importance of program implementation and message exposure on the success of evidence-based health communication efforts applied industrywide.

Mobile mammography in underserved populations: analysis of outcomes of 3,923 women.

Mobile health units are increasingly utilized to address barriers to mammography screening. Despite the existence of mobile mammography outreach throughout the US, there is a paucity of data describing the populations served by mobile units and the ability of these programs to reach underserved populations, address disparities, and report on outcomes of screening performance. To evaluate the association of variables associated with outcomes for women undergoing breast cancer screening and clinical evaluation on a mobile unit. Retrospective analysis of women undergoing mammography screening during the period 2008-2010. Logistic regression was fitted using generalized estimating equations to account for potential repeat annual visits to the mobile unit. In total, 4,543 mammograms and/or clinical breast exams were conducted on 3,923 women with a mean age of 54.6, 29 % of whom had either never been screened or had not had a screening in 5 years. Age < 50 years, lack of insurance, Hispanic ethnicity, current smoking, or having a family relative (<50 years of age) with a diagnosis of cancer were associated with increased odds of a suspicious mammogram finding (BIRADS 4,5,6). Thirty-one breast cancers were detected. The mobile outreach initiative successfully engaged many women who had not had a recent mammogram. Lack of insurance and current smoking were modifiable variables associated with abnormal screens requiring follow up.

Evaluation of Patient Needs and Patient Navigator Communication about Cervical Cancer Prevention in Appalachian Kentucky.

Few studies describe the way patient navigation processes may address disparities in treatment and follow-up care for medically underserved populations. Using a social ecological framework, we analyzed survey assessments of 519 patients completing a randomized navigation trial in Appalachia Kentucky to examine patient-reported barriers to follow-up cervical cancer care. We also analyzed in-depth interview transcripts with four lay patient navigators in the trial to identify barriers to follow-up care and to learn what communication strategies navigators use to successfully (or unsuccessfully) help patients navigate around those barriers. Our analysis provides insight into how patient navigation may improve adherence to follow-up care through assisted uncertainty management. We also discuss opportunities for improving navigator training to address disparities in clinical outcomes.

Expanding occupational sun safety to an outdoor recreation industry: a translational study of the Go Sun Smart program.

A successful occupational sun-protection program was translated to 67 ski areas where the effectiveness of two dissemination strategies was assessed. An industry professional association distributed materials to the resorts. Half of the resorts received the basic dissemination strategy (BDS) in which the materials were simply distributed to the resorts. In a randomized trial, the BDS was compared with an enhanced dissemination strategy (EDS) that added interpersonal contact with managers. Employees (n=2,228) at worksites that received the EDS had elevated program exposure (74.0% at EDS vs. 57.5% at BDS recalled a message). Exposure increased at two levels of program use: from less than four (55% exposed) to four to eight (68%) and to nine or more (82%) program items in use. More employees exposed to messages engaged in sun-safety behaviors than those unexposed. At worksites using nine or more items (versus 4-8 or <4), employees engaged in additional sun-safety behaviors. Program effects were strongly mediated by increased self-efficacy. Partnerships with industry associations facilitate dissemination of evidence-based programs. Dissemination methods are needed to maximize implementation and exposure to reduce health risk behaviors.

Enhancing industry-based dissemination of an occupational sun protection program with theory-based strategies employing personal contact.

PURPOSE: Industry-based strategies for dissemination of an evidence-based occupational sun protection program, Go Sun Smart (GSS), were tested. DESIGN: Two dissemination strategies were compared in a randomized trial in 2004-2007. SETTING: The North American ski industry. SUBJECTS: Ski areas in the United States and Canada (n  =  69) and their senior managers (n  =  469). INTERVENTION: Employers received GSS through a basic dissemination strategy (BDS) from the industry's professional association that included conference presentations and free starter kits. Half of the areas also received the enhanced dissemination strategy (EDS), in which project staff met face-to-face with managers and made ongoing contacts to support program use. MEASURES: Observation of program materials in use and managers' reports on communication about sun protection. ANALYSIS: The effects of two alternative dissemination strategies were compared on program use using PROC MIXED in SAS, adjusted for covariates using one-tailed p values. RESULTS: Ski areas receiving the EDS used more GSS materials (x¯  =  7.36) than those receiving the BDS (x¯  =  5.17; F  =  7.82, p < .01). Managers from more areas receiving the EDS reported communicating about sun protection in employee newsletters/flyers (x¯  =  .97, p  =  .04), in guest e-mail messages (x¯  =  .75, p  =  .02), and on ski area Web sites (x¯  =  .38, p  =  .02) than those receiving the BDS (x¯  =  .84, .50, .15, respectively). CONCLUSION: Industry professional associations play an important role in disseminating prevention programs; however, active personal communication may be essential to ensure increased implementation fidelity.

A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia.

OBJECTIVE: Faith Moves Mountains assessed the effectiveness of a faith-placed lay health advisor (LHA) intervention to increase Papanicolaou (Pap) test use among middle-aged and older women in a region disproportionately affected by cervical cancer and low screening rates (regionally, only 68% screened in prior 3 years). METHOD: This community-based RCT was conducted in four Appalachian Kentucky counties (December 2005-June 2008). Women aged 40-64 and overdue for screening were recruited from churches and individually randomized to treatment (n=176) or wait-list control (n=169). The intervention provided LHA home visits and newsletters addressing barriers to screening. Self-reported Pap test receipt was the primary outcome. RESULTS: Intention-to-treat analyses revealed that treatment group participants (17.6% screened) had over twice the odds of wait-list controls (11.2% screened) of reporting Pap test receipt post-intervention, OR=2.56, 95% CI: 1.03-6.38, p=0.04. Independent of group, recently screened participants (last Pap >1 but <5 years ago) had significantly higher odds of obtaining screening during the study than rarely or never screened participants (last Pap ≥5 years ago), OR=2.50, 95% CI: 1.48-4.25, p=0.001. CONCLUSIONS: The intervention was associated with increased cervical cancer screening. The faith-placed LHA addressing barriers comprises a novel approach to reducing cervical cancer disparities among Appalachian women.

A pilot study for using fecal immunochemical testing to increase colorectal cancer screening in Appalachia, 2008-2009.

INTRODUCTION: The Appalachian region of the United States has disproportionately high colorectal cancer (CRC) death rates and low screening rates. The purpose of this pilot study was to assess acceptability of a take-home fecal immunochemical test (FIT) and the effect of follow-up telephone counseling for increasing CRC screening in rural Appalachia. METHODS: We used a prospective, single-group, multiple-site design, with centralized laboratory reports of screening adherence and baseline and 3-month questionnaires. Successive patients, aged 50 or older, at average CRC risk and due for screening were enrolled during a routine visit to 3 primary care practices in rural Appalachian Pennsylvania and received a free take-home FIT and educational brochure. Those who had not returned the test 2 weeks later were referred for telephone counseling. RESULTS: Of 232 patients approached, 200 (86.2%) agreed to participate. Of these, 145 (72.5%) completed the FIT as recommended (adherent) and 55 (27.5%) were referred for telephone counseling (nonadherent), of whom 23 (41.8%) became adherent after 1 to 2 counseling sessions, an 11.5 percentage-point increase in screening after telephone counseling and 84% FIT adherence overall. Lack of CRC-related knowledge and perceived CRC risk were the screening barriers most highly associated with nonadherence. Although not statistically significant, the rate of conversion to screening adherence was higher among participants who received telephone counseling compared to an answering machine reminder. CONCLUSION: If confirmed in future randomized trials, provider-recommended take-home FIT and follow-up telephone counseling may be methods to increase CRC screening in Appalachia.