Transcript IS IT TIME FOR COMMUNITY HEALTH WORKERS (CHWS) TO BE CONSIDERED STANDARD THERAPY FOR DIABETES? Implications of the Results of the Mexican-American Trial of Community Health Workers (MATCH) Molly.

IS IT TIME FOR
COMMUNITY HEALTH
WORKERS (CHWS) TO BE
CONSIDERED STANDARD
THERAPY FOR DIABETES?
Implications of the Results of the
Mexican-American Trial of
Community Health Workers
(MATCH)
Molly A. Martin, MD
Steven K. Rothschild, MD
Susan M. Swider, PhD, APHN-BC
Carmen M. Tumialan-Lynas, PhD
Imke Janssen, PhD
©2006 RUSH University Medical Center
Disclosures
Research funding received from
• NIH: NIDDK, NHLBI, and NINR
• John A. Hartford Foundation of New York
• Lloyd Fry Foundation (Chicago)
I am not on the speakers bureau of any
pharmaceutical companies.
The MATCH Investigators agree to comply with
the American Public Health Association Conflict
of Interest and Commercial Support Guidelines,
and will not discuss any off-label or experimental
uses of a commercial product or service in this
presentation.
©2006 RUSH University Medical Center
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Overview of Presentation
•
•
•
•
MATCH study design
Primary outcomes
What additional studies are needed?
Advocacy for CHWs as evidence-based
therapy
• What if CHWs were a new medication?
©2006 RUSH University Medical Center
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Preliminary Evidence
Swider, 2002
• ACCESS TO CARE
• KNOWLEDGE
• BEHAVIOR CHANGE
• HEALTH STATUS
… but few well-designed randomized controlled trials
that demonstrate the efficacy of CHWs
©2006 RUSH University Medical Center
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Limitations of Literature
• Absence of clear conceptual intervention model
• Failure to state hypothesis and outcomes a priori
• Weak attention to intervention fidelity
• No behavioral attention control
• Failure to blind outcome assessment
• Poor participant retention
Lewin S, Dick J, Pond P, Zwarenstein M, Aja GN, van Wyk BE, et al.
Cochrane Database of Systematic Reviews. 2005
Viswanathan M, Kraschnewski J, Nishikawa B, Morgan LC, Thieda P,
Honeycutt A, et al. Agency for Healthcare Research and Quality; 2009.
©2006 RUSH University Medical Center
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MEXICAN-AMERICAN TRIAL OF COMMUNITY HEALTH WORKERS
• Behavioral Randomized Controlled Trial
• Efficacy: Testing CHWs under ideal conditions
• Population:
• Community-dwelling urban MexicanAmericans
• Defined as born in Mexico themselves - or -
1 parent or 2 grandparents born in MX
• Type 2 Diabetes mellitus without major endorgan complication
[R01 DK061289]
©2006 RUSH University Medical Center
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Health Status, Behavior Change
PRIMARY STUDY OUTCOMES
Improved risk factors after 2 years
• A1c – glucose control
• % with Blood Pressure at goal
(<130/80)
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INTERVENTION
• Diabetes Self-management training
• Delivered by Community Health Workers
• 36 home visits over 24 months, 1-on-1 coaching
– Scheduled every 2 weeks for 1st year
– Scheduled every month in 2nd year
• Behavioral Content from
American Association of
Diabetes Educators
(AADE-7)
©2006 RUSH University Medical Center
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MATCH CURRICULUM
Diabetes Self-Management BEHAVIORS
(AADE-7)
1) Check blood glucose daily and
understand the results
General Self-Management SKILLS
1) Problem-solve using brainstorming
(“lluvia de ideas”)
2) Take action to respond to abnormally
high or low blood glucose results
2) Record adherence to specific diabetes
behaviors through the use of a journal or
written log (“márquelo”)
3) Obtain regular medical care and
communicate your concerns with your
medical providers
3) Restructure the environment to either
support desired behaviors or reduce the
risk of unhealthy behaviors (“cambielo”)
4) Take medications as prescribed by your
medical provider
4) Seek out social support from family
members or friends
5) Check your feet regularly
5) Use strategies to reduce stress
6) Engage in daily physical activity
7) Make healthy dietary choices, with
emphasis on reducing the fat content of
meals
©2006 RUSH University Medical Center
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INTERVENTION FIDELITY
• CHWs documented
content of visits, duration,
skills taught
• All encounters
audiotaped with random
audits and feedback by
physician, psychologist
• Average visit time ~ 90 minutes
• High rates of adherence / completion
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©2006 RUSH University Medical Center
CONTROL CONDITION
• Diabetes Self-management
curriculum
• Delivered by bilingual
newsletters mailed to home
• 36 newsletters, 24 months
• Same AADE 7
Content and selfmanagement
skills as in CHW
intervention arm
©2006 RUSH University Medical Center
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OUTCOME ASSESSMENT
• Research Assistants blinded to group
allocation; separated from CHW
interventionists
• NO use of information from CHWs used to
follow-up participants (differential
ascertainment)
• High retention rates at 2 years: 121 out of
144 randomized (84% retention)
• Intention to treat analysis
©2006 RUSH University Medical Center
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BASELINE DATA
Overall
Intervention
144
73
53.7 (12.2) 53.7 (11.7)
Mean age (sd)
Control
71
53.6 (12.7)
Preferred Language, N(%)
English
Female
14 (9.7)
6 (8.2)
8 (11.3)
Spanish 130 (90.3)
67 (91.7)
63 (88.7)
97 (67.4)
47 (64.4)
50 (70.4)
44 (60.3)
50 (70.4)
12 (16.4)
6 (8.2)
7 (9.9)
6 (8.5)
Marital Status, N(%)
Married/Common Law
94 (65.3)
Marriage
Separated/Divorced 19 (13.2)
Widowed 12 (8.3)
©2006 RUSH University Medical Center
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BASELINE DATA
Overall
Intervention
Control
144
73
71
42 (57.6)
13 (17.8)
18 (24.7)
40 (55.3)
12 (16.9)
19 (26.8)
7 (16.3)
21 (48.8)
15 (34.9)
12 (32.4)
17 (46.0)
8 (21.6)
Number of years in school, N(%)
≤6
7 – 11
> 11
82(56.9)
25 (17.4)
37 (25.7)
Difficulty paying for basics, N(%)
Very hard 19 (23.8)
Somewhat hard 38 (47.5)
Not hard at all 23 (28.8)
©2006 RUSH University Medical Center
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BASELINE CLINICAL DATA
Overall
Intervention
Control
Mean (SD)
8.3 (2.0)
8.5 (2.2)
8.1 (1.6)
<7
42 (30.0)
24 (33.8)
18 (26.1)
7–9
52 (37.1)
22 (31.0)
30 (43.5)
>9
46 (32.9)
25 (35.2)
21 (30.4)
87 (60.4)
49 (67.1)
38 (53.5)
133.6 (16.5)
129.7 (12.9)
72.5 (8.5)
69.2 (11.5)
Hemoglobin A1c
High Blood Pressure
% diagnosed with
Hypertension
SBP (mmHg), mean(sd) 131.7 (14.9)
DBP (mmHg), mean(sd)
70.8 (10.2)
©2006 RUSH University Medical Center
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BASELINE CLINICAL DATA
Overall
Intervention
Control
Waist (in), mean(sd)
41.7 (5.5)
41.5 (5.4)
42 (5.6)
BMI (continuous), mean(sd)
33.4 (8.5)
32.7 (7.4)
34.2 (9.5)
< 25
20 (14.1)
10 (13.7)
10 (14.5)
25 – < 30
35 (24.7)
20 (27.4)
15 (21.7)
Class I and II Obesity 30 – < 40
61 (43.0)
42 (43.8)
29 (42.0)
≥ 40
26 (18.3)
11 (15.1)
15 (21.7)
4.8 (2.9)
4.5 (2.7)
5.1 (3.0)
BMI (categorized), N(%)
Overweight
Class 2 Obesity
Total # of medications, mean(sd)
©2006 RUSH University Medical Center
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MATCH
Mexican-American Trial of Community Health workers
PRIMARY OUTCOMES
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RETENTION OF PARTICIPANTS
• 144 randomized
• 121 completed follow-up at 24 mos. (84%)
– 17 Lost to follow-up: 10 in CHW arm, 7 in
control
– 3 Withdrew from study: 2 in CHW, 1 in control
– 1 Administrative withdrawal: CHW arm
– 2 Died: 1 in CHW, 1 in control
©2006 RUSH University Medical Center
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# of Completed CHW Visits
25
#of Participants
20
15
10
5
0
0
1 to 6
7 to 12
13 to 18
19 to 24
25 to 30
©2006 RUSH University Medical Center
31- 35
36
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Hemoglobin A1c levels
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Rates of Blood Pressure control
Baseline Year 1
Year 2
CHW
37.2%
57.0%
44.9%
Control
47.4%
52.6%
59.5%
©2006 RUSH University Medical Center
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Adverse Events
• NO increase in hypoglycemia,
diabetes complications, or
hospitalizations
• Low drop-out rate from
intervention arm
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Costs of Intervention
Monthly
Cost
Reduction
in A1c
Nateglinide (Starlix)
$60
0.1 – 0.8
Hypoglycemia
Hypersensitivity
Cholestatic hepatitis
Flu-like symptoms
Diarrhea
Sitagliptin (Januvia)
$175
0.6 – 0.8
Stevens-Johnson syndrome
Angioedema
Pancreatitis
Acute Renal Failure
Abdominal Pain
$112
(30 units
daily)
0.5 – 1.7
Hypoglycemia
Hypokalemia
Anaphylaxis
Weight Gain
Rash
Edema
$85
0.5 – 0.7
Treatment
Insulin Glargine (Lantus)
COMMUNITY HEALTH
WORKER ($15 / hour + benefits)
Side Effects
©2006 RUSH University Medical Center
NONE
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NEXT STEPS?
• Other racial / ethnic groups
• Increased emphasis on BP control
• Increased emphasis to other risk factors
• Evaluate sustainability post-intervention
• Determine optimal maintenance dose
• Multi-center Effectiveness Trial – test under
“real world conditions”
• Patient-oriented outcomes (Hospitalization,
Complications, Death)
©2006 RUSH University Medical Center
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AN ACTION AGENDA FOR CHWs
• Document the costs and benefits of
existing CHW interventions
• Educate payer & business community
• Educate health care sector
• Advocate for policies that support
CHWs
– Training
– Career ladder
– Reimbursement
©2006 RUSH University Medical Center
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Conclusion
We have an effective, safe intervention
that brings best clinical practices and
improved diabetes control to people who
experience excess disability and death due
diabetes health disparities
Is there a reason to wait to
disseminate this intervention
while we gather more data and
refine the intervention further?
©2006 RUSH University Medical Center
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What if CHWs were a Medication?
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©2006 RUSH University Medical Center
Instead of showing you this…
©2006 RUSH University Medical Center
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COHELWO marketing plan
Progressive
Diabetes
Solutions, LLC
©2006 RUSH University Medical Center
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ACKNOWLEDGEMENTS
• Molly Martin, MD
MATCH Promotoras
• Susan Swider, RN, PhD
• Pilar Gonzalez
• Carmen Lynas, PhD
• Susana Leon
• Lynda Powell, PhD
• Maria Sanchez
• Elizabeth Avery, MS
• Imke Janssen, PhD
• Magdalena Nava
The staff of Centro San
Bonifacio
• Janet Footlik
• Elsa Arteaga
Erie Family Health Center