Clinical Practice GuidelinesTEFICANCT05601349
TeleEducation for Implementing a Clinical Practice Guideline For Amputees
A study testing Telehealth-based strategy in people with Clinical Practice Guidelines and Lower Limb Amputation Above Knee (Injury), run by Grupo Rehabilitacion en Salud at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Practice Guidelines, Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Telehealth-based strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- 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
- Being tested
- Telehealth-based strategy
- Keywords
- lower limb amputation, clinical practice guidelines, implementation strategies, rehabilitation
- Medical subject headings
- Wounds and Injuries, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-based strategyBehavioural
Teleducation course, based on the CPG recommendations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Telehealth-based strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours
Rate of patients who received myodesis
Myodesis (Suture of the adductor muscles to the bone through transosseous tunnels)
Measured: 24 hours
Rate of patients who received immediate postoperative prosthesis
verify the order of the immediate prosthesis and if it was manufactured
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 3 to 6 months
Rate of patients who received occupational therapy
occupational rehabilitation and ergonomic adaptations
Measured: 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
Measured: 2 weeks to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Jan 2020
- Primary completion20 Dec 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Practice GuidelinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Rehabilitacion en Salud
- Sponsor type
- Research network
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Universidad de Antioquia
- Responsible party
- Sponsor
- Investigators
- Jesús A Plata Contreras, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601349
- Sponsor's protocol ID
- GrupoRS005
- Acronym
- TEFICA
- Status last verified
- Nov 2022
- First submitted
- 26 Dec 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05601349
- Acronym / sponsor ID
- TEFICA / GrupoRS005
- 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
- Keywords
- lower limb amputation, clinical practice guidelines, implementation strategies, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Grupo Rehabilitacion en SaludResearch network
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Universidad de Antioquia
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Implementation of the Clinical Practice Guideline | Other | Behavioral: Telehealth-based strategyIn 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-education strategy | Active comparator | Behavioral: Telehealth-based strategyTele-educational program consisting of a virtual course with recommendations from the CPG of lower limb amputees, with three modules: Perioperative, rehabilitation and prostheses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Hospital providing medium and high complexity services in Antioquia that are linked or linked to the telehealth network of the University of Antioquia.
Key exclusion criteria (2 listed)
- Patients who were amputated for other causes not included in the target population of the CPG, such as cancer and congenital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth-based strategyTeleducation course, based on the CPG recommendations | Behavioural | Tele-education strategy, Usual Implementation of the Clinical Practice Guideline |
Primary outcome
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
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
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
Rate of patients who received transfemoral amputation instead of knee disarticulation
Time frame: 24 hours
Transfemoral amputation instead of knee disarticulation
Rate of patients who received myodesis
Time frame: 24 hours
Myodesis (Suture of the adductor muscles to the bone through transosseous tunnels)
Rate of patients who received immediate postoperative prosthesis
Time frame: 24 hours
verify the order of the immediate prosthesis and if it was manufactured
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)
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
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
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
Rate of patients who received occupational therapy
Time frame: 3 to 6 months
occupational rehabilitation and ergonomic adaptations
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús A Plata Contreras principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth-based strategy in people with Clinical Practice Guidelines and Lower Limb Amputation Above Knee (Injury), run by Grupo Rehabilitacion en Salud at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who received two stages amputation in severe infection (time frame: 1 week). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022; AzTrials last refreshed its copy on 2 Nov 2026.