Talking with terminally ill patients and their caregivers about death, dying, and bereavement: is it stressful? Is it helpful?

BACKGROUND: Discussing end-of-life issues with terminally ill patients is often considered distressing and harmful. This study was conducted to assess whether interviewing terminally ill patients and their caregivers about death, dying, and bereavement is stressful and/or helpful. METHODS: Patients from 6 sites in the United States who were estimated to have 6 months or less to live were interviewed in person and reinterviewed 2 to 6 months later. Their caregivers were interviewed separately. At the end of the interviews, patients and caregivers were asked how stressful and how helpful the interview had been. Of 1131 eligible patients, 988 (87.4%) were interviewed, and of 915 eligible caregivers, 893 (97.6%) were interviewed. RESULTS: At the end of the first interview, 1.9% of the patients reported having experienced a great deal of stress, 7.1% some stress, and 88.7% little or no stress from the interview. Among the caregivers, 1.5% reported a great deal of stress, 8.4% some stress, and 89.7% little or no stress. Slightly more stress was reported to have been caused by the reinterview. Overall, 16.9% of the patients reported the initial interview as very helpful, 29.6% as somewhat helpful, and 49.6% as offering little or no help. Among the caregivers, 19.1% reported the initial interview as very helpful, 34.3% as somewhat helpful, and 44.9% as offering little or no help. The reported helpfulness of the second interview was slightly less. Patients experiencing pain (odds ratio [OR], 1.26; 95% confidence interval [CI], 1.02-1.56), more personal meaning in dying (OR, 3.05; 95% CI, 2.02-4.59), and less ease with talking about the end of life (OR, 1.32; 95% CI, 1.09-1.60) were significantly more likely to report stress. Patients who were from an ethnic minority (OR, 1.85; 95% CI, 1.31-2.63), anxious about the end of their life (OR, 1.39; 95% CI 1.16-1.67), more spiritual (OR, 1.30; 95% CI, 1.06-1.61), and serene (OR, 1.25; 95% CI, 1.08-1.45) were significantly more likely to report the interview helpful. There was no relationship between stress and helpfulness. CONCLUSIONS: Terminally ill patients and their caregivers can discuss death, dying, and bereavement in a structured interview with minimal stress and report that the interview was helpful. Institutional review boards should not preemptively restrict surveys with terminally ill patients without reliable evidence that they will be stressful or otherwise harmful.

Provider and hospital characteristics associated with geographic variation in the evaluation and management of elderly patients with heart failure.

BACKGROUND: Rates of guideline-based care for elderly patients with heart failure vary by state, and overall are not optimal. Identifying factors associated with the lack of uniformly high-quality health care might aid efforts to improve care. We therefore sought to determine the extent to which provider and hospital characteristics contribute to small-area geographic variation in heart failure care after controlling for patient factors. METHODS: We studied 30 228 Medicare patients who were older than 65 years and hospitalized with heart failure. We mapped rates for 2 quality measures-documentation of left ventricular ejection fraction and appropriate prescription of angiotensin-converting enzyme inhibitors-across the United States, using a Bayesian technique that smooths rates and enhances assessment for significant patterns of small-area variation. We used nonlinear hierarchical models to assess for associations between the the quality indicators and provider and hospital characteristics independent of patient characteristics. RESULTS: Smoothed, unadjusted rates of left ventricular ejection fraction documentation ranged from 30.1% to 67.2% and of angiotensin-converting enzyme inhibitor prescription from 55.8% to 87.1% among hospital referral regions; regional patterns were apparent. After patient factors were controlled for, care at hospitals without a medical school affiliation, without invasive cardiac capabilities, or in a rural location, as well as not having a cardiologist as an attending physician, was significantly associated with lower rates of left ventricular ejection fraction documentation. Hospitalization at a nonteaching facility was significantly associated with failure to prescribe angiotensin-converting enzyme inhibitors. CONCLUSION: Characteristics of providers and hospitals explain in part the geographic variation in guideline-based care for elderly patients with heart failure.

Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure.

BACKGROUND: Although it is widely accepted that clinical trials in heart failure may not apply to older populations, the magnitude of the discrepancy between trial populations and patients seen in community-based practice are not known. Our objective was to determine the proportion of older persons meeting enrollment criteria of randomized controlled trials of agents that prolong life in heart failure. METHODS: We conducted a cross-sectional study of Medicare beneficiaries >64 years old with the principal diagnosis of heart failure who were discharged from acute care hospitals in the United States between April 1998 and March 1999. Enrollment criteria of the Studies of Left Ventricular Dysfunction (SOLVD), Metroprolol CR/LX Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF), and Randomized Aldactone Evaluation Study (RALES) trials were applied to the population, and the proportions meeting the criteria were determined by subgroups of age and sex. RESULTS: Of the 20,388 patients studied, 18%, 13%, and 25% met the enrollment criteria of the SOLVD, MERIT-HF, and RALES trials, respectively. Although trial eligibility was less than a third for any sex or age group, significantly fewer women than men met trial criteria (13% vs 23% for SOLVD, 11% vs 17% for MERIT-HF, and 21% vs 32% for RALES, P <.0001 for all). The oldest patients were also less likely to fulfill enrollment criteria. The proportion of all patients not included because of preserved left ventricular systolic function was twice as large as the proportion meeting the inclusion criteria for any trial. CONCLUSIONS: A minority of hospitalized older persons with heart failure fit the profile of populations of clinical trials. There is an urgent need for research in heart failure for typical heart failure patients, including the very old, women, and patients with preserved left ventricular systolic function.

Spectrum of heart failure in older patients: results from the National Heart Failure project.

BACKGROUND: The elderly make up the majority of patients with heart failure (HF), but information on this segment of the HF population is lacking because clinical trials typically enroll younger patients and population-based studies lack clinical detail. We sought to describe a contemporary national sample of elderly patients with HF and to examine the sample for age-related trends in clinical characteristics. METHODS: We studied the charts of 800 Medicare patients per state who were hospitalized with a principal diagnosis of HF between April 1998 and March 1999. There were 34,587 patients in the sample after exclusion of patients who were <65 years old, repeat discharges, discharges to another acute care facility or against medical advice, or receiving long-term hemodialysis. RESULTS: Comorbidity was common. About one third of patients had chronic obstructive pulmonary disease, about 40% had diabetes, more than half had coronary heart disease, and more than half had a history of hypertension, but comorbidity rates declined with age. Left ventricular ejection fraction was <40% in only 50.4% of patients in whom it was assessed. Associated laboratory abnormalities were relatively constant across the age spectrum, but renal insufficiency was more common with advancing age. The likelihood that patients were in long-term care facilities before admission rose quite steeply with age. CONCLUSIONS: Elderly patients with HF are a heterogeneous group and appear to differ substantially from patients enrolled in clinical trials. Evidence-based guidance for treatment in the context of multiple comorbid conditions, poor renal function, HF with preserved left ventricular systolic function, and residence in long-term care facilities is urgently needed.

A losing battle: weight regain does not restore weight loss-induced bone loss in postmenopausal women.

Previously, we reported significant bone mineral density (BMD) loss in postmenopausal women after modest weight loss. It remains unclear whether the magnitude of BMD change in response to weight loss is appropriate (i.e., proportional to weight loss) and whether BMD is recovered with weight regain. We now report changes in BMD after a 1-year follow-up. Subjects (n = 23) in this secondary analysis were postmenopausal women randomized to placebo as part of a larger trial. They completed a 6-month exercise-based weight loss program and returned for follow-up at 18 months. Dual-energy X-ray absorptiometry (DXA) was performed at baseline, 6, and 18 months. At baseline, subjects were aged 56.8 ± 5.4 years (mean ± s.d.), 10.0 ± 9.2 years postmenopausal, and BMI was 29.6 ± 4.0 kg/m(2). They lost 3.9 ± 3.5 kg during the weight loss intervention. During follow-up, they regained 2.9 ± 3.9 kg. Six months of weight loss resulted in a significant decrease in lumbar spine (LS) (-1.7 ± 3.5%; P = 0.002) and hip (-0.04 ± 3.5%; P = 0.03) BMD that was accompanied by an increase in a biomarker of bone resorption (serum C-terminal telopeptide of type I collagen, CTX: 34 ± 54%; P = 0.08). However, weight regain was not associated with LS (0.05 ± 3.8%; P = 0.15) or hip (-0.6 ± 3.0%; P = 0.81) bone regain or decreased bone resorption (CTX: -3 ± 37%; P = 0.73). The findings suggest that BMD lost during weight reduction may not be fully recovered with weight regain in hormone-deficient, postmenopausal women. Future studies are needed to identify effective strategies to prevent bone loss during periods of weight loss.

Aspirin use in older patients with heart failure and coronary artery disease: national prescription patterns and relationship with outcomes.

OBJECTIVES: We sought to determine patterns of aspirin use and the relationship between aspirin prescription and outcomes in patients with coronary artery disease (CAD) and heart failure (HF). BACKGROUND: Because of the potential for exacerbating hypertension or renal insufficiency and possible interactions with angiotensin-converting enzyme (ACE) inhibitors, the use of aspirin for secondary prevention of coronary events is controversial in patients with HF. METHODS: We studied a national sample of Medicare beneficiaries > or =65 years old after hospitalization for HF with CAD and without aspirin contraindications between April 1998 and June 2001. We assessed factors associated with aspirin prescription and the relationship between aspirin and outcomes in regression models accounting for differences in patient, physician, and hospital characteristics and for clustering of patients by hospital. RESULTS: Of the 24,012 patients, 54% received aspirin. Treated patients had lower unadjusted rates of death (31% vs. 39% for those not receiving aspirin, p < 0.001). In multivariable analyses, aspirin remained associated with a lower risk of death (risk ratio [RR] 0.94; 95% confidence interval [CI] 0.90 to 0.99). This association was similar regardless of hypertension, renal insufficiency, or treatment with ACE inhibitors (p for all interactions > 0.2). Aspirin also was associated with lower risks of death or all-cause readmission (RR 0.98; 95% CI 0.97 to 0.99) and of death or readmission for HF (RR 0.98; 95% CI 0.96 to 0.99). CONCLUSIONS: Almost one-half of patients with CAD hospitalized for HF in the U.S. are not treated with aspirin. This study found no evidence of harm from aspirin in this population and suggests a treatment benefit. Withholding aspirin based upon theoretical concerns about adverse effects appears to be unjustified.

A randomized controlled trial of multiple tailored messages for smoking cessation among callers to the cancer information service.

Self-help materials computer-tailored to the specific needs of smokers have shown promise as a high-reach, low-cost intervention for smoking cessation. Adding tailored cessation materials to telephone-based cessation counseling may be a way of generating greater efficacy in promoting and maintaining cessation. The objective of this study is to assess the efficacy of adding different types of behavioral smoking cessation materials to brief telephone-based cessation counseling.A total of 1,978 smokers calling the National Cancer Institute's (NCI's) Cancer Information Service (CIS) for help in quitting smoking initially received brief cognitive-behavioral cessation counseling from a CIS information specialist. Following a baseline interview administered by the information specialist, subjects were randomly assigned to one of four conditions, each delivered by U.S. mail: a single, untailored smoking cessation guide (SU); a single, tailored smoking cessation guide (ST); a series of four (multiple) printed materials tailored only to baseline data (MT); and a series of four (multiple) printed materials tailored to baseline as well as retailored using 5-month interim progress data (MRT). The primary outcome measure was 7-day point prevalence abstinence rates assessed using a computer-assisted telephone interview (CATI) at 12-month follow-up.At 12-month follow-up, using intent-to-treat, imputed, and per-protocol analyses, no differences were found among the four experimental conditions (linear trend), or when the ST, MT, and MRT groups were compared with the control (SU) group. Participants in the two multiple message group conditions combined (MT + MRT), however, had significantly higher abstinence rates than participants in the two single message group conditions combined (SU + ST). Moreover, among subjects who reported quitting at the 5-month follow-up, participants receiving the MRT materials reported higher abstinence rates at 12 months than the other three groups combined (SU + ST + MT). The results of this study support the effectiveness, over and above a single telecounseling interaction, of multiple tailored print material contacts on cessation. These effects, however may be due to tailoring, or the longitudinal nature of the two multiple tailored conditions, or both. The strongest evidence for tailoring occurred in the MRT condition for relapse prevention, suggesting that print materials tailored to interim progress may be especially effective in this context. The qualities of specific psychosocial and communication elements in tailored materials should receive attention in future research.

Multiple tailored messages are effective in increasing fruit and vegetable consumption among callers to the Cancer Information Service.

Results are reported from a large (n = 3,402) four-group randomized trial to increase fruit and vegetable consumption among callers to the National Cancer Institute's (NCI's) Cancer Information Service (CIS) using tailored print materials. Following a baseline telephone interview, which included a brief educational message (BEM), participants were assigned randomly within CIS offices to one of four groups: single untailored (SU) group-one untailored set of materials; single tailored (ST) group-one tailored booklet; multiple tailored (MT) group-four tailored materials; and multiple retailored (MRT) group-four tailored materials with retailoring based on new information obtained at 5 months follow-up. Follow-up telephone interviews were conducted at 5 (n = 2,233) and 12 months (n = 1,927) after baseline. The main outcome measure was self-reported fruit and vegetable consumption using a seven-item food frequency questionnaire. At 12 months follow-up, there was a significant linear trend across groups of 0.21 servings (p = 0.0002). Specific nested hypotheses then were tested and revealed significant mean serving differences between SU (5.07) vs. MT (5.64) (p = 0.002) and SU vs. MRT (5.71; p < 0.001). Although the mean for ST (5.40) was greater than that for SU (5.07), the difference was not statistically significant (p = 0.07), and no difference was found between MT vs. MRT (p = 0.69). A higher proportion of recipients of tailored materials reported reading all of the materials and believing that they were written especially for them. No differences by experimental condition were found for the perceived usefulness or motivational impact of the print materials. In this trial, MT print materials were more effective at increasing fruit and vegetable (FV) consumption than were SU materials. The intervention mechanisms responsible for this effect merit further research. Retailoring did not produce a significant difference when compared with longitudinal baseline tailoring.

The efficacy of tailored print materials in promoting colorectal cancer screening: results from a randomized trial involving callers to the National Cancer Institute's Cancer Information Service.

In this large randomized trial among callers to the Cancer Information Service (CIS), tailored print materials were tested for efficacy in promoting colorectal cancer (CRC) screening (fecal occult blood test [FOBT], flexible sigmoidoscopy, or colonoscopy). All participants completed baseline interviews at the end of their usual service calls to the CIS, as well as short-term (6-month) and longer-term (14-month) telephone follow-up interviews. The study sample (n = 4,014) was restricted to English-speaking CIS callers 50 + years of age, who would be eligible for CRC screening at 14 months follow-up and did not call the CIS about CRC or CRC screening. Four experimental conditions were compared: a single untailored (SU) mailout of print material (the control condition); a single tailored (ST) mailout of print material; four (multiple) tailored (MT) mailouts of print materials spanning 12 months, all of which were tailored to information obtained at baseline; and four (multiple) retailored (MRT) mailouts also spanning 12 months, with retailoring of the print materials (mailouts 2, 3, and 4) based on updated information obtained from the 6-month follow-up interviews. Consistent with the main hypothesis of this trial, a significant linear trend across the SU, ST, MT, and MRT groups was found at 14 months (42%, 44%, 51%, and 48%, respectively, p = 0.05). Only for MT was there a significant difference compared with SU (p = 0.03) for the sample as a whole, while no differences were found for MT vs. MRT at 14 months. Significant moderator effects in the predicted direction were found among females, younger participants, and among those with a history of CRC screening, all of which involved the SU vs. MT MRT comparisons. Only among younger participants (ages 50-59) was there a difference between SU vs. ST at 14 months. Given these results, we conclude from this trial the following: (1) the MRT intervention failed to show added benefit beyond the MT intervention, (2) the significant intervention effects involving the MT and MRT conditions can be explained by tailoring and/or the longitudinal nature of both interventions, and (3) the most compelling evidence in support of tailoring was found for the ST condition among younger participants, where a significant need for interventions exists at the national level. Directions for future research are discussed in light of the results summarized above.