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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 432
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Bilbao, Spain
    • Primary Care Research Unit of Bizkaia, OSAKIDETZA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequential engagement; 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	Behavioral: Healthy lifestyle prescription; 3 actions for the prevention of DM2 in the clinical setting are recommended: A screening strategy for people with impaired glucose regulation or high risk of developing DM2, with the following recommendations: screening for DM2 within the strategy of opportunistic screening for CV risk factors in population ≥45 years Or ≥30 years in the presence of a previous risk factor (eg, hypertension); Screening for DM2 based on the presence of a BMI ≥25 in the population aged 40-70 years; Or, risk screening for DM2-FINDRISC in a population of 45-70 years.; With those identified at high risk, perform a structured program of intensive intervention focused on the prescription of personalized plans on lifestyle modification (low calorie and low fat diet, and at least 150 minutes of physical exercise per week).; A follow-up intervention component to maintain the motivation of those interviewed, with more frequent contacts initially, with at least annual review visits.
Active Comparator: Global engagement; 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	Behavioral: Healthy lifestyle prescription; 3 actions for the prevention of DM2 in the clinical setting are recommended: A screening strategy for people with impaired glucose regulation or high risk of developing DM2, with the following recommendations: screening for DM2 within the strategy of opportunistic screening for CV risk factors in population ≥45 years Or ≥30 years in the presence of a previous risk factor (eg, hypertension); Screening for DM2 based on the presence of a BMI ≥25 in the population aged 40-70 years; Or, risk screening for DM2-FINDRISC in a population of 45-70 years.; With those identified at high risk, perform a structured program of intensive intervention focused on the prescription of personalized plans on lifestyle modification (low calorie and low fat diet, and at least 150 minutes of physical exercise per week).; A follow-up intervention component to maintain the motivation of those interviewed, with more frequent contacts initially, with at least annual review visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Basque Health Service

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PI15/00350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No