NCT03254979: PREDIAPS

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

Completed NA Last updated 9 July 2020

What this trial tests

NA trial testing Healthy lifestyle prescription in Interprofessional Relations in 432 participants. Completed in 30 December 2019.

Timeline

15 March 2017

Primary endpoint
30 December 2019

30 December 2019

Quick facts

Lead sponsor	Basque Health Service
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	432
Start date	15 March 2017
Primary completion	30 December 2019
Estimated completion	30 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• Healthy lifestyle prescription

Conditions studied

• Interprofessional Relations — all drugs for Interprofessional Relations →
• Primary Health Care/Organization & Administration — all drugs for Primary Health Care/Organization & Administration →
• Diabetes Mellitus, Type 2/Prevention & Control — all drugs for Diabetes Mellitus, Type 2/Prevention & Control →
• Primary Prevention/Methods — all drugs for Primary Prevention/Methods →

Sponsor

Basque Health Service — full company profile →

Who can join

30 and older, any sex, with Interprofessional Relations or Primary Health Care/Organization & Administration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Screening for type 2 diabetes mellitus.
   Peer N, Balakrishna Y, Durao S. · · 2020 · cited 48× · PMID 32470201 · DOI 10.1002/14651858.cd005266.pub2
2. Engaging primary care professionals in collaborative processes for optimising type 2 diabetes prevention practice: the PREDIAPS cluster randomised type II hybrid implementation trial.
   Sanchez A, Grandes G, Pablo S, Espinosa M, et al · · 2018 · cited 8× · PMID 29996928 · DOI 10.1186/s13012-018-0783-0
3. 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.
   Sanchez A, Pablo S, Garcia-Alvarez A, Dominguez S, et al · · 2021 · cited 6× · PMID 34044869 · DOI 10.1186/s13012-021-01127-x
4. Fidelity evaluation of the compared procedures for conducting the PVS-PREDIAPS implementation strategy to optimize diabetes prevention in primary care.
   Sánchez A, Rogers HL, Pablo S, García E, et al · · 2021 · cited 5× · PMID 33573600 · DOI 10.1186/s12875-021-01378-z
5. Fidelity evaluation of the compared procedures for conducting the PREDIAPS implementation strategy to optimize diabetes prevention in Primary Care
   Sanchez A, Rogers HL, Pablo S, García E, et al · · 2020 · DOI 10.21203/rs.3.rs-50543/v2
6. Fidelity Evaluation of the Compared Procedures for Conducting the PREDIAPS Implementation Strategy to Optimize Diabetes Prevention in Primary Care
   Sanchez A, Rogers HL, Pablo S, García E, et al · · 2020 · DOI 10.21203/rs.3.rs-36703/v1