Chronic Pain Management During a Pandemic

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: telehealth consultation

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3H5S4
      • Silver Centre for Pain Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive community patients referred to the interdisciplinary clinic

Description

Inclusion Criteria:

all patients referred for consultation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with a matching diagnosis between telehealth and in-person consultation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a matching plan of care/recommendations between telehealth and in-person visit		6 months
Patient satisfaction from telehealth encountered measured on 7-point Likert scale		6 months
feasibility of telehealth visits	(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.	6 months
cost-saving	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.	6 months

Collaborators and Investigators

• Sponsor: Unika Medical Centre

Publications and helpful links

Helpful Links

• website of the participating clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Actual): April 8, 2021
• Study Completion (Actual): April 8, 2021

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: chronic pain, telehealth
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Telehealth_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No