Chronic Pain Management During a Pandemic

Sponsor
Unika Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT04370717
Collaborator
(none)
49
Enrollment
1
Location
11.5
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: telehealth consultation

Study Design

Study Type:
Observational
Actual Enrollment :
49 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Chronic Pain Management During a Pandemic: Will Telemedicine Replace In-person Consultation
Actual Study Start Date :
Apr 22, 2020
Actual Primary Completion Date :
Apr 8, 2021
Actual Study Completion Date :
Apr 8, 2021

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients with a matching diagnosis between telehealth and in-person consultation [6 months]

Secondary Outcome Measures

  1. Percentage of patients with a matching plan of care/recommendations between telehealth and in-person visit [6 months]

  2. Patient satisfaction from telehealth encountered measured on 7-point Likert scale [6 months]

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Silver Centre for Pain CareTorontoOntarioCanadaM3H5S4

Sponsors and Collaborators

  • Unika Medical Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Michael Gofeld, Principal Investigator, Unika Medical Centre
ClinicalTrials.gov Identifier:
NCT04370717
Other Study ID Numbers:
  • Telehealth_01
First Posted:
May 1, 2020
Last Update Posted:
Apr 21, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Gofeld, Principal Investigator, Unika Medical Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2021