Postoperative Follow-up Via Text Messages Automated Versus Telephone in Patients With Continuous Regional Anesthesia (txt-RA)

August 20, 2024 updated by: Pontificia Universidad Catolica de Chile

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile, 450881
        • Pontificia Universidad Catolica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elective surgery with continuous ambulatory regional analgesia
  • Able to understand, use and operate a smartphone to view the mobile application
  • ASA I - II

Exclusion Criteria:

  • Ages under 17 or over 76 years
  • Emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App Group
In this group the patients will use the app for asking about related to pain, patient satisfaction and another complications.
Other: Tracking application app
An app will be implemented for mobile monitoring in patients who use continuous postoperative ambulatory regional analgesia.
Active Comparator: Telephone interview group
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.
Other: Telephone interview
Patients who use continuous postoperative outpatient regional analgesia will be followed up using the current traditional method of post-discharge telephone call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1, 2 and 3 days after discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient adherence
Time Frame: 1, 2 and 3 days after discharge.
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.
1, 2 and 3 days after discharge.
Patient satisfaction with Perception of Quality in Anesthesia
Time Frame: 1, 2 and 3 days after discharge.

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.
1, 2 and 3 days after discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Study Chair: Fernando Altermatt, MD, Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2024

Primary Completion (Actual)

August 9, 2024

Study Completion (Actual)

August 13, 2024

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230929002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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