Optimizing the Primary Prevention of Type-2 Diabetes in Primary Health Care

Not Applicable

Completed

• Conditions: Primary Health Care/Organization & Administration; Risk Reduction Behavior; Interprofessional Relations; Diabetes Mellitus, Type 2/Prevention & Control; Primary Prevention/Methods; Randomized Controlled Trial; Life Style
• Interventions: Behavioral: Healthy lifestyle prescription

• Registration Number: NCT03254979
• Lead Sponsor: Basque Health Service

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 432

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential engagement	Healthy lifestyle prescription	Inter-professional collaborative practice directed by a local leader and an external facilitator to optimize the integration of a T2D primary prevention recommended clinical intervention. In this group, a sequential engagement of professional categories, initiated in nursing, which finally involves the whole professional groups of the center (eg. physicians, etc), will be followed
Global engagement	Healthy lifestyle prescription	Inter-professional collaborative practice directed by a local leader and an external facilitator to optimize the integration of a T2D primary prevention recommended clinical intervention. In this group, a global strategy of engagement with the participation of all professionals from the beginning, will be followed

Primary Outcome Measures

Name	Time	Method
Implementation of the recommended clinical intervention by health care porfessionals	12 months	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

Secondary Outcome Measures

Name	Time	Method
Lifestyle change at patient level	12 months	Proportion of exposed patients who change their habits (physical activity and diet) and lose 5% of their body weight

Trial Locations

Locations (1)

Primary Care Research Unit of Bizkaia, OSAKIDETZA; 🇪🇸 Bilbao, Spain