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The article by Warren et al in this issue of Cancer is timely,[1] because the US government has recently put into place a specific mandate for hospitals and health professionals to electronically screen for tobacco use. This mandate is spelled out in what are referred to as “meaningful use” regulations requiring that certain information be entered into each patient's electronic health record (EHR) and be available to patients and their providers.[2]

In this editorial, we provide a model for meeting the mandate that includes implementation of a comprehensive smoking (tobacco) cessation program for cancer patients and the supporting evidence base for doing so as an alternative to the minimal intervention approach discussed by Warren et al. We also discuss the importance of an institution-wide, automated system to identify and refer tobacco users to treatment within the context of implementing the meaningful use regulations for EHR as required by the Health Information Technology for Economic and Clinical Health (HITECH) Act.

Here, we briefly describe the effect of the meaningful use regulations for EHR on tobacco screening, the importance of automatic referrals for cessation assistance, and the continuing importance of provider referral and involvement. We then briefly discuss the Roswell Park Cancer Institute cessation program and the use of a public health model of care, which emphasizes providing minimal levels of intervention, and compare it with a more comprehensive model of cessation that provides a level of care tailored to the individual needs of cancer patients. Within this context, we discuss evidence supporting the use of a comprehensive treatment strategy for cancer patients that includes pharmacotherapy. To illustrate our points, we describe the comprehensive cessation program used at The University of Texas MD Anderson Cancer Center.

Meaningful Use and Electronic Health Records

The information targeted in the meaningful use regulations for EHR documentation includes a range of important parameters: patient demographics (sex, race, ethnicity, date of birth, preferred language), vital signs and chart changes, current and active diagnoses, medication list, medication allergy list, and smoking status.[2] Other core objectives of the regulations involve providing patients and their primary care providers with information from the EHR, electronic ordering of prescriptions, evaluating drug interactions, tracking institutional compliance and quality improvement, and protecting the privacy and security of the EHR. These regulations provide initial financial incentives for hospitals, clinics, and eligible providers who are early adopters and future penalties for those who do not comply. The goals of incentivizing EHR documentation are broad. They include improving quality, safety, and efficiency; reducing health disparities; engaging patients and their families; and improving overall care coordination. They aim to motivate hospitals or cancer centers that rely on Medicare or Medicaid reimbursements to screen for tobacco use and eventually provide referral to treatment. Consequently, cancer centers will likely screen patients for tobacco use and record the information in the patient's EHR; the more important issue, however, is how cancer centers can best use that information to refer patients to treatment and improve their overall care.

Importance of Automated Electronic Referral

We agree with Warren et al that automated electronic referral (AER) of patients who smoke, based on their EHR, to a tobacco treatment program dramatically extends the opportunity to offer cessation assistance to patients who smoke. Since its inception in 1996, the Smoking Cessation Guideline[3] has called for system-wide procedures to identify and treat all smokers in a health care setting. At MD Anderson, we began this process in 2010; more recently, we modified our procedures to comply with meaningful use guidelines. These assessments serve the dual purpose of ensuring regulatory compliance and providing the information necessary to determine eligibility for a tobacco treatment program. It is important for all hospitals, clinics, and health care professionals to recognize that developing procedures to comply with meaningful use criteria provides the perfect opportunity to make system-wide changes for identifying and treating every tobacco user.

Hospital-based tobacco treatment programs typically have relied on provider referrals. The change in patient volume as the result of a switch from a provider-based system to an automated referral system is dramatic. When we relied only on provider referrals, our volume of new patients at the MD Anderson Tobacco Treatment Program (TTP) averaged approximately 240 referrals per month. However, after the implementation of AER (automatic referral without provider initiation), we experienced an increase greater than 250% in referrals and an increase greater than 60% in new, in-person TTP enrollments. This occurred at a time during which the hospital experienced an overall increase in patient enrollment of 5%. All eligible referrals receive some level of service; some patients receive traditional in-person service (approximately 15%); some receive a combination of phone only support plus written materials (approximately 65%); and, as at the Roswell Park Cancer Institute, some receive only mailings (approximately 20%).

Importance of Provider Referrals and Involvement

It is important to note that, although AER can be used to increase the volume of referrals, it should not replace referral by providers but, rather, should supplement it. The importance of providers advising their patients to quit smoking has long been recognized.[3, 4] We have observed that patients who are referred directly to smoking cessation treatment by their health care provider are more likely to attend a scheduled in-person visit than those who are proactively identified through the AER. At the TTP, to sustain and encourage providers' involvement in their patients' tobacco use, we also use EHR to update providers on whether their patients enrolled in TTP and, if so, their progress.

The Roswell Park Cancer Institute Program

The Roswell Park Cancer Institute tobacco cessation program appears to function like a quitline, providing telephone-based behavioral counseling for smoking cessation to cancer patients who agree to participate. Nicotine replacement therapies (NRTs) are discussed but not provided, and Warren et al report that other forms of pharmacotherapy (varenicline or bupropion) are not discussed unless the patient requests them. The median call length reported is 8 minutes, but no information is provided on the number of calls per patient or the duration of support to individual patients. In addition, quit rates are not provided.

Minimal Intervention Versus Comprehensive Care

Warren et al state that the clinical implications of their results are important and indicate that, according to behavioral economics, a smaller effect in a larger population may produce a dramatically better outcome than a larger effect in a much smaller population.[1] This has been the general argument in the public health environment for providing minimal levels of care. Although we agree that a certain proportion of smokers will respond to minimal treatment, we disagree with the implication by Warren et al that this level of care is appropriate for all smokers, and particularly for cancer patients, many of whom are highly nicotine-dependent and present with complex medical and psychiatric comorbid conditions. Approximately 40% of our TTP patients present with at least 1 psychiatric comorbid condition, and approximately 30% of those patients have 2 or more such conditions.[4] These patients would not be well served by the minimalist approach. In particular, the absence of systematic provision of pharmacotherapy other than NRT is a distinct disadvantage, because medications and combination treatments provide a significant increment in cessation success over minimal counseling approaches alone.[5] We do acknowledge, however, that certain programs, such as that described by Warren et al, operate with limited resources. Nevertheless, in our view, it is imperative that institutions make an investment in a comprehensive program without the prospect of having it pay for itself, because it is a value-added service for seeking care at that institution and can have important downstream effects on medical outcomes, eg decreasing the side effects of radiation.[6, 7]

Why Cancer Patients May Need More Support

Although no compelling randomized trials on the effectiveness of different levels of cessation support for cancer patients have been reported, relevant data are available for consideration. Cancer patients face greater risks from smoking than the general population, and some of these risks are more immediate. Cancer patients who continue to smoke are at risk for reduced treatment effectiveness, increased treatment complications, greater likelihood of cancer recurrence or development of a second primary cancer, and decreased duration of survival, both disease-specific and overall.[6-8] A large proportion of cancer patients quit smoking at the time of diagnosis but experience relapse at various points after treatment.[9]

Although there are no trials that have evaluated the impact of treatment intensity in cancer patients specifically, we are aware of a review that has evaluated this question in hospitalized smokers. Rigotti et al indicated that counseling interventions for smoking cessation among hospitalized patients that provide support for less than 1 month after discharge do not increase cessation rates, whereas those that provide support for longer than 1 month after discharge are more effective and do increase cessation rates.[5] This finding is consistent with the literature on neurobiology of addiction, as long-term cigarette smoking modifies the neuronal pathways in the brain, including the reward pathway, which makes it difficult to stop smoking and to remain abstinent after stopping.[10] Nicotine use (like all drugs of dependence) produces long-term neuroadaptations in the brain, increasing the reward value of smoking while decreasing behavioral inhibition. A high level of nicotine dependence can be expected in cancer patients who continue to smoke after diagnosis. In the TTP, on average, they have been smoking for > 30 years, and they continue to smoke about 1 pack of cigarettes per day despite their cancer diagnoses.[4]

Importance of Pharmacotherapy

Pharmacotherapies have a large impact on smoking cessation. In individuals who receive a combination of pharmacotherapy and even minimal counseling, the chances of successfully quitting are 70%–100% higher compared to receiving brief support alone.[1] Nicotine replacement was the first treatment for nicotine dependence.[3] Several forms of NRT are currently available in the United States, including patch, gum, lozenge, inhaler, and nasal spray and on average result in a relative risk of cessation of about 1.6 (95% confidence interval 1.53-1.68) at 6-months post-quit.[11] In current practice, NRT is started before a patient's quit date to provide a supplement of nicotine to the brain that reduces the need for nicotine from tobacco. Once the individual quits tobacco, it is believed that NRT ameliorates the withdrawal from nicotine.[12] For some cancer patients, however, some NRTs may not be indicated; for example, those who develop sores in the oral mucosa during chemotherapy would not tolerate oral NRT (inhaler, gum, or lozenge). For patients who are facing reconstructive surgery, the presence of nicotine may delay wound healing and jeopardize the success of surgical procedures by impairing flap adhesion.[13]

Bupropion-SR was approved in the early 1990s for smoking cessation at 150 mg once or twice daily and on average results in a relative risk of cessation of about 1.81 (95% confidence interval 1.51-2.16 Risk Ratio [RR] 1.69; 95% confidence interval [CI] 1.53-1.85).[14] It is believed that bupropion works as a direct antagonist on nicotine receptors as well as through inhibiting dopamine and norepinephrine reuptake. It has advantages for the cancer patient, because it is an antidepressant with stimulant qualities, which are useful features for patients who are depressed or feeling “worn down” from chemotherapy or radiation. Bupropion also has some appetite-suppressing effect, a useful quality for patients who are wary of gaining weight after quitting smoking but would not be indicated for patients at risk for weight loss.[15]

The latest and most effective treatment for smoking is varenicline a partial agonist of the nicotine receptor.[16] This agent simulates nicotine's effect on the brain, while a patient is still smoking, albeit to a lesser degree than smoking, thereby reducing the need for cigarettes. It has a long half-life and strong affinity for nicotine receptors which prevents nicotine from tobacco from displacing it, resulting in lower satisfaction from smoking and a net decrease in the number of cigarettes smoked. For patients who receive varenicline at the full dose of 1 mg twice daily, the average relative risk of cessation is about 2.27 (95% confidence interval 2.02-2.55) at 6-months post-quit.[17] Some precautions need to be taken with using varenicline in cancer patients who may be depressed or at high risk for neuropsychiatric events (ie, prior history of depression or other psychiatric disorders). There have been reports of increased risk for exacerbating or de novo neuropsychiatric symptoms[18]; however, our group has reported that varenicline is protective against symptoms of depression and negative affect in volunteers who are not depressed while they quit smoking.[19]

Cost-Effectiveness

Smoking cessation programs that prescribe varenicline generally have been cost-effective.[20-23] Linden et al observed that, although treatment with varenicline initially costs more than treatment with bupropion or unaided cessation, varenicline was both more effective and more cost-effective than these alternatives.[21] The cost-effectiveness calculation for hospitalized cancer patients is more favorable than that for nonhospitalized patients. In 2009, the average cost of hospitalization for cancer patients in the United States varied as a function of cancer site from $2200 per day (for patients with colon, pancreas, and lung cancer) to $4600 per day (for patients with prostate cancer).[23] If a smoking cessation program is able to reduce a subsequent hospitalization by only 1 or 2 days, then the cost of a comprehensive cessation program, including pharmacotherapy, is recovered. To our knowledge, however, no research has been published on the cost-effectiveness of smoking cessation among cancer patients. Research is needed to inform this area.

An Example of Comprehensive Cessation Support

Since 2006, the MD Anderson TTP has provided, free of charge, a program of comprehensive, individually tailored cessation support to cancer patients who currently smoke or have recently quit. The program includes behavioral counseling for smoking cessation, psychological and psychiatric support for conditions that can derail a cessation attempt, and aggressively managed cessation pharmacotherapy, including NRT, varenicline, and bupropion. Although each patient's treatment is individually tailored, the program is designed to provide 10 to 12 weeks of support. To receive free medications, the patient must have an in-person medical evaluation and an initial meeting with a counseling clinician. Subsequent sessions may be in person, by telephone, or over the Internet using a webcam. Approximately 80% of subsequent sessions are conducted by telephone. The average intent-to-treat cessation rates for patients who were enrolled and treated in this program between 2006 and 2012 were approximately 45% at 3 months after treatment initiation and approximately 35% at 9 months.[4]

In May 2013, we expanded our services to include a telephone-only option, in which we provide telephone counseling and support to patients who are either unable to come to the medical center for treatment or ambivalent about quitting. This service is specific to those who, for various reasons, elect not to have a face-to-face appointment. We know that patients vary greatly in their readiness to engage in a quit attempt. We aim to meet them where they are and provide clinically significant interventions that will encourage smoking cessation. We believe the focus should be on how to provide the best care we can to these patients rather than providing the least costly intervention.

Conclusion

In summary, we agree with Warren et al about the importance of using an AER system to identify all tobacco users and to provide automatic referral to treatment. We disagree, however, that a minimal intervention approach is sufficient to meet the needs of cancer patients and suggest instead that a more flexible and comprehensive approach be adopted. That is not to say that a minimal intervention would not be appropriate for some patients. Indeed, in a comprehensive program, the level of intervention would be tailored to the patient's needs; and, in some cases, a less intensive, minimal intervention may be all that is needed. But that alone would be inadequate for many patients, particularly those with more complex comorbidities, such as psychiatric disorders. Furthermore, according to the Smoking Cessation Guideline all patients should be offered pharmacotherapy. We believe that pharmacotherapy should be systematic and should include the full range of medications and medication combinations that have been empirically demonstrated to be effective.[12, 24]

FUNDING SUPPORT

  1. Top of page
  2. FUNDING SUPPORT
  3. CONFLICT OF INTEREST DISCLOSURES
  4. REFERENCES

The authors are supported in part by the NCI, P30 CA16672 Cancer Center Support Grant to MD Anderson. The Tobacco Treatment Program is supported by State of Texas Tobacco Settlement Funds.

CONFLICT OF INTEREST DISCLOSURES

  1. Top of page
  2. FUNDING SUPPORT
  3. CONFLICT OF INTEREST DISCLOSURES
  4. REFERENCES

Paul M. Cinciripini is a site principal investigator and Maher Karam-Hage is a co-investigator on a clinical trial sponsored by Pfizer. They have also received grants and nonfinancial support from Pfizer, including medication for an NIH-funded trial.

REFERENCES

  1. Top of page
  2. FUNDING SUPPORT
  3. CONFLICT OF INTEREST DISCLOSURES
  4. REFERENCES
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