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

Quality of Life Clinical Trial

— Shared-Care  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03531476
• Other study ID #: 20180238-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: Ottawa Hospital Research Institute
• Contact: Patricia Poulin, PhD C. Psych
• Phone: 6137378899
• Email: ppoulin[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Quality of Life

Intervention

Behavioral:
• Online Chronic Pain Management Program
With the support of a study therapist, the participant will be enrolled in a 5 week self-directed pain management program. The study therapist is a registered health professional. The program will consist of 5 weeks of mindfulness training. The mindfulness training focuses on the basics of mindfulness-based interventions including body, emotions, sensations, thoughts, compassion, pain and stress management.

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)	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.	At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary	Change in pain intensity, as measured by the Brief Pain Inventory.	The Brief Pain Inventory (BPI) Pain Severity Scale measures the severity of pain one feels at worst, at least, on average, and at the time of questionnaire completion on a scale from 0 to 10. The higher the score, the greater the pain severity.	At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary	Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale	The Pain Catastrophizing Scale (PCS) is a 13-item instrument which will evaluate the degree to which patients have negative self-statements and catastrophizing thoughts and ideations when in pain. The PCS uses a 5-point likert scale (0=not at all, 4=all the time) and consists of three subscales (rumination, magnification, helplessness).	At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary	Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.	Mindfulness will be measured using the Short Form Five Facet Mindfulness Questionnaire (FFMQ-SF). The FFMQ-SF is a 24-item instrument measuring five aspects of mindfulness: Non-reactivity to inner experience, observing, describing, acting with awareness, and non-judging of experience. Participants are asked to use a 5-point Likert-type scale (1 = never or rarely true; 5 = very often or always true) to rate how true of them they believe each statement to be.	At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary	Change in quality of life, as measured by the EuroQOL-5D	The EuroQOL-5D (EQ-5D) is a simple-to-use, valid, and sensitive instrument measuring quality of life. It covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, or severe problems and participants use a tick box to select the statement that is most representative of their conditions. Participants are also asked to rate, using a visual analogue scale (0 to 100), their state of health.	At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary	Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale	The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item scale used to assess the severity of depressive symptoms over the past two weeks and is based on Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for major depression. Total scores range from 0 to 27, and clinical cut-points correspond to mild, moderate, moderately severe, and severe depression.	At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary	Overall change in status from baseline, as measured by Patient Global Impression of Change scale	The participants' perceived degree of change in overall status will be measured using the Patient Global Impression of Change (PGIC) scale. The PGIC uses a 7-point likert scale (very much worse, to very much better) to measure how much the participant feels their overall status has changed since the start of the study.	At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary	Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder-7	The Generalized Anxiety Disorder - 7 (GAD-7) is a 7-item scale used to assess the severity of anxiety symptoms over the past two weeks. Total scores range from 0 to 15, and clinical cut-points correspond to mild, moderate, and severe anxiety.	At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program