©2006 RUSH University Medical Center

Molly A. Martin, MDSteven K. Rothschild, MDSusan M. Swider, PhD, APHN-BCCarmen M. Tumialan-Lynas, PhDImke Janssen, PhD

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)

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 Center2

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 Center3

©2006 RUSH University Medical Center4

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

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 Center5

©2006 RUSH University Medical Center6

MEXICAN-AMERICAN TRIAL OF COMMUNITY HEALTH

WORKERS

• Behavioral Randomized Controlled Trial

• Efficacy: Testing CHWs under ideal conditions

• Population:

• Community-dwelling urban Mexican-Americans

• Defined as born in Mexico themselves - or - 1 parent or 2 grandparents born in MX

• Type 2 Diabetes mellitus without major end-organ complication

[R01 DK061289]

©2006 RUSH University Medical Center7

Health Status, Behavior Change

PRIMARY STUDY OUTCOMES

Improved risk factors after 2 years

•A1c – glucose control

•% with Blood Pressure at goal (<130/80)

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

©2006 RUSH University Medical Center8

• Behavioral Content from American Association of Diabetes Educators (AADE-7)

MATCH CURRICULUMDiabetes Self-Management BEHAVIORS

(AADE-7)  General Self-Management SKILLS

1) Check blood glucose daily and understand the results

  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 Center9

INTERVENTION FIDELITY

• CHWs documented content of visits, duration, skills taught

• All encounters audiotaped with random audits and feedback by physician, psychologist

©2006 RUSH University Medical Center

10

• Average visit time ~ 90 minutes

• High rates of adherence / completion

CONTROL CONDITION

• Diabetes Self-management curriculum

• Delivered by bilingual newsletters mailed to home

• 36 newsletters, 24 months

• Same AADE 7 Content and self-management skills as in CHW intervention arm

©2006 RUSH University Medical Center11

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 Center12

BASELINE DATA

©2006 RUSH University Medical Center13

  Overall Intervention Control

144 73 71

Mean age (sd) 53.7 (12.2) 53.7 (11.7) 53.6 (12.7)

Preferred Language, N(%)

English 14 (9.7) 6 (8.2) 8 (11.3)

Spanish 130 (90.3) 67 (91.7) 63 (88.7)

Female 97 (67.4) 47 (64.4) 50 (70.4)

Marital Status, N(%)Married/Common Law

Marriage94 (65.3) 44 (60.3) 50 (70.4)

Separated/Divorced 19 (13.2) 12 (16.4) 7 (9.9)Widowed 12 (8.3) 6 (8.2) 6 (8.5)

Never married 19 (13.2) 11 (15.1) 8 (11.3)

BASELINE DATA

©2006 RUSH University Medical Center14

  Overall Intervention Control

144 73 71

Number of years in school, N(%)

≤ 6 82(56.9) 42 (57.6) 40 (55.3) 7 – 11 25 (17.4) 13 (17.8) 12 (16.9) > 11 37 (25.7) 18 (24.7) 19 (26.8)

Difficulty paying for basics, N(%)

Very hard 19 (23.8) 7 (16.3) 12 (32.4)Somewhat hard 38 (47.5) 21 (48.8) 17 (46.0)

Not hard at all 23 (28.8) 15 (34.9) 8 (21.6)

BASELINE CLINICAL DATA

©2006 RUSH University Medical Center15

  Overall Intervention Control

Hemoglobin A1c

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)

High Blood Pressure% diagnosed with

Hypertension 87 (60.4) 49 (67.1) 38 (53.5)

SBP (mmHg), mean(sd) 131.7 (14.9) 133.6 (16.5) 129.7 (12.9)

DBP (mmHg), mean(sd) 70.8 (10.2) 72.5 (8.5) 69.2 (11.5)

BASELINE CLINICAL DATA

©2006 RUSH University Medical Center16

  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)

BMI (categorized), N(%)      

< 25 20 (14.1) 10 (13.7) 10 (14.5)

Overweight 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)

Class 2 Obesity ≥ 40 26 (18.3) 11 (15.1) 15 (21.7)

Total # of medications, mean(sd) 4.8 (2.9) 4.5 (2.7) 5.1 (3.0)

PRIMARY OUTCOMES

MATCHMexican-American Trial of Community Health workers

©2006 RUSH University Medical Center17

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 Center18

# of Completed CHW Visits

©2006 RUSH University Medical Center19

Hemoglobin A1c levels

©2006 RUSH University Medical Center20

Rates of Blood Pressure control

©2006 RUSH University Medical Center21

Baseline Year 1 Year 2

CHW 37.2% 57.0% 44.9%

Control 47.4% 52.6% 59.5%

Adverse Events

©2006 RUSH University Medical Center22

• NO increase in hypoglycemia, diabetes complications, or hospitalizations

• Low drop-out rate from intervention arm

Costs of Intervention

©2006 RUSH University Medical Center23

Treatment Monthly Cost

Reduction in A1c Side Effects

Nateglinide (Starlix) $60 0.1 – 0.8 HypoglycemiaHypersensitivityCholestatic hepatitisFlu-like symptomsDiarrhea

Sitagliptin (Januvia) $175 0.6 – 0.8 Stevens-Johnson syndromeAngioedemaPancreatitisAcute Renal FailureAbdominal Pain

Insulin Glargine (Lantus) $112 (30 units

daily)

0.5 – 1.7 HypoglycemiaHypokalemiaAnaphylaxisWeight GainRashEdema

COMMUNITY HEALTH WORKER ($15 / hour + benefits)

$85 0.5 – 0.7 NONE

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 Center24

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

25

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 Center26

What if CHWs were a Medication?

©2006 RUSH University Medical Center

27

Instead of showing you this…

©2006 RUSH University Medical Center28

COHELWO marketing plan

©2006 RUSH University Medical Center29

ProgressiveDiabetesSolutions, LLC

ACKNOWLEDGEMENTS

• Molly Martin, MD

• Susan Swider, RN, PhD

• Carmen Lynas, PhD

• Lynda Powell, PhD

• Elizabeth Avery, MS

• Imke Janssen, PhD

• Magdalena Nava

• Janet Footlik

• Elsa Arteaga

MATCH Promotoras

•Pilar Gonzalez

•Susana Leon

•Maria Sanchez

The staff of Centro San Bonifacio

Erie Family Health Center