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TeleEducation for Implementing a Clinical Practice Guideline For Amputees (TEFICA)

Primary Purpose

Clinical Practice Guidelines, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Telehealth-based strategy
Sponsored by
Grupo Rehabilitacion en Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Clinical Practice Guidelines focused on measuring lower limb amputation, clinical practice guidelines, implementation strategies, rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad de Antioquia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Usual Implementation of the Clinical Practice Guideline

Tele-education strategy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
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
Rate of patients who received transfemoral amputation instead of knee disarticulation
Transfemoral amputation instead of knee disarticulation
Rate of patients who received myodesis
Myodesis (Suture of the adductor muscles to the bone through transosseous tunnels)
Rate of patients who received immediate postoperative prosthesis
verify the order of the immediate prosthesis and if it was manufactured
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)
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
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
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
Rate of patients who received occupational therapy
occupational rehabilitation and ergonomic adaptations
Rate of patients who received comprehensive Rehabilitation
recommends the implementation of a comprehensive rehabilitation process: cardiopulmonary, musculoskeletal, psychosocial, activities of daily living and work

Secondary Outcome Measures

Full Information

First Posted
December 26, 2019
Last Updated
November 2, 2022
Sponsor
Grupo Rehabilitacion en Salud
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT05601349
Brief Title
TeleEducation for Implementing a Clinical Practice Guideline For Amputees
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Rehabilitacion en Salud
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Universidad de Antioquia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Implementation of the Clinical Practice Guideline
Arm Type
Other
Arm Description
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.
Arm Title
Tele-education strategy
Arm Type
Active Comparator
Arm Description
Tele-educational program consisting of a virtual course with recommendations from the CPG of lower limb amputees, with three modules: Perioperative, rehabilitation and prostheses
Intervention Type
Behavioral
Intervention Name(s)
Telehealth-based strategy
Intervention Description
Teleducation course, based on the CPG recommendations
Primary Outcome Measure Information:
Title
Rate of patients who received two stages amputation in severe infection
Description
First stage for infection control and second stage for remodeling and definitive closure of the stump
Time Frame
1 week
Title
Rate of patients who received perioperative analgesia
Description
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
Time Frame
72 hours
Title
Rate of patients who received prophylactic antibiotics
Description
Antibiotic use (Cefazolin or Vancomycin in case of allergy to beta-lactams) from 2 hours before the incision until 24 hours after the amputation
Time Frame
2 hours before the incision until 24 hours after the amputation
Title
Rate of patients who received transfemoral amputation instead of knee disarticulation
Description
Transfemoral amputation instead of knee disarticulation
Time Frame
24 hours
Title
Rate of patients who received myodesis
Description
Myodesis (Suture of the adductor muscles to the bone through transosseous tunnels)
Time Frame
24 hours
Title
Rate of patients who received immediate postoperative prosthesis
Description
verify the order of the immediate prosthesis and if it was manufactured
Time Frame
24 hours
Title
Rate of patients who received a SACH foot
Description
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)
Time Frame
3 to 6 months
Title
Rate of patients who received an articulated foot
Description
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
Time Frame
3 to 6 months
Title
Rate of patients who received a prosthetic knee for above knee amputees
Description
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
Time Frame
3 to 6 months
Title
Rate of patients who received a prosthetic knee for knee disarticulated amputees
Description
mechanical polycentric knee was prescribed for disarticulation in K1 and polycentric fluid control for K2, K3, K4
Time Frame
3 to 6 months
Title
Rate of patients who received occupational therapy
Description
occupational rehabilitation and ergonomic adaptations
Time Frame
3 to 6 months
Title
Rate of patients who received comprehensive Rehabilitation
Description
recommends the implementation of a comprehensive rehabilitation process: cardiopulmonary, musculoskeletal, psychosocial, activities of daily living and work
Time Frame
2 weeks to 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús A Plata Contreras
Organizational Affiliation
Universidad de Antioquia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Antioquia
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050031
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TeleEducation for Implementing a Clinical Practice Guideline For Amputees

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