Chronic Pain Management During a Pandemic

NCT04370717 | Completed

• 1 other identifier: Telehealth_01
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain, telehealth

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (4)

• 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

• cost-saving

  6 months

Interventions

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.

Also known as: in-person visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive community patients referred to the interdisciplinary clinic

You may qualify if:

• all patients referred for consultation

You may not qualify if:

• 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

Sponsors & Collaborators

• Unika Medical Centre: lead

Study Sites (1)

Silver Centre for Pain Care

Toronto, Ontario, M3H5S4, Canada

Location

Related Links

• website of the participating clinic

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: May 1, 2020
• Study Start: April 22, 2020
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)