randomized trial of achieving healthy lifestyles in psychiatric rehabilitation achieve trial...
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Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation
ACHIEVE Trial
NCT00902694, R01MH080964
Society for Clinical Trials Annual MeetingMay 20, 2014
Gail L. DaumitNae-Yuh Wang
Joseph GennusaStacy GoldshollJeff Richardson
Disclosures
• No Relevant Financial Relationships with Commercial Interests
Presentation Overview
• Context and trial overview• Design and analysis• Recruitment, data
collection, retention• Weight-loss intervention• View from community
mental health programs
• Gail Daumit, PI
• Nae-Yuh Wang, Statistician
• Joseph Gennusa, Project Director
• Stacy Goldsholl, Intervention Director
• Jeff Richardson, Executive Director, Mosaic Community Services, Inc.
Serious Mental Illness (SMI)
Schizophrenia, bipolar disorder or disabling depression– 5.4% of U.S. adults, 1.1% schizophrenia, 2%
bipolar– Generally require continuous, long term
psychotropic medications– Medicaid, Medicare, public assistance
recipients, high health care utilization– Comorbid substance use ~50%
Standardized Mortality Ratio (SMR)
Cause of Death Comparing Maryland Medicaid SMI with Maryland Population* (1999-2001)
SMI = severe mental illness. *Adjusted for age, gender, and race; †death rate per 100,000 persons in Maryland Medicaid SMI. Daumit GL et al., Psychiatric Research, in press
Heart Disease (585.5)†
Renal Disease (64.6)†
Malignant Neoplasm (340.4)†
HIV (131.7)†
Diabetes Mellitus (118.0)†
Influenza/Pneumonia (103.4)†
Accidental (e.g., suicide) (37.2)†
Chronic Lung Disease (108.8)†
Septicemia (85.8)†
Cerebrovasc. Disease (110.9)†
All-Cause Mortality (1975.3)†
SMI Deaths per 100,000
person years
Contributors to Premature Mortality
• Cardiovascular disease risk factors– Health risk behaviors: obesity, physical
inactivity, tobacco smoking– Health risk factors: diabetes and glucose
control, hypertension, hyperlipidemia
• Cancer, Chronic Lung Disease, Liver Disease, HIV
• Health care quality
Overweight and Obesity in Serious Mental Illness
Comparison of Prevalence of Overweight and Obesity in U.S. Sample and Psychiatric Rehabilitation Program Attendees, % (95%
CI) SMI NHANES
All n=873 n=5926Overweight or
obesity 85 (83 ,87) 73 (70,76)Obesity 60 (57,64) 40 (37,43)
Extreme obesity 16 (14,19) 8.4 (7.2,9.5)Men n=535 n=2889
Overweight or obesity 84 (80,87) 74 (70,78)Obesity 54 (50,58) 38 (33, 42)
Extreme obesity 10 (8,13) 6 (5, 7)Women n=338 n=3037
Overweight or obesity 87 (83,91) 71 (67,74)Obesity 70 (65,75) 44 (41,47)
Extreme obesity 26 (21,31) 12 (10,14)
Weight Gain at 10 Weeks With Antipsychotics
6543210
-1-2-3
Placebo
Molin
done
Fluphenazin
e
Ziprasidone
Haloperidol
Risperid
one
Chlorpro
mazine
Serti
ndole
Olanzapine
Clozapine
Thioridazin
e/
Meso
ridazin
e
Wei
ght C
hang
e (k
g)
*At 6 Weeks; Adapted from: Allison DB et al. Am J Psychiatry. 1999;156(11):1686-1696
1210
86420
-2-4-6
Weight Change (lbs)
Quetiapine
*
Also cause weight gain
• Lithium
• Tricyclic antidepressants
• Selective serotonin reuptake inhibitors
• Valproic acid
Context for Lifestyle Interventions in Serious Mental Illness
• Cognitive impairment and persistent psychiatric symptoms frequent challenges in everyday functioning
• Disparities population – socioeconomic and environmental risk factors for CVD –– unemployment– low income – social isolation
• Lifestyle interventions for this group need tailoring
Objective and Setting
• Objective: Determine the effectiveness of an
18-month tailored behavioral weight
loss intervention in adults with serious
mental illness
• Setting: Psychiatric Rehabilitation Facilities
Psychiatric Rehabilitation Facilities
• Outpatient day programs providing classes in rehabilitation environment
• Attendees generally on-site ≥ 2 days per week
• Opportunities for lifestyle interventions– Frequent contacts– Physical activity classes– Meals served on-site
ACHIEVE Trial Design
= Measured weights and other outcomes
Control
Intervention
Randomization
Baseline 6 Mo 12 Mo 18 Mo
ACHIEVE Trial Design
= Measured weights and other outcomes
Control
Intervention
Randomization
Baseline 6 Mo 12 Mo 18 Mo
Program-wide recommendations for healthy menus
Participants
• Overweight or obese attendees at one of 10 Maryland psychiatric rehabilitation programs
• 18 years or older
• Major exclusion criteria:– Medical contraindication to weight loss– CVD event in previous 6 months– Inability to walk– Active alcohol or substance-use disorder
ACHIEVE Study Sites
●
Family Services Agency, Way Station, Prologue, Inc., Mosaic Community Services, Keypoint Health Services, Arundel Lodge, People Encouraging People
Types and Number of Intervention Contacts
6 months 7-18 months
Group weight management
Weekly Monthly
Individual weight management
Monthly(alternating with group)
Monthly
(alternating with group)
Group physical activity
3 times per week all lead by intervention staff
3 times per week
1 then 2/week by rehab staff with video
Weigh-in Every week Every 2 weeks
Characteristics (n=291)Age -yr 45±11
Women (%) 50
White (%) 56
African-American (%) 38
Weight -kg 103±21
Body Mass Index kg/m2 36±7
Characteristics (n=291)
Schizophrenia/schizoaffective disorder (%) 58
Bipolar disorder (%) 22
Substance abuse history (%) 52
Number of psychotropic medications 3.1±1.5
Atypical antipsychotic (%) 83
Never married (%) 74
Unable to work (%) 79
Lives in residential program or with care provider (%) 55
Follow-up Weights
Measured weight• 99% of participants at 6 months• 95% of participants at 12 months• 96% of participants at 18 months
Mean Weight Change (kg) According to Study Group
-0.3 -0.5 -0.2
-1.8
-3.0 -3.4
-1.5-2.5 -3.2 p=0.002
Weight-Loss Outcomes at 18 months
Control Intervention
At or lower than baseline weight
49% 64%*
> 5% weight loss 23% 38%**
> 10% weight loss 7% 19%**
*P <0.05 (vs. control), **P <0.01 (vs. control)
Offered and Attended* Sessions for the Intervention Group
* Median
Session Type First 6 Months
Offered Attended
Group weight management
16 10
Individual weight management
5 4
Group exercise 61 30
All sessions 82 46
Offered and Attended* Sessions for the Intervention Group
* Median
Session Type First 6 Months 7-18 Months
Offered Attended Offered Attended
Group weight management
16 10 13 7
Individual weight management
5 4 12 4
Group exercise 61 30 141 24
All sessions 82 46 164 31
Mean Weight Change (kg) in Intervention GroupACHIEVE
Mean Weight Change (kg) According to Study GroupACHIEVE and PREMIER*
*Elmer, et.al. Annals Intern Med 2006
Mean Weight Change (kg) According to Study GroupACHIEVE and PREMIER*
ACHIEVE-3.2 p=0.002
PREMIER-2.7p=0.001
*Elmer, et.al. Annals Intern Med 2006
Conclusions from Trial
• Despite myriad challenges, with a tailored lifestyle intervention, overweight and obese adults with serious mental illness can
• make lifestyle changes and • achieve substantial weight loss
• Our findings support implementation of targeted behavioral weight loss interventions in this high-risk population.
Sample Size and Power
• Minimum Detectable Difference = 4.5 lbs
(clinical relevance = SBP 3 mmHg
hypertension incidence 20%)
• Alpha error = 0.05, Beta error = 0.20
• SDΔ = 12Grant Revised Actual
Enroll (total N) 320 288 291Lost to follow-up 20% ~10% 4%N with Outcome 256 256 279
Design Considerations
• Individual vs. cluster randomization
• Randomization strata (site, sex)
• Environmental dietary intervention
• Psychotropic medications
Analysis Plan
• Intention-to-treat
• Likelihood-based mixed effects model– Expected weight as 8 cell-means (2 study-groups x
4 study visits)
– Full-rank, unstructured variance-covariance matrix
– Model adjusted for study site and sex
• Sensitivity analyses on potential impacts of missing data
Recruitment
• Partnership with each study site • Face-to-face approach
• Challenge: resource intensive• Benefits:
• Defined target population• Research team on-site
presence sets foundation for study success
Data Collection- Logistics
• 10 sites, windows for follow-up• Training in working with psychiatric
rehabilitation population• All measures administered in-person• Research team on-site daily
Data Collection- Logistics
• Space and time considerations• Bicycle ergometry – “cottage”• Phlebotomy – laundry room
Retention
• Facilitators: mental health program attendees
• Challenges: • transient population• lack of consistent phones, housing
Retention-Home Visits
•6 months – 12 visits•12 months – 32 visits•18 months – 49 visits
Lifestyle-Based Weight Loss
• Evidenced based recommendations
• Tailored to this population and setting
Types and Number of Intervention Contacts
Contact Type 6 Months 7-18 Months
Group Weight Management
3 times per month monthly
Individual Weight Management
monthly monthly
Group Exercise 3 times per week 3 times per week
Dietary Recommendations
PREMIER ACHIEVE
Individual target calorie goals
Drink Water, No “Sugar Drinks”
Choose “Smart” Snacks
Choose “Smart” Portions
Eat 9 Fruits and Vegetables/day Eat 5 Fruits and Vegetables/day
Calories from fat ≤ 25%
Avoid Junk Food
Calories from saturated fat ≤ 7%
Reduce sodium intake to ≤ 100mmol
Eat 2-3 servings of dairy/day
Exercise Recommendations
PREMIER ACHIEVE 180 min/week 180 min/week provided by study
Self-Monitoring Recommendations
PREMIER ACHIEVE Detailed food/exercise log Simplified food/exercise tracker
Weight Management Groups
• Build participant confidence
• Motivational Interviewing
• Self monitoring/awareness
• Interactive– Behavioral Rehearsal – Environmental Prompts
• Repetition• Material taught in small content units
Weight Management- Individual Sessions
• High attendance
• Weigh-Ins
• Motivational Interviewing
• Individual Problem Solving– High impact behavior– Consider both PRP and home environment
Group Exercise
• Exercise goal• Exercise on-site 3 times/ week• Exercise on other days 30 minutes on your own
• Classes• Low Impact Aerobic• Moderate Intensity• Progressive• Tailored to Population
Group Exercise: Individual
Challenges Strategies
Cognitive abilities of group Various forms of cueing, repetition
Poor motor coordination and various levels of physical abilities
Simple movements, repetition, visual and auditory cueing
Misinterpretation of physical symptoms
Discussion of physiological changes that occur during exercise
Shyness/Comfort level Repetition, create private space
Access to appropriate clothing and shoes
Work with participant and program staff to identify available resources
AttendanceBehavioral modification, work with program staff
Group Exercise: Environment
Challenges Strategies
Physical spaceModify movements to accommodate space
DistractionsTry to create a more private space
Psychiatric rehabilitation program member support
Establish rapport, work with program staff to establish expectations
Competing psychiatric rehabilitation groups
Program staff support
Transitioning to program-led Group Exercise Classes
Program staff training
Lifestyle Intervention – Summary
Challenges Strategies
Clear MessagingSimple recommendations, repetition, role-playing and interaction
Engaging in ConversationMotivational Interviewing, open-ended questions, directive approach
Heterogeneity in activity level and physical abilities
Simple/basic movements, offer a range of intensity options, repetition
AttendanceBehavioral modification strategies, collaboration with psychiatric program staff
Environmental Dietary Intervention
• Child and Adult Care Food Program guidelines
• Met with Kitchen Supervisor
• Focus on all meals/snacks served
• Focus on all vending (food and beverage)
• CALORIES, CALORIES, CALORIES
Environmental Dietary Intervention Challenges
• Kitchen Supervisors
• Budget
• Purveyors
• Vending
• Local mini-markets/gas stations
From Participants
Community Organization Perspective
•Increasing importance of improving physical health of mental heath consumers served•Barriers with accessing healthy foods and safe places to exercise•Stigma, low self-efficacy
ACHIEVE at Mosaic Community Services
High quality randomized clinical trial in community settings
•Strengths: •Level of care and concern for mental health consumers•Built collaborations with Mosaic staff at all levels•Took advantage of the existing environment
•Commercial kitchens•Using space for exercise classes
•Challenges:•Programming scheduling in limited hours•Staff turnover
Challenges of Preventive Health Intervention Implementation in Mental Health Settings
• Mental health settings traditionally not set up to deliver preventive/other somatic services
• Intensity of intervention needed for continued behavior change/health outcomes – not just “wellness”
• Competing demands (e.g., staff time)• Training and Supervision• Payment
Preventive Health and Somatic Services Programming at Mosaic Community Services
• IDEAL Trial (NHLBI)– comprehensive cardiovascular risk reduction intervention with health coaches hired by Mosaic, jointly supervised by Johns Hopkins
• Health Home program• Co-location of somatic medical services from
Federally Qualified Health Center at Mosaic site
Summary
• Persons with serious mental illness are a vulnerable population with increased mortality and increased burden of a broad range of medical conditions.
• This population needs targeted and tailored interventions to improve their physical health.
• ACHIEVE was successful, but future implementation and dissemination important.
• There is much more work to be done to decrease health disparities in this population.
Acknowledgements
• Participants• Staff and leadership of:
• Arundel Lodge, Inc.• Family Services, Inc.• Keypoint Health Services, Inc.• Mosaic Community Services, Inc.• Prologue, Inc.• People Encouraging People, Inc.• Way Station, Inc.
• Investigative team• Present today: Catherine Wren, Katie Rankin, Louis Sullivan,
Courtney Cook, Traci Lambert• National Institute of Mental Health• NCRR U54 RR023561 / NCATS UL1 TR000424
Characteristics (n=291)
Total Intervention(n=144)
Control(n=147)
Age-yr 45±11 47±12 44±11
Women (%) 50 49 51
White (%) 56 57 55
Black (%) 38 36 40
Weight -kg 103±21 101±22 104±21
Body Mass Index kg/m2
36±7 36±7 37±7
Characteristics (n=291)% Total Intervention
(n=144)Control(n=147)
Schizophrenia/schizoaffective disorder
58 59 57
Bipolar disorder 22 19 25Substance abuse history 52 53 50Number of psychotropic medications 3.1±1.5 2.8 ±1.3 3.3±1.6Atypical antipsychotic 83 83 83Never married 74 72 76Unable to work 79 78 80Lives in residential program or with care provider
55 50 59
Model-based estimates of between-group mean differences and 95% confidence intervals in cardiovascular risk factors and other
adiposity-related outcomes at 6 and 18 months
Model-based estimates of between-group mean differences and 95% confidence intervals in cardiovascular risk factors and other
adiposity-related outcomes at 6 and 18 months
Program-wide Menu Recommendations
-Assessing meals offered at sites
-Offering advice to sites to modify meals to make them more healthy-initial consultation and then quarterly follow-up
-Heterogeneity in what was offered
-Organizational change
Elevated CVD Risk Factors at Baseline in Antipsychotic Trial
CATIE Study
(n=689)
(%)
NHANES
(n=687)
(%)
Smoking 68 35
Diabetes mellitus 13 3
Hypertension 27 17
CATIE Study – Clinical Trials of Antipsychotic Treatment EffectivenessGoff, et.al., 2005.
Casagrande, et.al. Community Mental Health Journal, 2011
Next steps
• How can evidence-based interventions like ACHIEVE be implemented and disseminated?
• What would delivery models look like?
• Future training of mental health staff to deliver weight loss coaching?
Comprehensive CVD Risk Reduction Trial in Persons with Serious Mental Illness: IDEAL Trial
• Objective: Test the effectiveness of the IDEAL intervention compared to control in reducing overall CVD risk using the Framingham score
• Methods/Population: Randomized clinical trial, Mosaic Community services, 250 participants
• Intervention: Active arm - 18 months- Heart health coach provides individual behavioral risk reduction counseling, collaborates with mental health staff and social supports; Nurse works to optimize treatment for hypertension, dyslipidemia, diabetes mellitus and smoking cessation including coordination with primary care provider and psychiatrist
All participants – healthy menus and group exercise offered
• Outcomes: 1°= CVD risk (Global Framingham Risk Score); 2°=weight, fitness, smoking, waist circumference, lipids, glucose, quality of life, psychiatric symptoms
NHBLI R01-112299
Implementation Issues
• Sustainment• This type of behavioral intervention is time
and effort intensive • Contact time• Fidelity
• Different delivery models?• Mental health staff deliver all?• Larger organizations contract out
services?
Sustainment
• What happened after the study ended? Did sites continue physical activity classes and menu changes?
• K-24 – Sustainability of physical health intervention in mental health settings
• Describe and evaluate sustainment and factors associated with enhancing or hindering sustainment of the healthy lifestyles intervention in the ACHIEVE Trial
Opportunities
1. Widespread interest from mental health consumers, family members, mental health programs - demand for services
2. Demand for training from mental health programs
3. Interest from Maryland Department of Health and Mental Hygiene
Persons with SMI as a Health Disparities Population
CVD Risk FactorsHypertensionOverweight/obesityDiabetes mellitus‡
Dyslipidemias
Heart disease risk
SMI Biological Factors
Cultural Factors
Socioeconomic Factors
EducationMarital StatusEmploymentDisability StatusIncomeLiving Arrangements
Discrimination
Health BehaviorsTobacco smoking‡
DietPhysical activity‡
Alcohol use‡also CVD risk factors
Psychological Stress
DepressionMental health symptoms
Environmental StressHealthy food availabilitySafetyPlaces to exercise
Psychosocial Resources
Social SupportSelf-Efficacy
Medical CarePsychotropic medicationsMedications for CVD risk factors Primary care
Political Factors
Adapted from Williams and Schulz
Healthy Menu Changes Old BreakfastCheerios 1.5 cup2 slices white bread with butter and
jelly¼ cup sugarBanana2% milkOrange juice
Calories: 1150Fat calories: 200Fiber: 9.9 gramsProtein: 28 grams
New BreakfastRaisin bran cereal 1.5 cup1 slice wheat bread with margarine 1 hard boiled egg2% milkOrange juice
Calories: 870Fat calories: 200Fiber: 12.6 gramsProtein: 34 grams
Individual
Heart Health Interventionist
(HHI)
Improved CV Health Risks Risk BehaviorsWeightPhysical activityDietSmoking Risk FactorsDiabetes mellitusCholesterolBlood pressure
Improved CV HealthImproved Quality of Life
Primary care
provider (PCP)
Rehabprogram staff + social
supports
Mental health
providers
IDEAL Intervention Framework for Moving Towards CV Health in Persons with SMI
Heart Health Clinical
Consultant (HHCC)
-Dashed lines designate new relationships with HHI
Common Background
Intervention for healthy menus (like ACHIEVE)
Group exercise classes offered across sites
Dedicated staff person to coordinate exercise classes
Active Intervention
• Heart health interventionist provides– Individual counseling on CVD risk factors (e.g., smoking) –
regular visits set up– Coordination with primary care physician around heart
health goals• Includes accompanying on PCP visits, working on targets for blood
pressure, diabetes, lipid control, med adherence– Collaboration with other Mosaic staff and social supports
around these goals• Attend exercise class• Participate in regular meetings
• Heart Health interventionist is a Mosaic employee
Serious Mental Illness (SMI)
Schizophrenia, bipolar disorder or disabling depression– 5.4% of U.S. adults, 1.1% schizophrenia, 2% bipolar– Generally require continuous, long term
psychotropic medications– Medicaid, Medicare, public assistance recipients,
high health care utilization– Comorbid substance use ~50%
Premature Mortality in Serious Mental Illness
Contributors• Cardiovascular disease risk
factors– Health risk behaviors:
obesity, physical inactivity, tobacco smoking
– Health risk factors: diabetes and glucose control, hypertension, hyperlipidemia
• Cancer, Chronic Lung Disease, Liver Disease, HIV
• Health care quality
Calls to Action• SAMHSA 10x10 Wellness
Campaign• National Alliance on Mental
Illness• NIMH Strategic Plan• Institute of Medicine Top
100 Topics for Comparative Effectiveness Research