Anesthesiatxt-RANCT06313294
Postoperative Follow-up Via Text Messages Automated Versus Telephone in Patients With Continuous Regional Anesthesia
A study testing Tracking application app and Telephone interview in people with Anesthesia and Regional Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Monitoring performed by a trained operator has proven to be useful and valued by patients after the use of continuous regional anesthesia. A health professional calls each patient to gather information about their recovery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Regional Anesthesia, Nerve Pain
- What is being tested?
- Tracking application app and Telephone interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 31 May 2024to 13 Aug 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery with continuous ambulatory regional analgesia
- Able to understand, use and operate a smartphone to view the mobile application
- ASA I - II
Who cannot join
- Ages under 17 or over 76 years
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 450881
About this study
Monitoring performed by a trained operator has proven to be useful and valued by patients after the use of continuous regional anesthesia. A health professional calls each patient to gather information about their recovery. However, this direct communication strategy requires time and resources, especially if many patients are involved.
A modern and convenient approach involves the use of immediate communication technology for follow-up after a procedure. They may contain specific questions that patients can easily answer from their mobile devices.
Read more
Automated text messages could be associated with greater convenience and ease for patients with response rates at least like the traditional method. Phone calls, on the other hand, may be less scalable and require more human resources.
The objective of the project is to evaluate the feasibility of monitoring through automated electronic messaging by evaluating its usability using a validated scale in Spanish. response rate on the first day and adherence rate compared to that of the traditional method. Secondarily, adherence and differences in satisfaction will be compared.
Read the detailed description
Communication with patients after performing any procedure under regional anesthesia is essential to evaluate pain control, measure patient satisfaction, and detect post-surgical and post-anesthetic complications.
However, for outpatients, achieving follow-up through phone calls can be a real challenge. Gessner et al report that successful daily telephone contact for patients discharged with a continuous perineural blocking catheter varies between 49 and 65%. While their results with the use of an automated messaging system, delivered results as promising as a response rate of 91%, considering a range of 18 to 90 years.
It is known that the mobile application market is expanding with great diversity on different devices. For this reason, there is great competition among application developers to create those that best fulfill the tasks proposed each day.
For this, the usability of mobile applications is a crucial tool to obtain a competitive advantage in these circumstances.
The significance of the expected results described above will open a door to the sequential or gradual implementation of a system that allows us to reduce the time and/or number of people required per day to achieve adequate follow-up of the patients. In addition, it would leave room for new projects that seek to devise an ordered work plan to identify the subgroup of patients who objectively require a live call to evaluate complications of the procedure.
The hypothesis is that the use of a mobile monitoring application in patients using postoperative continuous ambulatory regional analgesia is associated with usability levels equal to or higher than the 64th percentile measured on the SUS usability scale in its Spanish version.
To determine the degree of satisfaction that exists between the use of an automated system for the monitoring of patients undergoing continuous regional anesthesia at the UC-Christus Clinical Hospital. How much it impacts adherence to follow-up will also be reviewed, comparing it with the traditional method (telephone interview).
A convenience sample of 100 consecutive patients will be selected with continuous outpatient regional analgesia performed in the wards of the UC-Christus Clinical Hospital, San Carlos de Apoquindo Clinic and Santa Lucía Medical Center. For this, for a maximum period of 6 months, 100 patients will be randomly distributed into 2 groups, one for conventional telephone follow-up and the other for use of the app.
- Conditions
- Anesthesia, Regional Anesthesia, Nerve Pain
- Being tested
- Tracking application app, Telephone interview
- Keywords
- Anesthesia, Regional, Regional Anesthesia, Continuous Nerve Block, Ambulatory, Outpatient follow-up
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracking application appOther
An app will be implemented for mobile monitoring in patients who use continuous postoperative ambulatory regional analgesia.
Telephone interviewOther
Patients who use continuous postoperative outpatient regional analgesia will be followed up using the current traditional method of post-discharge telephone call.
| Study group | Role | What they receive |
|---|---|---|
| App Group | Experimental | In this group the patients will use the app for asking about related to pain, patient satisfaction and another complications. Receives: Other: Tracking application app |
| Telephone interview group | Active comparator | In this group the patients will receive the calling by one member of the healthcare team asking items related to pain, patient satisfaction and another complications. Receives: Other: Telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability level of the tracking application
To determine the level of usability of the application using the SUS scale developed by John Brooke in 1986. This scale consists of 10 Likert-type statements. To calculate the result, the statements have an answer that will be equivalent to 1, 2, 3, 4 or 5, depending on said answer. The answers to the odd and even statements are added and then subtracted 5 and 25, respectively. The sum of both results is subsequently multiplied by 2.5 to obtain a result that ranges from 0 to 100, with 64 being our cut-off point to consider it acceptable.
Measured: 1, 2 and 3 days after discharge.
Secondary outcomes (2)
Patient satisfaction with Perception of Quality in Anesthesia
Measure and compare the level of patient satisfaction using the Perception of Quality in Anesthesia (PQA) scale validated in Spanish. In this instrument, the patient was asked to respond using a five-point Likert scale.
The extremes of the scale were labelled 'very poor' to 'very good' or 'definitely not' to 'definitely yes' depending upon the question. Unsatisfactory patient responses were defined as a score of ≤3, any response 'yes' to the awareness question, or any description of nausea or vomiting in the PONV question.
A quality index was calculated for each PQA question by multiplying the importance score against the performance score.
Measured: 1, 2 and 3 days after discharge.
Patient adherence
Measure and compare patient adherence using the app versus the telephone follow-up method, defined as rate of response during the three days of follow-up.
Measured: 1, 2 and 3 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start31 May 2024
- Primary completion9 Aug 2024
- Study completion13 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will are assigned to one of two groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Altermatt, MD, Study chair, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313294
- Sponsor's protocol ID
- 230929002
- Acronym
- txt-RA
- Status last verified
- Aug 2024
- First submitted
- 23 Feb 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strange E, Altermatt FR, Caceres L, Morrison C, Cortes L, Sumonte N, Neyem A; FAR-UC Group. Postoperative follow-up by automated text messaging versus telephone call in outpatient care with continuous regional analgesia: a randomized controlled feasibility trial. Reg Anesth Pain Med. 2025 Sep 18:rapm-2025-106818. doi: 10.1136/rapm-2025-106818. Online ahead of print.
PubMed 40973445
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Follow-up Via Text Messages Automated Versus Telephone in Patients With Continuous Regional Anesthesia
- ClinicalTrials.gov ID
- NCT06313294
- Acronym / sponsor ID
- txt-RA / 230929002
- Conditions
- Anesthesia, Regional Anesthesia, Nerve Pain
- Keywords
- Anesthesia, Regional, Regional Anesthesia, Continuous Nerve Block, Ambulatory, Outpatient follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 15 Mar 2024 (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.
Monitoring performed by a trained operator has proven to be useful and valued by patients after the use of continuous regional anesthesia. A health professional calls each patient to gather information about their recovery. However, this direct communication strategy requires time and resources, especially if many patients are involved.
A modern and convenient approach involves the use of immediate communication technology for follow-up after a procedure. They may contain specific questions that patients can easily answer from their mobile devices.
Automated text messages could be associated with greater convenience and ease for patients with response rates at least like the traditional method. Phone calls, on the other hand, may be less scalable and require more human resources.
The objective of the project is to evaluate the feasibility of monitoring through automated electronic messaging by evaluating its usability using a validated scale in Spanish. response rate on the first day and adherence rate compared to that of the traditional method. Secondarily, adherence and differences in satisfaction will be compared.
Detailed description
Communication with patients after performing any procedure under regional anesthesia is essential to evaluate pain control, measure patient satisfaction, and detect post-surgical and post-anesthetic complications.
However, for outpatients, achieving follow-up through phone calls can be a real challenge. Gessner et al report that successful daily telephone contact for patients discharged with a continuous perineural blocking catheter varies between 49 and 65%. While their results with the use of an automated messaging system, delivered results as promising as a response rate of 91%, considering a range of 18 to 90 years.
It is known that the mobile application market is expanding with great diversity on different devices. For this reason, there is great competition among application developers to create those that best fulfill the tasks proposed each day.
For this, the usability of mobile applications is a crucial tool to obtain a competitive advantage in these circumstances.
The significance of the expected results described above will open a door to the sequential or gradual implementation of a system that allows us to reduce the time and/or number of people required per day to achieve adequate follow-up of the patients. In addition, it would leave room for new projects that seek to devise an ordered work plan to identify the subgroup of patients who objectively require a live call to evaluate complications of the procedure.
The hypothesis is that the use of a mobile monitoring application in patients using postoperative continuous ambulatory regional analgesia is associated with usability levels equal to or higher than the 64th percentile measured on the SUS usability scale in its Spanish version.
To determine the degree of satisfaction that exists between the use of an automated system for the monitoring of patients undergoing continuous regional anesthesia at the UC-Christus Clinical Hospital. How much it impacts adherence to follow-up will also be reviewed, comparing it with the traditional method (telephone interview).
A convenience sample of 100 consecutive patients will be selected with continuous outpatient regional analgesia performed in the wards of the UC-Christus Clinical Hospital, San Carlos de Apoquindo Clinic and Santa Lucía Medical Center. For this, for a maximum period of 6 months, 100 patients will be randomly distributed into 2 groups, one for conventional telephone follow-up and the other for use of the app.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| App Group | Experimental | Other: Tracking application appIn this group the patients will use the app for asking about related to pain, patient satisfaction and another complications. |
| Telephone interview group | Active comparator | Other: Telephone interviewIn this group the patients will receive the calling by one member of the healthcare team asking items related to pain, patient satisfaction and another complications. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective surgery with continuous ambulatory regional analgesia
- Able to understand, use and operate a smartphone to view the mobile application
- ASA I - II
Key exclusion criteria (2 listed)
- Ages under 17 or over 76 years
- Emergency surgery
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 |
|---|---|---|
| Tracking application appAn app will be implemented for mobile monitoring in patients who use continuous postoperative ambulatory regional analgesia. | Other | App Group |
| Telephone interviewPatients who use continuous postoperative outpatient regional analgesia will be followed up using the current traditional method of post-discharge telephone call. | Other | Telephone interview group |
Primary outcome
Usability level of the tracking application
Time frame: 1, 2 and 3 days after discharge.
To determine the level of usability of the application using the SUS scale developed by John Brooke in 1986. This scale consists of 10 Likert-type statements. To calculate the result, the statements have an answer that will be equivalent to 1, 2, 3, 4 or 5, depending on said answer. The answers to the odd and even statements are added and then subtracted 5 and 25, respectively. The sum of both results is subsequently multiplied by 2.5 to obtain a result that ranges from 0 to 100, with 64 being our cut-off point to consider it acceptable.
2 secondary outcomes
Patient satisfaction with Perception of Quality in Anesthesia
Time frame: 1, 2 and 3 days after discharge.
Patient adherence
Time frame: 1, 2 and 3 days after discharge.
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 22 Aug 2024.
- Derived from this study: PubMed 40973445Strange E, Altermatt FR, Caceres L, Morrison C, Cortes L, Sumonte N, Neyem A; FAR-UC Group. Postoperative follow-up by automated text messaging versus telephone call in outpatient care with continuous regional analgesia: a randomized controlled feasibility trial. Reg Anesth Pain Med. 2025 Sep 18:rapm-2025-106818. doi: 10.1136/rapm-2025-106818. Online ahead of print.
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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.
Fernando Altermatt, MD study chair
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracking application app and Telephone interview in people with Anesthesia and Regional Anesthesia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 3 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 22 Aug 2024. 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 Chile. 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?
Usability level of the tracking application (time frame: 1, 2 and 3 days after discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06313294, which also lists 1 linked publication.
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 22 Aug 2024.