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Chronic PainCIPAPNCT02237391

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

A study testing CIPAP Program and Treatment as Usual (TAU) in people with Chronic Pain and Peer Review, Health Care, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CIPAP Program and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteCanada
Study dates
Dec 2014to 1 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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."

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

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

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.

Read the 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).

Being tested
CIPAP Program, Treatment as Usual (TAU)
Keywords
High Frequency Emergency Department Visits, Healthcare Utilization, Chronic Pain, Interdisciplinary
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIPAP ProgramOther

    Also called Complex Interdisciplinary Pain Assessment 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.

  • Treatment as Usual (TAU)Other

    Also called Treatment as Usual control group

    Control group

Study groups in NCT02237391
Study groupRoleWhat they receive
CIPAP ProgramExperimentalComplex Interdisciplinary Pain Assessment Program
Receives: Other: CIPAP Program
Treatment as Usual (TAU)OtherTreatment as usual control group
Receives: Other: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 12-months post-study enrollment

    The primary outcome is pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale. The Brief Pain Inventory (BPI) - Pain Interference consists of 7 numerical scales (0 to 10) rating pain interference with general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life.

    Measured: Baseline and 12 months post-enrollment

Secondary outcomes (10)

  1. Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 12-months post-study enrollment

    Pain Catastrophizing Scale (PCS): The PCS is a 13-item self-report measure that uses a 5-point Likert scale allowing participants to rate the degree to which they adopt a negative or aversive orientation towards their pain. The PCS has a stable three-factor structure (rumination, magnification, and helplessness).

    Measured: Baseline and 12 months post-enrollment

  2. Change from baseline in self-reported anxiety, as measured by the Generalized Anxiety Disorder Scale - 7, at 12-months post-study enrollment

    Generalized Anxiety Disorder Scale-7 (GAD-7): The GAD-7 will be used to evaluate symptoms of anxiety. It is a 7-item self-report measure that uses a 4-point Likert scale allowing participants to rate themselves with scores of either 0,1,2 or 3 (representing answers of "not at all," "several days," "more than half the days," and "nearly every day," respectively). Total scores range from 0-21 with cut-off points of 5, 10 and 15 representing mild, moderate and severe anxiety, respectively.

    Measured: Baseline and 12 months post-enrollment

  3. Change from baseline in self-reported depressive symptoms, as measured by the Patient Health Questionnaire - 9, at 12-months post-study enrollment

    Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 will be used to evaluate depressive symptoms. This 9-item scale assesses the frequency of depressive symptoms experienced over the past two weeks.

    Measured: Baseline and 12 months post-enrollment

  4. Change from baseline in self-reported sleep problems, as measured by the Insomnia Severity Index, at 12-months post-study enrollment

    Insomnia Severity Index (ISI): The ISI is a 7-item self-report questionnaire that evaluates the severity of initial insomnia, sleep maintenance problems, terminal insomnia, satisfaction with sleep patterns, interference with daily functioning, impairment attributed to sleep problems and level of distress caused by sleep problems. It uses a 5-point Likert scale (0 = not at all; 4 = extremely), total scores range from 0 to 28, with high scores indicating greater insomnia severity.

    Measured: Baseline and 12 months post-enrollment

  5. 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

    Screener and Opioid Assessment for Patients with Pain (SOAPP): The SOAPP is a 24-item questionnaire used to evaluate the risk for opioid abuse in patients with chronic pain who are being considered for long-term opioid therapy. A consensus of 26 pain and addiction experts was obtained in order to determine the important characteristics of patients with chronic pain that can predict medication misuse. Fourteen of the 24 SOAPP items predict future aberrancies.

    Measured: Baseline and 12 months post-enrollment

  6. Change from baseline in self-reported traumatic stress, as measured by the PTSD Checklist for DSM - 5, at 12-months post-study enrollment

    PTSD Checklist for DSM - 5 (PCL-5): The PCL-5 is a self-report questionnaire that assesses symptoms for post-traumatic stress disorder (PTSD). It is used as a measure of the 20 symptoms of PTSD that are mentioned in the Diagnostic and Statistical Manual of Mental Disorders - fifth edition (DSM-V) and has been validated. Each item on the questionnaire is rated on a scale of 0 to 4, representing answers of "not at all," "a little bit," "moderately," "quite a bit," and "extremely," respectively. Total scores range from 0-80 with a cut-off point of 38 suggesting endorsement of PTSD.

    Measured: Baseline and 12 months post-enrollment

  7. Change from baseline in self-reported quality of life, as measured by The Quality of Life Questionnaire EuroQol, at 12-months post-study enrollment

    The Quality of Life Questionnaire EuroQol (EQ-5D): The 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.

    Measured: Baseline and 12 months post-enrollment

  8. Change from 3-months pre-study enrollment in healthcare utilization, as measured by the Pain Economics Questionnaire, at 12-months post-study enrollment

    The Pain Economics Questionnaire (PEQ): The PEQ is a brief self-report questionnaire created for this study to obtain information regarding participants' health care utilization. This questionnaire has not been tested for reliability or validity. It will be used to capture participants' use of non-The Ottawa Hospital Emergency Department (TOH ED) hospitalizations, family doctor visits, diagnostic tests, surgeries, allied health care visits and medications.

    Measured: 3 months pre-study and 12 months post-enrollment

  9. 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

    With participant consent, we will be requesting information regarding participants' health care utilization from Ministry of Health and Long-Term Care (MOHLTC).

    Measured: 3 months pre-study and 12 months post-enrollment

  10. Change from 3-months pre-study enrollment in opioid usage, as measured by morphine equivalents, at 12-months post-study enrollment

    With participant consent, we will be requesting medication information from participants' pharmacy and calculating morphine equivalent values for all opioids prescribed.

    Measured: 3 months pre-study and 12 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion1 Jan 2018
  4. Study completion1 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02237391
Sponsor's protocol ID
20140575-01H
Acronym
CIPAP
Status last verified
Oct 2021
First submitted
9 Sep 2014
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CIPAP Program and Treatment as Usual (TAU) in people with Chronic Pain and Peer Review, Health Care, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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