Skip to main content
OpenTrials
Completed

NCT Number: NCT04370717

Chronic Pain Management During a Pandemic

This is an open-label cohort study of chronic pain patients referred to an interdisciplinary community outpatient clinic. The aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and planning subsequent interventions. The null hypothesis is that there is no difference in the International Statistical Classification of Diseases 10th edition (ICD-10) codes established via telehealth and subsequent clinic visits. The patients will complete standard health questionnaires online and undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. A limited telehealth physical examination based on direct observation will be conducted.

At the subsequent clinic visit, the accuracy of diagnosis and adherence to the plan of care will be evaluated.

The primary and secondary endpoints will be gathered from the electronic charts and from the recruited participants by questionnaires completed online one week after the telemedicine consultation. The diagnosis and plan of care semi-structured match will be performed during the in-person follow-up visit.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Silver Centre for Pain Care

Toronto, Ontario, M3H5S4, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all patients referred for consultation

Exclusion criteria

  • Not English-speakers
  • Patients who do not have any compatible telecommunication devices
  • Patients illiterate in basic telecommunication and have no one in their household to help
  • Patients unable to complete online self-assessment forms and study questionnaires
  • Patients unable to make a follow-up visit
  • Individuals with unstable pain complaints

Treatment and study plan

telehealth consultation

Other

A telehealth consultation will be scheduled and conducted without modifications from the routine clinic protocol. The case report will include ICD-10 code and plan of care.

After one week, patients will receive an electronic satisfaction survey. An in-person follow-up and/or procedural visit will be subsequently scheduled. During this visit, the same physician will complete physical examination, document the diagnosis and proceed with either the same or modified plan of care. The research coordinator will enter diagnostic and procedural codes in the case report form.

Other names: in-person visit

Primary outcomes

  1. Percentage of patients with a matching diagnosis between telehealth and in-person consultation

    Time frame: 6 months

Secondary outcomes

  1. Percentage of patients with a matching plan of care/recommendations between telehealth and in-person visit

    Time frame: 6 months

  2. Patient satisfaction from telehealth encountered measured on 7-point Likert scale

    Time frame: 6 months

  3. feasibility of telehealth visits

    Time frame: 6 months

    (a) percentage of patients who accepted telemedicine as an equal substitute to in-person consultation. Participants will be asked the question with possible answers "Yes" or "No", "Why Yes?" "Why No?" (b) dropout rates and causes of dropouts (medical or technical reasons) will be registered (c) participants' satisfaction with video quality and sound quality (patients will be asked if they were "satisfied" with the video quality and sound quality after telemedicine consultation; "Yes" or "No", "Why not?"), (d) technical errors with the telemedicine equipment, and (e) specialist consultation time in minutes.

  4. cost-saving

    Time frame: 6 months

    Calculated cost-saving included (a) cost of travel in Canadian dollars, (b) estimated loss of income (<3.5 hours=a half day's salary, >3.5 hours spent on travel and consultation=one day's salary), (c) travelling distance in kilometres and travelling time in hours as estimated by Google Maps.

Sponsors and collaborators

Lead sponsor

Unika Medical Centre

Network

Registry information

Official study title

Chronic Pain Management During a Pandemic: Will Telemedicine Replace In-person Consultation

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 1, 2020
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.