Balancing Adherence and Expense: The Cost-Effectiveness of Two-Sample vs One-Sample Fecal Immunochemical Test.

Colorectal cancer (CRC) causes more than 50,000 deaths each year in the United States but early detection through screening yields survival gains; those diagnosed with early stage disease have a 5-year survival greater than 90%, compared to 12% for those diagnosed with late stage disease. Using data from a large integrated health system, this study evaluates the cost-effectiveness of fecal immunochemical testing (FIT), a common CRC screening tool. A probabilistic decision-analytic model was used to examine the costs and outcomes of positive test results from a 1-FIT regimen compared with a 2-FIT regimen. The authors compared 5 diagnostic cutoffs of hemoglobin concentration for each test (for a total of 10 screening options). The principal outcome from the analysis was the cost per additional advanced neoplasia (AN) detected. The authors also estimated the number of cancers detected and life-years gained from detecting AN. The following costs were included: program management of the screening program, patient identification, FIT kits and their processing, and diagnostic colonoscopy following a positive FIT. Per-person costs ranged from $33 (1-FIT at 150ng/ml) to $92 (2-FIT at 50ng/ml) across screening options. Depending on willingness to pay, the 1-FIT 50 ng/ml and the 2-FIT 50 ng/ml are the dominant strategies with cost-effectiveness of $11,198 and $28,389, respectively, for an additional AN detected. The estimates of cancers avoided per 1000 screens ranged from 1.46 to 4.86, depending on the strategy and the assumptions of AN to cancer progression.

Performance of a quantitative fecal immunochemical test for detecting advanced colorectal neoplasia: a prospective cohort study.

BACKGROUND: The fecal immunochemical test (FIT) is easier to use and more sensitive than the guaiac fecal occult blood test, but it is unclear how to optimize FIT performance. We compared the sensitivity and specificity for detecting advanced colorectal neoplasia between single-sample (1-FIT) and two-sample (2-FIT) FIT protocols at a range of hemoglobin concentration cutoffs for a positive test. METHODS: We recruited 2,761 average-risk men and women ages 49-75 referred for colonoscopy within a large nonprofit, group-model health maintenance organization (HMO), and asked them to complete two separate single-sample FITs. We generated receiver-operating characteristic (ROC) curves to compare sensitivity and specificity estimates for 1-FIT and 2-FIT protocols among those who completed both FIT kits and colonoscopy. We similarly compared sensitivity and specificity between hemoglobin concentration cutoffs for a single-sample FIT. RESULTS: Differences in sensitivity and specificity between the 1-FIT and 2-FIT protocols were not statistically significant at any of the pre-specified hemoglobin concentration cutoffs (10, 15, 20, 25, and 30 µg/g). There was a significant difference in test performance of the one-sample FIT between 50 ng/ml (10 µg/g) and each of the higher pre-specified cutoffs. Disease prevalence was low. CONCLUSIONS: A two-sample FIT is not superior to a one-sample FIT in detection of advanced adenomas; the one-sample FIT at a hemoglobin concentration cutoff of 50 ng/ml (10 µg/g) is significantly more sensitive for advanced adenomas than at higher cutoffs. These findings apply to a population of younger, average-risk patients in a U.S. integrated care system with high rates of prior screening.

Implementation challenges and successes of a population-based colorectal cancer screening program: a qualitative study of stakeholder perspectives.

BACKGROUND: Few studies describe system-level challenges or facilitators to implementing population-based colorectal cancer (CRC) screening outreach programs. Our qualitative study explored viewpoints of multilevel stakeholders before, during, and after implementation of a centralized outreach program. Program implementation was part of a broader quality-improvement initiative. METHODS: During 2008-2010, we conducted semi-structured, open-ended individual interviews and focus groups at Kaiser Permanente Northwest (KPNW), a not-for-profit group model health maintenance organization using the practical robust implementation and sustainability model to explore external and internal barriers to CRC screening. We interviewed 55 stakeholders: 8 health plan leaders, 20 primary care providers, 4 program managers, and 23 endoscopy specialists (15 gastroenterologists, 8 general surgeons), and analyzed interview transcripts to identify common as well as divergent opinions expressed by stakeholders. RESULTS: The majority of stakeholders at various levels consistently reported that an automated telephone-reminder system to contact patients and coordinate mailing fecal tests alleviated organizational constraints on staff's time and resources. Changing to a single-sample fecal immunochemical test (FIT) lessened patient and provider concerns about feasibility and accuracy of fecal testing. The centralized telephonic outreach program did, however, result in some screening duplication and overuse. Higher rates of FIT completion and a higher proportion of positive results with FIT required more colonoscopies. CONCLUSIONS: Addressing barriers at multiple levels of a health system by changing the delivery system design to add a centralized outreach program, switching to a more accurate and easier-to-use fecal test, and providing educational and electronic support had both benefits and problematic consequences. Other health care organizations can use our results to understand the complexities of implementing centralized screening programs.

Participant uptake of the fecal immunochemical test decreases with the two-sample regimen compared with one-sample FIT.

BACKGROUND: Fecal immunochemical tests (FITs) are recommended to screen average-risk adults for colorectal cancer (CRC). Little research has examined whether a two-sample FIT affects participant uptake, compared with a one-sample FIT. Examining participant uptake is important, as evidence suggests that a two-sample FIT may increase the sensitivity to detect CRC. OBJECTIVE: This study had two objectives: (i) to evaluate FIT completion in a population that received either a one-sample FIT kit (1-FIT) or a two-sample FIT kit (2-FIT) and (ii) to understand whether uptake varies by age, sex, or receipt of prior CRC screening. METHODS: We conducted a randomized controlled trial in which 3081 participants who were aged between 50 and 75 years and were at an average risk for CRC, and who had requested FITs, randomly received 1-FIT (n=1540) or 2-FIT (n=1541) kits. FIT completion was defined as the completion and return of a one-sample test by the patients in the 1-FIT group or of both sample tests by those in the 2-FIT group. Cox proportional hazard regression models were used to determine the independent effect of group type (2-FIT vs. 1-FIT) on the completion of the FIT, adjusting for age, sex, and receipt of prior CRC screening. RESULTS: The 2-FIT group had lower test completion rates (hazard ratio=0.87; 95% confidence interval=0.78-0.97; P=0.01) after adjusting for age, sex, and receipt of prior CRC screening. Participant uptake did not vary by age, sex, or receipt of prior CRC screening. CONCLUSION: This unique, rigorous randomized controlled trial found that the 2-FIT regimen decreases completion of FIT. Further research is needed to understand whether decreases in participant uptake are offset by increased gains in test sensitivity.

Effect of self-referral on bone mineral density testing and osteoporosis treatment.

BACKGROUND: Despite national guidelines recommending bone mineral density screening with dual-energy x-ray absorptiometry (DXA) in women aged 65 years and older, many women do not receive initial screening. OBJECTIVE: To determine the effectiveness of health system and patient-level interventions designed to increase appropriate DXA testing and osteoporosis treatment through (1) an invitation to self-refer for DXA (self-referral); (2) self-referral plus patient educational materials; and (3) usual care (UC, physician referral). RESEARCH DESIGN: Parallel, group-randomized, controlled trials performed at Kaiser Permanente Northwest (KPNW) and Kaiser Permanente Georgia (KPG). SUBJECTS: Women aged 65 years and older without a DXA in past 5 years. MEASURES: DXA completion rates 90 days after intervention mailing and osteoporosis medication receipt 180 days after initial intervention mailing. RESULTS: From >12,000 eligible women, those randomized to self-referral were significantly more likely to receive a DXA than UC (13.0%-24.1% self-referral vs. 4.9%-5.9% UC, P<0.05). DXA rates did not significantly increase with patient educational materials. Osteoporosis was detected in a greater proportion of self-referral women compared with UC (P<0.001). The number needed to receive an invitation to result in a DXA in KPNW and KPG regions was approximately 5 and 12, respectively. New osteoporosis prescription rates were low (0.8%-3.4%) but significantly greater among self-referral versus UC in KPNW. CONCLUSIONS: DXA rates significantly improved with a mailed invitation to schedule a scan without physician referral. Providing women the opportunity to self-refer may be an effective, low-cost strategy to increase access for recommended osteoporosis screening.

More comprehensive discussion of CRC screening associated with higher screening.

OBJECTIVES: Examine association of comprehensiveness of colorectal cancer (CRC) screening discussion by primary care physicians (PCPs) with completion of CRC screening. STUDY DESIGN: Observational study in Kaiser Permanente Northwest, a group-model health maintenance organization. METHODS: A total of 883 participants overdue for CRC screening received an automated telephone call (ATC) between April and June 2009 encouraging CRC screening. Between January and March 2010, participants completed a survey on PCPs' discussion of CRC screening and patient beliefs regarding screening. PRIMARY OUTCOME MEASURE: receipt of CRC screening (assessed by electronic medical record [EMR], 9 months after ATC). Primary independent variable: comprehensiveness of CRC screening discussion by PCPs (7-item scale). Secondary independent variables: perceived benefits of screening (4-item scale assessing respondents' agreement with benefits of timely screening) and primary care utilization (EMR; 9 months after ATC). The independent association of variables with CRC screening was assessed with logistic regression. RESULTS: Average scores for comprehensiveness of CRC discussion and perceived benefits were 0.4 (range 0-1) and 4.0 (range 1-5), respectively. A total of 28.2% (n = 249) completed screening, 84% of whom had survey assessments after their screening date. Of screeners, 95.2% completed the fecal immunochemical test. More comprehensive discussion of CRC screening was associated with increased screening (odds ratio [OR] = 1.51, 95% confidence interval [CI] = 1.03-2.21). Higher perceived benefits (OR = 1.46, 95% CI = 1.13-1.90) and 1 or more PCP visits (OR = 5.82, 95% CI = 3.87-8.74) were also associated with increased screening. CONCLUSIONS: More comprehensive discussion of CRC screening was independently associated with increased CRC screening. Primary care utilization was even more strongly associated with CRC screening, irrespective of discussion of CRC screening.

Health care worker perspectives inform optimization of patient panel-support tools: a qualitative study.

Electronic decision-support systems appear to enhance care, but improving both tools and work practices may optimize outcomes. Using qualitative methods, the authors' aim was to evaluate perspectives about using the Patient Panel-Support Tool (PST) to better understand health care workers' attitudes toward, and adoption and use of, a decision-support tool. In-depth interviews were conducted to elicit participant perspectives about the PST-an electronic tool implemented in 2006 at Kaiser Permanente Northwest. The PST identifies "care gaps" and recommendations in screening, medication use, risk-factor control, and immunizations for primary care panel patients. Primary care physician (PCP) teams were already grouped (based on performance pre- and post-PST introduction) into lower, improving, and higher percent-of-care-needs met. Participants were PCPs (n=21), medical assistants (n=11), and quality and other health care managers (n=20); total n=52. Results revealed that the most commonly cited benefit of the PST was increased in-depth knowledge of patient panels, and empowerment of staff to do quality improvement. Barriers to PST use included insufficient time, competing demands, suboptimal staffing, tool navigation, documentation, and data issues. Facilitators were strong team staff roles, leadership/training for tool implementation, and dedicated time for tool use. Higher performing PCPs and their assistants more often described a detailed team approach to using the PST. In conclusion, PCP teams and managers provided important perspectives that could help optimize use of panel-support tools to improve future outcomes. Improvements are needed in tool function and navigation; training; staff accountability and role clarification; and panel management time.

Change to FIT increased CRC screening rates: evaluation of a US screening outreach program.

OBJECTIVES: To compare completion rates of colorectal cancer screening tests within a health maintenance organization before and after widespread adoption of the fecal immunochemical test (FIT). STUDY DESIGN: Retrospective cohort study. METHODS: Using electronic medical records of 113,901 patients eligible for colorectal cancer screening, we examined test completion during 2 successive time periods among those who received an automated screening outreach call. The time periods were: 1) the "guaiac fecal occult blood test (gFOBT) era," a 15-month period during which only gFOBT was routinely offered, and 2) a 9-month "FIT era," when only a new FIT was routinely offered. In addition to analyzing completion rates, we analyzed the impact of practice-level variables and patient-level variables on overall screening completion during the 2 different observation periods. RESULTS: The change from gFOBT to FIT in an integrated care delivery system increased the likelihood of screening completion by 7.7% overall, and the likelihood of screening with a fecal test by 8.9%. The greatest gains in screening completion using FIT were among women and elderly patients. Completion of FIT was not as strongly associated with medical office visits or with having a primary care provider as was screening with gFOBT. CONCLUSIONS: Adoption of FIT within an integrated care system increased completion of colon cancer screening tests within a 9-month assessment period, compared with a previous 15-month gFOBT era. Higher completion rates of the FIT may allow for more effective dissemination of programs to increase colorectal cancer screening through centralized outreach programs.

Incidence and demography of femur fractures with and without atypical features.

The case definition, community incidence, and characteristics of atypical femoral shaft fractures (FSFs) are poorly understood. This retrospective study utilized electronic medical records and radiograph review among women ≥50 years of age and men ≥65 years of age from January 1996 to June 2009 at Kaiser Permanente Northwest to describe the incidence rates and characteristics of subgroups of femur fractures. Fractures were categorized based on the American Society for Bone and Mineral Research (ASBMR) as atypical fracture major features (AFMs) (low force, shaft location, transverse or short oblique, noncomminuted) and AFMs with additional minor radiograph features (AFMms) (beaking, cortical thickening, or stress fracture). There were 5034 fractures in the study. The incidence rates of FSFs (without atypical features) and AFMs appeared flat (cumulative incidence: 18.2 per 100,000 person-years, 95% CI = 16.0-20.7; 5.9 per 100,000 person-years, 95% CI = 4.6-7.4; respectively) with 1,271,575 person-years observed. The proportion of AFMs that were AFMms increased over time. Thirty percent of AFMs had any dispensing of a bisphosphonate prior to the fracture, compared to 15.8% of the non-atypical FSFs. Years of oral glucocorticosteroid dispensing appeared highest in AFM and AFMm fractures. Those with AFMs only were older and had a lower frequency of bisphosphonate dispensing compared to those with AFMms. We conclude that rates of FSFs, with and without atypia, were low and stable over 13.5 years. Patients with only AFMs appear to be different from those with AFMms; it may be that only the latter group is atypical. There appear to be multiple associated risk factors for AFMm fractures.

Primary care colorectal cancer screening recommendation patterns: associated factors and screening outcomes.

BACKGROUND: The relationship of a primary care provider's (PCP's) colorectal cancer (CRC) screening strategies to completion of screening is poorly understood. OBJECTIVE: To describe PCP test recommendation patterns and associated factors and their relationship to patient test completion. DESIGN: This cross-sectional study used a PCP survey, in-depth PCP interviews, and electronic medical records. SETTING: Kaiser Permanente Northwest health maintenance organization. PARTICIPANTS: Participants included 132 PCPs and 49,259 eligible patients aged 51 to 75. MEASUREMENTS: The authors grouped PCPs by patterns of CRC screening recommendations based on reported frequency of recommending fecal occult blood testing (FOBT), flexible sigmoidoscopy (FS), and colonoscopy. They then compared PCP demographics, reported CRC screening test influences, concerns, decision-making and counseling processes, and actual rates of patient CRC screening completion by PCP group. RESULTS: The authors identified 4 CRC screening recommendation groups: a "balanced" group (n = 54; 40.9%) that recommended the tests nearly equally, an FOBT group (n = 31; 23.5%) that largely recommended FOBT, an FOBT + FS group (n = 25; 18.9%), and a colonoscopy + FOBT group (n = 22; 16.7%) that recommended these tests nearly equally. Internal medicine (v. family medicine) PCPs were more common in groups more frequently recommending endoscopy. The FOBT and FOBT + FS groups were most influenced by clinical guidelines. Groups recommending more endoscopy were most concerned that FOBT generates a relatively high number of false positives and FOBT can miss cancers. The FOBT and FOBT + FS groups were more likely to recommend a specific screening strategy compared to the colonoscopy + FOBT and balanced groups, which were more likely to let the patient decide. CRC screening rates were 63.9% balanced, 62.9% FOBT, 61.7% FOBT + FS, and 62.2% colonoscopy + FOBT; rates did not differ significantly by group. LIMITATIONS: Small numbers within PCP groups. CONCLUSIONS: Specialty, the influence of guidelines, test concerns, and the "jointness" of the test selection decision distinguished CRC screening recommendation patterns. All patterns were associated with similar overall screening rates.

Patient Barriers to Mammography Identified During a Reminder Program.

Background: Patient mammogram reminders are effective at increasing screening, but patient barriers remain. We evaluated patient characteristics and reported barriers for their association with mammogram completion after a reminder program. Methods: This retrospective cohort study used data from electronic records and a subgroup survey. Participants were female Kaiser Permanente Northwest health maintenance organization (HMO) members aged 50-69 who were 20 months past their last mammogram (index date) and had received a reminder intervention (n = 4708). A mailed survey was completed by 340 of 667 (50.2%) women who received it. The intervention was a "mammogram due soon" postcard 20 months after the last mammogram, followed by up to two automated phone calls and one live call for nonresponders. The outcome was mammogram completion at 10 months after index date. Results: Characteristics associated with lower mammogram completion rates were aged <60 (odds ratio [OR] 0.69, p < 0.0001), health plan membership <5 years (OR 0.81, p = 0.019), family income <$40,000/year (OR 0.77, p = 0.018), and obesity (OR 0.67, p < 0.0001). Obese women were more likely than nonobese women to report "too much pain" from mammograms (31.3% vs.18.8%, p < 0.01). Younger women were more likely to endorse that they were "too busy" (19.1% vs. 6.4%, p < 0.001) and had more worries about mammogram accuracy (2.5 vs. 2.3 on a 5-point scale, p < 0.05). Pain mediated the relationship between obesity and mammogram completion rates (indirect effect = -0.111, p = 0.008). Conclusions: Important barriers to mammogram completion remain even after an effective mammogram reminder system among insured patients. Tailored interventions are necessary to overcome these barriers.

Effect of a patient panel-support tool on care delivery.

OBJECTIVE: To evaluate the effect of a patient panel-support tool (PST) on care delivery for diabetes mellitus (DM) and cardiovascular disease (CVD). STUDY DESIGN: Retrospective longitudinal cohort study among primary care providers (PCPs), with 2005 as the preintervention, 2006 as the implementation, and 2007 as the postintervention period. METHODS: We estimated the intervention effect using electronic medical record data and hierarchical linear models. The intervention was a PST displaying "care gaps" and recommendations for glycosylated hemoglobin, low-density lipoprotein cholesterol, and blood pressure screening and control; retinopathy, nephropathy, and foot screening; aspirin, statin, and angiotensin-converting enzyme inhibitor or beta-blocker use; and influenza and pneumococcal vaccination. Participants were qualifying PCPs and health maintenance organizations; patients. Patients had DM or CVD and 12 months of membership (n = 30,273 DM; 26,414 CVD). Main measures were mean percentages of care recommendations that were met by PCPs per patient per month (the care score). RESULTS: From 2005 to 2007, the mean care score (95% confidence interval) increased for both DM and CVD, from 63.5 (62.7, 64.3) to 70.6 (69.8, 71.4) and from 67.9 (67.2, 68.7) to 72.6 (71.9, 73.3), respectively. After adjustments, DM and CVD patients had improvements in the care score of 7.6 and 5.1, respectively, in 2007 compared with 2005 (P < .001). CONCLUSIONS: Delivery of care recommendations for DM and CVD improved after implementation of a PST. More research is necessary to optimize results and determine whether patient outcomes improve.

Automated telephone calls improved completion of fecal occult blood testing.

BACKGROUND: Although colorectal cancer (CRC) prognosis is improved by early diagnosis, screening rates remain low. OBJECTIVE: To determine the effect of an automated telephone intervention on completion of fecal occult blood testing (FOBT). RESEARCH DESIGN: In this randomized controlled trial conducted at Kaiser Permanente Northwest, a not-for-profit health maintenance organization, 5905 eligible patients aged 51 to 80, at average risk for CRC and due for CRC screening, were randomly assigned to an automated telephone intervention (n = 2943) or usual care (UC; n = 2962). The intervention group received up to three 1-minute automated telephone calls that provided a description and health benefits of FOBT. During the call, patients could request that an FOBT kit be mailed to their home. Those who requested but did not return the cards received an automated reminder call. Cox proportional hazard method was used to determine the independent effect of automated telephone calls on completion of an FOBT, after adjusting for age, sex, and prior CRC screening. RESULTS: By 6 months after call initiation, 22.5% in the intervention and 16.0% in UC had completed an FOBT. Those in the intervention group were significantly more likely to complete an FOBT (hazard ratio, 1.31; 95% confidence interval, 1.10-1.56) compared with UC. Older patients (aged 71-80 vs. aged 51-60) were also more likely to complete FOBT (hazard ratio, 1.48; 95% confidence interval, 1.07-2.04). CONCLUSIONS: Automated telephone calls increased completion of FOBT. Further research is needed to evaluate automated telephone interventions among diverse populations and in other clinical settings.

Efficacy of continued alendronate for fractures in women with and without prevalent vertebral fracture: the FLEX trial.

In the Fracture Intervention Trial (FIT) Long Term Extension (FLEX) Trial, 10 years of alendronate (ALN) did not significantly reduce the risk of nonvertebral fractures (NVFs) compared with 5 years of ALN. Continuing ALN reduced the risk of clinical but not morphometric vertebral fractures regardless of baseline vertebral fracture status. In previous studies, ALN efficacy for NVF prevention in women without prevalent vertebral fracture was limited to those with femoral neck (FN) T-scores of -2.5 or less. To determine whether the effect of long-term ALN on fracture differs by vertebral fracture status and femoral neck (FN) T-score, we performed a post hoc analysis using FLEX data, a randomized, double-blind, placebo-controlled trial among 1099 postmenopausal women originally randomized to ALN in the FIT with mean ALN use of 5 years. In the FLEX Trial, women were randomized to placebo (40%) or ALN 5 mg/day (30%) or ALN 10 mg/day (30%) for an additional 5 years. Among women without vertebral fracture at FLEX baseline (n = 720), continuation of ALN reduced NVF in women with FLEX baseline FN T-scores of -2.5 or less [relative risk (RR) = 0.50, 95% confidence interval (CI) 0.26-0.96] but not with T-scores of greater than -2.5 and -2 or less (RR 0.79, 95% CI 0.37-1.66) or with T-scores of greater than -2 (RR 1.41, 95% CI 0.75-2.66; p for interaction = .019). Continuing ALN for 10 years instead of stopping after 5 years reduces NVF risk in women without prevalent vertebral fracture whose FN T-scores, achieved after 5 years of ALN, are -2.5 or less but does not reduce risk of NVF in women whose T-scores are greater than -2.

Association of cardiometabolic risk factors and prevalent cardiovascular events.

BACKGROUND: Although cardiovascular disease causes substantial morbidity and mortality, how individual and groups of risk factors contribute to cardiovascular outcomes is incompletely understood. This study evaluated cardiometabolic risk factors and their relationship to prevalent diagnosis of acute myocardial infarction (AMI) and stroke. METHODS: We used retrospective data from 3 integrated health-care systems that systematically collect and store detailed patient-level data. Adult enrollees were eligible for inclusion if they had all of the following clinical measurements: weight, height, blood pressure, high density lipoproteins, triglycerides, and fasting blood glucose or evidence of diabetes from July 1, 2003, to June 30, 2005. We used National Cholesterol Education Program Adult Treatment Panel III guidelines to determine qualifying levels for cardiometabolic risk factors. RESULTS: A total of 170,648 persons met the inclusion/exclusion criteria; 11,757 had no qualifying risk factors, 25,684 had 1, 38,176 had 2, and 95,031 had 3 or more risk factors. Compared to those without risk factors, persons with any 1 risk factor were 2.21 (95% confidence interval [CI], 1.78-2.74) times more likely to have had a diagnosis of AMI or stroke. The risk increased to 2.79 (95% CI, 2.26-3.42) for persons with 2, 3.45 (95% CI, 2.80-4.24) for persons with 3, 4.35 (95% CI, 3.54-5.35) for persons with 4, and 5.73 (95% CI, 4.65-7.07) for persons with 5 risk factors. The highest risk was conferred by having the combination of risk factors of diabetes, hypertension, and dyslipidemia, with or without weight risk. CONCLUSIONS: This study demonstrates a direct association between an increasing number of cardiometabolic risk factors and prevalent diagnosis of AMI and stroke. The combination of risk factors conferring the highest risk was diabetes, hypertension, and dyslipidemia.

Effect of a multimodal reminder program on repeat mammogram screening.

BACKGROUND: Patient mammogram reminders are effective but have not been fully implemented in practice to improve routine screening. The effectiveness of implementation and maintenance phases of a multimodal reminder program that incorporated automated calls capable of efficiently reaching large numbers of women was evaluated to improve repeat mammography screening. DESIGN: A quasi-experimental study was conducted in 2008 using electronic medical record data during three time periods: pre-reminder phase (2004), post-reminder implementation phase (2006), and post-reminder maintenance phase (January 1-July 1, 2007). SETTING/PARTICIPANTS: Participants were female Kaiser Permanente Northwest HMO members aged 42 years or more who were 20 months past their last mammogram (index date) (N=35,104). The intervention program targeted women aged 50-69 years. Women aged 42-49 years (for whom clinical guidelines also recommend mammography) not targeted by the program constituted the primary comparison group (CG1). INTERVENTION: A "mammogram due soon" postcard was mailed to participants 20 months after their last mammogram, followed by up to two automated phone calls and one live call for nonresponders. MAIN OUTCOME MEASURES: The outcome measure was the time until participants received a mammogram in the 10 months following the index date. RESULTS: Pre-reminder, 63.4% of targeted women completed a mammogram; this number increased to 75.4% in the post-reminder implementation phase; 80.6% completed a mammogram in the maintenance phases. After controlling for demographics and clinic visits, intervention women were 1.51 times more likely to complete a mammogram (CI=1.40, 1.62) post-reminder implementation, compared to CG1. The effect was maintained in 2007 (hazard ratio 1.81, CI=1.65, 1.99). CONCLUSIONS: The study found that this multimodal reminder system could be effectively implemented and maintained in a large health system. If widely implemented, this intervention could substantially improve community mammography screening.

Reducing the prescribing of heavily marketed medications: a randomized controlled trial.

CONTEXT: Prescription drug costs are a major component of health care expenditures, yet resources to support evidence-based prescribing are not widely available. OBJECTIVE: To evaluate the effectiveness of computerized prescribing alerts, with or without physician-led group educational sessions, to reduce the prescribing of heavily marketed hypnotic medications. DESIGN: Cluster-randomized controlled trial. SETTING: We randomly allocated 14 internal medicine practice sites to receive usual care, computerized prescribing alerts alone, or alerts plus group educational sessions. MEASUREMENTS: Proportion of heavily marketed hypnotics prescribed before and after the implementation of computerized alerts and educational sessions. MAIN RESULTS: The activation of computerized alerts held the prescribing of heavily marketed hypnotic medications at pre-intervention levels in both the alert-only group (adjusted risk ratio [RR] 0.97; 95% CI 0.82-1.14) and the alert-plus-education group (RR 0.98; 95% CI 0.83-1.17) while the usual-care group experienced an increase in prescribing (RR 1.31; 95% CI 1.08-1.60). Compared to the usual-care group, the relative risk of prescribing heavily marketed medications was less in both the alert-group (Ratio of risk ratios [RRR] 0.74; 95% CI 0.57-0.96) and the alert-plus-education group (RRR 0.74; 95% CI 0.58-0.97). The prescribing of heavily marketed medications was similar in the alert-group and alert-plus-education group (RRR 1.02; 95% CI 0.80-1.29). Most clinicians reported that the alerts provided useful prescribing information (88%) and did not interfere with daily workflow (70%). CONCLUSIONS: Computerized decision support is an effective tool to reduce the prescribing of heavily marketed hypnotic medications in ambulatory care settings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00788346.

Improving laboratory monitoring of medications: an economic analysis alongside a clinical trial.

OBJECTIVE: To test the efficiency and cost-effectiveness of interventions aimed at enhancing laboratory monitoring of medication. STUDY DESIGN: Cost-effectiveness analysis. METHODS: Patients of a not-for-profit, group-model HMO were randomized to 1 of 4 interventions: an electronic medical record reminder to the clinician, an automated voice message to patients, pharmacy-led outreach, or usual care. Patients were followed for 25 days to determine completion of all recommended baseline laboratory monitoring tests. We measured the rate of laboratory test completion and the cost-effectiveness of each intervention. Direct medical care costs to the HMO (repeated testing, extra visits, and intervention costs) were determined using trial data and a mix of other data sources. RESULTS: The average cost of patient contact was $5.45 in the pharmacy-led intervention, $7.00 in the electronic reminder intervention, and $4.64 in the automated voice message reminder intervention. The electronic medical record intervention was more costly and less effective than other methods. The automated voice message intervention had an incremental cost-effectiveness ratio (ICER) of $47 per additional completed case, and the pharmacy intervention had an ICER of $64 per additional completed case. CONCLUSIONS: Using the data available to compare strategies to enhance baseline monitoring, direct clinician messaging was not an efficient use of resources. Depending on a decision maker's willingness to pay, automated voice messaging and pharmacy-led efforts can be efficient choices to prompt therapeutic baseline monitoring, but direct clinician messaging is probably a less efficient use of resources.

Effectiveness of bisphosphonate therapy in a community setting.

BACKGROUND: Osteoporosis is a major cause of morbidity and mortality. Clinical trials have shown the effectiveness of bisphosphonates, the most commonly prescribed treatments, in reducing fracture risk. The population-based effectiveness of bisphosphonates in clinical practice is uncertain. METHODS: This retrospective cohort study used a matched design that compared time to clinical fracture in at-risk community women who initiated a bisphosphonate medication between 7/1/1996 and 6/30/2006 to those who did not. The study was conducted in an HMO in Oregon and Washington. Clinical electronic databases provided data. Eligible members were newly treated women aged > or = 55 years with either a BMD T-score of < or = -2.0 or a prior qualifying clinical fracture. They did not have contraindications for bisphosphonate therapy or a diagnosis associated with secondary osteoporosis (n=1829). They were matched to a similar comparison group (n=1829; total N=3658). The primary outcome was the first new incident fracture validated through chart review (closed clinical fracture of any bone except face, skull, finger, or toe or pathological fracture secondary to malignancy) during follow-up. An intention-to-treat analysis used Cox proportional hazards models to estimate the hazard ratio of fracture for treated relative to comparison patients, adjusting for differences in potential confounders. RESULTS: Treated and comparison patients were similar in mean age (72.0 years) and history of fracture (about 45%). The treated group had more women with T-scores of < or = -2.5 (67.3% vs. 54.7%) and a lower mean weight (146.6 lb vs. 151.8 lb). Only about 45% of treated patients had a bisphosphonate medication possession ratio (MPR) of > or = 0.80. During follow-up, 198 (10.8%) of patients in the treated group had incident fractures, vs. 179 (9.8%) of patients in the comparison group. After adjustments, patients in the treated group were 0.91 (95% CI 0.74-1.13) as likely to have an incident fracture as the comparison patients (p=0.388). The treatment effect remained non-significant after accounting for MPR. CONCLUSIONS: In this analysis of a community cohort of post-menopausal women at risk, the fracture risk of patients who received bisphosphonates did not differ significantly from those who did not. An enhanced understanding of this lack of treatment effect is urgently needed.

Weight change in diabetes and glycemic and blood pressure control.

OBJECTIVE: Weight loss in type 2 diabetes is undisputedly important, and data from community settings are limited. We evaluated weight change and resulting glycemic and blood pressure control in type 2 diabetic patients at an HMO. RESEARCH DESIGN AND METHODS: Using electronic medical records, this retrospective cohort study identified 2,574 patients aged 21-75 years who received a new diagnosis of type 2 diabetes between 1997 and 2002. We estimated 3-year weight trajectories using growth curve analyses, grouped similar trajectories into four categories using cluster analysis, compared category characteristics, and predicted year-4 above-goal A1C and blood pressure by group. RESULTS: The weight-trajectory groups were defined as higher stable weight (n = 418; 16.2%), lower stable weight (n = 1,542; 59.9%), weight gain (n = 300; 11.7%), and weight loss (n = 314; 12.2%). The latter had a mean weight loss of 10.7 kg (-9.8%; P < 0.001) by 18 months, with near-complete regain by 36 months. After adjusting for age, sex, baseline control, and related medication use, those with higher stable weight, lower stable weight, or weight-gain patterns were more likely than those who lost weight to have above-goal A1C (odds ratio [OR] 1.66 [95% CI 1.12-2.47], 1.52 [1.08-2.14], and 1.77 [1.15-2.72], respectively). Those with higher stable weight or weight-gain patterns were more likely than those who lost weight to have above-goal blood pressure (1.83 [1.31-2.57] and 1.47 [1.03-2.10], respectively). CONCLUSIONS: A weight-loss pattern after new diagnosis of type 2 diabetes predicted improved glycemic and blood pressure control despite weight regain. The initial period postdiagnosis may be a critical time to apply weight-loss treatments to improve risk factor control.