Clinical trial NCT05601349: TeleEducation for Implementing a Clinical Practice Guideline For Amputees
Official title: Effectiveness of a Telehealth-based Strategy to Improve the Implementation of the Clinical Practice Guide for Lower Limb Amputees by Neurovascular Disease and Trauma: Intervention Trial Randomised by Clusters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: lower limb amputation
clinical practice guidelines
implementation strategies
rehabilitation
Lead sponsor: Grupo Rehabilitacion en Salud
Sponsor class: NETWORK
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
name: Universidad de Antioquia
First posted: 2022-11-01
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of patients who received two stages amputation in severe infection
timeFrame: 1 week
measure: Rate of patients who received perioperative analgesia
timeFrame: 72 hours
measure: Rate of patients who received prophylactic antibiotics
timeFrame: 2 hours before the incision until 24 hours after the amputation
measure: Rate of patients who received transfemoral amputation instead of knee disarticulation
timeFrame: 24 hours
measure: Rate of patients who received myodesis
timeFrame: 24 hours
measure: Rate of patients who received immediate postoperative prosthesis
timeFrame: 24 hours
measure: Rate of patients who received a SACH foot
timeFrame: 3 to 6 months
measure: Rate of patients who received an articulated foot
timeFrame: 3 to 6 months
measure: Rate of patients who received a prosthetic knee for above knee amputees
timeFrame: 3 to 6 months
measure: Rate of patients who received a prosthetic knee for knee disarticulated amputees
timeFrame: 3 to 6 months
measure: Rate of patients who received occupational therapy
timeFrame: 3 to 6 months
measure: Rate of patients who received comprehensive Rehabilitation
timeFrame: 2 weeks to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Jesús A Plata Contreras
role: PRINCIPAL_INVESTIGATOR
References: