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Clinical Trials/NCT03531476
NCT03531476UnknownNot Applicable

Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN

Ottawa Hospital Research Institute1 site in 1 country240 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
240
Locations
1
Primary Endpoint
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)

Study Overview

Brief Summary

The study is evaluating an intervention consisting of a five week online mindfulness program for patients being referred to the Pain Clinic and triaged to eConsult. A pain specialist will be in contact with the patient's family physician to confirm it's appropriate and then a therapist will initiate contact with the patient to assess eligibility. The therapist will be a registered health professional with experience with patients with chronic health problems and will be supporting the online program where the participant will have communication access to them. Questionnaires will be sent at three time points to assess changes.

Detailed Description

There are currently many patients waiting to be seen at The Ottawa Hospital Pain Clinic (TOHPC). However, many patients with chronic pain (CP) have exhausted medical options or could be served in the community with appropriate support for them and their family physicians (FPs). eConsult is a secure web-based platform that allows TOHPC physicians to provide pain management advice within seven days within the Champlain Local Health Integration Network (LHIN).

In order to provide enhanced care to patients and improve the uptake of eConsult for CP, the investigators have developed a shared care model for CP in the Champlain LHIN. This program combines the use of eConsult for FPs and a 5-week self-directed online CP management program with therapist support available as needed.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •aged 18-years or older
  • •ability to understand oral and written English
  • •report chronic pain (≥3months)

Exclusion Criteria

  • •refusal or inability to provide informed consent
  • •severe, unstable or untreated psychiatric conditions (ex. severe depression, psychosis, bipolar, etc.)
  • •does not have access to the internet or electronic device capable of watching videos

Arms & Interventions

Online chronic pain management program

Experimental

There is only one arm. Those who consent to participate in the study and take the online self-directed chronic pain management program with therapist support.

Intervention: Online Chronic Pain Management Program (Behavioral)

Outcomes

Primary Outcomes

Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)

Time Frame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program

The interference scale measures the degree to which pain interferes in the lives of participants in 7 domains: general activity, mood, walking ability, normal work, relations with other persons, sleep and enjoyment of life on a scale from 0 to 10. The higher the score, the greater the pain interferes with patient's activities.This is a well-validated measure of pain-related disability. The minimum clinically significant difference is 1 point.

Secondary Outcomes

  • Change in quality of life, as measured by the EuroQOL-5D(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder-7(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change in pain intensity, as measured by the Brief Pain Inventory.(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)
  • Overall change in status from baseline, as measured by Patient Global Impression of Change scale(At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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