Life Style Clinical Trial
— PREDIAPSOfficial title:
How to Engage Primary Health Care Providers in an Inter-professional Collaborative Modeling Process for the Optimization of Type-2 Diabetes Primary Prevention: a Randomized Hybrid Implementation Trial
Verified date | July 2020 |
Source | Basque Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE The translation into clinical practice of Primary Care (PHC) of effective and
sustainable interventions to prevent of type-2 diabetes (T2D) remains an unresolved
challenge. Leadership, active involvement of professionals, facilitation and adaptation to
the local context and their determinants are known to be key components in the success of
implementation strategies that seek to optimize clinical practice. However, one of the areas
in which there is still no evidence is related to the effectiveness of different strategies
to engage healthcare professionals in such innovation processes. Especially in real-world
Primary Care clinical contexts characterized by work overload and limited time, with marked
differentiation of professional status, both at the level of identity and competency.
OBJECTIVES To assess the effect of PHC providers engagement procedure in the creation and
execution of a facilitated collaborative modelling process, in the adoption, reach,
implementation and effectiveness of the recommended clinical practice for the prevention of
type-2 Diabetes
METHODOLOGY
Randomized cluster hybrid trial in which 9 PHC centres from Osakidetza will be allocated to
two different strategies to engage professionals and create an inter-professional
collaborative practice directed by a local leader and an external facilitator, to optimize
the integration of a T2D primary prevention program:
- A strategy focused on the sequential activation: started in nursing, which finally
manages to involve the whole center
- A global strategy with the participation of all professionals from the beginning
All centres and PHC professionals will receive training on current guidelines and scientific
evidence in primary prevention of T2D and effective interventions to promote healthy
lifestyles. Headed by a local leader and an external facilitator, centres will conduct a
collaborative structured process to model and adapt the intervention and its implementation
to the specific context of professionals and centres, and the determinants of T2D prevention
practice. One of the groups will perform this strategy globally, promoting the cooperation of
all health professionals from the beginning. The other will perform it sequentially, centred
first in nursing, who will lately seek the pragmatic cooperation of physicians and other
professionals.
All patients without diabetes aged ≥30 years old who attend at least once in collaborating
centres at high risk of developing T2DM (FINDRISC> = 14 points and / or intermediate
hyperglycaemia) will be eligible for program inclusion. The main outcome measures focus on
observed changes in T2DM prevention clinical practice at centre level after 12 and 24 months,
as a result of the implementation of one or another engagement strategy. Secondary outcomes
will compare their clinical effectiveness in changing exposed eligible patients' main
cardio-metabolic risk factors (Weight, BMI, Cholesterol, Glucose, Triglycerides) and
lifestyles behaviours (physical activity and diet) after 12 months.
Status | Completed |
Enrollment | 432 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: - All patients without diabetes aged =30 years old who attend at least once in collaborating centres at high risk of developing T2DM (Body Mass Index >=25 or intermediate hyperglycaemia) will be eligible for program inclusion. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Spain | Primary Care Research Unit of Bizkaia, OSAKIDETZA | Bilbao |
Lead Sponsor | Collaborator |
---|---|
Basque Health Service |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implementation of the recommended clinical intervention by health care porfessionals | The proportion of non-diabetic patients at high risk of developing DM2 exposed to the recommended intervention actions : assessing habits, personalized advice, prescription of lifestyle change plans and follow-up | 12 months | |
Secondary | Lifestyle change at patient level | Proportion of exposed patients who change their habits (physical activity and diet) and lose 5% of their body weight | 12 months |
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