Overview

This trial is active, not recruiting.

Conditions chronic pain, peer review, health care, interdisciplinary communication
Treatments cipap program, treatment as usual (tau)
Sponsor Ottawa Hospital Research Institute
Collaborator The Physicians' Services Incorporated Foundation
Start date December 2014
End date March 2017
Trial size 46 participants
Trial identifier NCT02237391, 20140575-01H

Summary

While significant advances in pain management have occurred in the last 20 years, the majority of patients with chronic pain (CP) are unable to access evidence-based treatment at either the primary or tertiary care level.

Moreover, research has shown that unrelieved CP and the lack of available expertise contribute to emergency department (ED) visits and hospital admissions. At The Ottawa Hospital (TOH), close to 18,000 ED visits per year are related to CP (12.9%). Among high frequency visitors (HFV; >= 8 visits per year), a small number of patients with CP use an inordinate amount of acute care resources. The investigators study will use a randomized controlled (RCT) design to conduct a pilot evaluation of the impact of a Complex Interdisciplinary Pain Assessment Program (CIPAP) linked with primary care physicians (PCP) compared to a treatment as usual (TAU) control arm.

The investigators hypothesis is that implementing a CIPAP will increase health care value through improved patient outcomes and reduced costs in HFV with chronic pain (CP-HFV). The investigators believe that a CIPAP will provide CP-HFV patients long-term pain management solutions, ED visits for CP will be reduced, and hospital admissions for CP will be prevented. This pilot RCT study will inform a larger-scale RCT study to be conducted in the future.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
Complex Interdisciplinary Pain Assessment Program
cipap program Complex Interdisciplinary Pain Assessment Program
The interdisciplinary assessment will, involve a pain specialist, a clinical health psychologist, and a nurse. As needed, it may involve a social worker, an addiction specialist, and other specialists. The pain specialist will conduct a detailed evaluation that includes: history of presenting illness, review of systems, review of pain treatments, medical history, surgical history, addiction history, medications and allergies, insurance for medication, psychosocial history, opioid risk assessment, physical examination, and review of tests and investigations (including a urine drug screen for prescribed and illicit substances). The psychologist will conduct a detailed evaluation that includes: a structured diagnostic clinical interview, a review of coping strategies, and a review of the various questionnaires completed prior to the assessment pertaining to mood, anxiety, trauma, and beliefs about pain.
(Other)
Treatment as usual control group
treatment as usual (tau) Treatment as Usual control group
Control group

Primary Outcomes

Measure
Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 12-months post-study enrollment
time frame: Baseline and 12 months post-enrollment

Secondary Outcomes

Measure
Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 12-months post-study enrollment
time frame: Baseline and 12 months post-enrollment
Change from baseline in self-reported anxiety, as measured by the Generalized Anxiety Disorder Scale - 7, at 12-months post-study enrollment
time frame: Baseline and 12 months post-enrollment
Change from baseline in self-reported depressive symptoms, as measured by the Patient Health Questionnaire - 9, at 12-months post-study enrollment
time frame: Baseline and 12 months post-enrollment
Change from baseline in self-reported sleep problems, as measured by the Insomnia Severity Index, at 12-months post-study enrollment
time frame: Baseline and 12 months post-enrollment
Change from baseline in risk for opioid abuse, as measured by the Screener and Opioid Assessment for Patients with Pain, at 12-months post-study enrollment
time frame: Baseline and 12 months post-enrollment
Change from baseline in self-reported traumatic stress, as measured by the PTSD Checklist for DSM - 5, at 12-months post-study enrollment
time frame: Baseline and 12 months post-enrollment
Change from baseline in self-reported quality of life, as measured by The Quality of Life Questionnaire EuroQol, at 12-months post-study enrollment
time frame: Baseline and 12 months post-enrollment
Change from 3-months pre-study enrollment in healthcare utilization, as measured by the Pain Economics Questionnaire, at 12-months post-study enrollment
time frame: 3 months pre-study and 12 months post-enrollment
Change from 3-months pre-study enrollment in healthcare utilization, as measured by participant Ministry of Health and Long-Term Care Personal Claims History Information, at 12-months post-study enrollment
time frame: 3 months pre-study and 12 months post-enrollment
Change from 3-months pre-study enrollment in opioid usage, as measured by morphine equivalents, at 12-months post-study enrollment
time frame: 3 months pre-study and 12 months post-enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult (18+ years old) - Working knowledge of English or French - Presented to The Ottawa Hospital Emergency Department (TOH ED) with a primary complaint of chronic or recurrent pain a minimum of 8 times over the last 12 months, with 3 of the visits occurring in the 3 months prior to study enrollment. - Patients fit criteria for chronic pain (CP) if they have had "pain that has lasted longer than three months." As per the International Association for the Study of Pain (IASP) taxonomy of CP syndromes, this includes: "relatively generalized syndromes," "relatively localized syndromes of the head and neck," "spine and radicular pain syndromes," "local syndromes of the upper limbs," and "visceral pain syndromes." Exclusion Criteria: - Malignant pain - patients will be referred to our complex cancer pain program - Canadian Triage and Acuity Scale Level 1 and Level 2; Level 3 will be assessed on a case-by-case basis and we will document reason for exclusion - Refusal or inability to provide consent

Additional Information

Official title Evaluation of a Complex Interdisciplinary Pain Assessment Program Linked to Primary Care to Improve Clinical Outcomes and Reduce Health Care Utilization Among Patients With Chronic Pain and Frequent Emergency Department Visits
Principal investigator Catherine Smyth, MD PhD
Description As this is a phase 2 trial, the sample size is primarily determined by logistical constraints; however, as this trial will yield valuable information about the preliminary impact of the program for planning a larger, more definitive trial in the future, we determined the maximum width of a two-sided 95% confidence interval around the differences between the arms at 12 months. For self-report measures, 18 patients per arm would yield a margin of error of 0.65 standard deviations (total width of confidence interval = 1.3 on the standard deviation unit scale), which is considered acceptable for the self-report measures. For number of visits over 3 months, we assumed a standard deviation of 3 (based on our preliminary data). Assuming approximate normality, our sample size of 18 patients per arm would yield a margin of error of 2 visits (total width of confidence interval = 4 visits) which is adequate to yield preliminary evidence of change. These are conservative estimates as our analyses will include repeated measures, and adjust for baseline measures of response in addition to other demographic and clinical covariates. To account for 20% attrition, we will plan to enrol 23 participants per arm (total number of participants =46).
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.