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OpenTrials
Completed

NCT Number: NCT05601349

TeleEducation for Implementing a Clinical Practice Guideline For Amputees

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.

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Key information

Conditions

Clinical Practice Guidelines Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Lower Limb Amputation Above Knee (Injury) Lower Limb Amputation Below Knee (Injury) Lower Limb Amputation Knee Lower Limb Ischemia Metabolic Diseases Nutritional and Metabolic Diseases Prosthesis User Rehabilitation Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Antioquia

Medellín, Antioquia, 050031, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telehealth-based strategy

Behavioral

Teleducation course, based on the CPG recommendations

Primary outcomes

  1. Rate of patients who received two stages amputation in severe infection

    Time frame: 1 week

    First stage for infection control and second stage for remodeling and definitive closure of the stump

  2. Rate of patients who received perioperative analgesia

    Time frame: 72 hours

    Perioperative epidural analgesia in patients who are going to be amputated from lower limbs to decrease acute pain of the stump and phantom limb in the period

  3. Rate of patients who received prophylactic antibiotics

    Time frame: 2 hours before the incision until 24 hours after the amputation

    Antibiotic use (Cefazolin or Vancomycin in case of allergy to beta-lactams) from 2 hours before the incision until 24 hours after the amputation

  4. Rate of patients who received transfemoral amputation instead of knee disarticulation

    Time frame: 24 hours

    Transfemoral amputation instead of knee disarticulation

  5. Rate of patients who received myodesis

    Time frame: 24 hours

    Myodesis (Suture of the adductor muscles to the bone through transosseous tunnels)

  6. Rate of patients who received immediate postoperative prosthesis

    Time frame: 24 hours

    verify the order of the immediate prosthesis and if it was manufactured

  7. Rate of patients who received a SACH foot

    Time frame: 3 to 6 months

    Adapt a solid ankle cushion heel (SACH) foot for amputations of the lower limbs above or below the knee and a low expected level of activity (K1 or K2)

  8. Rate of patients who received an articulated foot

    Time frame: 3 to 6 months

    adapt an articulated foot or a dynamic response foot in people with greater activity requirements (K3 / K4) or who must use the prosthesis on irregular or inclined surfaces

  9. Rate of patients who received a prosthetic knee for above knee amputees

    Time frame: 3 to 6 months

    Monocentric knee with manual locking or a knee with load brake in the K1 and monocentric or polycentric knee of fluid control in the K2, K3, K4 was prescribed

  10. Rate of patients who received a prosthetic knee for knee disarticulated amputees

    Time frame: 3 to 6 months

    mechanical polycentric knee was prescribed for disarticulation in K1 and polycentric fluid control for K2, K3, K4

  11. Rate of patients who received occupational therapy

    Time frame: 3 to 6 months

    occupational rehabilitation and ergonomic adaptations

  12. Rate of patients who received comprehensive Rehabilitation

    Time frame: 2 weeks to 12 weeks

    recommends the implementation of a comprehensive rehabilitation process: cardiopulmonary, musculoskeletal, psychosocial, activities of daily living and work

Sponsors and collaborators

Lead sponsor

Grupo Rehabilitacion en Salud

Network

Collaborators

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

Registry information

Official study 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

Acronym: TEFICA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 1, 2022
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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