Nicotine replacement therapy sampling via primary care: Methods from a pragmatic cluster randomized clinical trial.

BACKGROUND: Primary care is the most important point of healthcare contact for smokers. Brief physician advice to quit, based on the 5As/AAR model, offers some efficacy but is inconsistently administered and has limited population impact. Nicotine replacement therapy (NRT) sampling, defined as provision of a brief NRT starter kit, when added to the 5As/AAR, is well-suited to primary care because it is simple, brief, and can be provided to all smokers. This article describes the design and methods of an ongoing comparative effectiveness trial testing standard care vs. standard care + NRT sampling within primary care. METHODS: Smokers were recruited directly from primary care practices between July 2014 and December 2017 within an established network of South Carolina clinics. Interventions were delivered randomly by clinic personnel, and phone-based follow-ups were centrally coordinated by research staff to track outcomes through six months post-intervention. Primary study aims are to examine the impact of NRT sampling on smoking, inclusive of cessation, quit attempts, and uptake of evidence-based treatment. RESULTS: Twenty-two clinics were recruited. Across clinics, patient census ranged from 985 to 10,957 and number of providers ranged from 1 to 63. Average patient age across clinics was 52.9 years and smoking prevalence across ranged from 10.6% to 28.5%. CONCLUSION: Improving the effectiveness and reach of brief interventions within primary care could have a considerable impact on population quit rates. We consider the advantages and disadvantages of key methodological decisions relevant to the design of future primary care-based cessation trials.

Low Blood Pressure Is Associated With Greater Risk for Cardiovascular Events in Treated Adults With and Without Apparent Treatment-Resistant Hypertension.

Apparent treatment-resistant hypertension (aTRH) may confound the reported relationship between low blood pressure (BP) and increased cardiovascular disease (CVD) in treated hypertensive patients. Incident CVD was assessed in treated hypertensive patients with and without aTRH (BP ≥140 and/or ≥90 mm Hg on ≥3 medications or <140/<90 mm Hg on ≥4 BP medications) at three BP levels: 1: <120 and/or <70 mm Hg and <140/<90 mm Hg; 2: 120-139/70-89 mm Hg; and 3: ≥140 and/or ≥90 mm Hg. Electronic health data were matched to emergency and hospital claims for incident CVD in 118 356 treated hypertensive patients. In adults with and without aTRH, respectively, CVD was greater in level 1 versus level 2 (multivariable hazard ratio, 1.88 [95% confidence interval [CI], 1.70-2.07]; 1.71 [95% CI, 1.59-1.84]), intermediate in level 1 versus level 3 (hazard ratio, 1.32 [95% CI, 1.21-1.44]; 0.99, [95% CI, 0.92-1.07]), and lowest in level 2 versus level 3 (hazard ratio, 0.70 [95% CI, 0.65-0.76]; 0.58, [95% CI, 0.54-0.62]). Low treated BP was associated with more CVD than less stringent BP control irrespective of aTRH.

2013 ACC/AHA Cholesterol Guideline and Implications for Healthy People 2020 Cardiovascular Disease Prevention Goals.

BACKGROUND: Healthy People 2020 aim to reduce fatal atherosclerotic cardiovascular disease (ASCVD) by 20%, which translates into 310 000 fewer events annually assuming proportional reduction in fatal and nonfatal ASCVD. We estimated preventable ASCVD events by implementing the American College of Cardiology/American Heart Association (ACC/AHA) 2013 Cholesterol Guideline in all statin-eligible adults. Absolute risk reduction (ARR) and number needed-to-treat (NNT) were calculated. METHODS AND RESULTS: National Health and Nutrition Examination Survey data for 2007-2012 were analyzed for adults aged 21 to 79 years and extrapolated to the US population. Literature-guided assumptions were used including (1) low-density lipoprotein cholesterol falls 33% with moderate-intensity statins and 51% with high-intensity statins; (2) for each 39 mg/dL decline in low-density lipoprotein cholesterol, 10-year ASCVD10 risk would fall 21% when ASCVD10 risk was ≥20% and 33% when ASCVD10 risk was <20%; and (3) either all statin-eligible untreated adults or all with ASCVD10 risk ≥7.5% would receive statins. Of 175.9 million adults aged 21 to 79 years not taking statins, 44.8 million (25.5%) were statin eligible. Treating all statin-eligible adults would prevent an estimated 243 589 ASCVD events annually (ARR 5.4%, 10-year NNT 18). Treating all statin-eligible adults with ASCVD10 risk ≥7.5% reduces the number treated to 32.2 million (28.2% fewer), whereas ASCVD events prevented annually fall only 10.5% to 217 974 (6.8% ARR, NNT 15). CONCLUSIONS: Implementing the ACC/AHA 2013 Cholesterol Guideline in all untreated, statin-eligible adults could achieve ≈78% of the Healthy People 2020 ASCVD prevention goal. Most of the benefit is attained by individuals with 10-year ASCVD risk ≥7.5%.

Aldosterone Antagonists or Renin-Guided Therapy for Treatment-Resistant Hypertension: A Comparative Effectiveness Pilot Study in Primary Care.

BACKGROUND: Uncontrolled treatment-resistant hypertension (TRH), i.e., blood pressure (BP, mm Hg) ≥140/≥90mm Hg in and out of office on ≥3 different BP medications at optimal doses, is common and has a poor prognosis. Aldosterone antagonist (AA) and renin-guided therapy (RGT) are effective strategies for improving BP control in TRH but have not been compared. METHODS: A comparative effectiveness TRH pilot study of AA vs. RGT was conducted in 4 primary care clinics with 2 each randomized to AA or RGT. The primary outcome was change in clinic BP defined by means of 5 automated office BP values. Eighty-nine patients with apparent TRH were screened and 44 met criteria for true TRH. RESULTS: Baseline characteristics of 20 patients in the AA (70% Black, 45% female, mean age: 57.4 years) and 24 patients in RGT (79% Black, 50% female, 57.8 years) arms were similar with baseline BP 162±5/90±3 vs. 153±3/84±3, respectively, P = 0.11/0.20. BP declined to 144±5/86±4 in AA vs. 132±4/75±3 in RGT, P = 0.07/0.01; BP was controlled to JNC7 (Seventh Joint National Committee Report) goal in 25% vs. 62.5%, respectively, P < 0.01. Although BP changes from baseline, the primary outcome, were not different (-17.6±5.1/-4.0±3.0 AA vs. -20.4±3.8/-9.7±2.0 RGT, P = 0.65/0.10.), more BP medications were added with AA than RGT (+0.9±0.1 vs. +0.4±0.1 per patient, P < 0.01). CONCLUSIONS: In this TRH pilot study, AA and RGT lowered BP similarly, although fewer additional medications were required with RGT. A larger comparative effectiveness study could establish the utility of these treatment strategies for lowering BP of uncontrolled TRH patients in primary care.

Impact of Implementing the 2013 ACC/AHA Cholesterol Guidelines on Vascular Events in a Statewide Community-Based Practice Registry.

Electronic health record data were analyzed to estimate the number of statin-eligible adults with the 2013 American College of Cardiology/American Heart Association cholesterol guidelines not taking statin therapy and the impact of recommended statin therapy on 10-year atherosclerotic cardiovascular disease (ASCVD10 ) events. Adults aged 21 to 80 years in an outpatient network with ≥1 clinic visit(s) from January 2011 to June 2014 with data to calculate ASCVD10 were eligible. Moderate-intensity statin therapy was assumed to lower low-density lipoprotein cholesterol by 30% and high-intensity therapy was assumed to reduce low-density lipoprotein cholesterol by 50%. ASCVD events were assumed to decline 22% for each 39 mg/dL decline in low-density lipoprotein cholesterol. Among 411,768 adults, 260,434 (63.2%) were not taking statins and 103,478 (39.7%) were eligible for a statin, including 79,069 (76.4%) patients with hypertension. Estimated ASCVD10 events were 18,781 without and 13,328 with statin therapy, a 29.0% relative and 5.3% absolute risk reduction with a number needed to treat of 19. The 2013 cholesterol guidelines are a relatively efficient approach to reducing ASCVD in untreated, statin-eligible adults who often have concomitant hypertension.