Chronic Pain Management During a Pandemic

Completed

• Conditions: Chronic Pain

• Registration Number: NCT04370717
• Lead Sponsor: Unika Medical Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-22
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-05-01
• Status Verified: 2021-04
• Primary Completion: 2021-04-08
• Study Completion: 2021-04-08
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a matching diagnosis between telehealth and in-person consultation	6 months

Secondary Outcome Measures

Name	Time	Method
cost-saving	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.
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	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.

Trial Locations

Locations (1)

Silver Centre for Pain Care; 🇨🇦 Toronto, Ontario, Canada