TeleEducation for Implementing a Clinical Practice Guideline For Amputees

NCT ID: NCT05601349

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-05-01

Brief Summary

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The publication of a Clinical Practice Guideline (CPG) is often not enough for its correct use in the field of health care. There are barriers to the implementation of the CPG recommendations, including those related to the lack of knowledge or skills on the part of health service providers. Strategies have been proposed to improve the implementation of the CPGs through interventions with different levels of effectiveness, such as the use of reminders, informative meetings, sending educational material, audits, among others. Some of these interventions can be carried out through Telehealth strategies, that is, with remote services. The purpose of this study is to evaluate the effectiveness of a Telehealth program to improve the implementation of the Clinical Practice Guideline for diagnosis and preoperative, intraoperative and postoperative treatment of the amputee, the prescription of the prosthesis and comprehensive rehabilitation, through strategies to publicize the recommendations included in the CPG and train doctors, reducing the barriers related to the lack of knowledge of the CPG. For this, two groups of institutions that provide health services in Antioquia will be compared, randomized according to two interventions: the socialization of the recommendations of the CPG for amputees, against a combined strategy of education through a Telehealth platform and the delivery of educational material. Compliance with prioritized recommendations of the CPG will be evaluated, related to surgical techniques, perioperative practices, the prescription of prosthetic components and referral to services that allow the comprehensive rehabilitation of the person with amputation. Additionally, the theoretical knowledge of the doctors of each participating institution before and after the interventions will be evaluated through a written test.

Detailed Description

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The effectiveness of the educational program based on telehealth tools (TeleEducation: virtual course with recommendations from the CPG of lower limb amputees, at least four modules: Orthopedics, surgery, rehabilitation and prostheses; TeleAssistance: virtual conference between CPG researchers and professional from selected hospitals and delivery of educational material containing the recommendations of the CPG) compared to the usual socialization of the CPG in an informative meeting to the health personnel of the institutions, will be evaluated by means of a generalized estimated equation model (GEE) for dichotomous variables using the binomial distribution and logit as a link function since the outcomes that will be used will be handled with two coded response options 1 = satisfy 0 = does not satisfy and given the design of conglomerates where the measurements would be correlated.

The investigators are expecting to improve the implementation of the CPG be at least 15% higher than compare the intervention group with the control group.

The effectiveness of a telehealth based strategy is expected to improve the Implementation of the Clinical Practice Guide for diagnosis and preoperative treatment, intraoperative and postoperative period of the amputated person, the prescription of the prosthesis and the comprehensive rehabilitation in health institutions in Antioquia, Colombia, be at least 15% higher than compare the intervention group with the control group.

Conditions

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Clinical Practice Guidelines Lower Limb Amputation Above Knee (Injury) Lower Limb Amputation Below Knee (Injury) Lower Limb Amputation Knee Lower Limb Ischemia Diabetes Mellitus Rehabilitation Prosthesis User

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Community based intervention study randomized by clusters. These studies are differentiated by the method of randomisation, in which a group of individuals is randomly assigned to an intervention as a group or cluster rather than as individuals.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Each cluster is conformed by one hospital of middle or higher attention level, the individuals in each cluster don´t know the intervention options, and the outcomes assessor either

Study Groups

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Usual Implementation of the Clinical Practice Guideline

In this group, all participants (cluster) have access to the clinical practice guideline that has been sent to the office responsible for implementing the guideline in the hospital. Due to the characteristics of the intervention in the control group it does not work as a placebo or a sham intervention.

Group Type OTHER

Telehealth-based strategy

Intervention Type BEHAVIORAL

Teleducation course, based on the CPG recommendations

Tele-education strategy

Tele-educational program consisting of a virtual course with recommendations from the CPG of lower limb amputees, with three modules: Perioperative, rehabilitation and prostheses

Group Type ACTIVE_COMPARATOR

Telehealth-based strategy

Intervention Type BEHAVIORAL

Teleducation course, based on the CPG recommendations

Interventions

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Telehealth-based strategy

Teleducation course, based on the CPG recommendations

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Hospital providing medium and high complexity services in Antioquia that are linked or linked to the telehealth network of the University of Antioquia.

* Patients with lower limb amputation due to traumatic, vascular or diabetes mellitus that are treated in the aforementioned institutions.
* Health professionals who use CPG for people with amputation.
* Hospitals, patients and professionals who agree to participate in the project

Exclusion Criteria

* Patients who were amputated for other causes not included in the target population of the CPG, such as cancer and congenital.

* Amputee patients under 16 years.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role collaborator

Universidad de Antioquia

OTHER

Sponsor Role collaborator

Grupo Rehabilitacion en Salud

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesús A Plata Contreras

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

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Universidad de Antioquia

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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GrupoRS005

Identifier Type: -

Identifier Source: org_study_id

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