Evaluation of a Interdisciplinary Pain Program Among Patients With Chronic Pain and Frequent Emergency Department Visits

NCT ID: NCT02237391

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-01-01

Brief 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.

Detailed 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).

Conditions

Chronic Pain; Peer Review, Health Care; Interdisciplinary Communication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

CIPAP Program

Complex Interdisciplinary Pain Assessment Program

Group Type: EXPERIMENTAL

CIPAP Program

Intervention Type: OTHER

The intervention 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 an 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. The psychologist will conduct an evaluation that includes: a structured diagnostic clinical interview, a review of coping strategies, and a review of the questionnaires completed prior to the assessment pertaining to mood, anxiety, trauma and beliefs about pain.

Treatment as Usual (TAU)

Treatment as usual control group

Group Type: OTHER

Treatment as Usual (TAU)

Intervention Type: OTHER

Control group

Interventions

CIPAP Program

The intervention 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 an 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. The psychologist will conduct an evaluation that includes: a structured diagnostic clinical interview, a review of coping strategies, and a review of the questionnaires completed prior to the assessment pertaining to mood, anxiety, trauma and beliefs about pain.

Intervention Type: OTHER

Treatment as Usual (TAU)

Control group

Intervention Type: OTHER

Other Intervention Names

Complex Interdisciplinary Pain Assessment Program; Treatment as Usual control group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

The Ottawa Hospital Academic Medical Association

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Smyth, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Patricia Poulin, PhD C.Psych

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20140575-01H

Identifier Type: -

Identifier Source: org_study_id