Amy S. Jeffreys

Medical Clinics Versus Usual Care for Patients With Both Diabetes and Hypertension: A Randomized Trial

BACKGROUND Group medical clinics (GMCs) are widely used in the management of diabetes and hypertension, but data on their effectiveness are limited. OBJECTIVE To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension. DESIGN Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00286741) SETTING 2 Veterans Affairs Medical Centers in North Carolina and Virginia. PATIENTS 239 patients with poorly controlled diabetes (hemoglobin A(1c) [HbA(1c)] level > or =7.5%) and hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg). INTERVENTION Patients were randomly assigned within each center to either attend a GMC or receive usual care. Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist, a pharmacist, and a nurse or other certified diabetes educator. Each session included structured group interactions moderated by the educator. The pharmacist and physician adjusted medication to manage each patients HbA(1c) level and blood pressure. MEASUREMENTS Hemoglobin A(1c) level and systolic blood pressure, measured by blinded research personnel at baseline, study midpoint (median, 6.8 months), and study completion (median follow-up, 12.8 months). Linear mixed models, adjusted for clustering within GMCs, were used to compare HbA(1c) levels and systolic blood pressure between the intervention and control groups. RESULTS Mean baseline systolic blood pressure and HbA(1c) level were 152.9 mm Hg (SD, 14.2) and 9.2% (SD, 1.4), respectively. At the end of the study, mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group (P = 0.011 by linear mixed model), whereas mean HbA(1c) level improved by 0.8% in the GMC group and 0.5% in the usual care group (P = 0.159). LIMITATION Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention. CONCLUSION Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c) level in diabetic patients. PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service.

A Multidimensional Integrative Medicine Intervention to Improve Cardiovascular Risk

AbstractBACKGROUND: Integrative medicine is an individualized, patient-centered approach to health, combining a whole-person model with evidence-based medicine. Interventions based in integrative medicine theory have not been tested as cardiovascular risk-reduction strategies. Our objective was to determine whether personalized health planning (PHP), an intervention based on the theories and principles underlying integrative medicine, reduces 10-year risk of coronary heart disease (CHD). METHODS: We conducted a randomized, controlled trial among 154 outpatients age 45 or over, with 1 or more known cardiovascular risk factors. Subjects were enrolled from primary care practices near an academic medical center, and the intervention was delivered at a university Center for Integrative Medicine. Following a health risk assessment, each subject in the intervention arm worked with a health coach and a medical provider to construct a personalized health plan. The plan identified specific health behaviors important for each subject to modify; the choice of behaviors was driven both by cardiovascular risk reduction and the interests of each individual subject. The coach then assisted each subject in implementing her/his health plan. Techniques used in implementation included mindfulness meditation, relaxation training, stress management, motivational techniques, and health education and coaching. Subjects randomized to the comparison group received usual care (UC) without access to the intervention. Our primary outcome measure was 10-year risk of CHD, as measured by a standard Framingham risk score, and assessed at baseline, 5, and 10 months. Differences between arms were assessed by linear mixed effects modeling, with time and study arm as independent variables. RESULTS: Baseline 10-year risk of CHD was 11.1% for subjects randomized to UC (n=77), and 9.3% for subjects randomized to PHP (n=77). Over 10 months of the intervention, CHD risk decreased to 9.8% for UC subjects and 7.8% for intervention subjects. Based on a linear mixed-effects model, there was a statistically significant difference in the rate of risk improvement between the 2 arms (P=.04). In secondary analyses, subjects in the PHP arm were found to have increased days of exercise per week compared with UC (3.7 vs 2.4, P=.002), and subjects who were overweight on entry into the study had greater weight loss in the PHP arm compared with UC (P=.06). CONCLUSIONS: A multidimensional intervention based on integrative medicine principles reduced risk of CHD, possibly by increasing exercise and improving weight loss.

Do Unmet Expectations for Specific Tests, Referrals, and New Medications Reduce patients' Satisfaction?

AbstractBACKGROUND: Patient-centered care requires clinicians to recognize and act on patients’ expectations. However, relatively little is known about the specific expectations patients bring to the primary care visit. OBJECTIVE: To describe the nature and prevalence of patients’ specific expectations for tests, referrals, and new medications, and to examine the relationship between fulfillment of these expectations and patient satisfaction. DESIGN: Prospective cohort study. SETTING: VA general medicine clinic. PATIENTS/PARTICIPANTS: Two hundred fifty-three adult male outpatients seeing their primary care provider for a scheduled visit. MEASUREMENTS AND MAIN RESULTS: Fifty-six percent of patients reported at least 1 expectation for a test, referral, or new medication. Thirty-one percent had 1 expectation, while 25% had 2 or more expectations. Expectations were evenly distributed among tests, referrals, and new medications (37%, 30%, and 33%, respectively). Half of the patients who expressed an expectation did not receive one or more of the desired tests, referrals, or new medications. Nevertheless, satisfaction was very high (median of 1.5 for visit-specific satisfaction on a 1 to 5 scale, with 1 representing “excellent”). Satisfaction was not related to whether expectations were met or unmet, except that patients who did not receive desired medications reported lower satisfaction. CONCLUSIONS: Patients’ expectations are varied and often vague. Clinicians trying to implement the values of patient-centered care must be prepared to elicit, identify, and address many expectations.

Barriers to Full Colon Evaluation for a Positive Fecal Occult Blood Test

Background: Failure to appropriately evaluate a positive cancer screening test may negate the value of doing that test. The primary aim of this study was to explore the factors associated with undergoing a full colon evaluation for a positive fecal occult blood test (FOBT) in a single Veterans Affairs center. Methods: Medical records of consecutive patients ages ≥50 years, who had a positive screening FOBT from March 2000 to February 2001, were abstracted. Patient demographics, dates of ordering and doing follow-up test(s), and adherence with scheduled procedures were collected. The primary outcome, full colon evaluation, was defined as having a colonoscopy or double-contrast barium enema plus flexible sigmoidoscopy completed within 12 months. Results: The sample (N = 538) was 98% men (58% Caucasian, 29% African-American, and 13% unknown race). Approximately 77% of the patients were referred to gastroenterology. Ultimately, only 44% underwent full colon evaluation within 12 months. Approximately 20% of the patients failed to attend a scheduled procedure. Referral to gastroenterology and adherence to follow-up appointments were associated with full colon evaluation. There was no association between African-American versus Caucasian race and full colon evaluation. Conclusions: Less than half of the patients with a positive FOBT had a full colon evaluation within 12 months. Multiple failures were identified, including lack of referral for further testing and patient nonadherence. Although the overall performance in evaluating a positive colorectal cancer screening test was poor, no racial disparity was observed. (Cancer Epidemiol Biomarkers Prev 2006;15(6):1232–5)

A Randomized Trial of a Low-Carbohydrate Diet vs Orlistat Plus a Low-Fat Diet for Weight Loss

BACKGROUND Two potent weight loss therapies, a low-carbohydrate, ketogenic diet (LCKD) and orlistat therapy combined with a low-fat diet (O + LFD), are available to the public but, to our knowledge, have never been compared. METHODS Overweight or obese outpatients (n = 146) from the Department of Veterans Affairs primary care clinics in Durham, North Carolina, were randomized to either LCKD instruction (initially, <20 g of carbohydrate daily) or orlistat therapy, 120 mg orally 3 times daily, plus low-fat diet instruction (<30% energy from fat, 500-1000 kcal/d deficit) delivered at group meetings over 48 weeks. Main outcome measures were body weight, blood pressure, fasting serum lipid, and glycemic parameters. RESULTS The mean age was 52 years and mean body mass index was 39.3 (calculated as weight in kilograms divided by height in meters squared); 72% were men, 55% were black, and 32% had type 2 diabetes mellitus. Of the study participants, 57 of the LCKD group (79%) and 65 of the O + LFD group (88%) completed measurements at 48 weeks. Weight loss was similar for the LCKD (expected mean change, -9.5%) and the O + LFD (-8.5%) (P = .60 for comparison) groups. The LCKD had a more beneficial impact than O + LFD on systolic (-5.9 vs 1.5 mm Hg) and diastolic (-4.5 vs 0.4 mm Hg) blood pressures (P < .001 for both comparisons). High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups. Low-density lipoprotein cholesterol levels improved within the O + LFD group only, whereas glucose, insulin, and hemoglobin A(1c) levels improved within the LCKD group only; comparisons between groups, however, were not statistically significant. CONCLUSION In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00108524.

Patient–oncologist communication in advanced cancer: predictors of patient perception of prognosis

Goals of workAdvanced 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 methodsWe 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.Main resultsOncologists 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.ConclusionsCommunication 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.

What concerns me is... Expression of emotion by advanced cancer patients during outpatient visits.

ObjectiveCancer 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 methodsAs 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.ResultsPatients 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.ConclusionsPatients 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.

How Oncologists and Their Patients with Advanced Cancer Communicate about Health-Related Quality of Life

Objective: 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.

Contracting, prompting, and reinforcing substance use disorder continuing care: a randomized clinical trial.

Although continuing care is strongly related to positive treatment outcomes for substance use disorder (SUD), participation rates are low and few effective interventions are available. In a randomized clinical trial with 150 participants (97% men), 75 graduates of a residential Veterans Affairs Medical Center SUD program who received an aftercare contract, attendance prompts, and reinforcers (CPR) were compared to 75 graduates who received standard treatment (STX). Among CPR participants, 55% completed at least 3 months of aftercare, compared to 36% in STX. Similarly, CPR participants remained in treatment longer than those in STX (5.5 vs. 4.4 months). Additionally, CPR participants were more likely to be abstinent compared to STX (57% vs. 37%) after 1 year. The CPR intervention offers a practical means to improve adherence among individuals in SUD treatment.

IGF1 (CA)19 Repeat and IGFBP3 -202 A/C Genotypes and the Risk of Prostate Cancer in Black and White Men

We investigated the relationship between the insulin-like growth factor-1 (IGF1) cytosine-adenine repeat (CA)19 polymorphism located upstream of the genes transcription start site, the insulin-like growth factor binding protein-3 (IGFBP3) −202 A/C promoter region polymorphism, and prostate cancer risk in Black and White men. Study subjects were U.S. veterans ages 41 to 75 years identified at the Durham Veterans Administration Medical Center over a 2.5-year period. Controls (n = 93) were frequency matched to cases (n = 100) based on race (Black or White) and age. Multivariable unconditional logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CI) for the associations between the polymorphisms and prostate cancer risk. For Blacks and Whites combined, an inverse association between prostate cancer and being homozygous for the most common IGF1 repeat allele, (CA)19, (adjusted OR, 0.3; 95% CI, 0.1-0.7) was observed. Similar associations were noted for both Blacks (OR, 0.2; 95% CI, 0.0-0.8) and Whites (OR, 0.4; 95% CI, 0.1-1.6) separately. No statistically significant associations between the IGFBP3 C allele and prostate cancer were noted for Blacks (adjusted OR, 2.3; 95% CI, 0.8-6.2) or Whites (OR, 1.0; 95% CI, 0.3-3.1). The prevalence of the homozygous IGF1 (CA)19 genotype was much lower in Black controls (21%) than White controls (46%), which may, in part, explain the increased prostate cancer incidence in Black versus White men. Further research is needed to confirm these findings.