Clinical trial NCT03254979: Optimizing the Primary Prevention of Type-2 Diabetes in Primary Health Care
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interprofessional Relations
Primary Health Care/Organization & Administration
Diabetes Mellitus, Type 2/Prevention & Control
Primary Prevention/Methods
Risk Reduction Behavior
Randomized Controlled Trial
Life Style
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2017-08-21
Enrollment: 432
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The implementation strategy to facilitate the adoption of the recommended clinical intervention in primary prevention of T2DM will be common to both comparison groups. In order to differentiate and isolate the effect of the procedure of creation of the Multi-professional Community of Practice, the centers have been randomly assigned to two comparison groups: 5 centers assigned to the sequential procedure and the other 4 centers to the group procedure.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Implementation of the recommended clinical intervention by health care porfessionals
timeFrame: 12 months
Secondary outcomes:
measure: Lifestyle change at patient level
timeFrame: 12 months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Primary Care Research Unit of Bizkaia, OSAKIDETZA
Study officials:
References:
citation: Sanchez A, Pablo S, Garcia-Alvarez A, Dominguez S, Grandes G; PREDIAPS Group. Effectiveness of two procedures for deploying a facilitated collaborative modeling implementation strategy-the PVS-PREDIAPS strategy-to optimize type 2 diabetes prevention in primary care: the PREDIAPS cluster randomized hybrid type II implementation trial. Implement Sci. 2021 May 27;16(1):58. doi: 10.1186/s13012-021-01127-x.
citation: Sanchez A, Rogers HL, Pablo S, Garcia E, Rodriguez I, Flores MA, Galarza O, Gaztanaga AB, Martinez PA, Alberdi E, Resines E, Llarena AI, Grandes G; PREDIAPS Group. Fidelity evaluation of the compared procedures for conducting the PVS-PREDIAPS implementation strategy to optimize diabetes prevention in primary care. BMC Fam Pract. 2021 Feb 11;22(1):34. doi: 10.1186/s12875-021-01378-z.
citation: Sanchez A, Grandes G, Pablo S, Espinosa M, Torres A, Garcia-Alvarez A; PREDIAPS Group. Engaging primary care professionals in collaborative processes for optimising type 2 diabetes prevention practice: the PREDIAPS cluster randomised type II hybrid implementation trial. Implement Sci. 2018 Jul 11;13(1):94. doi: 10.1186/s13012-018-0783-0.