Behavioral Therapy for Functional Heartburn: Recommendation Statements.

BACKGROUND & AIMS: Brain-gut behavior therapies (BGBT) are increasingly recognized as effective therapeutic interventions for functional heartburn. However, recommendations regarding candidacy for treatment, initial treatment selection, and navigating treatment non-response have not been established for functional heartburn specifically. The aim of this study was to establish expert-based recommendations for behavioral treatment in patients with functional heartburn. METHODS: The validated RAND/University of California, Los Angeles Appropriateness Method was applied to develop recommendations. A 15-member panel composed of 10 gastrointestinal psychologists and 5 esophageal specialists ranked the appropriateness of a series of statements on a 9-point interval scale over 2 ranking periods. Statements were within the following domains: pre-therapy evaluation, candidacy criteria for BGBT, selection of initial BGBT, role of additional therapy for initial non-response to BGBT, and role of pharmacologic neuromodulation. The primary outcome was appropriateness of each intervention based on the recommendation statements. RESULTS: Recommendations for psychosocial assessment (eg, hypervigilance, symptom-specific anxiety, health-related quality of life), candidacy criteria (eg, motivated for BGBT, acknowledges the role of stress in symptoms), and treatment were established. Gut-directed hypnotherapy or cognitive behavioral therapy were considered appropriate BGBT for functional heartburn. Neuromodulation and/or additional BGBT were considered appropriate in the context of non-response. CONCLUSIONS: Gut-directed hypnotherapy and/or cognitive behavioral therapy are recommended as appropriate behavioral interventions for heartburn symptoms, depending on clinical indication, specific gut-brain targets, and preferred treatment modality (pharmacologic vs non-pharmacologic). Pre-therapy evaluation of psychosocial processes and candidacy for BGBT are important to determine eligibility for referral to psychogastroenterology services.

Older Adult Preferences of Mobile Application Functionality Supporting Medication Self-Management.

Health systems and insurers alike are increasingly interested in leveraging mHealth (mobile health) tools to support patient health-related behaviors including medication adherence. However, these tools are not widely used by older patients. This study explores patient preferences for functionality in a smartphone application (app) that supports medication self-management among older adults with multiple chronic conditions. We conducted six discussion groups in Chicago, Miami, and Denver (N = 46). English-speaking older adults (55 and older) who owned smartphones and took five or more prescription medicines were invited to participate. Discussions covered familiarity with and use of current apps and challenges with taking multidrug regimens. Participants reviewed a range of possible mobile app functions and were asked to give feedback regarding the acceptability and desirability of each to support medication management. Very few participants (n = 3) reported current use of a mobile app for medication support, although all were receptive. Challenges to medication use were forgetfulness, fear of adverse events, and managing medication information from multiple sources. Desired features included (1) a list and consolidated schedule of medications, (2) identification and warning of unsafe medication interactions, (3) reminder alerts to take medicine, and (4) the ability record when medications were taken. Features relating to refill ordering, pharmacy information, and comparing costs for medication were not considered to be as important for an app.

Clinic-based versus outsourced implementation of a diabetes health literacy intervention.

BACKGROUND: We compared two implementation approaches for a health literacy diabetes intervention designed for community health centers. METHODS: A quasi-experimental, clinic-randomized evaluation was conducted at six community health centers from rural, suburban, and urban locations in Missouri between August 2008 and January 2010. In all, 486 adult patients with type 2 diabetes mellitus participated. Clinics were set up to implement either: 1) a clinic-based approach that involved practice re-design to routinely provide brief diabetes education and counseling services, set action-plans, and perform follow-up without additional financial resources [CARVE-IN]; or 2) an outsourced approach where clinics referred patients to a telephone-based diabetes educator for the same services [CARVE-OUT]. The fidelity of each intervention was determined by the number of contacts with patients, self-report of services received, and patient satisfaction. Intervention effectiveness was investigated by assessing patient knowledge, self-efficacy, health behaviors, and clinical outcomes. RESULTS: Carve-out patients received on average 4.3 contacts (SD = 2.2) from the telephone-based diabetes educator versus 1.7 contacts (SD = 2.0) from the clinic nurse in the carve-in arm (p < 0.001). They were also more likely to recall setting action plans and rated the process more positively than carve-in patients (p < 0.001). Few differences in diabetes knowledge, self-efficacy, or health behaviors were found between the two approaches. However, clinical outcomes did vary in multivariable analyses; carve-out patients had a lower HbA1c (ß = -0.31, 95 % CI -0.56 to -0.06, p = 0.02), systolic blood pressure (ß = -3.65, 95 % CI -6.39 to -0.90, p = 0.01), and low-density lipoprotein (LDL) cholesterol (ß = -7.96, 95 % CI -10.08 to -5.83, p < 0.001) at 6 months. CONCLUSION: An outsourced diabetes education and counseling approach for community health centers appears more feasible than clinic-based models. Patients receiving the carve-out strategy also demonstrated better clinical outcomes compared to those receiving the carve-in approach. Study limitations and unclear causal mechanisms explaining change in patient behavior suggest that further research is needed.

Psychosocial Aspects of Metabolic and Bariatric Surgeries and Endoscopic Therapies.

Obesity is a prevalent progressive and relapsing disease for which there are several levels of intervention, including metabolic and bariatric surgery (MBS) and now endoscopic bariatric and metabolic therapies (EBMTs). Preoperative psychological assessment focused on cognitive status, psychiatric symptoms, eating disorders, social support, and substance use is useful in optimizing patient outcomes and minimizing risks in MBS. Very little is known about the psychosocial needs of patients seeking EBMTs, though these investigations will be forthcoming if these therapies become more widespread. As MBS and EBMT inherently alter the gastrointestinal (GI) tract, considerations for the longer-term GI functioning of the patient are relevant and should be considered and monitored.

Ask, understand, remember: a brief measure of patient communication self-efficacy within clinical encounters.

Patients' ability to effectively communicate with their health care providers is an essential aspect of proper self-care, especially for those with chronic conditions. We wanted to develop and validate a brief, reliable measure of patient communication self-efficacy within clinical encounters. Consecutively recruited patients (n = 330) with diagnosed hypertension from seven primary care clinics in Chicago, Illinois, Grand Rapids, Michigan, and Shreveport, Louisiana completed an in-person interview including chronic disease self-efficacy, hypertension knowledge, health literacy assessments, and items modified from the Communication and Attitudinal Self-Efficacy (CASE) - Cancer scale. Six items from the CASE were candidates for a new scale due to their focus on the patient-provider relationship. Using principal components analysis with varimax rotation, four items strongly loaded onto one factor (Eigenvalue = 2.33; proportion of variance explained = 58%) with a Cronbach's α coefficient of 0.75. The measure, referred to as the Ask, Understand, Remember Assessment, (AURA) was moderately correlated with the total score from an existing chronic disease management self-efficacy scale (r = 0.31) and disease knowledge (beta coefficient = 0.2, 95% Confidence Interval 0.04 - 0.3, p = .03). Patients with low health literacy had lower scores on the AURA than those with marginal or adequate health literacy (p < .05). The AURA demonstrated high internal consistency and was correlated with both hypertension knowledge and a chronic disease self-efficacy scale. The AURA is brief, valid, has low reading demands, and is an appropriate tool for use among patients with chronic illness. It may also be useful in identifying and assisting patients who are at risk for errors or non-adherence with self-care behaviors.

Availability of Spanish prescription labels: a multi-state pharmacy survey.

BACKGROUND: Patient misunderstanding of prescription drug label instructions is a leading cause of medication errors. Among Latino patients, limited English proficiency is a major barrier to comprehension of medication instructions. OBJECTIVES: To determine the availability of Spanish prescription drug label instructions. RESEARCH DESIGN: A telephone survey was conducted in 4 states selected due to either a rapid growth in their Latino population (GA, NC) or a large, existing Latino population (CO, TX). SUBJECTS: A list of retail pharmacies was obtained from each state board of pharmacy. A simple random sample of 10 percent of pharmacies within each state was generated (N = 764). MEASURES: The ability of pharmacies to print prescription instructions in Spanish and the process for translating instructions. RESULTS: Two hundred sixty-seven (34.9%) pharmacies reported no translation services, 166 (21.7%) reported limited translation services, and 331 (43.3%) stated they were able to perform translations. In bivariate analyses, significant differences between pharmacy characteristics and the availability of Spanish labels were noted. In multivariate analysis including pharmacy type, location, percentage Latino population, and state, only metropolitan location was found to be a significant independent predictor of pharmacies offering full Spanish translation services (adjusted odds ratio: 1.72, 95% confidence interval: 1.04-2.84). CONCLUSIONS: The majority of pharmacies surveyed offered limited or no translation services. Lack of translation services is not isolated to rural areas or locations with a marginal Latino population. Spanish-speaking patients encounter barriers to acquiring instructions that support the safe and effective use of medications.

Development and Validation of the Consumer Health Activation Index.

BACKGROUND: Although there has been increasing interest in patient engagement, few measures are publicly available and suitable for patients with limited health literacy. OBJECTIVE: We sought to develop a Consumer Health Activation Index (CHAI) for use among diverse patients. METHODS: Expert opinion, a systematic literature review, focus groups, and cognitive interviews with patients were used to create and revise a potential set of items. Psychometric testing guided by item response theory was then conducted among 301 English-speaking, community-dwelling adults. This included differential item functioning analyses to evaluate item performance across participant health literacy levels. To determine construct validity, CHAI scores were compared to scales measuring similar personality constructs. Associations between the CHAI and physical and mental health established predictive validity. A second study among 9,478 adults was used to confirm CHAI associations with health outcomes. RESULTS: Exploratory factor analyses revealed a single-factor solution with a 10-item scale. The CHAI showed good internal consistency (alpha = 0.81) and moderate test-retest reliability (ICC = 0.53). Reading grade level was found to be at the 6th grade. Moderate to strong correlations were found with similar constructs (Multidimensional Health Locus of Control, r = 0.38, P < 0.001; Conscientiousness, r = 0.41, P < 0.001). Predictive validity was demonstrated through associations with functional health status measures (depression, r = -0.28, P < 0.001; anxiety, r = -0.22, P < 0.001; and physical functioning, r = 0.22, P < 0.001). In the validation sample, the CHAI was significantly associated with self-reported physical and mental health ( r = 0.31 and 0.32 respectively; both P < 0.001). CONCLUSIONS: The CHAI appears to be a valid, reliable, and easily administered tool that can be used to assess health activation among adults, including those with limited health literacy. Future studies should test the tool in actual use and explore further applications.

The availability, functionality, and quality of mobile applications supporting medication self-management.

OBJECTIVE: To systematically review mobile applications currently available to patients to support outpatient medication self-management. METHODS: Three online stores were searched in March 2013 using nine distinct search terms. Applications were selected if they supported general outpatient medication self-management for adults; they were excluded if they focused on only one medication or condition, provided only a medication list or reference, only ordered refills, were written in a non-English language, or were for local pharmacy/hospital patients only. A multi-step review process was utilized by two independent reviewers to identify eligible applications. A standardized form was used to abstract data. User reviews were compiled from a subsample of applications and qualitatively coded to identify common criticisms. RESULTS: 14,893 applications were initially identified. After the multi-step review process, 424 applications were deemed eligible for inclusion by reviewers (κ=0.85). On average, applications were rated 2.8 stars (out of 5) from 107 reviews. Almost all provided medication reminders (91.0%), half enabled patients to create a medication history or log (51.5%), and 22% could email the log to a third party. Few helped patients organize their regimen (6.2%), check for drug interactions (2.8%), or identify pills (4.0%). User reviews (N=1091) from the subsample of 26 applications revealed common criticisms, including technical malfunctions, poor compatibility with certain medications, and absence of desired features. CONCLUSIONS: Hundreds of applications exist in the marketplace to support medication self-management. However, their quality, content, and functionality are highly variable. Research is needed to determine optimal capabilities, evaluate utility, and determine clinical benefit.

Disease-related distress, self-care and clinical outcomes among low-income patients with diabetes.

BACKGROUND: The purpose of this study is to determine the prevalence of diabetes distress and its relationship with health behaviours and clinical outcomes in low-income patients. METHODS: Secondary analyses were conducted using baseline data from a clinical trial evaluating a diabetes self-management intervention. Interviews were conducted with 666 participants receiving care at nine safety net clinics in Missouri. Distress was measured using the Diabetes Distress Scale, and outcomes included medication adherence, physical activity, nutrition and clinical biomarkers (haemoglobin A1C (HbA1C), blood pressure, low-density lipoprotein (LDL) cholesterol). RESULTS: In a sample of 666 participants, 14.1% and 27.3% of patients were identified as highly and moderately distressed, respectively, with higher rates among younger, female and lower income patients. When compared with moderately and no distress groups, highly distressed patients were less adherent to medications (20.7% vs 29.9% vs 39.4%, p<0.001) and had higher HbA1C values (9.3% (SD=2.0) vs 8.2% (SD=1.8) vs 7.8% (SD=1.7), p<0.001), diastolic blood pressure (81.8 (SD=9.4) vs 80.2 (9.7) vs 78.9 (SD=8.8), p=0.02) and LDL cholesterol (104.6 (SD=42.4) vs 97.2 (34.3) vs 95.5 (37.9)) In multivariable analyses, high and moderate distress were associated with lower medication adherence (OR=0.44; 0.27 to 0.23, p=0.001) and (OR=0.58; 0.42 to 0.79; p=0.001), respectively, and higher HbA1C in only the highly distressed group (B=1.3; 0.81 to 1.85; p<0.001) compared with the no distress group. CONCLUSIONS: Diabetes distress is prevalent and linked to poorer adherence to health behaviours and glycemic control in a sample of patients receiving care from low-income clinics.

Factors associated with patient understanding of preeclampsia.

OBJECTIVE: To explore the extent to which pregnant women understand the symptoms and potential complications related to preeclampsia and to determine the factors that are associated with better understanding. METHODS: This was a cross-sectional study in which 112 pregnant patients were interviewed to determine their preeclampsia knowledge. Knowledge was evaluated using a 25-item survey addressing the symptoms, consequences, and proper patient actions associated with preeclampsia. Patients were also asked in an open-ended question to define preeclampsia; all responses were rated by three obstetricians. Information about demographics, medical and obstetrical history, and health literacy was also obtained. Health literacy was assessed using the short Test of Functional Health Literacy in Adults (S-TOFHLA). RESULTS: Patients correctly answered only 43% of the 25 questions assessing preeclampsia knowledge. Moreover, only 14% of the patients were able to provide a definition that correctly reflected the syndrome. Factors associated with a greater proportion of correct answers on the questionnaire were higher literacy, multiparity, history of preeclampsia, and receipt of information about preeclampsia from a clinician or another information source (e.g., the Internet, television, a book, or a friend). CONCLUSIONS: Pregnant patients have a generally poor understanding of preeclampsia, although improved understanding is associated with having received information about the disease. Further investigation will be needed to determine how best to educate patients and whether this education can also decrease adverse outcomes associated with this syndrome.

Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use.

BACKGROUND: Medication errors are an important public health concern, and poor understanding of medication labels are a root cause. Research shows that labels are variable, of poor quality, and not patient-centered. No real-world trials have evaluated whether improved medication labels can affect appropriate medication use, adherence or health outcomes. TRIAL DESIGN: We developed an evidence-based prescription label that addresses both content and format. The enhanced label includes a universal medication schedule (UMS) that standardizes the directions for use incorporating 1) standard time periods for administration (morning, noon, evening, and bedtime), 2) numeric vs. alpha characters, 3) 'carriage returns' to separate daily dose and 4) a graphic aid to visually depict dose and frequency. We will evaluate the effect of providing this label to randomly sampled patients who receive their care from free clinics, mobile vans and federally qualified health centers (FQHCs) in Northern Virginia. We will recruit patients with diabetes or hypertension; these patients will be randomly assigned to receive all of their medications with improved labels or to receive prescriptions with standard labels. The primary outcome will be the patient's ability to correctly demonstrate dosing instructions. Other outcomes include adherence, error rates and health outcomes. CONCLUSION: To our knowledge, this trial is the first to evaluate the effect of prescription label improvement on understanding, medication use and outcomes in a clinical setting. If successful, these findings could be implemented broadly to promote safe and appropriate medication use and to support evidence-based standards in the development of labels.

Predictors of misunderstanding pediatric liquid medication instructions.

BACKGROUND AND OBJECTIVES: Our objective was to determine the level of adult understanding of dosage instructions for a liquid medication commonly prescribed for children. METHODS: Structured interviews were conducted with 373 adults waiting for an appointment at family medicine clinics serving low-income populations in Shreveport, La; Chicago; and Jackson, Mich, from July 2003-August 2004. Subjects were asked to read a prescription label for amoxicillin and explain how they would take the medication. Correct interpretation was determined by a panel of blinded physician reviewers who coded subjects' verbatim responses. Qualitative methods were used to determine the nature of incorrect responses. RESULTS: Twenty-eight percent of subjects misunderstood medication instructions. The prevalence of misinterpreting instructions among subjects with adequate, marginal, and low literacy was 18%, 34%, and 43%, respectively. Common causes for misunderstanding included problems with dosage measurement (28%; ie, tablespoon instead of teaspoon) and frequency of use (33%; ie, every 3 hours instead of every 6-8 hours). In an adjusted analysis that excluded literacy, African Americans were more likely to misunderstand instructions than Caucasians (adjusted odds ratio [AOR] 1.63, 95% confidence interval [CI]=1.02-2.61). When literacy was included in the model, the effect of race on misunderstanding was reduced and nonsignificant. Inadequate and marginal literacy remained independent predictors of misunderstanding (inadequate--AOR 2.90, 95% CI= 1.41-6.00; marginal--AOR 2.20, 95% CI=1.19-3.97). CONCLUSIONS: Misinterpretation of pediatric liquid medication instructions is common. Limited literacy is a significant risk factor for misunderstanding and could contribute to racial disparities. Instructions should be written in a concise manner and standardized to ensure comprehension.

Education, literacy, and health: Mediating effects on hypertension knowledge and control.

OBJECTIVE: To determine whether literacy mediates the association between education, hypertension knowledge and control. METHODS: In-person interviews with a literacy assessment and chart review were conducted with 330 hypertensive patients from six primary care safety net clinics. Mediational analysis was used to test the role of literacy skills in explaining the relationship between education and hypertension knowledge and control. RESULTS: In multivariate analyses that did not make an adjustment for the other variable, both lower educational attainment and more limited literacy were found to be significant independent predictors of poorer hypertension knowledge and control. When literacy was entered into models that included education only, the association between education and knowledge was fully attenuated and no longer significant (Grades 1-8: beta=-0.30, 95% CI=-1.44-0.83), while the relationship between education and blood pressure control was only minimally reduced (AOR 2.46, 95% CI 2.10-2.88). More limited literacy skills also was associated with hypertension control in the final model (AOR 2.68, 95% CI 1.54-4.70). CONCLUSION: Patient literacy mediated the relationship between education and hypertension knowledge. Literacy was a significant independent predictor of blood pressure control, but only minimally explained the relationship between education and blood pressure. PRACTICE IMPLICATIONS: Health literacy is critical to the design of educational tools to improve knowledge acquisition. However, in order to impact health outcome, future health literacy studies should also address other psychosocial factors that impact motivation and capability to manage disease.