Bernice Ruo

Multisite Randomized Trial of a Single-Session Versus Multisession Literacy-Sensitive Self-Care Intervention for Patients With Heart Failure

Background— Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy. Methods and Results— A 1-year, multisite, randomized, controlled comparative effectiveness trial with 605 patients with HF was conducted. Those randomized to a single session received a 40-minute in-person, literacy-sensitive training; the multisession group received the same initial training and then ongoing telephone-based support. The primary outcome was combined incidence of all-cause hospitalization or death; secondary outcomes included HF-related hospitalization and HF-related quality of life, with prespecified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio, 1.01; 95% confidence interval, 0.83–1.22). The effect of multisession training compared with single-session training differed by literacy group: Among those with low literacy, the multisession training yielded a lower incidence of all-cause hospitalization and death (incidence rate ratio, 0.75; 95% confidence interval, 0.45–1.25), and among those with higher literacy, the multisession intervention yielded a higher incidence (incidence rate ratio, 1.22; 95% confidence interval, 0.99–1.50; interaction P=0.048). For HF-related hospitalization, among those with low literacy, multisession training yielded a lower incidence (incidence rate ratio, 0.53; 95% confidence interval, 0.25–1.12), and among those with higher literacy, it yielded a higher incidence (incidence rate ratio, 1.32; 95% confidence interval, 0.92–1.88; interaction P=0.005). HF-related quality of life improved more for patients receiving multisession than for those receiving single-session interventions at 1 and 6 months, but the difference at 12 months was smaller. Effects on HF-related quality of life did not differ by literacy. Conclusions— Overall, an intensive multisession intervention did not change clinical outcomes compared with a single-session intervention. People with low literacy appear to benefit more from multisession interventions than people with higher literacy. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00378950.

“Teach to Goal”: Theory and Design Principles of an Intervention to Improve Heart Failure Self-Management Skills of Patients with Low Health Literacy

Self-management is vital for achieving optimal health outcomes for patients with heart failure (HF). We sought to develop an intervention to improve self-management skills and behaviors for patients with HF, especially those with low health literacy. Individuals with low health literacy have difficulty reading and understanding written information and comprehending numerical information and performing calculations, and they tend to have worse baseline knowledge, short-term memory, and working memory compared with individuals with higher health literacy. This paper describes theoretical models that suggest methods to improve the design of educational curricula and programs for low literate audiences, including cognitive load theory and learning mastery theory. We also outline the practical guiding principles for designing our intervention, which includes a multisession educational strategy that teaches patients self-care skills until they reach behavioral goals (“Teach to Goal”). Our intervention strategy is being tested in a randomized controlled trial to determine if it is superior to a single-session brief educational intervention for reducing hospitalization and death. If this trial shows that the “Teach to Goal” approach is superior, it would support the value of incorporating these design principles into educational interventions for other diseases.

Persistent Depressive Symptoms and Functional Decline Among Patients With Peripheral Arterial Disease

Objective: Because depressive symptoms are prevalent among patients with peripheral arterial disease (PAD), our goal was to study the effect of depressive symptoms over time on functional decline among patients with PAD. Methods: We conducted a prospective cohort study of 417 patients with PAD followed annually for 2 years. A Geriatric Depression Scale Short Form (GDS-S) score >5 was considered positive for depressive symptoms. Depressive symptom categories based on annual GDS-S measures included persistent, new, resolved, and no depressive symptoms. Outcome variables were change in 6-minute walk distance, 4-meter fast walking velocity, and short physical performance battery (0–12 scale, 12 = best). Results are adjusted for age, sex, race, body mass index, marital status, exercise level, smoking, ankle brachial index, leg symptoms, comorbidities, beta-blocker medication use, anti-depressant medications, and interim medical events. Results: In adjusted analyses, patients with new depressive symptoms had greater annual decline in fast walking velocity compared with that of patients with no depressive symptoms (−0.08 versus −0.01 meters/second per year, p = .02). Patients with persistent depressive symptoms had greater annual decline in 6-minute walk distance (−86.4 versus −41.5 feet/yr, p = .04), fast walking velocity (−0.08 versus −0.01 meters/second per year, p = .004), and short physical performance battery (−0.73 versus −0.18 per year, p = .005) compared with that of patients with no depressive symptoms. Conclusions: Among patients with PAD, persistent and new depressive symptoms are associated with greater annual decline in functional performance. Further study is needed to determine the mechanisms of these associations and whether treatment of depressive symptoms prevents functional decline in persons with PAD. ABI = Ankle Brachial Index; BMI = Body Mass Index; FV-1 = first follow-up visit; FV-2 = second follow-up visit; GDS-S = Geriatric Depression Scale Short Form; PAD = Peripheral Arterial Disease; WALCS = Walking and Leg Circulation Study.

Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial

BackgroundHeart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level.Methods/DesignIn this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 monthsUpon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success.The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects.DiscussionEnrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011.Trial RegistrationClinicalTrials.gov http://www.clinicaltrials.gov/ NCT00378950

Brief, valid measures of dyspnea and related functional limitations in chronic obstructive pulmonary disease (COPD).

OBJECTIVE Chronic obstructive pulmonary disease (COPD) is a progressive disease with functional decline leading to disability. Dyspnea, the prominent symptom, can be measured using existing measures, but a lack of consensus about standardization of dyspnea measurement remains. We examined the psychometric performance of two item-response theory-based (IRT) measures of dyspnea and related functional limitations (FLs) in patients with COPD and simulated computerized adaptive testing (CAT) of the banks to determine the number of questions required to achieve high precision. METHODS A total of 102 patients completed banks measuring dyspnea and FLs (33 items), from which the 10-item dyspnea and FL short forms were scored as well as other self-report measures of respiratory and physical function and emotional distress. A subset of patients completed the banks 7 to 10 days later. Pulmonary function test results were obtained from medical charts. RESULTS The 33-item banks and 10-item short forms had excellent internal consistency (alphas >0.9) and test-retest reliability (intraclass correlation coefficients >0.89). Patients sorted by severity level on the Medical Research Council scale were differentiated by item banks (P < 0.001) and the short forms (P < 0.01). The banks and short forms were also associated with related measures of dyspnea (e.g., Baseline Dyspnea Index, r = 0.47-0.53), physical function (e.g., 36-Item Short Form Health Survey, r = -0.83 to -0.86) and forced expiratory volume in 1 second (r = -0.32 to -0.35). On average, CAT required 4 and 5 items for accurate measurement of dyspnea and FLs, respectively. CONCLUSION The Functional Assessment of Chronic Illness Therapy-Dyspnea short forms and banks provide options for brief, psychometrically sound measures of dyspnea and/or FLs in COPD.

Self-reported recall and daily diary-recorded measures of weight monitoring adherence: Associations with heart failure-related hospitalization

BackgroundWeight monitoring is an important element of HF self-care, yet the most clinically meaningful way to evaluate weight monitoring adherence is uncertain. We conducted this study to evaluate the association of (1) self-reported recall and (2) daily diary-recorded weight monitoring adherence with heart failure-related (HF-related) hospitalization.MethodsWe conducted a prospective cohort study among 216 patients within a randomized trial of HF self-care training. All patients had an initial self-care training session followed by 15 calls (median) to reinforce educational material; patients were also given digital scales, instructed to weigh daily, record weights in a diary, and mail diaries back monthly. Weight monitoring adherence was assessed with a self-reported recall question administered at 12 months and dichotomized into at least daily versus less frequent weighing. Diary-recorded weight monitoring was evaluated over 12 months and dichotomized into ≥80% and <80% adherence. HF-related hospitalizations were ascertained through patient report and confirmed through record review.ResultsOver 12 months in 216 patients, we identified 50 HF-related hospitalizations. Patients self-reporting daily or more frequent weight monitoring had an incidence rate ratio of 1.34 (95% CI 0.24-7.32) for HF-related hospitalizations compared to those reporting less frequent weight monitoring. Patients who completed ≥80% of weight diaries had an IRR of 0.37 (95% CI 0.18-0.75) for HF-related hospitalizations compared to patients who completed <80% of weight diaries.ConclusionsSelf-reported recall of weight monitoring adherence was not associated with fewer HF hospitalizations. In contrast, diary-recorded adherence ≥80% of days was associated with fewer HF-related hospitalizations. Incorporating diary-based measures of weight monitoring adherence into HF self-care training programs may help to identify patients at risk for HF-related hospitalizations.

Measuring disparities: bias in the Short Form-36v2 among Spanish-speaking medical patients.

BackgroundMany national surveys have found substantial differences in self-reported overall health between Spanish-speaking Hispanics and other racial/ethnic groups. However, because cultural and language differences may create measurement bias, it is unclear whether observed differences in self-reported overall health reflect true differences in health. ObjectivesThis study uses a cross-sectional survey to investigate psychometric properties of the Short Form-36v2 for subjects across 4 racial/ethnic and language groups. Multigroup latent variable modeling was used to test increasingly stringent criteria for measurement equivalence. SubjectsOur sample (N=1281) included 383 non-Hispanic whites, 368 non-Hispanic blacks, 206 Hispanics interviewed in English, and 324 Hispanics interviewed in Spanish recruited from outpatient medical clinics in 2 large urban areas. ResultsWe found weak factorial invariance across the 4 groups. However, there was no evidence for strong factorial invariance. The overall fit of the model was substantially worse (change in Comparative Fit Index >0.02, root mean square error of approximation change >0.003) after requiring equal intercepts across all groups. Further comparisons established that the equality constraints on the intercepts for Spanish-speaking Hispanics were responsible for the decrement to model fit. ConclusionsObserved differences between SF-36v2 scores for Spanish-speaking Hispanics are systematically biased relative to the other 3 groups. The lack of strong invariance suggests the need for caution when comparing SF-36v2 mean scores of Spanish-speaking Hispanics with those of other groups. However, measurement equivalence testing for this study supports correlational or multivariate latent variable analyses of SF-36v2 responses across all the 4 subgroups, as these analyses require only weak factorial invariance.

Patients With Worse Mental Health Report More Physical Limitations After Adjustment for Physical Performance

Objective: To determine whether mental health scores are associated with self-reported physical limitations after adjustment for physical performance. Patient-reported physical limitations are widely used to assess health status or the impact of disease. However, patients’ mental health may influence their reports of their physical limitations. Methods: Mental health and physical limitations were measured using the SF-36v2 mental health and physical functioning subscales in a cross-sectional study of 1024 participants. Physical performance was measured using tests of strength, endurance, dexterity, and flexibility. Multivariable linear regression was performed to examine the relationship between self-reported mental health and physical limitations adjusting for age, gender, race/ethnicity, education, body mass index, and measured physical performance. Results: The score distributions for mental health and physical functioning were similar to that of the United States population in this age range. In unadjusted analyses, every 10-point decline in mental health scores was associated with a 4.8-point decline in physical functioning scores (95% Confidence Interval (CI) = −4.2 to −5.3; p < .001). After adjusting for covariables including measured physical performance, every 10-point decline in mental health scores was associated with a 3.0-point decline in physical functioning scores (95% CI = −2.5 to −3.6; p < .001). Conclusions: People with poor mental health scores seem to report more physical limitations than would be expected based on physical performance. When comparing self-reported physical limitations between groups, it is important to consider differences in mental health. BMI = body mass index; CI = Confidence Interval; SD = standard deviation; SF-36v2 = SF-36v2 Health Survey.

Development and Validation of a Computer Adaptive Test for Measuring Dyspnea in Heart Failure

BACKGROUND Dyspnea is a common symptom among patients with heart failure. Currently, there is no standardized, rapid, precise method to assess dyspnea. METHODS AND RESULTS From a review of the literature, we pooled questions from various questionnaires assessing dyspnea. A total of 201 patients with heart failure completed all questions in the preliminary item bank. Each item asks how much shortness of breath the patient had when doing an activity. Medical charts were reviewed for hospitalization within 1 or 3 months of completing the questions. We created a dyspnea item bank of 44 items. Computer adaptive tests (CAT) generated from this item bank can assess dyspnea by administering on average 10 questions. Simulation CAT scores were generated to compare with the item bank scores. The CAT scores had a correlation of 0.98 with item bank scores. Logistic regression models predicting the probability of being hospitalized from the dyspnea score were statistically significant (P < .05). A 5-point score increase was associated with a 32% increased odds of hospitalization in 1 month and a 20% increased odds of hospitalization in 3 months. CONCLUSIONS This computer-based tool for dyspnea assessment obtains similar precision to that of answering the entire dyspnea item bank with less patient burden.

MedLink: A mobile intervention to improve medication adherence and processes of care for treatment of depression in general medicine:

Background Major depressive disorder is a common psychological problem affecting up to 20% of adults in their lifetime. The majority of people treated for depression receive antidepressant medication through their primary care physician. This commonly results in low rates of recovery. Failure points in the process of care contributing to poor outcomes include patient non-adherence to medications, failure of physicians to optimize dose and absence of communication between patients and physicians. Objective This pilot study evaluated the feasibility of a systemic digital intervention (MedLink) designed to address failure points and improve treatment of depression in primary care among patients during the first eight weeks of initiating a new course of antidepressant therapy. Methods Participants were provided with the MedLink mobile app that provided dose reminders, information and surveys of symptoms and side effects. A cellularly enabled pillbox monitored antidepressant medication adherence. Reports were provided to physicians and participants to prompt changes in medication regimen. Study outcomes were assessed via self-report and interview measures at baseline, week 4 and week 8. Results Medication adherence detected by the MedLink system was 82%. Participants demonstrated significant decreases in depressive symptoms on the patient health questionnaire-9 (PHQ-9) (p = 0.0005) and the Quick Inventory of Depressive Symptomatology (p = 0.0008) over the eight-week trial. Usability was generally rated favorably. Conclusions The MedLink system demonstrated promise as an intervention to address failure points in the primary care treatment of major depressive disorder. Current findings support the further development of MedLink through a randomized controlled trial to evaluate the efficacy of improving processes of care, patient adherence and symptoms of depression.