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Real-World Data for Enhancement of a National Smoking Cessation Intervention SmokefreeTXT Erik Augustson, PhD, MPH Director, Smokefree.gov Initiative Tobacco Control Research Branch Behavioral Research Program National Cancer Institute

Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

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Page 1: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

Real-World Data for Enhancement of a National Smoking Cessation Intervention –SmokefreeTXT

Erik Augustson, PhD, MPH Director, Smokefree.gov Initiative Tobacco Control Research Branch Behavioral Research Program National Cancer Institute

Page 2: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

DISCLOSURES

This work was supported by the National Cancer Institute.

No financial relationships to disclose.

Page 3: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

Smokefree

Apps:

SmokefreeMOM

HealthyYouTXT

SMOKEFREE PROGRAM

Page 4: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

BACKGROUND

Text message-based interventions show promise for smoking

cessation

Current evidence on text message-based interventions comes

from RCTs

NCI launched SmokefreeTXT in 2011

42-day intervention, option to start 2 weeks prior to quit date

Two-way messaging for quit status, cravings, mood, and slips

35+ behavior change techniques built into the messages

RCT showed quit rates of ~20%

5

Page 5: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

RESEARCH OBJECTIVE

Assess engagement and self-reported

cessation rates among real-world

smokers who subscribe to the

SmokefreeTXT program

6

Page 6: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

Inclusion Criteria

Opted-in to the SmokefreeTXT

program September 20, 2011, to May

22, 2014

Had the opportunity to complete the

42-day treatment by May 22, 2014

Exclusion Criteria

Failed to set a quit date on or after

enrollment date

Opted out on or before their quit date

18,080 of 25,283 included in study

7

METHODS

Page 7: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

METHODS

Subscribers could opt out of the

program at any time by texting

STOP

Cessation status was self-reported

as a response to a text message

prompt at the following time points:

7 days post-quit

End of the program

1-month post-treatment

3-months post-treatment

6-months post-treatment

Sensitivity Analyses

Logistic Regression

8

Page 8: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

SAMPLE DEMOGRAPHICS

9

Demographics

Mean Age: 34.8 years; Median Age: 32 years

62% Female

88% Daily Smokers

70% had Web-Enabled Phone

Page 9: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

MEASURING CESSATION

Point prevalence abstinence Assessment of cessation status at the

particular point in time when the question is

asked

End of treatment- Primary

7-days post-quit

3-months post-treatment

6-months post-treatment

10

Page 10: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

RESULTS: ABSTINENCE RATES

All Subscribers, Non-

responders & Opt-outs = Smokers

Responders Only

Response Rate

Treatment Completers

Response Rate

7 Days Post-Quit 20.3% 64.4% 31.5% 23.7% 34.8%

End of Treatment 7.2% 75.1% 9.6% 12.9% 17.0%

3 Months Post-Treatment 4.0% 52.0% 7.7% 7.3% 13.4%

6 Months Post-Treatment 2.0% 45.4% 4.4% 3.7% 7.6%

11

SmokefreeTXT Point-Prevalence Abstinence Rates

Page 11: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

MEASURING ENGAGEMENT

Time in Program

Treatment Initiation

Opt out

Program Interactions

Response rates

Page 12: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

GUIDING QUESTIONS FOR ANALYSIS To what extent does SmokefreeTXT engage

users in a quit attempt?

To what extent does SmokefreeTXT keep users

engaged?

How can SmokefreeTXT more effectively

re-engage users who have opted out?

Page 13: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

POTENTIAL FAIL POINTS

Initiating the quit attempt

Establishing an initial period of abstinence

Recovering from a lapse

2 weeks Pre-Treatment

6 Week Treatment

Page 14: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

PURPOSE

15

To describe baseline user characteristics associated with SmokefreeTXT user engagement Age

Gender

Frequency of Smoking

Region

Emphasis on key “fail points” Treatment Initiation

Opt Out

Re-engagement

Page 15: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

METHODS

Retrospective records analysis of

SmokefreeTXT user data between 2011-2014

N=25,283 subscribers

Logistic regression to examine differences in

baseline characteristics on key engagement

metrics

Page 16: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

TREATMENT INITIATION

28.5%

71.5%

0.00

20.00

40.00

60.00

80.00

100.00

Non-initiator Treament Initiator

Treatment Initiation

Page 17: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

USER CHARACTERISTICS OF NON-INITIATORS

Non-daily smokers were more likely to be

non-initiators compared to daily smokers

OR: 1.461; 95%CI: 1.313, 1.625

No other baseline characteristics differed

significantly by treatment initiation status

Page 18: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

FAIL POINT

19

1 Week Treatment

0

1045

615

630

533

440 389 406

197 182

522

275 227

194 196

92

489

124 71 83 76

247

52 75

155 103

38 75

138

35 58

28 72

35 35 65

33

164

27

60

54

0

200

400

600

800

1000

1200

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

0 7 14 21 28 35 42

Nu

mb

er o

f Su

bsc

rib

ers

Wh

o O

pt

Ou

t

Per

cen

t o

f To

tal S

ub

scri

ber

s R

emai

nin

g

Days of Treatment Percent of Total Subscribers Remaining in Treatment

Quit Date End of Treatment

Number of Subscribers Who Opt Out

2 Weeks Pre-

Treatment Weeks 2-6 Treatment

Page 19: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

USER CHARACTERISTICS OF TREATMENT ENGAGEMENT

Odds of opting out

Males

OR: 0.866, 95% CI: 0.807, 0.928

Older

OR: 0.987, 95% CI: 0.984, 0.990

Non-daily smokers

OR: 0.866, 95% CI: 0.763, 0,984

Page 20: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

IN-DEPTH INTERVIEWS

From March 14, 2014, to April 4, 2014, the

research team conducted IDIs with users of

SmokefreeTXT

9 male, 9 female

Qualitative data

Usability & acceptability

User interactions with the program, feasibility

Page 21: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

OPPORTUNITIES: RESULTS

In-depth interviews with program users suggest that

opting-out was associated with relapse to smoking

Page 22: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

CONCLUSIONS

23

Analysis of user data provides insight to guide

further research and intervention refinement

Many subscribers opt out before program end

Some subscribers do not respond

SmokefreeTXT supports short-term cessation

in a real-world implementation

CONSIDERATIONS

Low response rates for long-term follow up

Does no response/opt-out mean relapse?

Page 23: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

CONCLUSIONS CONTINUED

24

Sub-optimal engagement is a challenge for

mHealth interventions

“Fail points” are opportunities for improvement

Real world process data is needed to guide the

design and implementation of mHealth

interventions

Page 24: Real-World Data for Enhancement of a National Smoking ......End of the program 1-month post-treatment 3-months post-treatment ... Time in Program Treatment Initiation Opt out Program

25

Thank you!

Smokefree.gov/SmokefreeTXT

[email protected]