Clinical trial NCT03531476: Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN
Official title: Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Quality of Life
Keywords: Mindfulness
Chronic Pain
Disability
Quality of Life
Online
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
timeFrame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary outcomes:
measure: Change in pain intensity, as measured by the Brief Pain Inventory.
timeFrame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
measure: Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
timeFrame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
measure: Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.
timeFrame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
measure: Change in quality of life, as measured by the EuroQOL-5D
timeFrame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
measure: Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale
timeFrame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
measure: Overall change in status from baseline, as measured by Patient Global Impression of Change scale
timeFrame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
measure: Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder-7
timeFrame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Patricia Poulin, PhD C. Psych
role: PRINCIPAL_INVESTIGATOR
References: