TeleEducation for Implementing a Clinical Practice Guideline For Amputees

Diabetes Mellitus Clinical Trial

— TEFICA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601349
• Other study ID #: GrupoRS005
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2022
• Source: Grupo Rehabilitacion en Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 1, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Telehealth-based strategy
Teleducation course, based on the CPG recommendations

Locations

Country	Name	City	State
Colombia	Universidad de Antioquia	Medellín	Antioquia

Sponsors (3)

Lead Sponsor	Collaborator
Grupo Rehabilitacion en Salud	Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who received two stages amputation in severe infection	First stage for infection control and second stage for remodeling and definitive closure of the stump	1 week
Primary	Rate of patients who received perioperative analgesia	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	72 hours
Primary	Rate of patients who received prophylactic antibiotics	Antibiotic use (Cefazolin or Vancomycin in case of allergy to beta-lactams) from 2 hours before the incision until 24 hours after the amputation	2 hours before the incision until 24 hours after the amputation
Primary	Rate of patients who received transfemoral amputation instead of knee disarticulation	Transfemoral amputation instead of knee disarticulation	24 hours
Primary	Rate of patients who received myodesis	Myodesis (Suture of the adductor muscles to the bone through transosseous tunnels)	24 hours
Primary	Rate of patients who received immediate postoperative prosthesis	verify the order of the immediate prosthesis and if it was manufactured	24 hours
Primary	Rate of patients who received a SACH foot	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)	3 to 6 months
Primary	Rate of patients who received an articulated foot	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	3 to 6 months
Primary	Rate of patients who received a prosthetic knee for above knee amputees	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	3 to 6 months
Primary	Rate of patients who received a prosthetic knee for knee disarticulated amputees	mechanical polycentric knee was prescribed for disarticulation in K1 and polycentric fluid control for K2, K3, K4	3 to 6 months
Primary	Rate of patients who received occupational therapy	occupational rehabilitation and ergonomic adaptations	3 to 6 months
Primary	Rate of patients who received comprehensive Rehabilitation	recommends the implementation of a comprehensive rehabilitation process: cardiopulmonary, musculoskeletal, psychosocial, activities of daily living and work	2 weeks to 12 weeks