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临床试验/NCT03254979
NCT03254979已完成不适用

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

Basque Health Service1 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2017年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
432
试验地点
1
主要终点
Implementation of the recommended clinical intervention by health care porfessionals

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Since the new program is an optimization of the type-2 diabetes prevention services already offered in Osakidetza, it is expected that the participating patients will be blind to group allocation.

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

Sequential engagement

Experimental

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

干预措施: Healthy lifestyle prescription (Behavioral)

Global engagement

Active Comparator

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

干预措施: Healthy lifestyle prescription (Behavioral)

结局指标

主要结局

Implementation of the recommended clinical intervention by health care porfessionals

时间窗: 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

次要结局

  • Lifestyle change at patient level(12 months)

研究者

发起方
Basque Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alvaro Sanchez Perez

PhD

Basque Health Service

研究点 (1)

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