NRT in Combination with Quitline Counseling: What Delivery and Protocol Design Methods are Working Best?

Establishing Best Practices for Quitline Operations: Back to Basics... a conference callseries dedicated to the exchange and dissemination ofquitline research and innovations in practice NRT in Combination with Quitline Counseling: What Delivery and Protocol Design Methods are Working Best? Introduction The delivery of pharmacotherapy in combination with quitline services was the topic of our very first conference call in October of 2004. At that time, only 9 state quitlines offered free NRT and 5 provided low-cost NRT. According to preliminary 2006 NAQC annual survey data, there are now 21 states offering free NRT to quitline callers; 5 that offer discounted NRT, 9 that use a voucher or coupon system, and 17 that provide referral for free or discounted NRT. In Canada, none of the quitlines offer free NRT, but 3 offer referral for free or discounted NRT and all provide information on NRT. The interest in NRT within the quitline community continues to grow. While the title of the call may connote that we know for certain which NRT delivery and design protocols are working best, the truth is that we do not. The ultimate truth is, we are still working at how best to decrease access barriers to NRT via quitlines; we are still learning from one another; and thankfully, we continue to measure our results. New York State Smokers Quitline Paula Celestino and Sara Abrams, MPH INTRODUCTION The primary strategy of the New York State Smokers Quitline is to maximize the state s resources to reach a larger population using evidence based strategies that achieve broader impact. This strategy is the basis for the following services provided by the quitline: Quit coaching in English or Spanish (other languages available through translators). Specialists serviced 89,688 incoming clients in FY 05-06. Starter kit (2-week supply) of Nicotine Replacement Therapy (NRT) for eligible smokers.44,405 clients received NRT starter kit in FY 05-06 One scheduled callback to smokers who get a free starter kit of NRT Up to four scheduled coaching calls for eligible Medicaid and uninsured smokers.18,800 clients with Medicaid or uninsured enrolled in Enhanced Proactive in FY 05-06

Up to a 6-week supply of NRT for eligible Medicaid, Family Health Plus or uninsured smokers Online support @ www.nysmokefree.com THE NRT PROGRAM The types of NRT available through the NYS Quitline include patches, gum or the lozenge and in fact, nearly 92% of the NRT distributed are patches. There are eligibility criteria which include that a person must be NYS resident, at least 18, *no medical contraindications, not pregnant or breastfeeding, report a commitment to quit and agree to a call back. Since first offering NRT in December 2004, 99,445 clients have received NRT. Unlike some quitlines that offer NRT, NYS Quitline also functions as a fulfillment site the medication is sent directly from the quitline to the client. In July 2006, an online request and fulfillment process became available to those residents who did not want help via the phone. The purpose of the online process was also to service more clients during high call volume periods and, in line with their overarching strategy, to extend reach. In the short time that this online fulfillment process has been operational, the quitline has improved reach to younger & male clients: 42.8% < age 35 online vs. 33.6% for callers* 45.1% males online vs. 43.5% for callers* In a two-week follow up survey of online NRT clients, the quitline found that: 53% of those who received NRT thru the web report stopping smoking (compared to 56% of those who completed the Intake IV over the phone) 91% report being very satisfied with the QL service (vs. 93% of callers) 91% would seek help again from the QL (vs. 93% of callers) 92% would recommend the QL to a friend (vs. 93% of callers) NYS QUITLINE AND NRT: LESSONS LEARNED FROM 2002 PRESENT The NYS Quitline has been instrumental in the development and implementation of various NRT give-aways both at the state and local level. Some programs were designed to provide only one week of free NRT and other programs provided 8 weeks of therapy all with very little paid media and some with nothing more than a press release. In a quasi-experimental design, trying to determine how much free NRT smokers should be given through a quitline, the NYS Quitline looked at 7- day non-smoker prevalence rates for those receiving 2 weeks, 4 weeks, 6 weeks and 8 weeks. Below is a highlight of what they learned essentially that the amount of free patches sent to a client was related to their use of

the patches; the purchase of additional medication was inversely related to the number of patches sent to clients; there was no significant difference in quit rates by amount of free nicotine patches sent to clients; and satisfaction with the Quitline service was not related to number of patches sent. 50.0% 7-Day Non-smoker Prevalence Rate By Number of Free Nicotine Patches 40.0% 37.0% 33.3% 37.0% 34.8% 30.0% 27.2% 20.0% 10.0% 0.0% 2-weeks 4-weeks 6-weeks Contingent 6-weeks 8-weeks * Quitters defined as participants who reported smoking not at all and reported no cigarettes smoked in the 7 days prior to their follow-up interview. Presentation by Paula Celestino and Sara Abrams, NYS Smokers Quitline, March 2006. THINGS TO CONSIDER BEFORE MOVING FORWARD WITH NRT Call Volume: be prepared for incredible increases to your call volume and make sure you have infrastructure to support this increase. Amount: be intentional about how much you are providing clients and why you settled on this amount. Eligibility Criteria: determine clear criteria which match up with the strategies and philosophy of your quitline. NRT product and dosing: which NRTs will you offer and what are the limitations that will be placed on the dosing? Safety nets for distribution: how will you ensure that people don t abuse the system? Tracking outcomes and utilization Staff training Onsite or Offsite fulfillment or Voucher-Coupon: which system will you use? Ensure that there are quality-improvement processes in place especially if you are depending on someone else to do the actual distribution/shipping to the client.

NRT Effects on Quitline Activity: Ohio and Colorado David Tinkelman, MD and Steve Wilson, MA, National Jewish Medical and Research Center INTRODUCTION The NRT program delivered by National Jewish Medical and Research Center (NJMRC) for Ohio and Colorado is used to increase cessation rates; to increase call volume; and to be cost effective. Participants must be: Enrolled in counseling 18 years or older Medically eligible Participants who meet these criteria receive 8 weeks of free nicotine patches 4 weeks at the time of enrollment and an additional 4 weeks if they remain in the counseling program. THE IMPACT ON CALL VOLUME These data come from aggregated datasets from Ohio and Colorado. The graph below shows the intake volumes before and after the launch of the NRT program for Colorado nearly a 1,000% increase from 2005 to 2006. 7000 6000 5950 Colorado QuitLine Intake Call Volume 2003-2006 6629 5000 Intake Volume 4000 3000 3699 3399 3166 3074 3478 3501 3215 2003 2004 2005 2006 2000 1000 321 356 251 635 749 951 824 0 Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Months After launching their NRT program, Ohio was averaging 3,606 intake calls per month, or 118 intakes per day. This represented a 23% increase when compared to the 96 intakes per day for the same period one year earlier. THE IMPACT ON CESSATION RATES Outcomes for both Ohio and Colorado NRT programs were measured at 3, 6, and 12 months by an independent research agency. The rates reported are both responder rates, as well as intention to treat (ITT) rates ITT rates being the most conservative calculation.

OHIO COACHING PARTICIPANTS RECEIVING MEDICATIONS 3 Months 9,089 5,320 2,456 46.2% 27.0% 6 Months 8,222 4,851 1,877 38.7% 22.8% 12 Months 2,137 1,391 495 35.6% 23.2% COACHING PARTICIPANTS NOT RECEIVING MEDICATIONS # Attempted # Reached # Quit Responder QR ITT QR 3 Months 6,874 3,179 661 20.8% 9.6% 6 Months 4,994 2,496 558 22.4% 11.2% 12 Months 885 530 132 24.9% 14.9% Colorado QuitLine FOLLOW-UP QUIT RATES Post-NRT (December 15, 2005 January 31, 2007) Call Number Number Attempted Number Reached Number Quit Responder Quit Rate ITT Rate COACHING PARTICIPANTS RECEIVING NRT 3 Months 13,090 6,500 2,599 40.0% 19.9% 6 Months 8,050 3,533 1,262 35.7% 15.7% 12 Months 782 346 118 34.1% 15.1% COACHING PARTICIPANTS NOT RECEIVING NRT 3 Months 960 399 106 26.6% 11.0% 6 Months 592 227 63 27.8% 10.6% 12 Months 53 14 4 28.6% 7.6% It is evident from both states results, that a combination of counseling and NRT has been documented to provide excellent quit rates at 6 months that have been sustained at 12 months.

THE IMPACT ON COST As stated in the introduction, the goal of the NJMRC NRT program goes beyond simply increasing call volume and outcomes they also want to ensure that adding NRT to a quitline proves cost effective. After careful analysis (shown in chart below), NJMRC does believes that the programmatic costs of adding NRT to a quitline program is outweighed by the increase in cessation rates. Cost Per Quit Considering NRT and Marketing Total Program NRT Group Non-NRT Group Self-Guided Group Marketing % 100% 49.8% of total 29.0% of total 21.2% of total Marketing Cost $5,478,015 $2,728,051 $1,588,624 $1,161,340 Operations % 100% 56.5% of total 32.9% of total 10.6% of total Operations Cost $2,471,300 $1,396,285 $813,058 $261,957 NRT Cost $1,214,833 $1,214,833 0 0 Total Cost $9,164,148 $5,339,169 $2,401,682 $1,423,297 Number Involved 46,962 intakes 23,387 intakes 13,618 intakes 9,957 intakes Quit Rate x 0.314 (quit rate) x 0.387 (quit rate) X 0.224 (quit rate) X.184 (quit rate) Number of Quitters 14,746 9,051 3,050 1,832 Cost Per Quit $621 $590 $787 $777 Questions, Ideas & Concerns Noted from the Conference Call In Wisconsin, a lot of folks have insurance and yet, their insurance doesn t cover over-the-counter medications. I m wondering if in NY you would classify these types of folks as uninsured even though they do have insurance? In order to get the 6 weeks of free NRT, a person must be either Medicaidinsured or uninsured. If they do have insurance, we encourage them to save their money, as they will still get the free 2-week supply and likely want to continue using the NRT on their own. Can callers to the NY Smokers Quitline get NRT without coaching? Essentially, the answer is yes. At a minimum, they have to answer a few questions related to quitting when the go through the online fulfillment process. When a person calls, we do provide support.

What protocols do you have in place to determine who is 'medically eligible' to receive patches? What medical conditions or medications would make your callers ineligible to receive the patch from you? National Jewish = As an academic medical center, we are very conservative in terms of our protocols. Essentially, we follow the insert guidelines, which for us translates into requiring permission from a primary care physician for pregnant women, for example. NY Smokers Quitline = We follow the package insert as well. How do you track if a callers is taking any other medications? At NY Smokers Quitline, we ask if a person is using other meds. We have seen a significant uptake of chantax ultimately, it is self-report. At National Jewish, our approach is the same. Two things about differences: quasi experimental comparing mediaciad and insured is t good; we have not yet published RCT in OR a nested 2 to 8 weeks and did find difference 25-35% relative quit rates from public health jury still out When you (NY Smokers Quitline) looked at increased enrollment related to the local programs NRT give-aways, did you look at absolute number or is it based on relative difference/impact in overall population? Yes. We looked at overall increases in enrollment an absolute number. On slides 14,15,16 of the National Jewish presentation, there seems to be a dramatic fall-off in the number of people who you attempted to reach for follow up? Why was there a decrease is sample size? Did criteria change? Due to budget, we needed to cut our sample size. There really is a lot of question about what is best - 2,4,6,8 weeks. National Jewish has data to look at this and is looking at NRT as a therapy not just giving it, but looking at levels of addiction compared to the course of therapy. The protocols out there may not reflect the actual NEED of the caller. In order to get a better idea of the true value of NRT perhaps we need to individualize the amount of NRT, rather than provide a standard protocol or standard course of therapy for every caller. NY mentioned that 92% of callers get the patch. Did this percentage change after you started offering three NRTs? No this percentage has not changed. I m wondering how different states verify insurance status of callers? In NY, we rely on self-report. We are starting to work on a project in which we would partner with health plans and provide information to their clients and in some cases, even warm-transfer to their services. For Ohio, we actually did take client ID numbers so that we could link with the insurers, but in Colorado we rely on self-report.

Just a word of advice based on our experience in Colorado. Be proactive. We invite National Jewish to speak to policy makers and present data to our Board of Health quarterly. These presentations go a long way. I d just like to add that really it boils down to what the philosophy of your quitline is. If your goal is to reach large numbers of people then offering free NRT with limited counseling meets your goal. If the goal is to produce a high percentage of quits with a smaller number of people, then free NRT with more coaching is the answer. There are fundamental differences among quitlines and you have to determine the philosophy and goals of yours before moving forward with NRT. I know what we are talking about here is relative efficacy but there is also the question on how offering free NRT through quitlines may serve as a disincentive for healthplans and employers to covering cessation. Any comment? Actually, Ohio has had tremendous success garnering support from health plans. They have partnered with 60 groups and 8 plans. Joyce Swetlick would be a great contact for further information on this work. Joyce can be reached at JSwetlick@otpf.org. I know that there has been a proven cost-benefit, but my sense is that health plans don t feel that their members will be with them long enough to really see this long-term benefit. If you re talking about commercial and managed Medicaid plans, their turnover rate has really steadied over the years to about 18-25%. Plus, we have been able to document a lot of early, immediate cost benefits for instance, secondhand smoke reduction/elimination and kids. Another word of advice - be clear about the intentions of the program before rolling out! There is a sticker shock when key stakeholders learn the cost of offering free NRT. I was wondering about the comments about 25% of people having side effects in NY and that most of them simply stopped the medication. Has NY or anybody else tried to medically manage those people so that they don't stop the medications if they don't have to? For example, helping them deal with the side effects or changing the dose or type of NRT? Yes to the extent that we can through information and support we only know what they tell us though. Have quitlines developed detailed protocols to deal with callers who develop side effects? To a certain degree. We make suggestions to clients and really our information or protocol comes right off of the pharmaceutical website. The information on side effects is right there.