Effectiveness and feasibility of a

program for the primary prevention of type 2 diabetes in

routine context of Primary Heath Care

Álvaro Sánchez, Carmen Silvestre, Catalina Martinez, Naroa Valderrama, Natalia Campo, Gonzalo Grandes

ObjectiveIndependent evaluation of the feasibility and effectiveness of commisioned implementation of an educational programme for the primaryprevention of type 2 diabetes (T2DM) in high risk populations in the routinecontext of primary care in the Basque Health Service - Osakidetza.

Design• Phase IV cluster clinical trial • 14 health centers randomized to intervention or control group• Non-diabetic patients aged 45 to 70 years old attending the collaborating

centers detected at high risk of T2DM (FINDRISC ≥14 points) were eligible

• Educational healthy lifestyles promotion intervention vs. standard care • Main outcomes:

Feasibility: Adoption, Reach, Implementation and sustainabilityEffectiveness: cumulative incidence of T2DM at 24 months.

Clinical intervention1) Risk screening: high risk FINDRISC >= 14 points2) Four group based 1.5 hour educative sessions onhealthy lifestyles3) On-going remote support (eg., phone contacts every 6 weeks after the educational intervention)

Implementation strategyPassive dissemination strategy: 14 hour training and resources on intervention components' content and procedures

ScreeningReach6.2%

InterventionReach48%Implementation

≈ 80 % completed

Adoption43% vs 31% FPs69% vs 58% NPs

ReachOR (IC 95%)

EfficiencyOR (IC 95%)

RefusalOR (IC 95%)

Targetedscreeningstrategy

0.47(0.33‐0.68)

2.4(1.19‐4.83)

0.29(0.18‐0.48)

Without an implementation strategy centers did their best…

Cumulative Incidence of T2DM at 24 monthsInterventionControl

Includedn=454

Includedn=634

OGTT 24 mesesN= 549 (86.5%)

Lost: 85 (12.6%)DM2 = 77 (12.1%)

OGTT 24 mesesN= 411 (90.5%)Lost: 43 (9.5%)DM2 = 38 (8.4%)

15,7%

15,4%

15,0%

10,2%

10,0%

8,4%

5,7%

0% 5% 10% 15% 20%

ZUAZO

TXURDINAGA

LLODIO

SAN MARTIN

AMARA BERRI

AZPEITIA

IRUN ‐ CENT

13,4%

10,7%

9,3%

7,8%

7,3%

5,9%

2,6%

0% 2% 4% 6% 8% 10% 12% 14% 16%

GALDAKAO

ARANBIZKARR

DUMBOA

SAN VICENTE

IZTIETA ‐ E

LEGAZPI

BOLUETA

Unadjusted (n=1088, ITT):Risk diference= 3.8 % (0.18% – 7.4%)

Relative Risk: 0.66 (0.44 – 0.99)

Adjusted (n=1063, ITT):Relative Risk: 0.63 (0.40 – 0.99)

Propensity Scores (n =850):Relative Risk: 0.62 (IC 95%: 0.39- 0.99)

LESSONS LEARNED1. Effective intervention for the primary prevention of T2DM versus poorly translated into routine PCH services: low adoption, limited reach, not integrated, discontinued,…

2. Multiple clinical practice determinants impeded a successful implementation: specific context is key

3. A passive implementation strategy (training & materials) reduced the likelihood of an optimal adoption and implementation

4. Multicomponent intervention strategies targeting determinants of T2DM prevention practice are needed in order to attain generalized adoption of evidence based interventions