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Background: Only 31% of Americans with hypertension have their blood pressure (BP) under effective control. We describe a study that tests 3 different interventions in a randomized controlled trial using home BP telemedicine monitoring.

Methods: A sample of hypertensive patients with poor BP control at baseline (N = 600) are randomized to 1 of 4 arms: (1) control group—a group of hypertensive patients who receive usual care; (2) nurse-administered tailored behavioral intervention; (3) nurse-administered medication management according to a hypertension decision support system; (4) combination of the 2 interventions. The interventions are triggered based on home BP values transmitted via telemonitoring devices over standard telephone lines. The tailored behavioral intervention involves promoting adherence with medication and health behaviors. Patients randomized to the medication management or the combined arm have their hypertension regimen changed by the study team using a validated hypertension decision support system based on evidence-based hypertension treatment guidelines and individualized to patients' comorbid illnesses. The primary outcome is BP control: ≤140/90 mm Hg (nondiabetic) and ≤130/80 mm Hg (diabetics) measured at 6-month intervals over 18 months (4 total measurements).

Conclusions: Given the increasing prevalence of hypertension and our inability to achieve adequate BP control using traditional models of care, testing novel interventions in patients' homes may improve access, quality, and outcomes.

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American Heart Journal
Authors
Mary K. Goldstein
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Context: Quality problems and spiraling costs have resulted in widespread interest in solutions that improve the effectiveness and efficiency of the health care system. Care coordination has been identified by the Institute of Medicine as one of the key strategies for potentially accomplishing these improvements.

Objectives: The objectives of this project were to develop a working definition of care coordination, apply it to a review of systematic reviews, and identify theoretical frameworks that might predict or explain how care coordination mechanisms are influenced by factors in the health care setting and how they relate to patient outcomes and health care costs.

Data Sources and Review Methods: We used literature databases, Internet searches, and personal contacts to assemble background information on ongoing care coordination programs; potential definitions; conceptual frameworks and related empirical evidence; and care coordination measures. We also conducted literature searches through September 30, 2006, of MEDLINE®, and November 15, 2006, for CINAHL®, Cochrane database of systematic reviews, American College of Physicians Journal Club, Database of Abstracts of Reviews of Effects, PsychInfo, Sociological Abstracts, and Social Services Abstracts to identify systematic reviews of care coordination interventions. We excluded systematic reviews with a narrow focus, namely those conducted solely in the inpatient setting, or where the only two participants involved in care were the patient and a health care provider.

Results: We identified numerous ongoing programs in the private and public sector, most of which have not yet been evaluated. We identified over 40 definitions of care coordination and related terminology, and developed a working definition drawing together common elements:

Care coordination is the deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient's care to facilitate the appropriate delivery of health care services. Organizing care involves the marshalling of personnel and other resources needed to carry out all required patient care activities, and is often managed by the exchange of information among participants responsible for different aspects of care.

We used this definition to develop our inclusion/exclusion criteria for selecting potentially relevant systematic reviews. Our literature search yielded 4,730 publications, of which 75 systematic reviews evaluating care coordination interventions, either fully or as a part of the review, met inclusion criteria. From these, we identified 20 different coordination interventions (e.g., multidisciplinary teams, case management, disease management) covering 12 clinical populations (e.g., mental health, heart disease, diabetes) and conducted in multiple settings (e.g., outpatient, community, home). Finally, we identified four conceptual frameworks (Andersen's behavioral framework, Donabedian's structure-process-outcome framework, Nadler/Tushman and others' Organizational design framework with Wagner's Chronic Care Model provided as an example of such design, and Gittell's Relational coordination framework) with potential applicability to studying care coordination by assessing baseline characteristics of the environment, specific coordination mechanism alternatives, and outcomes.

The strongest evidence shows benefit of care coordination interventions for patients who have congestive heart failure, diabetes mellitus, severe mental illness, a recent stroke, or depression, though evidence about key intervention components is lacking.

Conclusions: Care coordination interventions represent a wide range of approaches at the service delivery and systems level. Their effectiveness is most likely dependent upon appropriate matching between intervention and care coordination problem, though more conceptual, empirical and experimental research is required to explore this hypothesis.

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Working Papers
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Stanford-UCSF Evidence-based Practice Center, for the Agency for Healthcare Research and Quality
Authors
Douglas K. Owens
Number
Publication No. 04(07)-0051-7
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Background: Many alcohol treatment outcome studies exclude some patients with particular problems, such as psychiatric disorders, noncompliance, and homelessness. Such criteria may increase the likelihood of a study being successfully conducted, but may also have the unintended consequence of reducing a study's ability to comply with National Institutes of Health guidelines for inclusion of racial minorities, women, and children in treatment research.

Methods and Results: This paper examined this issue empirically using 5 prior studies of treatment systems enrolling over 100,000 alcohol patients. Widely used eligibility criteria in the alcohol treatment field typically exclude between one-fifth to one-third of patients from enrolling in research. Under several eligibility criteria, most notably those for drug use and social/residential instability, women and African-American patients are substantially more likely to be excluded than are men and non-African-American patients, respectively.

Conclusions: In designing treatment studies with many eligibility criteria, researchers may therefore inadvertently be thwarting their own good faith efforts to ensure that a range of vulnerable populations are able to participate in research. We analyze the implications of this dilemma for the generalizability of treatment results and for research design, and provide data that may help researchers working in different treatment systems estimate the impact of various eligibility criteria.

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Alcoholism: Clinical and Experimental Research
Authors
Keith Humphreys
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Purpose: Recent studies and anecdotal evidence suggest that patient safety may be compromised on weekends. Our objective was to determine whether rates of complications in hospitals are higher on weekends than on weekdays.

Methods: We examined records from 4,967,114 admissions to acute care hospitals in 3 states and analyzed complication rates using the Patient Safety Indicators. We selected 8 indicators that could be assigned to a single day: complications of anesthesia, retained foreign bodies, postoperative hemorrhage, accidental cuts and lacerations during procedures, birth trauma, obstetric trauma during vaginal deliveries with and without instrumentation, and obstetric trauma during cesarean delivery. Odds ratios (ORs) comparing weekends versus weekdays were adjusted for demographics, type of admission, and admission route. In a subgroup analysis of surgical complications, we restricted the population to patients who underwent cardiac or vascular procedures.

Results: Four of the 8 complications occurred more frequently on weekends: postoperative hemorrhage (OR 1.07, 95% confidence interval [CI], 1.01-1.14), newborn trauma (OR 1.06, 95% CI, 1.03-1.10), vaginal deliveries without instrumentation (OR 1.03, 95% CI, 1.02-1.04), and obstetric trauma during cesarean sections (OR 1.36, 95% CI, 1.29-1.44). Complications related to anesthesia occurred less frequently on weekends (OR 0.86). Among patients undergoing vascular procedures, surgical complications occurred more frequently on weekends (OR 1.46, 95% CI, 1.16-1.85).

Conclusions: Rates of complications are marginally higher on weekends than on weekdays for some surgical and newborn complications, but more significantly for obstetric trauma and for surgical complications involving patients undergoing vascular procedures. Hospitals should work toward increasing the robustness of safeguards on weekends.

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American Journal of Medicine
Authors
Eran Bendavid
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Breast cancer is one of the most common causes of death for women in their 40s in the United States. Individualized risk assessment plays an important role when making decisions about screening mammography, especially for women 49 years of age or younger. The purpose of this guideline is to present the available evidence for screening mammography in women 40 to 49 years of age and to increase clinicians' understanding of the benefits and risks of screening mammography.

Summary

Screening mammography probably reduces breast cancer mortality in women 40 to 49 years of age modestly. However, the reduction in this age group is smaller than that in women 50 years of age or older, is subject to greater uncertainty about the exact reduction in risk, and comes with the risk for potential harms (such as false-positive and false-negative results, exposure to radiation, discomfort, and anxiety).

Because of the variation in benefits and harms associated with screening mammography, we recommend tailoring the decision to screen women on the basis of women's concerns about mammography and breast cancer, as well as their risk for breast cancer. Assessment of an individual woman's risk for breast cancer is important because the balance of harms and benefits will shift to net benefit as a woman's baseline risk for breast cancer increases, all other factors being equal. For many women, the potential reduction in risk for death due to breast cancer associated with screening mammography will outweigh other considerations.

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Annals of Internal Medicine
Authors
Douglas K. Owens
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Objective: To examine inpatient intensive care unit (ICU) and intensive procedure use by race among Medicare decedents, using utilization among survivors for comparison.

Design: Retrospective observational analysis of inpatient claims using multivariable hierarchical logistic regression.

Setting: United States, 1989-1999.

Participants: Hospitalized Medicare fee-for-service decedents (n = 976,220) and survivors (n = 845,306) aged 65 years or older.

Measurements and Main Results: Admission to the ICU and use of one or more intensive procedures over 12 months, and, for inpatient decedents, during the terminal admission. Black decedents with one or more hospitalization in the last 12 months of life were slightly more likely than non-blacks to be admitted to the ICU during the last 12 months (49.3% vs. 47.4%, p <.0001) and the terminal hospitalization (41.9% vs. 40.6%, p < 0.0001), but these differences disappeared or attenuated in multivariable hierarchical logistic regressions (last 12 months adjusted odds ratio (AOR) 1.0 [0.99-1.03], p = .36; terminal hospitalization AOR 1.03 [1.0-1.06], p = .01). Black decedents were more likely to undergo an intensive procedure during the last 12 months (49.6% vs. 42.8%, p < .0001) and the terminal hospitalization (37.7% vs, 31.1%, p < .0001), a difference that persisted with adjustment (last 12 months AOR 1.1 [1.08-1.14], p < .0001; terminal hospitalization AOR 1.23 [1.20-1.26], p < .0001). Patterns of differences in inpatient treatment intensity by race were reversed among survivors: blacks had lower rates of ICU admission (31.2% vs. 32.4%, p < .0001; AOR 0.93 [0.91-0.95], p < .0001) and intensive procedure use (36.6% vs. 44.2%; AOR 0.72 [0.70-0.73], p <.0001). These differences were driven by greater use by blacks of life-sustaining treatments that predominate among decedents but lesser use of cardiovascular and orthopedic procedures that predominate among survivors. A hospital's black census was a strong predictor of inpatient end-of-life treatment intensity.

Conclusions: Black decedents were treated more intensively during hospitalization than non-black decedents, whereas black survivors were treated less intensively. These differences are strongly associated with a hospital's black census. The causes and consequences of these hospital-level differences in intensity deserve further study.

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Journal of General Internal Medicine
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This guideline summarizes the current approaches for the diagnosis of venous thromboembolism. The importance of early diagnosis to prevent mortality and morbidity associated with venous thromboembolism cannot be overstressed. This field is highly dynamic, however, and new evidence is emerging periodically that may change the recommendations. The purpose of this guideline is to present recommendations based on current evidence to clinicians to aid in the diagnosis of lower extremity deep venous thrombosis and pulmonary embolism.

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Journal Articles
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Annals of Internal Medicine
Authors
Douglas K. Owens
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Objective: We sought to identify characteristics of pediatricians that were associated with identification or management (referral and/or treatment) of mothers with depression.

Methods: A cross-sectional survey was mailed to a random sample of 1600 of the 50,818 US nonretired members of the American Academy of Pediatrics. Overall, 832 responded, with 745 responses from nontrainee members. The 662 fellow nontrainee members who engaged in direct patient care and completed information on identifying, referring, and treating maternal depression were included in the analyses.

Results: A total of 511 of 662 respondents reported identifying maternal depression; of those who reported identifying maternal depression, 421 indicated they referred and 29 that they treated maternal depression in their practices. Pediatricians who are older, work in practices that provide child mental health services, see primarily (> or = 75%) white patients, use > or = 1 method to address maternal depression, agree that pediatricians should be responsible for identifying maternal depression, think that maternal depression has an extreme effect on children's mental health, and are attitudinally more inclined to identify or manage maternal depression had significantly higher odds of reporting identification of maternal depression. Positive correlates of identification and management of maternal depression included practicing in the Midwest, using > or = 1 method to address maternal depression, working in a practice that provides child mental health services, thinking that caregiving problems attributable to maternal health have an extreme effect on children's physical health, having attitudes that are more inclined to identify and to manage maternal depression, and usually inquiring about symptoms routinely to identify maternal depression.

Conclusions: Pediatricians' practice characteristics and attitudes are associated with their identification and management of mothers with depression.

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Pediatrics
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This issue of CHP/PCOR's Quarterly Update covers news from the Fall 2006 quarter and includes articles about:

  • the effect of health insurance on obese individuals' behaviors, as well as possible approaches and policy questions with regards to the obesity epidemic;
  • the state of disaster preparedness in the United States. Are we ready yet? Experts provided comments at a fall conference and presented data on the intricacies of the topic;
  • the state of children's health -- two pieces provide broad coverage of international and U.S.-based news on current policies and debates surrounding children's health;
  • the health services and policy research scholarly concentration within the School of Medicine, with a special profile piece from a third-year medical student; and
  • two Research in Brief selections, a new feature that highlights recently-published CHP/PCOR research and how such research is informing health care practices and public perceptions.
The newsletter also contains a special Letter from the Director and various other news items that may be of interest to our readers. Note to the reader: The newsletter is fully-navigational. Any text that is surrounded by a dashed box is clickable and will allow the reader to navigate the newsletter more efficiently. The end of each article contains a special symbol (§) that, when clicked, will take the reader back to the table of contents. Please feel free to contact Amber Hsiao with any questions.
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Newsletters
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Quarterly Update
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Background

Human growth hormone (GH) is widely used as an antiaging therapy, although its use for this purpose has not been approved by the U.S. Food and Drug Administration and its distribution as an antiaging agent is illegal in the United States.

Purpose

To evaluate the safety and efficacy of GH therapy in the healthy elderly.

Data Sources

The authors searched MEDLINE and EMBASE databases for English-language studies published through 21 November 2005 by using such terms as growth hormone and aging.

Study Selection

The authors included randomized, controlled trials that compared GH therapy with no GH therapy or GH and lifestyle interventions (exercise with or without diet) with lifestyle interventions alone. Included trials provided GH for 2 weeks or more to community-dwelling participants with a mean age of 50 years or more and a body mass index of 35 kg/m2 or less. The authors excluded studies that evaluated GH as treatment for a specific illness.

Data Extraction

Two authors independently reviewed articles and abstracted data.

Data Synthesis

31 articles describing 18 unique study populations met the inclusion criteria. A total of 220 participants who received GH (107 person-years) completed their respective studies. Study participants were elderly (mean age, 69 years [SD, 6]) and overweight (mean body mass index, 28 kg/m^2 [SD, 2]). Initial daily GH dose (mean, 14 µg per kg of body weight [SD, 7]) and treatment duration (mean, 27 weeks [SD, 16]) varied. In participants treated with GH compared with those not treated with GH, overall fat mass decreased (change in fat mass, -2.1g [95% CI, -2.8 to -1.35] and overall lean body mass increased (change in lean body mass, 2.1 kg [CI, 1.3 to 2.9]) (P 0.001), and their weight did not change significantly (change in weight, 0.1 kg [CI, -0.7 to 0.8]; P = 0.87). Total cholesterol levels decreased (change in cholesterol, -0.29 mmol/L [-11.21 mg/dL]; P = 0.006), although not significantly after adjustment for body composition changes. Other outcomes, including bone density and other serum lipid levels, did not change. Persons treated with GH were significantly more likely to experience soft tissue edema, arthralgias, carpal tunnel syndrome, and gynecomastia and were somewhat more likely to experience the onset of diabetes mellitus and impaired fasting glucose.

Limitations

Some important outcomes were infrequently or heterogeneously measured and could not be synthesized. Most included studies had small sample sizes.

Conclusions

The literature published on randomized, controlled trials evaluating GH therapy in the healthy elderly is limited but suggests that it is associated with small changes in body composition and increased rates of adverse events. On the basis of this evidence, GH cannot be recommended as an antiaging therapy.

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Annals of Internal Medicine
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