Concept and design of a cluster-randomized trial testing the impact of disseminating evidence-based recommendations in non-communicable diseases in Colombia

Article type
Authors
Villar JC1, Moreno K2, Vaquiro E2, Muñoz A2
1Universidad Autonoma de Bucaramanga
2Fundación Cardioinfantil
Abstract
Background: in recent years, Colombia has made progress towards the implementation of evidence-based healthcare practice, including the emergence of over 50 clinical practice guidelines backed by the ministry of health, and a national health technology assessment agency. Despite these advances, it is still uncertain to which extent a systematic strategy to disseminate evidence-based recommendations (EBR) can change practices among patients, caregivers, and health professionals locally.

Study design: we designed a parallel-group, cluster-randomized trial to test whether a systematic approach to deliver selected EBR through a combination of communication media, may change the frequency of recommended practices on selected non-communicable disease, compared to current use of information. The study setting will be the care for three major cardiovascular events (acute coronary syndrome, stroke and heart failure), two known risk factors (diabetes and hypertension) and two respiratory conditions (chronic obstructive pulmonary disease (COPD) and asthma) in Bogotá, Colombia.

Population: participants (250 clusters, with 20 individuals in each) will be patients with the conditions of interest (25% of the trial population), caregivers of this type of patients (25% of the trial population) and clinicians (general practitioners, family physicians or internists) whose practice involves at least 50% of patients with at least one of these conditions.

Intervention: the intervention will include both content and communication media. The content will be 40 selected EBR across the seven conditions of interest, different care scenarios (prehospital, post discharge or outpatient care), type of recommendations (in direction and strength), or PICO (Participants, Intervention, Comparator, Outcomes) questions posed (diagnosis or treatment), using predetermined quotas.
The communication media will be a composite of printed, SMS, email or web-page interactive messages and person-to-person visits, offered in two pre-established levels of frequency, with or without supporting content by random allocation, using a 2x2 factorial design. We also plan a series of qualitative studies to run alongside the interventions, in order to increase our understanding of how the interventions are perceived, understood, and respond to.
In addition to the primary comparisons (all clusters for both the inter-study arms and within the active arm), we plan to make a number of additional subgroup analysis of both randomized and non-randomized comparisons.

Outcomes and implications: this project will report for the first time in Colombia, the efficacy of systematic EBR to deliver, and the best possible way to reach patients, caregivers, and health professionals, to have a positive impact on health practices. These results may promote active participation in care practices and bring patients and caregivers closer to evidence-based practice; for health professionals, they may provide tools to enhance the appropriation and understanding of scientific evidence.