Evaluation of Stepped CAre 

Chronic Pain (ESCAPE) in

Iraq/Afghanistan Veterans Tr

Matthew J. Bair, MD, MS

Center of Excellence for Implementing Evidence Based Practi

Regenstrief Regenstrief Institute, Institute, Inc, and

Indiana University School of Medicine, Indianapolis

September 4, 2012
Funding Funding Source

• VA Rehabilitation Research & Developm

Merit Review No: F44371

• Special thanks

– Patricia Dorn, PhD (VA RR&D Director)

– Tom Pierce, PhD (Scientific Program Officer

Officer
Pain: A public health pro

pro

• Affects > 100 million

in US

• Reduces quality of

life

• C t os s $560–$635

billion/billion/ yr
Pain: A critical problem am

Veterans

• Most symptom reported in PGW vets (Kroenke • 50% of Veterans in primary care report chr

(Kerns et al., 2003; Clark, 2002)

• Prevalence as high as 75% in female Veter

2006)
Pain among OEF/OIF Ve

• One of most frequent presenting concerns 

OEF/OIF vets (Kalra et al., 2008)

• 43% & 47% of OEF/OIF veterans reported 

pain (Clark, 2004; Gironda et al., 2006)

• Few intervention intervention studies studies to address address chron

chron
Gap in the literatur

• Best outcomes outcomes in multidisciplinary multidisciplinary pain cli

cli

– But not widely available

• Evidence for effective individual treatmen

Modest improvement

• Need for combined combined interventions interventions to impro

impro
Long‐term goal

• To test the effectiveness effectiveness of multi‐modal, m

disciplinary interventions

• To determine best combinations of non‐

pharmacological and pharmacological trea

for chronic pain

• Applied in VA primary care settings
epped

Study ObjectivObjective

• To determine if a stepped‐care interve

reduces/imprduces/improves:

– P i a n‐rel t a ed disability and pain sev– SecondarSecondar Secondary outcomes

• In OEF/OIF veterans with chronic

musculoskmusculoskeletal pain
What is a Stepped‐Care

Intervention?

• Starting with lower intensity, less co

treatments (Step 1)

• “Stepping up” to more intensive, cos

complex treatments

– “poor responders”– Low Back Pain (Von Korff), PGW Syndrome ( g En e
t d sab

ESCAPE Conceptual ConceptualConceptual Mo

Table 1. Conceptual model for ESCAPE trial 

Care Intensity Targeted

Participants Participants 

Intervention 

Step 1 

(2 parts) (2 parts) 

OIF/OEF veterans

with disabling

musculoskeletal pain 

Analgesics coupled 

w/ self w/ self-management management 

strategies 

Re

EE

P

Step 2 Veterans with 

persistent pain and 

disability at 12 weeks 

Cognitive behavioral

therapy 

I

R
Primary HypothesesHypotheses Hypotheses

• Stepped Stepped care is more effective effective than 

care in reducing:

– pain‐related disability– Interference Interference with activities– pain severity
y

Secondary Hypothese

• Stepped care is more effective than us

in reducing psychological distress

• And improving secondary outcomes:

• Health‐related quality of life

• Self‐efficacy to manage pain

• Negative pain beliefs and coping
Study Design

Chronic

Musculoskeletal

Pain

Stepped Care Randomization Randomization pp

1.Analgesics + Self‐

management

2. Cognitive behavioral

training

Usual Care
–

Study Sites

• At Roud b e ush VA Med l ica Center

– 5 primary primary care clinics clinics– 1 post‐deployment clinic
• Chronic musculoskeletal pain (> 3 months

ESCAPE EligibilityEligibility Criteria

• OEF/OIF veterans

( 

– Low back, cervical cervical spine, or extremities extremities 

hip, knee)

– Moderate functional impairment define

Roland Disability Disability Score ≥ 7
ESCAPE EligibilityEligibility Criter

• E l xc usions:

– Active suicidal ideation

– Current alcohol/substance dependence

– Prior surgery for pain or surgery pending

– Pain‐related disability claim under adjudicat

– Severe cognitive impairment– Bipolar or substance disorder/Schizophrenia
RandomizRandomiz Randomization and Blind

Blind

Blind

• Randomized 1:1 to stepped‐care or usua

(control) arms

• Lists computer generated

• Assignments supplied in sealed opaque

envelopes

• Baseline and follow‐up assessments con

by research assistant blinded to treatme
e

)

Stepped‐Care Intervention: Ste

weeks)

• Analgesic management (WHO Ladder)

– Evidence based algorithm

– Optimize simple analgesics– Introduce co‐analgesics– Address opioid regimen
WHO Analgesic Ladd
Analgesic Algorithm: Non‐o

o

Step Analgesic

Step 1 • Acetaminophen

• Naproxen

Step 2 • Ibuprofen

• Meloxicam• Etodolac• Diclofenac• Salsalate

Step 3 • Cyclobenzaprine

• Gabapentin• Tramadol• Capsaicin

Step 4 • Nortriptyline

• Amitriptyline
Analgesic Algorithm: Op

Op

Step Analgesic

Step 5 • Hydrocodone/acetamin

• Oxycodone/acetaminop

Step 6 • Morphine SR

• Morphine IR

• Methadone
Stepped‐Care Intervention: S

• Pain Self‐Management Program (Damush, Lor

– Pain education

– Physical Physical Activity Activity (return (return to normal activities

activities

– Alternative thinking (goal setting)

– Working with health care providers

– Stress management (e.g. deep breathing)
e

)

Stepped‐Care Intervention: Ste

weeks)

• Brief cognitive‐behavioral training

– Cognitive behavioral therapy‐based

– Treatment Treatment manual modeled modeled after Lysa

Davis’s VA Vocational Rehab Program 

Lysaker, 2005)

– 6 sessions delivered via phone
‐

–

Treatment Details

• All aspects aspects of stepped stepped‐care delivere

delivere

nurse case manager

• Weekly case management management meetings meetings

• Regular contacts with participants t

– Monitor pain/disability– Assess response to treatment

– Assess side effects

– Query d i es re for treatment change

– Introduce self‐management strategies
Usual Care: Control Grou

• Treatment‐as‐usual• Recommended commended to seek treatment adv• No other attempts to provide treatme

–Unless psychiatric emergency e.g. s

s

ideation)
Design: Design: Summary Summary

• RCT: Stepped‐care vs. usual care

• Sample: OEF/OIF Vets w/ chronic musculoskmusculoskele

• Pain location: Spine (lumbar or cervical) or extr

• Site: 5 VA primary primary care and post‐deployment cl

cl

• Outcome assessments: Baseline,Baseline, 3, 6, and 9 mo
–

Primary Primary Outcomes

• Pain related disability

– Roland Morris Disability Scale (24‐items)

Validated Validated in back pain (Roland & Morris, 1983)

– Validated in other pain conditions– 0 (no disabilit disability) to 24 (severe disabilit disability)
–

Primary Primary Outcomes

• Pain Interference

– 7‐item BPI Interference Scale (BPI) (Cleeland (1990)

0 (no interference) interference) to 10 (severe (severe interference) interference)

– Items summed and averaged

• Pain Severity

– Grade Chronic Pain Scale (CGPS) (Von Korff, Dworkin, & Le, 1990– 0 (no pain) to 100 (severe)
Brief Pain Inventory

INTERFERENCE

How has pain interfered interfered with your

– General activity– Mood– Walking ability– Work– Relationships– Sleep– Enjoyment of life
‐

‐

Secondary Outcome

• Psychological distress

• Depression (PHQ‐9)• Anxiety (GAD‐7)• PTSD (PCL‐17)

• Health‐related related quality quality of Life

• SF‐36 domains

• Pain beliefs beliefs and cognitions cognitions

• Pain catastrophizing

• Centrality of pain
Other Measures Measures

• Demographics• Military history• Medical comorbidit comorbiditcomorbidity

• Pain treatments

• W k or function

• Pain beliefs/cognitionsognitions

• Alcohol Alcohol use• Somatization• Stressors• CognitivCognitive functionfunction• Social support support• Deployment expos• Physical activity
Analysis

• Intention Intention‐to‐treat method• Assessed change (baseline to 9 month) b

stepped‐care and usual care

• Last‐observation observation carried carried forward forward imputa

imputa

“complete case”
Power and Sample s

• To detect a stepped stepped care treatment treatment effect 

SD

• Need 100 patients patients per group

– alpha = .05 (two‐tailed)– beta = .20 (power = 80%)– Estimated > 15% attrition– Goal of 120 per treatment arm
Recruitmencruitment • DecemberDecember December 2007 to June 2011

• Follow‐up concludedconcluded in April 2012
ESCAPE Participanrticipan rticipant Fl

–

–

Sample characteristics (n=2

• Mean age: 36.7(10.2) 3⁄4 Military branch

3⁄4 Army ‐ 66.4% • Sex: 88.4% men

3⁄4 DeploymenDeployment • Married:Married: 54.4% 3⁄4 Iraq‐ 74.9%

• Race: 3⁄4 Afghanistan ‐ 8.8%

– 76.8 % White 3⁄4 Duty:

– 12.9% Black 3⁄4 R ti e red/discharged 

• Employment status 3⁄4 Pain location:

– 73.3% employed/student 3⁄4 Back pain ‐ 57.3%

3⁄4 Knee – 21.6% • Income

3⁄4 Neck – 7.5%

– 36.5% comfortable

3⁄4 Shoulder – 7.1%

18.7% NOT enough 3⁄4 Hip – 6.6%
BaselineBaseline Baseline Analgesics

Class Stepped Stepped‐care Usual ca

NSAIDs 69 (57.0) 69 (57.5

Anti-depressants depressants 45 (37.2) 50 (41.7

Opioids 42 (34.7) 38 (31.7Muscle relaxants Muscle relaxants 37 (30.6) 20 (16.7

Acetaminophen Acetaminophen 20 (16.5) 17 (14.2Anti-convulsants convulsants 20 (16.5) 17 (14.2
= =

BaselineBaseline “Current”

Treatments

Class Stepped‐care

N = 121

Usual c

N 121 N = 12

Pain Clinic, nClinic, n (%) 7 (5.8) 12 (10

Mental health, n health, n (%) 54 (44.6) 57 (47

Physical Physical therapy therapy 9 (7.4) 12 (10
BaselineBaseline Baseline Pain Measure

Measure Stepped‐care

Mean (SD)

Usual care

Mean (SD)

Roland Disability 14.0 (4.3) 13.7 (4.7) 

BPI‐Interference 5.3 (2.1) 5.4 (2.4) 

GCPS Pain Severity 67.3 (12.1) 65.1 (15.2) 
9 ess o 

t

d l 

BaselineBaseline Baseline Psychological Mea

Measure Stepped‐care

Mean (SD)

Usual care

Mean (SD)

PHQ -9 Dep ression 11.1 (6 ) .2 11.3 (5.6) 11.3 (5.6) PCL-PTSD 27 6 (19 2) 27.6 (19.2) 25 2 (19 7) 25.2 (19.7) GAD-7 A i nx ety 8 9 (5 3) 8.9 (5.3) 8 7 (5 2) 8.7 (5.2) 
Between group difference (BL t

months): Pain DisabilityDisability

Measure Stepped‐care

Mean (SD)

Usual care

Mean (SD)

Baseline Roland Baseline Roland DisabilityDisability 14.0 (4.3) 13.7 (4.7) 

9-month Roland 10.6 (6.3) 12.1 (6.4) 

Change -3.4 (12.1) -1.6 (5.1) 
Between group difference (BL t

months): Pain Interference

Measure Stepped‐care

Mean (SD)

Usual care

Mean (SD)

Baseline BPI Baseline BPI Interference Interference 5.3 (2.1) 5.4 (2.4) 

9-month BPI 3.8 (2.6) 4.5 (2.7) 

Change -1.6 (2.3) -0.86 (2.2) 
Between group difference (BL t

months): Pain Severity
Secondary outcomes: Analy

pending
Study Findings

• OEF/OIF Veterans have received several p

treatments

• Moderate comorbid psychological sympto

• A stepped care intervention reduced:

– Pain‐related disability– Pain interference with activities– Pain severity
DiscussionDiscussion

• SCAMP Trial (Kroenke (Kroenke, 2009)

– Targeted depression and pain in primary care– Anti‐depressants combined w/ pain self‐man

program

• Substantial improvement in depression• Moderate reductions in pain severity and disabilit
–

DiscussionDiscussion

• Collaborative Collaborative intervention intervention for chronic chronic pain 

– 2‐session clinician education program

Patient assessment assessment, education education and activation activation

– Facilitation of specialty care– feedback feedback and recommendations recommendations to clinicians clinicians

• Modest improvements in pain and depres
Summary

• One of first intervention studies for OEF/

veterans with chronic musculoskeletal p

• Intervention that included analgesics cou

with self‐management management strategies strategies and cog

cog

behavioral therapy in context of nurse ca

management:

– Moderate improvements in pain outcomes
ConclusionsConclusions

• Multimodal Multimodal strategies strategies needed to improve improve 

outcomes

• Given frequent comorbid psychological sy

nee

d to treat concurrently

for even

better

outcomes
Unique Challenges in Caring for 

Veterans
ESCAPE STUDY TEAM

• Dennis Ang• Jeff Barnd

• Teresa Damush

• Louanne Davis• Amanda Gerwig• Carol Kempf• Kurt Kroenke

• Marianne M• Laura Myer• Samantha O• Christy Sarg• Arlene Schm• Jingwei Wu• Zhangsheng 
QUESTIONS?

Thank you for attending 
VA Stepped P Stepped P Stepped PRISKain Care V Stepped P ain Care

RISK Tertiary Interdisciplinary Pain 

Comorbidities Secondary Consultation 

Advanced diagnostics & interv

CARF accredited pain rehabil

Pain Medicine 

Rehabilitation Medicine 

Behavioral Pain Management 

M l idi i li P i Cli i 

P ti t Ali d Cli i l T (PACT) 

Treatment Refractory Multidisciplinary Pain Clinics 

SUD Programs 

Mental Health Programs 

Patient Aligned Clinical Team (PACT) 

Routine screening for presence & intensity of 

Comprehensive pain assessment 

Management of common pain conditions 

Complexity 

g p 

MH-PC Integration, OEF/OIF, & Post-Deploymen

Expanded care management 

Opioid Renewal Clinics 

54 
IneligiblesIneligibles

• 417 Subjects ineligible• 97 Low or “0” Roland Morris• 31 No Pain

• 31 Previous Back Surgery

• 33 Potential Drug/Acholol

• issue• 61 Not OEF/OIF Veteran

• 5 No longer seen at VA

• 8 P i a n location i li ne gible

• 2 Pregnant

• 3 Schizophrenia

• 1 No phone

• 108 Not interested but eligible• 37 Scheduled but did not show