Chronic Pain Management During a Pandemic

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370717
• Other study ID #: Telehealth_01
• Status: Completed
• Start date: April 22, 2020
• Est. completion date: April 8, 2021

Study information

• Verified date: April 2021
• Source: Unika Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 8, 2021
• Est. primary completion date: April 8, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• telehealth consultation
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.

Locations

Country	Name	City	State
Canada	Silver Centre for Pain Care	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unika Medical Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a matching diagnosis between telehealth and in-person consultation		6 months
Secondary	Percentage of patients with a matching plan of care/recommendations between telehealth and in-person visit		6 months
Secondary	Patient satisfaction from telehealth encountered measured on 7-point Likert scale		6 months
Secondary	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
Secondary	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

External Links

•   website of the participating clinic