Overview Tobacco Use & Multiple Risk Factors: Opportunities & for Concurrent Behavior Change Relation between mental health, physical health, and health behaviors Relation between tobacco and other health risk factors Rationale for multiple risk factor (MRF) interventions Benefits and challenges of MRF interventions Step Up Trial rationale, design, & preliminary findings Discussion May 2010 Jennifer McClure, PhD Group Health Research Institute Inter-relationship of MRF s Smoking & Concurrent Risk Behaviors Addiction Depression Psychosis Anxiety Etc. CAD/CVD Cancer COPD Obesity Etc. Smokers have multiple behavioral risk factors 92% have at least 1 additional risk factor (Fine et al., 2004) Tobacco/drug/ETOH use Physical Activity Diet Risky Sex Treatment adherence Etc. Smoking & Concurrent Risk Behaviors Smoking & Concurrent Risk Behaviors Smokers are less physically active Smokers report less leisure time physical activity (French, Henrikus, & Jeffrey, 1996 55-69% have sedentary lifestyle (Rosal et al., 2001; Mukamal et al., 2006) Smokers have worse dietary patterns 75% have high fat diet (Rosal et al., 2001) Less likely to eat recommended levels of fruit & vegetables (McClure et al., 2009) Smokers are more likely to use alcohol & other substances Smoking is gateway drug to other substance use 12% report high risk drinking (Rosal et al., 2001) ~20% of smokers report recent binge drinking (5 + drinks/one occasion) vs. 6.5% of nonsmokers (Dawson, 2000) 1
MENU Trial Results: F&V Intake Compliance with daily F&C recs* M = 1.46 M = 1.99 M = 2.23 M = 2.55 M = 3.69 M = 4.52 % Meeting Minimum Daily Rec M = 23.8% M = 36.6% N= 2,513 *Recommendation of 5 or more a day Tobacco & Other Risk Behaviors Tobacco & Depression p<.001 Depression is more prevalent among smokers p<.001 p<.001 (former); p<. 01 (never) Lifetime depression history ranges from 5%-12% for males and 12%-20% for females 35%- 60% of smokers in clinical trials report depression history p<.01 (former); p<. 001 (never) Smokers are more likely to be depressed ~20%-22% of adults smoke 43% of adults with depression are smokers Smoking prevalence increases as depression intensity increases McClure et al., 2008 Tobacco Use & Other Mental Health Dx Smoking rates are higher among people with mental illness (Lasser et al., 2000) 22.5% no mental illness 34.8% among lifetime mental illness 41.0% among past-month mental illness 70% - 88% of persons with psychosis smoke (Baker et al., 2006) As many as 90% of schizophrenics smoke (Glassman, 1993) Tobacco Use & Other Mental Health Dx WHY is there an association between nicotine addiction and other psychiatric conditions? Nicotine is used to self-medicate, so may be used more among psychiatrically vulnerable Tobacco use often precedes, and may cause, some mental illness Shared genetic predisposition? Strong correlation between anxiety disorders and smoking 2
So What? Disease risk increases with each health additional unhealthy behavior So what? Life expectancy declines with increasing number of risk behaviors. # of unhealthy behaviors* All Cause Mortality Deaths, HR (95%CI) CVD 0 1 1 1 Cancer 1 1.85 (1.28-2.28) 2.02 (1.08 3.77) 1.65 (0.89-3.06) 2 2.23 (1.55 3.20) 2.48 (1.34-4.58) 2.00 (1.10-3.64) 3 2.76 (1.91-3.99) 2.77 (1.48-5.18) 2.60 (1.41-4.80) 4 3.49 (2.31 5.26) 3.14 (1.57-6.29) 3.35 (1.67-6.70) * smoking, alcohol intake, leisure time physical activity, and fruit & vegetable intake Kvaavik et al., 2010. Survival function by number of poor health behaviors in 4886 men and women 18 years or older, adjusted for age, sex, occupational social class, body mass index, blood pressure, and prior illness. Kvaavik, E. et al. Arch Intern Med 2010;170:711-718. So What? Conclusion Co-morbid risk behaviors may also reduce one s likelihood of quitting smoking, e.g.: ¼ of smoking lapses are associated with drinking (Baer & Lichtenstein, 1988; Borland, 1990; Shiffman, 1982). Depression or mental illness increase likelihood of relapse Smokers are prime candidates for MRF interventions! Making other lifestyle changes in the absence of quitting smoking may reduce positive health gains, and vice versa. Benefits of MRF Interventions Benefits of MRF Interventions Improved mood Increased ability to quit smoking Improved energy Abstinence Increased physical activity Increased selfefficacy & other positive lifestyle changes 3
Benefits of MRF Interventions Fewer people are eligible for MRF interventions % Respondents N= 66901 members of health plan Unclear if people will be interested: Motivation to change one behavior does not imply motivation to change other behaviors Many logistical details TBD: Program structure: sequential behavior change, concurrent behavior change? Changing MRF s may require increased treatment intensity & burden Many logistical details TBD: How should success be measured? Change in one vs. change in all behaviors? How to quantify change across multiple behaviors? see Prochaska, Velicer, Nigg & Prochaska 2008 for discussion Option #1: report change in each individual behavior Option #2: create combined statistical index of overall change Many logistical details TBD: Will health care systems or other payers (e.g., states) pay for MRF interventions for smokers? Potentially more time & labor intensive Unclear if bang is worth the buck May be viewed as detracting from goal of smoking cessation Option #3: create behavior change index reflecting # behaviors that reach criterion change Option #4: assess impact (efficacy X participation/# of behavioral targets) Option #5: assess quality of life, morbidity & mortality, biometrics (e.g., lung functioning), cost, etc. 4
Conclusions There is a sound rationale for designing and evaluating MRF interventions targeted to smokers, but it is too early to tell how successful these will be or how acceptable they will be to smokers and payors. Step Up! A MRF Intervention Case Study More formative research is clearly needed. Step Up Trial - Purpose Step Up Intervention Rationale To assess the feasibility and acceptability of a MRF intervention targeting depression, smoking, & physical activity Assess co-morbidity of risk factors in health plan population Conduct a one-arm, refining pilot trial Conduct small, randomized pilot trial Assess acceptability of intervention from perspective of eligible health plan members and key stakeholders in delivery system Increased ability to quit smoking Improved mood Increased physical activity Improved energy Pilot Trial Activities Refining Pilot - Design Conduct one arm pre-pilot (n = 10) to develop and refine the study intervention Conduct two arm pilot RCT to assess feasibility, acceptability, and potential impact on depression, smoking behavior, & physical activity. Identify potentially eligible GH members from health plan records Call & screen Schedule appointment & confirm eligibility with doctor Baseline appointment (in person) Step Up Program Self-help materials & referral to health plan services 8 call counseling program Weekly walking group EOT Survey 5
Eligibility Criteria Moderate to severe depression PHQ score >= 10 Sedentary behavior Failure to meet recommended physical activity guidelines Current smoker Regardless of interest in quitting Adult member of health plan living in Seattle area Not currently receiving specialty mental health services If taking antidepressant, use > 1 month (Initial) Intervention Design 8 acute (weekly) phone counseling calls* with health coach Behavioral activation Cognitive restructuring Smoking cessation motivation & action plans for quitting Weekly walking group Intervention workbook Pedometer *Additional booster calls planned for Randomized pilot Refining Pilot Results & Lessons Learned Recruitment 49 screened 10 eligible & enrolled (9% total or 20% of screened) 39 ineligible PHQ score too low (n = 17) Nonsmoker (n = 14) Too active (n=8) 45 refused screening 17 unable to contact Refining Pilot Results & Lessons Learned Walking group Goal: Attend up to 3 weekly sessions Reality: 0 participants attended after 3 months Barrier to call participation felt guilty not attending Require extra staff effort Limited sample geographically Refining Pilot Results & Lessons Learned Refining Pilot Results & Lessons Learned Smoking cessation: Recruited smokers in Precontemplation, Contemplation & Preparation stages of change. Goal: Address smoking based on readiness to quit at any time during intervention or at least by session 8 Reality: Quitting not high priority for most participants hard to weave into weekly sessions if not explicit part of planned weekly content Adherence/Engagement with calls Goal: Weekly sessions at prescheduled time Reality: Adherence inconsistent. Many forgotten appointments. MIA s common. Poor compliance related to guilt about not joining walking groups for some. 6
Refining Pilot Results & Lessons Learned Individual physical activity exercises are better accepted than group activity Focus on motivation & engagement before beginning counseling Use small, structured exercises to weave physical activity and smoking into weekly sessions Assertive, proactive outreach & patience are required Requiring participants to be sedentary may exclude many depressed smokers who could benefit from this type of program Summary of Changes to Design Dropped walking group added more explicit physical activity homework assignments each week Added explicit smoking cessation exercises each week to build & strengthen skills for not smoking Added pre-counseling engagement session to build & strengthen motivation for participation in program and health behavior change prior to initiating counseling Redoubled efforts to pre-schedule appointments at flexible hours Revised physical activity inclusion criteria. Step Up RCT Pilot Design Identify potentially eligible GH members from health plan records Results - Engagement Call participation: Call & screen Baseline appointment (in person) 29.6% completed 12 calls 25.9% completed 10-11 calls 55.5% took 10 or more calls! Usual Care (n=25) Standard self-help materials & referral to GH services Step Up Program (n = 27) Standard self-help materials & referrals 12 call counseling program 11.1% completed 6-7 calls 11.1% completed 4-5 calls 18.5% completed 2-3 calls Follow-up Survey at 4 and 6 months post-enrollment 3.7% completed 1 call Average call duration = 30 minutes Results - Acceptability Impact on Behavior Change Participant Feedback: Great program. It could help a lot of people. Enjoyed being part of the study. Liked the homework. It made me do things and pushed me weekly. Got me thinking about stuff more.??? Liked the focus on walking. Cut down on my smoking. Planning to quit smoking now. Quit smoking for a few weeks. 7
Summary Smoking does not occur in a behavioral vacuum. Cessation interventions should take into account other issues (e.g., mental health and substance abuse) or risk behaviors even if they do not treat them specifically. MRF interventions, if shown to be acceptable and effective, will likely be more prominent in the future. Risk Behaviors in Health Plan Population Health risk assessment data (n = 66,901*) 8.9 % smokers 8.2% meet criteria for moderate to severe depression Physical activity 24.5% low physical activity on IPAQ 31.6% moderate physical activity 36.6 % high physical activity Co-morbidity in health plan Among smokers: 18.8% moderate to severe depression 33.1% low physical activity 29.5% moderate physical activity 37.4% high physical activity Overall: 0.6% = depressed smokers with low physical activity 0.4% = depressed smokers with moderate physical activity * Volunteer sample. Implications Only a small proportion of health plan members are likely to meet criteria for all three behaviors. 8