Chronic Pain Management During a Pandemic

NCT ID: NCT04370717

Last Updated: 2021-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-22

Study Completion Date

2021-04-08

Brief Summary

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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

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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in-person visit

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unika Medical Centre

NETWORK

Sponsor Role lead

Responsible Party

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Michael Gofeld

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Silver Centre for Pain Care

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Related Links

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https://silverpaincare.com/

website of the participating clinic

Other Identifiers

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Telehealth_01

Identifier Type: -

Identifier Source: org_study_id

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