Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE): A randomized trial to improve post myocardial infarction management.

OBJECTIVE: We evaluated the impact of a low intensity web-based and intensive nurse-administered intervention to reduce systolic blood pressure (SBP) among patients with prior MI. METHODS: Secondary Prevention Risk Interventions via Telemedicine and Tailored Patient Education (SPRITE) was a three-arm trial. Patients were randomized to 1) post-MI education-only; 2) nurse-administered telephone program; or 3) web-based interactive tool. The study was conducted 2009-2013. RESULTS: Participants (n = 415) had a mean age of 61 years (standard deviation [SD], 11). Relative to the education-only group, the 12-month differential improvement in SBP was - 3.97 and - 3.27 mmHg for nurse-administered telephone and web-based groups, respectively. Neither were statistically significant. Post hoc exploratory subgroup analyses found participants who received a higher dose (>12 encounters) in the nurse-administered telephone intervention (n = 60; 46%) had an 8.8 mmHg (95% CI, 0.69, 16.89; p = 0.03) differential SBP improvement versus low dose (<11 encounters; n = 71; 54%). For the web-based intervention, those who had higher dose (n = 73; 53%; >1 web encounter) experienced a 2.3 mmHg (95% CI, -10.74, 6.14; p = 0.59) differential SBP improvement versus low dose (n = 65; 47%). CONCLUSIONS: The main effects were not statistically significant. PRACTICAL IMPLICATIONS: Completing the full dose of the intervention may be essential to experience the intervention effect. CLINICAL TRIAL REGISTRATION: The unique identifier is NCT00901277 (http://www. CLINICALTRIALS: gov/ct2/show/NCT00901277?term=NCT00901277&rank=1).

Caregiver experience during advanced chronic illness and last year of life.

OBJECTIVES: To compare the prevalence and predictors of caregiver esteem and burden during two different stages of care recipients' illnesses-advanced chronic illness and the last year of life. DESIGN: Longitudinal, observational cohort study. SETTING: Community sample recruited from outpatient clinics at Duke University and Durham Veterans Affairs Medical Centers. PARTICIPANTS: Individuals with advanced cancer, congestive heart failure, or chronic obstructive pulmonary disease and their primary caregiver, retrospectively coded as chronic-illness (n = 62) or end-of-life (EOL; n = 62) care recipient-caregiver dyads. MEASUREMENTS: Caregiver experience was measured monthly using the Caregiver Reaction Assessment, which includes caregiver esteem and four domains of burden: schedule, health, family, and finances. RESULTS: During chronic illness and at the end of life, high caregiver esteem was almost universal (95%); more than 25% of the sample reported health, family, and financial burden. Schedule burden was the most prevalent form of burden; EOL caregivers (58%) experienced it more frequently than chronic-illness caregivers (32%). Caregiver esteem and all dimensions of burden were relatively stable over 1 year. Few factors were associated with burden. CONCLUSION: Caregiver experience is relatively stable over 1 year and similar in caregivers of individuals in the last year of life and those earlier in the course of chronic illness. Schedule burden stands out as most prevalent and variable among dimensions of experience. Because prevalence of burden is not specific to stage of illness and is relatively stable over time, multidisciplinary healthcare teams should assess caregiver burden and refer burdened caregivers to supportive resources early in the course of chronic illness.

Burden and well-being among a diverse sample of cancer, congestive heart failure, and chronic obstructive pulmonary disease caregivers.

CONTEXT: Three important causes of death in the U.S. (cancer, congestive heart failure, and chronic obstructive pulmonary disease) are preceded by long periods of declining health; often, family members provide most care for individuals who are living with serious illnesses and are at risk for impaired well-being. OBJECTIVES: To expand understanding of caregiver burden and psychosocial-spiritual outcomes among understudied groups of caregivers-cancer, congestive heart failure, and chronic obstructive pulmonary disease caregivers-by including differences by disease in a diverse population. METHODS: The present study included 139 caregiver/patient dyads. Independent variables included patient diagnosis and function; and caregiver demographics, and social and coping resources. Cross-sectional analyses examined distributions of these independent variables between diagnoses, and logistic regression examined correlates of caregiver burden, anxiety, depressive symptoms, and spiritual well-being. RESULTS: There were significant differences in patient functioning and caregiver demographics and socioeconomic status between diagnosis groups but few differences in caregiver burden or psychosocial-spiritual outcomes by diagnosis. The most robust social resources indicator of caregiver burden was desire for more help from friends and family. Anxious preoccupation coping style was robustly associated with caregiver psychosocial-spiritual outcomes. CONCLUSION: Caregiver resources, not patient diagnosis or illness severity, are the primary correlates associated with caregiver burden. Additionally, caregiver burden is not disease specific to those examined here, but it is rather a relatively universal experience that may be buffered by social resources and successful coping styles.

Identifying, recruiting, and retaining seriously-ill patients and their caregivers in longitudinal research.

BACKGROUND: In order to improve the state of science in palliative care, we must increase our ability to document the real-time experience of patients and families as they traverse the end of life. Yet, frequently, prospective measurement is impeded by difficulty with patient identification, recruitment, enrollment, and retention. The palliative care literature is replete with descriptions of studies unable to meet enrollment goals, and that as a result, do not have adequate power to test hypotheses or draw conclusions. OBJECTIVES: To review the literature describing difficulties associated with ascertainment, enrollment, and attrition. To outline the successful recruitment methods of a new longitudinal study of patients and their caregivers. DESIGN: A two-year longitudinal study of 240 patients with Stage IV cancer (breast, prostate, colorectal, lung), advanced congestive heart failure (CHF) LVEFB < 40 or advanced chronic obstructive pulmonary disease (COPD) pCO(2) > 46, and their caregivers, interviewed monthly for up to two years. Patients were identified using clinical and administrative databases from one geographic region. RESULTS: Representative and successful ascertainment was associated with use of clinical criteria and medical record review versus physician or other provider prognostication, use of recruitment letters from personal physician, recruitment letter content, brochure content, small monetary incentives, refined phone scripts, use of matched ethnicity interviewers, in-home and phone interview strategies, measure selection, patient and caregiver rapport, and on-going staff support (including grief and bereavement). CONCLUSIONS: Recruitment to prospective longitudinal studies at the end of life is difficult, but possible. The lessons learned from this study are applicable to future investigators conducting prospective research.

Enrollment in clinical trials according to patients race: experience from the VA Cooperative Studies Program (1975-2000).

BACKGROUND: Racial distribution of clinical trial participants is important because results from these studies serve to define evidence-based practice. This report summarizes the experience of the VA Cooperative Studies Program (CSP) in enrolling white, black and Hispanic patients. METHODS: An analysis of enrollment in randomized controlled trials conducted by VA CSP between 1975 and 2000. A standardized enrollment ratio for each trial was calculated by dividing the observed number of enrolled white patients in the trial by the expected number of eligible white patients based on the proportion of white patients hospitalized at the enrolling VA Medical Centers. RESULTS: 138 VA CSP clinical trials were initiated between 1975 and 2000, 83 contained information on race for 71,463 patients. Overall, 76% of enrolled patients were white, 20% were black, and 4% were Hispanic. Based on standardized enrollment ratios, 60 of the 83 trials had 95% confidence intervals that excluded 1.0. Of these, 32 studies enrolled more white patients than expected and 28 enrolled more Black and/or Hispanic patients than expected based on the racial distribution of patients hospitalized at sites involved in the trials. When trials were separated by intervention type, 13 of the 19 trials that had an invasive arm enrolled fewer minority patients than expected. In trials that targeted diseases that affect minority populations to a greater degree than whites (diabetes, hypertension and end stage renal disease), 11 of the 14 trials enrolled more minority patients than expected. CONCLUSIONS: There were several trials that enrolled either more or less minority patients than expected based on patients hospitalized at study sites. Trials that included an invasive arm enrolled fewer minority participants than expected. Trials that involve invasive therapies may wish to adopt special recruitment strategies to reach minority populations.

Potential role of increased iron stores in diabetes.

Diabetes mellitus (DM) is an important risk factor for the development of cardiovascular disease. Extensive clinical, epidemiologic, and basic studies suggest that excessive tissue iron stores may contribute to the occurrence and complications of DM. Secondary diabetes occurs in inherited pathologic iron overload syndromes of European- and African-derived populations and is an established complication of transfusional iron overload. Epidemiologic studies have repeatedly shown positive correlation between levels of serum ferritin and those of fasting glucose, insulin, and glycosylated hemoglobin. Iron reduction therapy in hereditary hemochromatosis and transfusional iron overload is associated with improved glucose tolerance and reduced incidence of secondary diabetes. Trials of iron reduction therapy in diabetes mellitus, although limited and inconclusive, have shown clinical improvement in some patients. The current article reviews evidence suggesting that tissue iron contributes to DM and its complications and presents preliminary data that emphasize the potential importance of iron overload in DM of African Americans.