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Study Design & Methods

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Overview of Ferguson, et al. “Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline : randomised controlled trial” BMJ 2012;344:e1696 ( Published 23 March 2012). Study Design & Methods. - PowerPoint PPT Presentation
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Overview of Ferguson, et al. “Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial” BMJ 2012;344:e1696 (Published 23 March 2012)
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Page 1: Study Design & Methods

Overview of Ferguson, et al. “Effect of offering different levels of

support and free nicotine replacement therapy via an English national telephone quitline: randomised

controlled trial”

BMJ 2012;344:e1696 (Published 23 March 2012)

Page 2: Study Design & Methods

Study Design & Methods• Setting: National quitline, England• Participants: 2591 non-pregnant adult (16+)

smokers, called quitline and agreed to set a quit date

• Randomization: participants assigned to • standard support (no NRT) (n=648)• proactive support (no NRT) (n=648)• standard support (NRT) (n=648)• proactive support (no NRT) (n=649)

Page 3: Study Design & Methods

Intervention – Level of Support

Standard Support• Initial enrollment call• Messages sent before, on,

and after quit date (1, 3, and 6 mo) by email, letter, or text (opt-out)

• 4 Proactive telephone support calls offered. If accepted, contacted -1wk, on quit date, +2d, +3wk. Calls were brief and unstructured

Proactive Support• Initial enrollment call• Messages sent before, on,

and after quit date (1, 3, and 6 mo) by email, letter, or text (opt-out)

• 6-7 Proactive telephone support calls (no opt-out) at (-2wk), -1wk, quit date, +3d, +7d, +14d, +21d. Calls were highly structured, tailored to quit process

Page 4: Study Design & Methods

Intervention – Nicotine Replacement Therapy

No NRT• Info re: obtaining

support including NRT from NHS sources

NRT• 21 days of patches

(15mg)• Participants had to call

the NHS pharmacy (toll-free number) to have NRT mailed

• 2nd 21-day supply available in same way

Page 5: Study Design & Methods

Results

• Response rates and baseline characteristics similar across conditions

Page 6: Study Design & Methods

Results – Cessation Outcomes (standard vs. proactive)

Page 7: Study Design & Methods

Results – Cessation Outcomes (no NRT vs. NRT)

Page 8: Study Design & Methods

Successful Telephone Contacts

Reported use of support Standard Support (n=1295)

Proactive Support (n=1296)

No. participants receiving outbound calls

1053 1081

Mean (SD) No. of calls participants received

2.44 (1.38) 3.35 (1.97)

Median (interquartile range) no. of calls participants received

2 (1-3) 3 (1-5)

Page 9: Study Design & Methods

Use of NRT

Reported use of support No NRT (n=1296) NRT (n=1295)

Received any study NRT -- 555 (42.9%)

Non-trial support

NRT w/out prescription 222 (17.1%) 276 (21.3%)

NRT from health prof. 254 (19.6%) 225 (17.4%)

Bupropion 17 (1.3%) 20 (1.5%)

Varenicline 101 (7.8%) 64 (4.9%)

Page 10: Study Design & Methods

Discussion• In England, cessation medications are freely

available through the NHS, and standard care includes information about how to access them.

• Similar numbers of completed calls between groups

• Similarity between services received “probably explains the similarity in outcomes achieved.” (p. 5)

Page 11: Study Design & Methods

Conclusion and Policy Implications

“In England, where support for smoking cessation is available to all smokers either

free or at relatively low cost, adding additional proactive telephone counseling or an offer of free nicotine replacement therapy to usual

quitline care did not affect smoking cessation rates. On the basis of this study, providing

these through a quitline is not recommended.” (p. 5)

Page 12: Study Design & Methods

NAQC’s Position• NAQC agrees with the findings as stated by Ferguson et al.

for the national quitline in England within the context of the National Health Service.

• NAQC notes that the availability of NRT in England differs significantly from the availability of NRT in the U.S. and Canadian context. NRT is not freely available in the U.S. and Canada, thus making it difficult to generalize the study findings to a North American context.

• NAQC notes that the current state of the evidence suggests that providing NRT through quitlines in the U.S. does help more smokers quit. (McAfee et al. 2008; An et al. 2006; Schillo 2012 forthcoming)

Page 13: Study Design & Methods

NAQC’s Position (cont.)• Given the state of the evidence and that the context within

which quitlines operate is significantly different for U.S. and Canadian quitlines as compared to those in England, NAQC recommends that U.S. and Canadian quitlines should continue to provide NRT through quitlines, or consider providing it through quitlines.

• NAQC suggests that more research is needed around what elements of counseling make it more effective; what timing, dose and distribution mechanisms make it more effective; and for what populations. More research is also needed around the psychology of NRT use. (see http://www.naquitline.org/?page=RS for NAQC’s Research Agenda for Quitlines)

Page 14: Study Design & Methods

ReferencesMcAfee, T. A., Bush, T., et al. (2008). Nicotine patches and

uninsured quitline callers. A randomized trial of two versus eight weeks. Am J Prev Med; 35(2): 103-110.

An, L. C., Schillo, B. A., et al. (2006). Increased reach and effectiveness of a statewide tobacco quitline after the addition of access to free nicotine replacement therapy. Tob Control; 15(4): 286-293.

NAQC. Quitline Service Offering Models: A Review of the Evidence and Recommendations for Practice in Times of Limited Resources. Quality Improvement Initiative (B. Schillo, PhD). Oakland, CA. Forthcoming 2012.


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