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Paul Kolm

Publications and source records attributed to Paul Kolm.

14 recordsLinked to original sources
PubMed2006

An intervention to overcome clinical inertia and improve diabetes mellitus control in a primary care setting: Improving Primary Care of African Americans with Diabetes (IPCAAD) 8.

BACKGROUND: Although clinical trials have shown that proper management of diabetes can improve outcomes, and treatment guidelines are widespread, glycated hemoglobin (HbA1c) levels in the United States are rising. Since process measures are improving, poor glycemic control may reflect the failure of health care providers to intensify diabetes therapy when indicated--clinical inertia. We asked whether interventions aimed at health care provider behavior could overcome this barrier and improve glycemic control. METHODS: In a 3-year trial, 345 internal medicine residents were randomized to be controls or to receive computerized reminders providing patient-specific recommendations at each visit and/or feedback on performance every 2 weeks. When glucose levels exceeded 150 mg/dL (8.33 mmol/L) during visits of 4038 patients, health care provider behavior was characterized as did nothing, did anything (any intensification of therapy), or did enough (if intensification met recommendations). RESULTS: At baseline, residents did anything for 35% of visits and did enough for 21% of visits when changes in therapy were indicated, and there were no differences among intervention groups. During the trial, intensification increased most during the first year and then declined. However, intensification increased more in the feedback alone and feedback plus reminders groups than for reminders alone and control groups (P<.001). After 3 years, health care provider behavior in the reminders alone and control groups returned to baseline, whereas improvement with feedback alone and feedback plus reminders groups was sustained: 52% did anything, and 30% did enough (P<.001 for both vs the reminders alone and control groups). Multivariable analysis showed that feedback on performance contributed independently to intensification and that intensification contributed independently to fall in HbA1c (P<.001 for both). CONCLUSIONS: Feedback on performance given to medical resident primary care providers improved provider behavior and lowered HbA1c levels. Similar approaches may aid health care provider behavior and improve diabetes outcomes in other primary care settings.

Adult↗
PubMed2006

Economics methods in the Clinical Outcomes Utilizing percutaneous coronary Revascularization and Aggressive Guideline-driven drug Evaluation (COURAGE) trial.

Percutaneous coronary intervention (PCI) remains a major therapeutic option for the treatment of chronic coronary artery disease. In the COURAGE trial, 2287 patients with chronic coronary disease were randomized between PCI with medical management and medical management alone. Embedded within the COURAGE trial is a detailed economic analysis being conducted in three health care systems: the US Veterans Administration (VA), Canada, and the US non-VA. Resource use and costs are being collected for each system and overall. Survival is assessed internally in the trial with mean follow-up of 4.5 years. Long-term mean survival will be estimated by projecting survival beyond the trial period by extrapolating the in-trial hazard rates. Utility is being assessed at baseline and at 1, 3, and 6 months and annually thereafter, using a computer-administered standard gamble. Quality-adjusted life years are calculated by multiplying survival by utility. The incremental cost-effectiveness ratio of PCI will be defined as the additional cost of PCI divided by the gain in life years and quality-adjusted life years. The 95% confidence regions of efficacy and costs will be determined by bootstrap over a range of acceptability thresholds, which will then be displayed in the cost-effectiveness plane and as a cost-effectiveness acceptability curve. A multilevel regression model will assess cost-effectiveness from a net benefit perspective. These approaches should provide the most detailed assessment available of the cost-effectiveness of PCI for coronary artery disease.

Angioplasty, Balloon, Coronary↗
PubMed2006

Reduced 6-month resource use and costs associated with cilostazol in patients after successful coronary stent implantation: results from the Cilostazol for RESTenosis (CREST) trial.

BACKGROUND: The CREST trial demonstrated that after successful coronary stent implantation, the 6-month rate of target vessel revascularization (TVR) was similar (15.4% vs 16%, P = .90) for the 2 treatment groups, but restenosis rate was lower (22.0% vs 34.5%, P = .002) in cilostazol-treated patients. We sought to evaluate resource use, cost, and cost-effectiveness of cilostazol in CREST. METHODS: A total of 705 patients were randomized to cilostazol 100 mg twice daily (n = 354) versus placebo (n = 351) for 6 months. Resources included rehospitalizations, medications, and outpatient services. Costs were determined from the Medicare fee schedule. Cilostazol was priced at 1.64 dollars a day. Base-case cost and cost-effectiveness analysis was performed for the entire population using TVR as a measure of effectiveness. Sensitivity analysis was conducted among 526 patients because restenosis data were available only for this patient population. A bootstrap resample approach (5000 samples) was used to obtain confidence intervals for cost differences. RESULTS: For the entire population, costs of rehospitalizations, concomitant medications, outpatient tests, and physician or emergency department visits were lower during follow-up for cilostazol-treated patients. Overall, total 6-month follow-up costs remained 447 dollars lower for cilostazol (4178 dollars vs 4625 dollars), although this difference did not reach significance (95% CI -1458 dollars to 515 dollars). Cilostazol is likely a cost-saving strategy (similar rate of TVR and lower costs). Sensitivity analysis showed that cilostazol is likely a dominant strategy (lower restenosis rate and costs, 85% dominant, 88.9% <1000 dollars per restenosis averted). CONCLUSIONS: Treatment with cilostazol is likely a cost-saving or dominant strategy in patients with successful coronary bare metal stent implantation. Cilostazol may offer a low-cost alternative to restenosis prevention in patients who do not receive drug-eluting stents.

Adult↗
PubMed2006

The impact of age on outcomes after coronary artery bypass surgery versus stent-assisted percutaneous coronary intervention: one-year results from the Stent or Surgery (SoS) trial.

BACKGROUND: Relative outcomes of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) may differ between younger and older patients. There are no data comparing the age-related CABG versus PCI outcomes in the stent era. METHODS: The SoS trial compared CABG (n = 500) and stent-assisted PCI (n = 488). The impact of treatment assignment on 1-year outcomes was evaluated by age < or = 65 years (n = 295, CABG; n = 298, PCI) and > 65 years (n = 205, CABG; n = 190, PCI). RESULTS: One-year procedural outcomes were similar between treatment groups regardless of age, with the exception of more repeat revascularizations after PCI (age < or = 65, 16.1% vs 4.8%; age > 65, 19.5% vs 3.4%; both P < .001). Six and 12-month Seattle Angina Questionnaire scores improved from baseline in both age and treatment groups. However, CABG was associated with greater improvement in physical limitation, angina frequency, and quality of life in younger patients at 6 and 12 months (12-month difference in improvement between CABG and PCI: 5.6, 4.8, and 3.9 points for 3 domains), whereas in the elderly a significant benefit of CABG observed at 6 months did not persist at 12 months (12-month difference: 0.9, 1.9, and 1.4). One-year costs were significantly higher after CABG regardless of age. CONCLUSIONS: Although PCI and CABG result in similar rates in clinical outcomes irrespective of age, younger patients reported more health status benefits from CABG as compared with PCI, whereas in older patients the 2 approaches resulted in similar 1-year health status benefits.

Age Factors↗
PubMed2006

Diagnosing and managing cutaneous pigmented lesions: primary care physicians versus dermatologists.

BACKGROUND: Primary care physicians (PCPs) are often expected to screen for melanomas and refer patients with suspicious pigmented lesions to dermatologists. OBJECTIVE: To assess whether there is a difference between dermatologists and PCPs in accurately diagnosing melanoma and appropriately managing (based on decisions to refer/biopsy) suspicious pigmented lesions. DESIGN, PARTICIPANTS: A survey based on a random sample of 30 photographs of pigmented lesions with known pathology was administered to 101 dermatologists and 115 PCPs from October 2001 to January 2003. MEASUREMENTS: Likelihoods that a photographed lesion was melanoma and that the lesion should be biopsied/referred were scored on a 1 to 10 scale. Accuracy of melanoma diagnosis and appropriateness of pigmented lesion management were compared between dermatologists and PCPs by using the areas under (AUC) the receiver operating characteristic (ROC) curves. RESULTS: Dermatologists were superior to PCPs in diagnosing melanomas (AUC 0.89 vs 0.80, P<.001) and appropriately managing pigmented lesions (AUC .84 vs 0.76, P<.001). PCPs who tended to biopsy lesions themselves did better at managing pigmented lesions than PCPs who did not perform biopsies. Dermatology training during residency did not significantly improve the diagnostic accuracy of PCPs nor their management of pigmented lesions. CONCLUSIONS: Dermatologists have both better diagnostic accuracy and ability to manage pigmented lesions than PCPs. Yet, there is a shortage of dermatologists to meet the demand of accurate melanoma screening. More innovative strategies are needed to better train PCPs and enhance skin cancer screening.

Biopsy↗
PubMed2006

Predictors of medication self-management skill in a low-literacy population.

BACKGROUND: Patients' ability to manage medications is critical to chronic disease control. Also known as medication management capacity (MMC), it includes the ability to correctly identify medications and describe how they should be taken. OBJECTIVE: To evaluate the effects of low literacy, medication regimen complexity, and sociodemographic characteristics on MMC. DESIGN: Cross-sectional analysis of enrollment data from participants in a randomized trial. PARTICIPANTS: Patients with coronary heart disease in an inner-city clinic. MEASUREMENTS: Medication management capacity was measured with the Drug Regimen Unassisted Grading Scale (DRUGS), which scores subjects' ability to identify, open, describe the dose, and describe the timing of their medications. DRUGS overall and component scores were compared by literacy, Mini Mental State Exam score, regimen complexity (number of prescription medications), and sociodemographic characteristics. RESULTS: Most of the 152 participants were elderly (mean age 65.4 years), women (54.6%), and African American (94.1%). Approximately half (50.7%) had inadequate literacy skills, and 28.9% had marginal skills. In univariate analysis, MMC was significantly associated with literacy (P<.001), and this effect was driven by the ability to identify medications. In multivariable models, patients with inadequate literacy skills had 10 to 18 times the odds of being unable to identify all of their medications, compared with those with adequate literacy skills (P<.05). CONCLUSIONS: Adults with inadequate literacy skills have less ability to identify their medications. Techniques are needed to better educate low-literacy patients about their medications, as a potential strategy to enhance adherence.

Aged↗
PubMed2005

Long-term cost effectiveness of early and sustained dual oral antiplatelet therapy with clopidogrel given for up to one year after percutaneous coronary intervention results: from the Clopidogrel for the Reduction of Events During Observation (CREDO) trial.

OBJECTIVES: This study sought to evaluate the long-term cost effectiveness of a clopidogrel loading strategy before percutaneous coronary intervention (PCI) followed by continued treatment for one year. BACKGROUND: The Clopidogrel for the Reduction of Events During Observation (CREDO) trial, a randomized trial of 2,116 patients, showed the effectiveness of antiplatelet therapy with clopidogrel 300 mg before PCI and 75 mg daily for one year afterward compared with placebo load and placebo days 29 to 365 in reducing the combined risk of death, myocardial infarction, and stroke. All patients received clopidogrel on days 1 to 28 and aspirin on days 1 to 365. METHODS: All hospitalizations were assigned a diagnosis-related group. Associated costs were estimated three ways (including professional costs): 1) Medicare costs, 2) MEDSTAT costs, and 3) blend with Medicare for those age > or = 65 years and MEDSTAT for those age <65 years. Clopidogrel 75 mg cost 3.22 dollars. Life expectancy in trial survivors was estimated using external data. Confidence intervals were assessed by bootstrap. RESULTS: The primary composite end point occurred in 89 (8.45%) clopidogrel patients and in 122 (11.48%) placebo patients (relative risk reduction [RRR] 26.9%; 95% confidence interval [CI] 3.9% to 44.4%). The number of life-years gained (LYG) with clopidogrel was 0.1526 (95% CI 0.0263 to 0.2838) using Framingham data and 0.1920 (95% CI 0.054 to 0.337) using Saskatchewan data. Average total costs were 664 dollars higher for the clopidogrel arm (95% CI -461 dollars to 1,784 dollars). The incremental cost-effectiveness ratios (ICERs) based on Framingham data ranged from 3,685 dollars/LYG to 4,353 dollars/LYG, with over 97% of bootstrap-derived ICER estimates below 50,000 dollars/LYG. The ICERs based on Saskatchewan data were 2,929 dollars/LYG to 3,460 dollars/LYG, with over 98% of estimates below 50,000 dollars/LYG. CONCLUSIONS: Platelet inhibition with clopidogrel loading before PCI followed by therapy for one year is highly cost effective.

Aspirin↗
PubMed2005

Cost-effectiveness of eplerenone compared with placebo in patients with myocardial infarction complicated by left ventricular dysfunction and heart failure.

BACKGROUND: In the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS), aldosterone blockade with eplerenone decreased mortality in patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction. The present study was performed to evaluate the cost-effectiveness of eplerenone compared with placebo in these patients. METHODS AND RESULTS: A total of 6632 patients with left ventricular systolic dysfunction and heart failure after acute myocardial infarction were randomized to eplerenone or placebo and followed up for a mean of 16 months. The coprimary end points were all-cause mortality and the composite of cardiovascular mortality/cardiovascular hospitalization. The evaluation of resource use included hospitalizations, outpatient services, and medications. Eplerenone was priced at the average wholesale price, 3.60 dollars per day. Survival beyond the trial period was estimated from data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. The incremental cost-effectiveness of eplerenone in cost per life-year and quality-adjusted life-year gained compared with placebo was estimated. The number of life-years gained with eplerenone was 0.1014 based on Framingham (95% CI, 0.0306 to 0.1740), 0.0636 with Saskatchewan (95% CI, 0.0229 to 0.1038), and 0.1337 with Worcester (95% CI, 0.0438 to 0.2252) data. Cost was 1391 dollars higher over the trial period in the eplerenone arm (95% CI, 656 to 2165) because of drug cost. The incremental cost-effectiveness ratio was 13,718 dollars per life-year gained with Framingham (96.7% under 50,000 dollars per life-year gained), 21,876 dollars with Saskatchewan, and 10,402 dollars with Worcester. CONCLUSIONS: Eplerenone compared with placebo in the treatment of heart failure after acute myocardial infarction is effective in reducing mortality and is cost-effective in increasing years of life by commonly used criteria.

Aged↗
PubMed2005

An endocrinologist-supported intervention aimed at providers improves diabetes management in a primary care site: improving primary care of African Americans with diabetes (IPCAAD) 7.

OBJECTIVE: Management of diabetes is frequently suboptimal in primary care settings, where providers often fail to intensify therapy when glucose levels are high, a problem known as clinical inertia. We asked whether interventions targeting clinical inertia can improve outcomes. RESEARCH DESIGN AND METHODS: A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center. We studied all patients (4,138) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were randomized to be control subjects or to receive one of three interventions. Instead of consultative advice, the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient's visit, individual face-to-face feedback on performance for 5 min every 2 weeks, or both. RESULTS: Over an average patient follow-up of 15 months within the intervention site, improvements in and final HbA1c (A1C) with feedback + reminders (deltaA1C 0.6%, final A1C 7.46%) were significantly better than control (deltaA1C 0.2%, final A1C 7.84%, P < 0.02); changes were smaller with feedback only and reminders only (P = NS vs. control). Trends were similar but not significant with systolic blood pressure (sBP) and LDL cholesterol. Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP. Over a 2-year period, overall glycemic control improved in the intervention site but did not change in other primary care sites (final A1C 7.5 vs. 8.2%, P < 0.001). CONCLUSIONS: Feedback on performance aimed at overcoming clinical inertia and given to internal medicine resident primary care providers improves glycemic control. Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care settings.

Academic Medical Centers↗
PubMed2004

Left atrial structure and function after percutaneous left atrial appendage transcatheter occlusion (PLAATO): six-month echocardiographic follow-up.

OBJECTIVES: This study was designed to evaluate the effects of percutaneous left atrial appendage transcatheter occlusion (PLAATO) on the anatomic and hemodynamic properties of the mitral valve (MV) and left upper pulmonary vein (LUPV). BACKGROUND: PLAATO is a device designed to seal the neck of the left atrial (LA) appendage and reduce embolization in patients with atrial fibrillation intolerant of warfarin. The impact of deployment of this device on adjacent structures has not been reported. METHODS: Patients with atrial fibrillation participating in the ongoing study for evaluation of PLAATO were enrolled. Transesophageal echocardiographies at baseline, one, and six months were reviewed to measure LA and LUPV dimensions, degree of mitral regurgitation, stability of the device, peak MV E-wave velocity, and peak systolic and diastolic flow velocities in the LUPV. Data were analyzed by a linear mixed model for repeated measures. RESULTS: Eleven patients (mean age of 72 +/- 7 years) completed six months of follow-up. Left upper pulmonary vein diameter (mean: 1.55, 1.61, 1.54 cm, p = 0.13) and peak systolic (mean: 0.38, 0.34, 0.31 m/s, p = 0.72) and diastolic flow velocities (mean: 0.39, 0.40, 0.42 m/s, p = 0.46) did not differ over the follow-up period. Left atrial size, mitral regurgitation severity, and MV peak E-wave velocities (mean: 0.94, 0.94, 0.82 m/s, p = 0.58) showed no significant change from baseline. The devices remained stable at their sites of deployment with minimal residual flow around them. CONCLUSIONS: PLAATO achieved an adequate seal of the neck of the left atrial appendage without significant effect on the structure or function of the LA and LUPV.

Aged↗
PubMed2004

Methods for the economic and quality of life supplement to the cilostazol for RESTenosis (CREST) trial.

OBJECTIVE: To determine economic and quality of life outcomes for the Cilostazol for RESTenosis (CREST) trial, which is investigating the efficacy of cilostazol vs. placebo in preventing post-stent restenosis. DESIGN: CREST is a prospective, multicenter, randomized, placebo-controlled, double-blind trial. SETTING: 20 clinical sites; the Emory Center for Outcomes Research (ECOR) will serve as the economic and data coordinating center. PATIENTS: 705 patients (>18 years) who have undergone successful, uncomplicated placement of an intracoronary stent in a native coronary artery. INTERVENTION: Cilostazol (100 mg twice daily) or placebo for 6 months. OUTCOME MEASURES COSTS: Primary endpoint, total direct medical costs at 6 months; secondary endpoints, initial hospital costs and follow-up costs. QOL: Health-related quality of life (QOL) will be assessed using the EQ-5D and the Seattle Angina Questionnaire at baseline and at 1, 3, and 6 months. Cost-effectiveness analysis: Preliminary data show that cilostazol is clinically superior to placebo and if the mean cost for the cilostazol arm is higher than that for placebo, cost-effectiveness analysis will be determined for the cost per episode of restenosis prevented, the cost per episode of major clinical and angiographic endpoints averted, and the cost per quality-adjusted life-years gained.

Angioplasty, Balloon, Coronary↗
PubMed2002

Crisis intervention in a military population: a comparison of inpatient hospitalization and a day treatment program.

We describe transition from an inpatient psychiatric crisis intervention model to an outpatient program for nonpsychotic young adult active duty males presenting in crisis. We reviewed 300 medical records of comparable patients from each program. Demographics, clinical outcomes, and cost analysis are presented. Primary stressors were occupational and relational for both groups. Discharge diagnoses were similar with 98% patients in both groups having diagnosis adjustment disorder, personality disorder, occupational problem, or partner relational problem. Significantly more inpatients (59%) than outpatients (18%) were recommended for separation from the military for personality disorder or inability to adjust. Cost of inpatient treatment was $764 per day compared with $54.81 per day for outpatients. In the first year of operation of the outpatient program, inpatient admissions for crisis intervention in the population described declined by 195. Not only was the outpatient program much more cost-effective, it appeared to have superior clinical results.

Adult↗
PubMedDate not supplied

Use of a glucose algorithm to direct diabetes therapy improves A1C outcomes and defines an approach to assess provider behavior.

PURPOSE: The purpose of this study was to determine whether an algorithm that recommended individualized changes in therapy would help providers to change therapy appropriately and improve glycemic control in their patients. METHODS: The algorithm recommended specific doses of oral agents and insulin based on a patient's medications and glucose or A1C levels at the time of the visit. The prospective observational study analyzed the effect of the algorithm on treatment decisions and A1C levels in patients with type 2 diabetes. RESULTS: The study included 1250 patients seen in pairs of initial and follow-up visits during a 7-month baseline and/or a subsequent 7-month algorithm period. The patients had a mean age of 62 years, body mass index of 33 kg/m(2), duration of diabetes of 10 years, were 94% African American and 71% female, and had average initial A1C level of 7.7%. When the algorithm was available, providers were 45% more likely to intensify therapy when indicated (P = .005) and increased therapy by a 20% greater amount (P < .001). A1C level at follow-up was 90% more likelyto be <7% in the algorithm group, even after adjusting for differences in age, sex, body mass index, race, duration of diabetes and therapy, glucose, and A1C level at the initial visit (P < .001). CONCLUSIONS: Use of an algorithm that recommends patient-specific changes in diabetes medications improves both provider behavior and patient A1C levels and should allow quantitative evaluation of provider actions for that provider's patients.

Aged↗