TeleEducation for Implementing a Clinical Practice Guideline For Amputees

NCT05601349 | Completed DMC

• 1 other identifier: GrupoRS005
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• Rate of patients who received transfemoral amputation instead of knee disarticulation

  Transfemoral amputation instead of knee disarticulation

  24 hours

• Rate of patients who received myodesis

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

  24 hours

• Rate of patients who received immediate postoperative prosthesis

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

  24 hours

• 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

• 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

• 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

• 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

• Rate of patients who received occupational therapy

  occupational rehabilitation and ergonomic adaptations

  3 to 6 months

• 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

Study Arms (2)

Usual Implementation of the Clinical Practice Guideline

OTHER

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.

Behavioral: Telehealth-based strategy

Tele-education strategy

ACTIVE COMPARATOR

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

Behavioral: Telehealth-based strategy

Interventions

Telehealth-based strategy BEHAVIORAL

Teleducation course, based on the CPG recommendations

Tele-education strategy; Usual Implementation of the Clinical Practice Guideline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo Rehabilitacion en Salud: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator
• Universidad de Antioquia: collaborator

Study Sites (1)

Universidad de Antioquia

Medellín, Antioquia, 050031, Colombia

Location

MeSH Terms

Conditions

Wounds and Injuries; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jesús A Plata Contreras

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: November 1, 2022
• Study Start: January 1, 2020
• Primary Completion: December 20, 2021
• Study Completion: May 1, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)