Evaluating the implementation of a multi-level mHealth study to improve hydroxyurea utilization in sickle cell disease.

Background: Sickle Cell Disease (SCD) is a progressive genetic disease that causes organ damage and reduces longevity. Hydroxyurea is an underutilized evidence-based medication that reduces complications and improves survival in SCD. In a multi-site clinical trial, part of the NIH-funded Sickle Cell Disease Implementation Consortium (SCDIC), we evaluate the implementation of a multi-level and multi-component mobile health (mHealth) patient and provider intervention to target the determinants and context of low hydroxyurea use. Given the complexity of the intervention and contextual variability in its implementation, we combined different behavioral and implementation theories, models, and frameworks to facilitate the evaluation of the intervention implementation. In this report, we describe engagement with stakeholders, planning of the implementation process, and final analytical plan to evaluate the implementation outcomes. Methods: During 19 meetings, a 16-member multidisciplinary SCDIC implementation team created, conceived, and implemented a project that utilized Intervention Mapping to guide designing an intervention and its evaluation plan. The process included five steps: (1) needs assessment of low hydroxyurea utilization, (2) conceptual framework development, (3) intervention design process, (4) selection of models and frameworks, and (5) designing evaluation of the intervention implementation. Results: Behavioral theories guided the needs assessment and the design of the multi-level mHealth intervention. In designing the evaluation approach, we combined two implementation frameworks to best account for the contextual complexity at the organizational, provider, and patient levels: (1) the Consolidated Framework for Implementation Research (CFIR) that details barriers and facilitators to implementing the mHealth intervention at multiple levels (users, organization, intervention characteristics, broader community), and (2) the Technology Acceptance Model (TAM), a conceptual model specific for explaining the intent to use new information technology (including mHealth). The Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) framework was used to measure the outcomes. Discussion: Our research project can serve as a case study of a potential approach to combining different models/frameworks to help organize and plan the evaluation of interventions to increase medication adherence. The description of our process may serve as a blueprint for future studies developing and testing new strategies to foster evidence-based treatments for individuals living with SCD.

Patient experiences with a phone-based cardiovascular risk reduction intervention: Are there differences between women and men?

OBJECTIVES: To explore gender-based differences in experiences with a telehealth-delivered intervention for reduction of cardiovascular risk. METHODS: We conducted 23 semi-structured qualitative interviews by telephone with 11 women and 12 men who received a 12-month, pharmacist-delivered, telephone-based medication and behavioral management intervention. We used content analysis to identify themes. RESULTS: We identified three common themes for both men and women: ease and convenience of phone support, preference for proactive outreach, and need for trust building in the context of telehealth. While both genders appreciated the social support from the intervention pharmacist, women voiced appreciation for accountability whereas men generally spoke about encouragement. CONCLUSIONS: Rapport building may differ between telehealth and in-person healthcare visits; our work highlights how men and women's experiences can differ with telehealth care and which can inform the development of future, purposeful rapport building activities to strengthen the clinician-patient interaction. PRACTICE IMPLICATIONS: Clinicians should seek opportunities to provide frequent and routine support for patients with chronic disease. Telehealth interventions may benefit from gender-specific tailoring of social support.

Self-monitoring of Blood Pressure in Patients With Hypertension-Related Multi-morbidity: Systematic Review and Individual Patient Data Meta-analysis.

BACKGROUND: Studies have shown that self-monitoring of blood pressure (BP) is effective when combined with co-interventions, but its efficacy varies in the presence of some co-morbidities. This study examined whether self-monitoring can reduce clinic BP in patients with hypertension-related co-morbidity. METHODS: A systematic review was conducted of articles published in Medline, Embase, and the Cochrane Library up to January 2018. Randomized controlled trials of self-monitoring of BP were selected and individual patient data (IPD) were requested. Contributing studies were prospectively categorized by whether they examined a low/high-intensity co-intervention. Change in BP and likelihood of uncontrolled BP at 12 months were examined according to number and type of hypertension-related co-morbidity in a one-stage IPD meta-analysis. RESULTS: A total of 22 trials were eligible, 16 of which were able to provide IPD for the primary outcome, including 6,522 (89%) participants with follow-up data. Self-monitoring was associated with reduced clinic systolic BP compared to usual care at 12-month follow-up, regardless of the number of hypertension-related co-morbidities (-3.12 mm Hg, [95% confidence intervals -4.78, -1.46 mm Hg]; P value for interaction with number of morbidities = 0.260). Intense interventions were more effective than low-intensity interventions in patients with obesity (P < 0.001 for all outcomes), and possibly stroke (P < 0.004 for BP control outcome only), but this effect was not observed in patients with coronary heart disease, diabetes, or chronic kidney disease. CONCLUSIONS: Self-monitoring lowers BP regardless of the number of hypertension-related co-morbidities, but may only be effective in conditions such obesity or stroke when combined with high-intensity co-interventions.

Is diabetes associated with poorer self-efficacy and motivation for physical activity in older adults with arthritis?

OBJECTIVES: The primary aim was to explore whether arthritis is associated with poorer self-efficacy and motivation for, and participation in, two specific types of physical activity (PA): endurance training (ET) and strength training (ST). A further objective was to determine whether the added burden of diabetes contributes to a further reduction in these PA determinants and types. METHODS: Self-efficacy and motivation for exercise and minutes per week of ET and ST were measured in 347 older veterans enrolled in a home-based PA counselling intervention. Regression analyses were used to compare high versus low self-efficacy and motivation and PA minutes in persons without arthritis, with arthritis alone, and with arthritis plus diabetes. RESULTS: Persons with arthritis alone reported lower self-efficacy for ET and ST than those without arthritis [odds ratio (OR)ET 0.71, 95% confidence interval (CI) 0.39­1.20; ORST 0.69, 95% CI 0.39­1.20]. A further reduction in self-efficacy for these two types of PA was observed for those with both arthritis and diabetes (ORET 0.65, 95% CI 0.44­0.92; ORST 0.64, 95% CI 0.44­0.93; trend p < 0.001). There was no trend towards a reduction in motivation for PA in those with arthritis alone or with arthritis and diabetes. Persons with arthritis exhibited higher motivation for ET than those without arthritis (ORET 1.85, 95% CI 1.12­3.33). There were no significant differences between the three groups in minutes of ET (p = 0.93), but persons with arthritis plus diabetes reported significantly less ST compared to individuals with arthritis only (p = 0.03). CONCLUSIONS: Despite reduced self-efficacy for ET and ST and less ST in older persons with arthritis, motivation for both PA types remains high, even in the presence of diabetes.

The impact of self-reported arthritis and diabetes on response to a home-based physical activity counselling intervention.

OBJECTIVES: Physical activity (PA) has the potential to improve outcomes in both arthritis and diabetes, but these conditions are rarely examined together. Our objective was to explore whether persons with arthritis alone or those with both arthritis and diabetes could improve amounts of PA with a home-based counselling intervention. METHODS: As part of the Veterans LIFE (Learning to Improve Fitness and Function in Elders) Study, veterans aged 70-92 were randomized to usual care or a 12-month PA counselling programme. Arthritis and diabetes were assessed by self-report. Mixed models were used to compare trajectories for minutes of endurance and strength training PA for persons with no arthritis (n = 85), arthritis (n = 178), and arthritis plus diabetes (n = 84). RESULTS: Recipients of PA counselling increased minutes of PA per week independent of disease status (treatment arm by time interaction p < 0.05 for both; endurance training time p = 0.0006 and strength training time p < 0.0001). Although PA was lower at each wave among persons with arthritis, and even more so among persons with arthritis plus diabetes, the presence of these conditions did not significantly influence response to the intervention (arthritis/diabetes group x time interactions p > 0.05 for both outcomes) as each group experienced a nearly twofold or greater increase in PA. CONCLUSIONS: A home-based PA intervention was effective in increasing minutes of weekly moderate intensity endurance and strength training PA in older veterans, even among those with arthritis or arthritis plus diabetes. This programme may serve as a useful model to improve outcomes in older persons with these pervasive diseases.

Implementing evidence-based patient self-management programs in the Veterans Health Administration: perspectives on delivery system design considerations.

While many patient self-management (PSM) programs have been developed and evaluated for effectiveness, less effort has been devoted to translating and systematically delivering PSM in primary and specialty care. Therefore, the purpose of this paper is to review delivery system design considerations for implementing self-management programs in practice. As lessons are learned about implementing PSM programs in Veterans Health Administration (VHA), resource allocation by healthcare organization for formatting PSM programs, providing patient access, facilitating PSM, and incorporating support tools to foster PSM among its consumers can be refined and tailored. Redesigning the system to deliver and support PSM will be important as implementation researchers translate evidence based PSM practices into routine care and evaluate its impact on the health-related quality of life of veterans living with chronic disease.

Racial differences in osteoarthritis pain and function: potential explanatory factors.

OBJECTIVE: This study examined factors underlying racial differences in pain and function among patients with hip and/or knee osteoarthritis (OA). METHODS: Participants were n=491 African Americans and Caucasians enrolled in a clinical trial of telephone-based OA self-management. Arthritis Impact Measurement Scales-2 (AIMS2) pain and function subscales were obtained at baseline. Potential explanatory variables included arthritis self-efficacy, AIMS2 affect subscale, problem- and emotion-focused pain coping, demographic characteristics, body mass index, self-reported health, joint(s) with OA, symptom duration, pain medication use, current exercise, and AIMS2 pain subscale (in models of function). Variables associated with both race and pain or function, and which reduced the association of race with pain or function by >or=10%, were included in final multivariable models. RESULTS: In simple linear regression models, African Americans had worse scores than Caucasians on AIMS2 pain (B=0.65, P=0.001) and function (B=0.59, P<0.001) subscales. In multivariable models race was no longer associated with pain (B=0.03, P=0.874) or function (B=0.07, P=0.509), indicating these associations were accounted for by other covariates. Variables associated with worse AIMS2 pain and function were: worse AIMS2 affect scores, greater emotion-focused coping, lower arthritis self-efficacy, and fair or poor self-reported health. AIMS2 pain scores were also significantly associated with AIMS2 function. CONCLUSION: Factors explaining racial differences in pain and function were largely psychological, including arthritis self-efficacy, affect, and use of emotion-focused coping. Self-management and psychological interventions can influence these factors, and greater dissemination among African Americans may be a key step toward reducing racial disparities in pain and function.

Supporting self-management for patients with complex medical needs: recommendations of a working group.

Increasing numbers of persons live with complex chronic medical needs and are at risk for poor health outcomes. These patients require unique self-management support, as they must manage many, often interacting, tasks. As part of a conference on Managing Complexity in Chronic Care sponsored by the Department of Veterans Affairs, a working group was convened to consider self-management issues specific to complex chronic care. In this paper, we assess gaps in current knowledge on self-management support relevant to this population, report on the recommendations of our working group, and discuss directions for future study. We conclude that this population requires specialized, multidimensional self-management support to achieve a range of patient-centred goals. New technologies and models of care delivery may provide opportunities to develop this support. Validation and quantification of these processes will require the development of performance measures that reflect the needs of this population, and research to prove effectiveness.

The predictive value of self-report scales compared with physician diagnosis of depression in hemodialysis patients.

The prevalence of depression in end-stage renal disease (ESRD) patients on hemodialysis has not been definitively determined. We examined the prevalence of depression and the sensitivity, specificity, positive, and negative likelihood ratios (+LR and -LR) of self-report scales using the physician-administered Structured Clinical Interview for Depression (SCID) as the comparison. Ninety-eight consecutive patients completed the Beck Depression Inventory (BDI) and the Center for Epidemiological Study of Depression (CESD) scales. A physician blinded to BDI and CESD scores administered the SCID. Receiver/responder operating characteristic curves determined the best BDI and CESD cutoffs for depression. Depressed patients had more co-morbidities and lower quality of life, P<0.05. The prevalence of depression by SCID was 26.5% and of major depression was 17.3%. The CESD cutoff with the best diagnostic accuracy was 18, with sensitivity 69% (95% confidence interval (CI) (51%, 87%)), specificity 83% (95% CI (74%, 92%)), positive predictive value (PPV) 60%, negative predictive value (NPV) 88%, +LR 4.14, and -LR 0.37. The best BDI cutoff was 14, with sensitivity 62% (95% CI (43%, 81%)), specificity 81% (95% CI (72%, 90%)), PPV 53%, NPV 85%, +LR 3.26, and -LR 0.47. Self-report scales have high +LR but low -LR for diagnosis of depression. When used for screening, the threshold for depression should be higher for ESRD compared with non-ESRD patients. Identifying depression using physician interview is important, given the low -LR of self-report scales.

Identifying barriers to hypertension guideline adherence using clinician feedback at the point of care.

Factors contributing to low adherence to clinical guidelines by clinicians are not well understood. The user interface of ATHENA-HTN, a guideline-based decision support system (DSS) for hypertension, presents a novel opportunity to collect clinician feedback on recommendations displayed at the point of care. We analyzed feedback from 46 clinicians who received ATHENA advisories as part of a 15-month randomized trial to identify potential reasons clinicians may not intensify hypertension therapy when it is recommended. Among the 368 visits for which feedback was provided, clinicians commonly reported they did not follow recommendations because: recorded blood pressure was not representative of the patient's typical blood pressure; hypertension was not a clinical priority for the visit; or patients were nonadherent to medications. For many visits, current quality-assurance algorithms may incorrectly identify clinically appropriate decisions as guideline nonadherent due to incomplete capture of relevant information. We present recommendations for how automated DSSs may help identify "apparent" barriers and better target decision support.

Analysis of air contrast barium enema, computed tomographic colonography, and colonoscopy: prospective comparison.

BACKGROUND: The usefulness of currently available colon imaging tests, including air contrast barium enema (ACBE), computed tomographic colonography (CTC), and colonoscopy, to detect colon polyps and cancers is uncertain. We aimed to assess the sensitivity of these three imaging tests. METHODS: Patients with faecal occult blood, haematochezia, iron-deficiency anaemia, or a family history of colon cancer underwent three separate colon-imaging studies--ACBE, followed 7-14 days later by CTC and colonoscopy on the same day. The primary outcome was detection of colonic polyps and cancers. Outcomes were assessed by building an aggregate view of the colon, taking into account results of all three tests. FINDINGS: 614 patients completed all three imaging tests. When analysed on a per-patient basis, for lesions 10 mm or larger in size (n=63), the sensitivity of ACBE was 48% (95% CI 35-61), CTC 59% (46-71, p=0.1083 for CTC vs ACBE), and colonoscopy 98% (91-100, p<0.0001 for colonoscopy vs CTC). For lesions 6-9 mm in size (n=116), sensitivity was 35% for ACBE (27-45), 51% for CTC (41-60, p=0.0080 for CTC vs ACBE), and 99% for colonoscopy (95-100, p<0.0001 for colonoscopy vs CTC). For lesions of 10 mm or larger in size, the specificity was greater for colonoscopy (0.996) than for either ACBE (0.90) or CTC (0.96) and declined for ACBE and CTC when smaller lesions were considered. INTERPRETATION: Colonoscopy was more sensitive than other tests, as currently undertaken, for detection of colonic polyps and cancers. These data have important implications for diagnostic use of colon imaging tests.

Evaluating provider adherence in a trial of a guideline-based decision support system for hypertension.

Measurement of provider adherence to a guideline-based decision support system (DSS) presents a number of important challenges. Establishing a causal relationship between the DSS and change in concordance requires consideration of both the primary intention of the guideline and different ways providers attempt to satisfy the guideline. During our work with a guideline-based decision support system for hypertension, ATHENA DSS, we document a number of subtle deviations from the strict hypertension guideline recommendations that ultimately demonstrate provider adherence. We believe that understanding these complexities is crucial to any valid evaluation of provider adherence. We also describe the development of an advisory evaluation engine that automates the interpretation of clinician adherence with the DSS on multiple levels, facilitating the high volume of complex data analysis that is created in a clinical trial of a guideline-based DSS.

Congestive heart failure patients' perceptions of quality of life: the integration of physical and psychosocial factors.

Congestive heart failure (CHF) lowers survival and worsens the quality of life (QOL) of over four million older Americans. Both clinicians and standardized instruments used to assess the QOL of patients with CHF focus primarily on physical symptoms rather than capturing the full range of psychosocial concerns. The purpose of this study was to gather descriptions of the components of QOL as understood by patients living with CHF. Focus groups were conducted with patients with known CHF, New York Heart Association (NYHA) class I-IV, and left ventricular fraction of <40%. Focus groups were audiotaped, transcribed, and reviewed for common and recurrent themes using the methods of constant comparisons. We conducted three focus groups (n = 15) stratified by NYHA stage with male patients ranging in age from 47-82 years of age. Five patients were classified with NYHA stage III/IV and ten with NYHA stage I/II. Thirty attributes of QOL were identified which fell into five broad domains: symptoms, role loss, affective response, coping, and social support. Expectedly, patients reported the importance of physical symptoms; however, participants also identified concern for family, the uncertainty of prognosis, and cognitive function as dimensions of QOL. Changes in patients' lives attributed to CHF were not always considered deficiencies; rather, methods of coping with CHF were identified as important attributes representing possible opportunities for personal growth. Clinicians must understand the full range of concerns affecting the QOL of their older patients with CHF. The findings suggest that psychosocial aspects and patient uncertainty about their prognosis are important components of QOL among CHF patients.

The relationship between hostility and behavioral risk factors for poor health in women veterans.

BACKGROUND: While previous research has generally supported a relationship between hostility and health risk behaviors, the majority of this research has been conducted in predominately male, highly educated, Caucasian samples. The current study was designed to further examine the relationship between hostility and health risk behaviors in a sample of women. METHODS: Measures of health risk behavior and scores from the Cook-Medley hostility scale were obtained from 409 women veterans. Linear and logistic regression analyses were used to examine the relationship between hostility and health behaviors including tobacco smoking, alcohol use, body-mass index, caffeine use, and level of physical activity, after sociodemographic factors were accounted for. RESULTS: In a cohort of women veterans using VA health care, ages 35-81, hostility was significantly associated with tobacco smoking (OR = 2.10; 95% CI = 1.34 to 3.30), caffeine use (OR = 2.12; 95% CI = 1.16 to 3.85), and the number of alcoholic beverages consumed by women who drink alcohol. Hostility was not associated with body mass index (OR = 1.15; 95% CI = 0.77 to 1.72) or a lack of physical exercise (OR = 0.89; 95% CI = 0.55 to 1.43). CONCLUSIONS: Results are generally consistent with previous research and support the relationship between hostility and health risk behaviors. Awareness that hostility contributes to risk behaviors and disease may help in the design of interventions aimed at risk reduction.

Racial differences in physician recommendation of hormone replacement therapy.

PURPOSE: Previous studies have suggested that black women may be less likely than white women to be offered and to take hormone replacement therapy (HRT). Thus, race and other factors associated with physician recommendation of HRT that may influence women's decisions about HRT were examined. METHODS: Data were from a baseline assessment of participants in a randomized controlled trial designed to evaluate the efficacy of a tailored decision-aid on HRT decision-making. We telephone interviewed 581 Durham women ages 45-54. The association of race and other factors with reported physician recommendation of HRT was tested using chi(2) and logistic regression analysis. RESULTS: Overall, 45% of women surveyed reported that their physician recommended HRT; black women were significantly less likely than white women to report being advised about HRT (35% vs. 48%, respectively, P < 0.005). Additional factors associated with being recommended HRT included older age, being postmenopausal, having had a hysterectomy, having thought about the benefits of HRT, and being satisfied with information about HRT. CONCLUSIONS: Black women are less likely than white women to receive physician recommendation of HRT. Racial differences in patient-provider communication about HRT exist and thus require greater diligence on the part of health care providers to minimize such a gap.

Does social support buffer functional decline in elderly patients with unipolar depression?

OBJECTIVE: This study tested whether social support protects against functional decline, either generally or selectively, in the most severely depressed elderly patients undergoing treatment for major depressive disorder. METHOD: In a prospective cohort study design, 113 patients with incident and prevalent unipolar depression were followed for 12 months while they were undergoing naturalistic treatment. Outcome measures included performance on basic and instrumental activities of daily living; predictor variables included Hamilton Depression Rating Scale scores and four domains of informal social support. The analysis employed multivariable ordinary least squares regression models. RESULTS: Improved scores on instrumental activities of daily living and stable scores on basic activities of daily living characterized the subjects. In adjusted analyses, instrumental social support provided marginal protection against worsening performance on instrumental activities of daily living, which were primarily a function of baseline depression severity. Large social networks, more frequent social interaction, and the perceived adequacy of social support played a modest buffering role against declines in performance on basic activities of daily living among the most depressed elderly patients. CONCLUSIONS: Instrumental support was generally protective against worsening performance on instrumental abilities of daily living among elderly patients with recurrent unipolar depression. Subjective and structural dimensions of social support protected the most severely depressed elderly patients against the loss of basic maintenance abilities.

Depressive symptoms, menopausal status, and climacteric symptoms in women at midlife.

OBJECTIVE: Previous studies have found increased rates of depression in women aged 45 to 54 years, but the factors that influence these rates are not understood. It was assessed whether higher rates of depressive symptoms were associated with menopausal status, climacteric symptoms, and use of hormone replacement therapy. DESIGN: Cross-sectional survey. SETTING: Community sample. METHODS: Data are from 581 women ages 45 to 54 years who were interviewed by telephone between October 1998 and February 1999. MEASURES: Depression was measured with the abbreviated CES-D, a depressive symptoms screening measure. Women's reported perception of menopausal stage, frequency of periods in the preceding 12 months, and history of oophorectomy were used to classify their menopausal status into four categories: (1) no indication of menopause; (2) close to menopause; (3) had begun menopause; and (4) had completed menopause. RESULTS: There were 168 women (28.9%) who reported a high level (> or = 10) of depressive symptoms when the abbreviated CES-D was used. In a logistic-regression analysis, significant factors associated with increased depressive symptoms included physical inactivity, inadequate income, use of estrogen/progesterone combination, and presence of climacteric symptoms (trouble sleeping, mood swings, or memory problems). Menopausal status was not associated with depressive symptoms. CONCLUSIONS: In this sample of women age 45 to 54 years, climacteric symptoms but not menopausal status were associated with higher rates of depressive symptoms.

Personality and coping with a common stressor: cardiac catheterization.

The association between coping and personality was examined in a sample of 204 cardiac catheterization patients who were asked to evaluate the use of specific coping strategies used to deal with their cardiac catheterization. Personality, as measured by the NEO Five-Factor Inventory (FFI), was moderately correlated with coping measures. In multivariate analyses, after considering confounding factors, Neuroticism was positively and Extraversion was negatively related to avoidance coping and Neuroticism was negatively associated with counting one's blessings as a coping strategy. Personality was not related to either problem solving or seeking social support coping strategies for individuals experiencing a cardiac catheterization. However, important covariates were associated with coping strategies. Not being married was negatively correlated with use of seeking social support and not having a confidant was negatively related with seeking social support and positively with avoidance. These results suggest that there are specific relationships between personality and coping, but these relationships are, for the most part, moderate in persons coping with a cardiac catheterization, and that coping processes are associated with individual differences in available social resources.

Characteristics of socially isolated patients with coronary artery disease who are at elevated risk for mortality.

OBJECTIVES: Social isolation has been linked to poor survival in patients with coronary artery disease (CAD). Few studies have closely examined the psychosocial characteristics of CAD patients who lack social contact. METHODS: Social isolation was examined as a predictor of mortality in 430 patients with significant CAD. More isolated patients were compared with their less isolated counterparts on factors that might help explain the association between isolation and survival. RESULTS: The mortality rate was higher among isolated individuals. Those with three or fewer people in their social support network had a relative risk of 2.43 (p = .001) for cardiac mortality and 2.11 (p = .001) for all-cause mortality, controlling for age and disease severity. Adjustments for income, hostility, and smoking status did not alter the risk due to social isolation. With the exception of lower income, higher hostility ratings, and higher smoking rates, isolated patients did not differ from nonisolated patients on demographic indicators, disease severity, physical functioning, or psychological distress. Isolated patients reported less social support and were less pleased with the way they got along with network members, but they did not report less satisfaction with the amount of social contact received. CONCLUSIONS: Patients with small social networks had an elevated risk of mortality, but this greater risk was not attributable to confounding with disease severity, demographics, or psychological distress. These findings have implications for mechanisms linking social isolation to mortality and for the application of psychosocial interventions.