We analyzed participants with type 2 diabetes (n=46) within a larger weight loss trial (n=146) who were randomized to 48 weeks of a low-carbohydrate diet (LCD; n=22) or a low-fat diet + orlistat (LFD+O; n=24).
At baseline, mean BMI was 39.5 kg/m2 (SD 6.5) and HbA1c 7.6% (SD 1.3). Although the interventions reduced BMI similarly (LCD −2.4 kg/m2; LFD+O −2.7 kg/m2, p= 0.7), LCD led to a relative improvement in hemoglobin A1c: −0.7% in LCD vs. +0.2% in LFD+O (difference −0.8%, 95% CI= −1.6, −0.02; p=0.045). LCD also led to a greater reduction in antiglycemic medications using a novel medication effect score (MES) based on medication potency and total daily dose; 70.6% of LCD vs. 30.4% LFD+O decreased their MES by ≥50% (p=0.01).
Lowering dietary carbohydrate intake demonstrated benefits on glycemic control beyond its weight loss effects, while at the same time lowering antiglycemic medication requirements.
Glycemic control; Medication therapy management; Low carbohydrate diet; Low fat diet; Orlistat
Patients with co-occurrence of hypertension, hyperlipidemia, and diabetes have an increased risk of cardiovascular disease (CVD) events. Comprehensive programs addressing both tailored patient self-management and pharmacotherapy are needed to address barriers to optimal cardiovascular risk reduction. We are examining a Clinical Pharmacy Specialist (CPS), telephone administered intervention, relying on home monitoring, with a goal of providing tailored medication and behavioral intervention to Veterans with CVD risk.
Randomized controlled trial including patients with hypertension (blood pressure (BP) > 150/100 mmHg) or elevated low density liporotein (LDL) (> 130 mg/dl). Longitudinal changes in CVD risk profile and improvement in health behaviors over time will be examined.
Given the national prevalence of CVD and the dismal rates of risk factor control; intensive, but easily disseminated interventions are required to treat this epidemic. This study will be an important step in testing the effectiveness of a behavioral and medication intervention to improve CVD control among Veterans.
Clinicians have difficulty in identifying patients that are unlikely to adhere to hypertension self-management. Identifying non-adherence is essential to addressing suboptimal blood pressure control and high costs.
1) To identify risk factors associated with non-adherence to three key self-management behaviors in patients with hypertension: proper medication use, diet, and exercise; 2) To evaluate the extent to which an instrument designed to identify the number of risk factors present for non-adherence to each of the three hypertension self-management behaviors would be associated with self-management non-adherence and blood pressure.
Cross-sectional analysis of randomized trial data.
Six hundred and thirty-six primary care patients with hypertension.
1) Demographic, socioeconomic, psychosocial, and health belief-related factors; 2) measures of self-reported adherence to recommended medication use, diet recommendations, and exercise recommendations, all collected at baseline assessment; 3) systolic blood pressure (SBP) and diastolic blood pressure (DBP).
We identified patient factors associated with measures of non-adherence to medications, diet, and exercise in hypertension. We then combined risk factors associated with ≥1 adherence measure into an instrument that generated three composite variables (medication, diet, and exercise composites), reflecting the number of risk factors present for non-adherence to the corresponding self-management behavior. These composite variables identified subgroups with higher likelihood of medication non-adherence, difficulty following diet recommendations, and difficulty following exercise recommendations. Composite variable levels representing the highest number of self-management non-adherence risk factors were associated with higher SBP and DBP.
We identified factors associated with measures of non-adherence to recommended medication use, diet, and exercise in hypertension. We then developed an instrument that was associated with non-adherence to these self-management behaviors, as well as with blood pressure. With further study, this instrument has potential to improve identification of non-adherent patients with hypertension.
hypertension; self-management; medication adherence; diet; exercise
African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events.
The goal of this study was to examine whether there were differences in change in blood pressure (BP) for African American and non-Hispanic white patients in response to a medication management and tailored nurse-delivered telephone behavioral program.
Five hundred and seventy-three patients (284 African American and 289 non-Hispanic white) primary care patients who participated in the Hypertension Intervention Nurse Telemedicine Study (HINTS) clinical trial.
Study arms included: 1) nurse-administered, physician-directed medication management intervention, utilizing a validated clinical decision support system; 2) nurse-administered, behavioral management intervention; 3) combined behavioral management and medication management intervention; and 4) usual care. All interventions were activated based on poorly controlled home BP values.
Post-hoc analysis of change in systolic and diastolic blood pressure. General linear models (PROC MIXED in SAS, version 9.2) were used to estimate predicted means at 6-month, 12-month, and 18-month time points, by intervention arm and race subgroups (separate models for systolic and diastolic blood pressure).
Improvement in mean systolic blood pressure post-baseline was greater for African American patients in the combined intervention, compared to African American patients in usual care, at 12 months (6.6 mmHg; 95 % CI: -12.5, -0.7; p = 0.03) and at 18 months (9.7 mmHg; -16.0, -3.4; p = 0.003). At 18 months, mean diastolic BP was 4.8 mmHg lower (95 % CI: -8.5, -1.0; p = 0.01) among African American patients in the combined intervention arm, compared to African American patients in usual care. There were no analogous differences for non-Hispanic white patients.
The combination of home BP monitoring, remote medication management, and telephone tailored behavioral self-management appears to be particularly effective for improving BP among African Americans. The effect was not seen among non-Hispanic white patients.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-012-2138-x) contains supplementary material, which is available to authorized users.
hypertension; telemedicine; self-management; adherence; veterans
To describe the association of intensive care with trajectories of functional, emotional, social, and physical well-being in patients with 3 common advanced illnesses
Cross-sectional cohort study of 42 patients admitted to the intensive care unit selected from 210 patients with stage IV breast, prostate, or colon cancer or stage IIIb or IV lung cancer; New York Heart Association class III or IV congestive heart failure; and chronic obstructive pulmonary disease with hypercapnea (Pco2 > 46 mm Hg). Scores on subscales of the Functional Assessment of Chronic Illness Therapy-General survey were measured monthly for 6 months before and after admission to the intensive care unit and were analyzed by using the unit admission date as a point of discontinuous change to illustrate trajectories before and after the admission.
Overall, trajectories of well-being declined sharply after admission to the intensive care unit. Declines in physical, functional, and emotional well-being were statistically significant. During the 6 months after admission, physical, functional, and emotional well-being scores trended back up to baseline while social well-being scores continued to decline.
Well-being trajectories declined sharply after admission to the intensive care unit, with recovery in the subsequent 6 months, and may be characterized by common patterns. These results help to better describe intensive care as a marker for advancing illness in patients with advanced chronic illness.
Most patient chronic disease self-management interventions target single disease outcomes. We evaluated the effect of a tailored hypertension self-management intervention on the unintended targets of glycosylated hemoglobin (Hb A1c) and LDL cholesterol (LDL-C).
We examined 588 patients from the Veterans Study to Improve the Control of Hypertension (V-STITCH), a two year randomized controlled trial. Patients received either a hypertension self-management intervention delivered by a nurse over the telephone or usual care. Although the study focused on hypertension self-management, we compared changes in Hb A1c among a subgroup of 216 patients with diabetes and LDL-C among 528 patients with measurements during the study period. Changes in these lab values over time were compared between the two treatment groups using linear mixed-effects models.
For the patients with diabetes, the hypertension self-management intervention resulted in a 0.46% reduction in Hb A1c over two years compared to usual care (95% CI: 0.04% to 0.89%; p=0.03). For LDL-C, the self-management intervention arm resulted in a reduction of 0.9mg/dl over two years compared to usual care (95% CI: -7.3mg/dl to 5.6mg/dl; p=0.79).
There was no evidence of a hypertension self-management intervention effect on LDL-C, but there was a modest effect of the intervention on the unintended target of Hb A1c. This effect was similar to that seen in self-management interventions specifically targeting diabetes management. Chronic disease self-management interventions may spill over into patients’ co-morbid diagnoses.
Self-management; telemedicine; chronic disease; randomized controlled trial
Three important causes of death in the U.S. (cancer, congestive heart failure [CHF], and chronic obstructive pulmonary disease [COPD]) are preceded by long periods of declining health; often, family members provide the majority of care for individuals who are living with serious illnesses and are at risk for impaired well-being.
To expand understanding of caregiver burden and psychosocial-spiritual outcomes among understudied groups of caregivers – cancer, CHF, and COPD caregivers – by including differences by disease in a diverse population.
The current 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.
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.
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 rather a relatively universal experience that may be buffered by social resources and successful coping styles.
Cancer caregiving; CHF caregiving; COPD caregiving; caregiver burden; social support; coping
To test the effects of patient and patient–oncologist relationship factors on the time spent communicating about health-related quality of life (HRQOL) during outpatient clinic encounters between oncologists and their patients with advanced cancer.
Using mixed methods, we coded for duration of HRQOL talk in a subset of audio-recorded conversations from the Study of Communication in Oncologist–Patient Encounters (SCOPE) Trial. Multivariable linear regression modeling was used to investigate the relationship between duration of HRQOL talk and gender concordance, race concordance, patient education status, patient marital status, and length of the patient–oncologist relationship (i.e. number of previous visits).
Sixty-six encounters were analyzed that involved 63 patients and 34 oncologists. Patients were more likely to be female (51%), white (86%), married (78%), and possess a college or more advanced degree (33%). Most oncologists were male (82%) and white (82%). Mean ages were 58.8 years for patients and 44.9 years for oncologists. Regression results showed that the number of a patient’s previous visits with their oncologist was significantly associated with a longer duration of HRQOL talk during their audio-recorded clinic visit. The remaining independent variables, gender concordance, race concordance, patient education status, and patient marital status were not significant predictors of duration of HRQOL talk.
Our findings suggest that length of the patient–oncologist relationship is related to duration of HRQOL talk. Improvements in HRQOL communication may best be achieved through efforts directed at those in earlier stages of the doctor–patient relationship.
cancer; oncology; patient–provider relationship; communication; quality of life
At advanced stages, cancer, congestive heart failure (CHF), and chronic obstructive pulmonary disease (COPD) produce high rates of hospitalization, disability, and annual mortality. Despite similar prognoses, patients with cancer often are treated differently than those with other illnesses, the former being seen as terminal vs. chronic.
The purpose of this study was to compare the functional capacity, emotional well-being, and quality of life of patients in three disease groups to assess whether diagnosis distinguishes differences in patient experience, and compare patients with cancer and noncancer diagnoses.
Baseline data from a cohort study of 210 patients who had an estimated 50% two-year mortality were analyzed. The patients had Stage IV breast, prostate, or colon cancer; Stage IIIb or IV lung cancer; New York Heart Association Stage III or IV CHF with a left ventricular ejection fraction of <40%; or COPD with hypercapnea (pC02 > 46) and at least one hospitalization or Emergency Department visit during the past year. Measures included the Rosow-Breslau Activities of Daily Living/Instrumental Activities of Daily Living tool, Profile of Mood States anxiety subscale, brief Centers for Epidemiologic Studies Depression Scale, and the Functional Assessment of Cancer Therapy-General quality-of-life instrument. Analyses included descriptive statistics, analysis of variance, and adjusted linear regression models.
A majority of illness outcomes did not differ by diagnostic category. Functional status was associated with diagnosis, with CHF and COPD patients faring worse than those with cancer. Overall, illness experience was most significantly related to disease severity, demographics, and emotional and social well-being.
Comparing patients with advanced cancer, CHF, and COPD, illness experience was more similar than different. Patients living with life-limiting illnesses other than cancer may benefit from whole-person services often extended to cancer patients.
Chronic disease; patient-centered care; quality of life
Overweight and obesity are public health issues in the United States, and veterans have a higher rate of overweight and obesity than the general population. Our objective was to examine whether copayment elimination increased use of a weight loss clinic by veterans.
We examined clinic use by 44,411 new patients seen in a Veterans Affairs (VA) MOVE! weight management clinic before the copayment elimination and clinic use by 64,398 new patients seen in the year after copayment elimination. We examined clinic use via mixed-effects models for patients who were already exempt from copayment and patients who were newly exempt from copayment. We used 2 outcomes before and after copayment elimination: 1) the ratio of number of clinic visits by new users with the mean number of MOVE! clinic visits by all users, and 2) the number of clinic visits by each new user in the 6 months after their first visit. All models were adjusted for patient and clinic factors.
Among newly exempt patients, the clinic-standardized rate of new use increased by 2.2% after the copayment was eliminated but increased 12% among already exempt veterans. This finding was confirmed in adjusted analyses. Analysis of number of clinic visits adjusted for patient and clinic factors also found that exempt and nonexempt veterans had similar numbers of repeat clinic visits.
We saw an unexpected larger increase in demand among veterans who receive all VA care for free. These results suggest that VA should not assume that copayment reductions for selective preventive services will motivate patient change and achieve intended system-level outcomes.
Anxiety and depression are common in seriously ill patients and may be associated with spiritual concerns. Little research has examined how concerns in different domains of spirituality are related to anxiety and depression.
To examine the association of spiritual history and current spiritual well-being with symptoms of anxiety and depression in patients with advanced illness.
Cross-sectional cohort study
Two hundred and ten patients with advanced illness, of whom 1/3 were diagnosed with cancer, 1/3 COPD, and 1/3 CHF. The mean age of the sample was 66 years, and 91% were Christian.
Outcome measures were the Profile of Mood States’ Anxiety Subscale (POMS) and 10-item Center for Epidemiologic Studies Depression Scale (CESD). Predictors were three subscales of the Spiritual History Scale measuring past religious help-seeking and support, past religious participation, and past negative religious experiences and two subscales of the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale measuring the role of faith in illness and meaning, peace, and purpose in life. We conducted multiple regression analyses, controlling for demographics, disease type and severity, self-rated religiousness/spirituality, and frequency of religious attendance and devotion.
In adjusted analyses, greater spiritual well-being, including both beliefs about the role of faith in illness and meaning, peace, and purpose in life were associated with fewer symptoms of anxiety (P ≤ 0.001) and depression (P < 0.001). Greater past negative religious experiences were associated with more symptoms of anxiety (P = 0.04) and depression (P = 0.004). No other measures of spiritual history were associated with the outcomes.
In this diverse sample of seriously ill patients, current spiritual well-being and past negative religious experiences were associated with symptoms of anxiety and depression. Healthcare providers should consider asking about current spiritual well-being and past negative religious experiences in their assessment of seriously ill patients with symptoms of anxiety and depression.
spirituality; anxiety; depression; end-of-life care; terminal illness
Although research shows that empathic communication improves patient outcomes, physicians often fail to respond empathically to patients. Nurses and physician assistants (PAs) may be able to help fill the need for empathic communication. Our study compares the attitudes of oncologists, nurses, and PAs toward communication with patients who demonstrate negative emotions.
We analyzed surveys from 48 oncologists, 26 PAs, and 22 nurses who participated in the Studying Communication in Oncologist-Patient Encounters trial. Surveys included previously validated items that examined attitudes toward communication with patients about emotion.
The mean age of oncology physicians was higher (49 years) than that of PAs (40 years) or nurses (43 years), and 19% of physicians, 81% of PAs, and 100% of nurses were female. Race, years of oncology experience, and previous communication training were similar across provider types. Most nurses (82%) and PAs (68%) described themselves as having a socioemotional orientation, while most oncologists (70%) reported a technological/scientific orientation (p < .0001). PAs and nurses indicated more comfort with psychosocial talk than did oncologists (p < .0001). Discomfort with disclosing uncertainty and provider confidence and expectations when addressing patient concerns were similar across provider types.
PAs and nurses were more oriented toward socio-emotional aspects of medicine and were more comfortable with psychosocial talk than were oncologists. Future studies should examine whether these differences are attributable to other factors, including gender, and whether nurses and PAs are more likely than physicians to demonstrate empathic behaviors when patients express negative emotions.
Patients with advanced cancer often experience negative emotion; clinicians’ empathic responses can alleviate patient distress. Much is known about how physicians respond to patient emotion; less is known about non-physician clinicians. Given that oncology care is increasingly provided by an interdisciplinary team, it is important to know more about how patients with advanced cancer express emotions to non-physician clinicians (NPCs) and how NPCs respond to those empathic opportunities.
We audio recorded conversations between non-physician clinicians and patients with advanced cancer. We analyzed 45 conversations between patients and oncology physician assistants, nurse practitioners, and nurse clinicians in which patients or their loved ones expressed at least one negative emotion to the NPC (i.e., an empathic opportunity). Empathic opportunities were coded three ways: type of emotion (anger, sadness, or fear), severity of emotion (least, moderate, or most severe), and NPC response to emotion (not empathic, on-topic medical response, and empathic response).
We identified 103 empathic opportunities presented to 25 different NPCs during 45 visits. Approximately half of the empathic opportunities contained anger (53%), followed by sadness (25%) and fear (21%). The majority of emotions expressed were moderately severe (73%), followed by most severe (16%), and least severe (12%). The severity of emotions presented was not found to be statistically different between types of NPCs. NPCs responded to empathic opportunities with empathic statements 30% of the time. Additionally, 40% of the time, NPCs responded to empathic opportunities with on-topic, medical explanations and 30% of the responses were not empathic.
Patients expressed emotional concerns to NPCs typically in the form of anger; most emotions were moderately severe, with no statistical differences among types of NPC. On average, NPCs responded to patient emotion with empathic language only 30% of the time. A better understanding of NPC–patient interactions can contribute to improved communication training for NPCs and, ultimately, to higher quality patient care in cancer.
Communication; Emotions; Empathy; Nurse practitioners; Medical oncology; Physician assistants; Professional–patient relations
Most patients with advanced cancer experience negative emotion. When patients express emotions, oncologists rarely respond empathically. Oncologists may respond more empathically to some patients, and patients may perceive different levels of empathy and trust given past documentation of disparities in cancer care.
We audio-recorded 264 outpatient encounters between oncologists and patients with advanced cancer at three sites. We examined whether patient gender, age, race, marital status, education, economic security, and length of relationship with oncologist were related to oncologist empathic responses to patient’s negative emotion and patient’s perceptions of oncologist empathy and trust.
Half (51%) of the patients expressed a negative emotion. Oncologists sometimes responded with empathy (29%). Oncologists were equally empathic with all patients, except they were more empathic with patients with low economic security compared with those reporting high economic security (p=.002). Patients with low economic security viewed oncologists as more empathic (p=.06) compared with those with moderate security. Married patients also viewed oncologists as more empathic (p=.04). Patients who knew their oncologist for more than a year had more trust than patients who knew their oncologists for less time (p=.02).
Oncologists, in general, did not respond empathically to patient’s negative emotion, and did this equally for most patients. Oncologists responded more empathically to patients who were less economically advantaged. In turn, patients with lower economic security perceived more empathy. Although oncologists need more education in responding empathically, they may not need to correct many biases in care.
Empathy; Oncologist; Advanced cancer; Socioeconomic status; Negative emotion
Quality cancer care requires addressing patients’ emotions, which oncologists infrequently do. Multiday courses can teach oncologists skills to handle emotion; however, such workshops are long and costly.
To test whether a brief, computerized intervention improves oncologist responses to patient expressions of negative emotion.
Randomized, controlled, parallel-group trial stratified by site, sex, and oncologic specialty. Oncologists were randomly assigned to receive a communication lecture or the lecture plus a tailored CD-ROM. (ClinicalTrials.gov registration number: NCT00276627)
Oncology clinics at a comprehensive cancer center and Veterans Affairs Medical Center in Durham, North Carolina, and a comprehensive cancer center in Pittsburgh, Pennsylvania.
48 medical, gynecologic, and radiation oncologists and 264 patients with advanced cancer.
Oncologists were randomly assigned in a 1:1 ratio to receive an interactive CD-ROM about responding to patients’ negative emotions. The CD-ROM included tailored feedback on the oncologists’ own recorded conversations.
Postintervention audio recordings were used to identify the number of empathic statements and responses to patients’ expressions of negative emotion. Surveys evaluated patients’ trust in their oncologists and perceptions of their oncologists’ communication skills.
Oncologists in the intervention group used more empathic statements (relative risk, 1.9 [95% CI, 1.1 to 3.3]; P = 0.024) and were more likely to respond to negative emotions empathically (odds ratio, 2.1 [CI, 1.1 to 4.2]; P = 0.028) than control oncologists. Patients of intervention oncologists reported greater trust in their oncologists than did patients of control oncologists (estimated mean difference, 0.1 [CI, 0.0 to 0.2]; P = 0.036). There was no significant difference in perceptions of communication skills.
Long-term effects were not examined. The findings may not be generalizable outside of academic medical centers.
A brief computerized intervention improves how oncologists respond to patients’ expressions of negative emotions.
Primary Funding Source
National Cancer Institute.
Only one-half of Americans have their blood pressure controlled and there continue to be significant racial differences in blood pressure control. The goal of this study was to examine the effectiveness of two patient-directed interventions designed to improve blood pressure control within white and non-white subgroups (49% African Americans).
Post-hoc analysis of a 2 by 2 randomized trial with two-year follow-up in 2 university-affiliated primary care clinics. Within white and non-white patients (n=634), four groups were examined: 1) usual care; 2) home blood pressure monitoring (three times per week); 3) tailored behavioral self-management intervention administered via telephone by a nurse every other month; or, 4) a combination of the two interventions.
The overall race by time by treatment group effect suggested differential intervention effects on blood pressure over time for whites and non-whites (systolic blood pressure, p=0.08; diastolic blood pressure, p=0.01). Estimated trajectories indicated that among the 308 whites, there was no significant effect on blood pressure at either 12 or 24 months for any intervention compared to control group. At 12 months, the non-whites (n=328) in all three intervention groups had systolic blood pressure decreases of 5.3–5.7 mm hg compared to usual care (p<0.05). At 24 months, in the combined intervention, non-whites had sustained lower systolic blood pressure as compared to usual care (7.5 mm hg; p<0.02). A similar pattern was observed for diastolic blood pressure.
Combined home blood pressure monitoring and a telephone tailored-behavioral intervention appeared to be particularly effective for improving blood pressure in non-white patients.
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence; Disparities
To describe the content and frequency of communication about health-related quality of life (HRQOL) during outpatient encounters between oncologists and their patients with advanced cancer.
We coded for HRQOL talk in a subset of audio recorded conversations (each previously found to contain prognostic talk by the oncologist) from the Study of Communication in Oncologist-Patient Encounters (SCOPE) Trial, a randomized controlled trial conducted from 2003 to 2008 in two large U.S. academic medical centers and one Veterans Affairs Medical Center.
Seventy-three encounters that involved 70 patients and 37 oncologists. Patients were more likely to be female (53%), white (86%), married (78%), and possessing some college education (62%). Most oncologists were male (78%) and white (78%). Mean ages were 59 years for patients and 44 years for oncologists. Every encounter included some talk about HRQOL and HRQOL discussions made up, on average, 25% of the visit time. HRQOL segments described symptoms (50%); general HRQOL (27%); and the following concerns: physical (27%), functional (22%), psychological (9%), social (7%), spiritual (1%), and other (28%). Topics included treatment (56%), disease (14%), and testing (3%), and conversations focused on past (44%), present (68%), and future HRQOL (59%).
HRQOL discussions between oncologists and patients are common, but the emphasis is often on treatment (e.g., side effects) and symptoms (e.g., pain) even in patients with advanced disease. Given the often intense emotional experience of patients with advanced cancer, oncologists may need to pay more attention to psychological, social, and spiritual HRQOL concerns.
cancer; communication; oncology; patient-provider relationship; qualitative research; quality of life
The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention, patient self-monitoring, and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months. The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone. We examined direct and patient time costs associated with each intervention.
We conducted a prospective economic evaluation alongside a randomized controlled trial of 636 patients with hypertension participating in each study intervention. Medical costs were estimated using electronic data representing medical services delivered within the health system. Intervention-related costs were derived using information collected during the trial, administrative records, and published unit costs.
During 24 months, patients incurred a mean of $6965 (SD, $22,054) in inpatient costs and $8676 (SD, $9368) in outpatient costs, with no significant differences among the intervention groups. With base-case assumptions, intervention costs were estimated at $90 (SD, $2) for home blood pressure monitoring, $345 (SD, $64) for the behavioral intervention ($31 per telephone encounter), and $416 (SD, $93) for the combined intervention. Patient time costs were estimated at $585 (SD, $487) for home monitoring, $55 (SD, $16) for the behavioral intervention, and $741 (SD, $529) for the combined intervention.
Our analysis demonstrated that the interventions are cost-additive to the health care system in the short term and that patients’ time costs are nontrivial.
Costs and Cost Analysis; Hypertension; Patient Compliance
Despite the impact of hypertension and widely accepted target values for blood pressure (BP), interventions to improve BP control have had limited success.
We describe the design of a 'translational' study that examines the implementation, impact, sustainability, and cost of an evidence-based nurse-delivered tailored behavioral self-management intervention to improve BP control as it moves from a research context to healthcare delivery. The study addresses four specific aims: assess the implementation of an evidence-based behavioral self-management intervention to improve BP levels; evaluate the clinical impact of the intervention as it is implemented; assess organizational factors associated with the sustainability of the intervention; and assess the cost of implementing and sustaining the intervention.
The project involves three geographically diverse VA intervention facilities and nine control sites. We first conduct an evaluation of barriers and facilitators for implementing the intervention at intervention sites. We examine the impact of the intervention by comparing 12-month pre/post changes in BP control between patients in intervention sites versus patients in the matched control sites. Next, we examine the sustainability of the intervention and organizational factors facilitating or hindering the sustained implementation. Finally, we examine the costs of intervention implementation. Key outcomes are acceptability and costs of the program, as well as changes in BP. Outcomes will be assessed using mixed methods (e.g., qualitative analyses--pattern matching; quantitative methods--linear mixed models).
The study results will provide information about the challenges and costs to implement and sustain the intervention, and what clinical impact can be expected.
To examine how type and severity of patients’ negative emotions influence oncologists’ responses and subsequent conversations.
We analyzed 264 audio-recorded conversations between advanced cancer patients and their oncologists. Conversations were coded for patients’ expressions of negative emotion, which were categorized by type of emotion and severity. Oncologists’ responses were coded as using either empathic language or blocking and distancing approaches.
Patients presented fear more often than anger or sadness; severity of disclosures was most often moderate. Oncologists responded to 35% of these negative emotional disclosures with empathic language. They were most empathic when patients presented intense emotions. Responding empathically to patients’ emotional disclosures lengthened discussions by an average of only 21 seconds.
Greater response rates to severe emotions suggest oncologists may recognize negative emotions better when patients express them more intensely. Oncologists were least responsive to patient fear and responded with greatest empathy to sadness.
Oncologists may benefit from additional training to recognize negative emotions, even when displayed without intensity. Teaching cancer patients to better articulate their emotional concerns may also enhance patient-oncologist communication.
Doctor-patient relations; communication; cancer; emotion
Less than 40% of Americans with hypertension have adequate blood pressure (BP) control.
To compare two self-management interventions for improving BP control among hypertensive patients.
A 2 by 2 randomized trial stratified by enrollment site and patient literacy status with two-year follow-up (5/2004-1/2008).
Two university-affiliated primary care clinics.
636 patients were randomized (31% recruitment rate) among the 2060 eligible hypertensive patients.
Research assistants randomized eligible patients via a centralized blinded and stratified randomization algorithm to receive either: 1) usual care; 2) bi-monthly tailored nurse-administered telephone intervention targeting hypertension-related behaviors; 3) BP monitoring consisting of measuring BP three times per week, or; 4) a combination of the two interventions.
The primary outcome was BP control evaluated at six-month intervals over 24 months. 475 (75%) completed the 24-month BP follow-up.
Improvements in proportion of BP control for the intervention groups relative to the usual care group at 24 months were: behavioral group, 4.3% (95% CI: −4.5%, 12.9); home BP monitoring group, 7.6% (95% CI: −1.9%, 17.0%); and, combined interventions, 11.0% (95% CI: 1.9%, 19.8%). For systolic BP, relative to usual care, the 24 month difference was, +0.6 mmHg (95% CI: −2.2, 3.4) for the behavioral intervention group, −0.6 mmHg (95% CI: −3.6, 2.3) for the home monitoring group, and −3.9 mmHg (95% CI: −6.9, −0.9) for the combined interventions. Similar patterns were observed for diastolic BP at 24 months.
Changes in medication use and diet were only monitored in intervention participants; 25% lacked 24 month outcome data; 73% had adequate BP control at baseline; the study setting was an academic health center, all factors that potentially limit generalizability.
Combined home BP monitoring and tailored behavioral telephone intervention improved BP control, systolic BP, and diastolic BP at 24 months relative to usual care.
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence
Goals of work
Advanced cancer patients’ perceptions of prognosis, which are often overly optimistic compared to oncologist estimates, influence treatment preferences. The predictors of patients’ perceptions and the effect of oncologist communication on patient understanding are unclear. This study was designed to identify the communication factors that influence patient–oncologist concordance about chance of cure.
Materials and methods
We analyzed audiorecorded encounters between 51 oncologists and 141 advanced cancer patients with good (n=69) or poor (n=72) concordance about chance of cure. Encounters were coded for communication factors that might influence oncologist–patient concordance, including oncologist statements of optimism and pessimism.
Oncologists made more statements of optimism (mean=3.3 per encounter) than statements of pessimism (mean=1.2 per encounter). When oncologists made at least one statement of pessimism, patients were more likely to agree with their oncologist's estimated chance of cure (OR=2.59, 95%CI=1.31–5.12). Statements of optimism and uncertainty were not associated with an increased likelihood that patients would agree or disagree with their oncologists about chance of cure.
Communication of pessimistic information to patients with advanced cancer increases the likelihood that patients will report concordant prognostic estimates. Communication of optimistic information does not have any direct effect. The best communication strategy to maximize patient knowledge for informed decision making while remaining sensitive to patients’ emotional needs may be to emphasize optimistic aspects of prognosis while also consciously and clearly communicating pessimistic aspects of prognosis.
Communication; Cancer; Medical oncology; Prognosis; Physician–patient relations
Prolonged mechanical ventilation (PMV) provision is increasing markedly despite poor patient outcomes. Misunderstanding prognosis in the PMV decision making process could provide an explanation to this phenomenon. Therefore, we aimed to compare PMV decision makers' expectations for long-term patient outcomes with prospectively observed outcomes.
Design, Setting, and Patients:
126 patients undergoing PMV, their surrogates, and their intensive care unit physicians were enrolled consecutively (total n=378) at an academic medical center between April 2006 and April 2007 and followed prospectively for one year.
Participants were interviewed at the time of tracheostomy placement about their expectations for one-year patient survival, functional status, and quality of life. These expectations were then compared to observed one-year outcomes measured with validated questionnaires.
One-year follow up was 100%, with the exception of patient death or cognitive inability to complete interviews. At one year, only 11 (9%) patients were alive and independent of major functional status limitations. Most surrogates reported high baseline expectations for one-year patient survival (117 [93%]), functional status (90 [71%]), and quality of life (105 [83%]). In contrast, fewer physicians described high expectations for survival (54 [43%]), functional status (7 [6%]), and quality of life (5 [4%]). Surrogate-physician pair concordance in expectations was poor (all κ<0.08), as was their accuracy in outcome prediction (range 23-44%). Just 33 (26%) surrogates reported that physicians discussed what to expect for patients' likely future survival, general health, and caregiving needs.
One-year patient outcomes for PMV patients were significantly worse than expected by patients' surrogates and physicians. Lack of prognostication about outcomes, discordance between surrogates and physicians about potential outcomes, and surrogates' unreasonably optimistic expectations appear to be potentially modifiable deficiencies in surrogate-physician interactions.
respiration; artificial; tracheostomy; critical illness; intensive care units; prospective study
Assess use of and reactions to an interactive, tailored CD-ROM to enhance oncologist–patient communication.
Participating oncologists (n = 48) agreed to have patient interactions audio recorded, be randomly assigned to receive/not receive a CD-ROM, have CD-ROM usage monitored (intervention group) and complete a follow-up survey.
Twenty-one of 24 in the intervention group reported using the CD-ROM. Median usage minutes were 63.8. At follow-up, oncologists rated the CD-ROM from 1 (“none” or “not at all helpful”) to 5 (“a great deal” or “very helpful”). Mean responses were: 3.1 and 3.0 for 2 items assessing perceived impact on communications, 3.8–4.0 for 6 items assessing perceived helpfulness, 3.0 and 3.10 for 2 items assessing impact on affecting oncologists’ communication with patients and assistance with challenging conversations, respectively, and 3.6 for whether using the CD-ROM was worth their time. Self-report of how much oncologists had used the covered skills before and after intervention showed a perceived increase (2.8 before and 3.2 after).
Findings suggest the tailored interactive CD-ROM has promise for use and acceptance among oncologists.
If ultimately found effective in changing oncologist’s communication with patients, the CD-ROM’s widespread dissemination should be explored.
Tailored intervention; Physician; patient communication; Oncologist
Cancer patients have high levels of distress, yet oncologists often do not recognize patients’ concerns. We sought to describe how patients with advanced cancer verbally express negative emotion to their oncologists.
Materials and methods
As part of the Studying Communication in Oncologist–Patient Encounters Trial, we audio-recorded 415 visits that 281 patients with advanced cancer made to their oncologists at three US cancer centers. Using qualitative methodology, we coded for verbal expressions of negative emotion, identified words patients used to express emotion, and categorized emotions by type and content.
Patients verbally expressed negative emotion in 17% of the visits. The most commonly used words were: “concern,” “scared,” “worried,” “depressed,” and “nervous.” Types of emotion expressed were: anxiety (46%), fear (25%), depression (12%), anger (9%), and other (8%). Topics about which emotion was expressed were: symptoms and functional concerns (66%), medical diagnoses and treatments (54%), social issues (14%), and the health care system (9%). Although all patients had terminal cancer, they expressed negative emotion overtly related to death and dying only 2% of the time.
Patients infrequently expressed negative emotion to their oncologists. When they did, they typically expressed anxiety and fear, indicating concern about the future. When patients use emotionally expressive words such as those we described, oncologists should respond empathically, allowing patients to express their distress and concerns more fully.
Patients; Cancer; Emotion; Distress; Communication