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Chronic Non-malignant PainPPACT-UH2NCT01888146

Pain Program for Active Coping & Training

A study testing Interdisciplinary pain program in people with Chronic Non-malignant Pain, run by Kaiser Permanente at 1 site in United States.

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

The overall aim of this study is to adopt an integrative rehabilitation approach for helping patients adopt self-management skills for managing chronic pain, limiting use of opioid medications, and identifying exacerbating factors amenable to treatment (e.g., depression, sleep problems) that is feasible and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Non-malignant Pain
What is being tested?
Interdisciplinary pain program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
May 2013to Jun 2014
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

  • Paneled to a primary care provider practicing at one of the primary care clinics participating in the study
  • ≥18 years of age at time of inclusion. Current adult KP member (18 years or older)
  • Within the last 180 days either:
  • 90 day supply of short acting opioid spanning at least 120 days
  • or more long acting opioid dispenses
  • Pain diagnostic ICD-9 code within the past 180 days
  • Diagnostic categories include but are not limited to: Back pain, neck pain, fibromyalgia, arthritis, myofascial pain, neuropathies, migraine, tension headache, temporomandibular joint disorder, carpal tunnel syndrome, nonspecific chronic pain, abdominal pain, pelvic pain

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227

Other trials in United States

About this study

Official title: Collaborative Care for Chronic Pain in Primary Care

The overall aim of this study is to adopt an integrative rehabilitation approach for helping patients adopt self-management skills for managing chronic pain, limiting use of opioid medications, and identifying exacerbating factors amenable to treatment (e.g., depression, sleep problems) that is feasible and sustainable within the primary care setting.

Read the detailed description

Pain is a common and very costly public health problem. Common chronic pain conditions are expensive and pervasive, affecting at least 116 million American adults at an annual cost of $560 billion in direct medical treatment costs and lost productivity, and disproportionally affect vulnerable populations. Pain is the primary reason patients seek medical care and, as the first point of contact, primary care providers (PCPs) deliver the majority of that care. Unfortunately, PCPs face many challenges in managing these patients' care and often have little specific training in pain medicine. Yet with proper system support, PCPs are in the best position to coordinate pain management longitudinally. While pharmacotherapy is the predominant treatment approach for many PCPs, this limits the patient's role to taking medication, and he or she can become a passive recipient of care-leading to poor outcomes, potential overmedication, and possible disillusionment with the medical system. Further, increases in opiate prescribing for pain treatment -amidst increasing awareness of adverse outcomes, including addiction-and limited efficacy suggest the importance of broader treatment approaches that focus on patients' improvement of functioning. Although opiates may reduce pain symptoms while prescribed, patients are unlikely to experience significant and sustained improvements without the use of other nonpharmacologic pain management approaches. Medical management of patients with persistent pain and complex problems is often fragmented, which leads patients to seek a wide variety of primary and specialty care services in an effort to manage their pain and related conditions. Such fragmented care leads to poorer outcomes and significantly increases health care costs as patients often receive unneeded diagnostic and medical procedures. While research has identified evidence-based multidisciplinary behavioral treatment approaches that are effective for such patients and can even prevent the disability associated with persistent pain when offered earlier in the course of care, these interventions are rarely available in everyday practice settings and will require data from pragmatic clinical trials to change the care paradigm.

To address these issues, we are proposing a mixed-methods, cluster-randomized pragmatic clinical trial that will evaluate the integration of psychosocial services within the primary care environment. This project will implement an intervention into everyday clinical practice flow utilizing assessment measures and intervention staff directly from the clinical care system rather than utilizing a research-developed and administered structure. The intervention will be an integrated program that will guide all care for intervention patients. We will compare this primary care-based intervention to usual care using systematic, clinic-based assessments. During the initial phase, we will pilot the intervention with up to 50 patients in the Kaiser Permanente Northwest (KPNW) region with patients selected by their primary care providers who have non-malignant chronic pain (pain persisting for ≥ 3 months) and who are on long-term opiate therapy for the treatment of their condition. This pilot portion of the project is in preparation for the effective implementation of a large-scale, cluster-randomized pragmatic clinical trial to be conducted throughout three regions of Kaiser Permanente - Northwest, Georgia, and Hawaii comparing this primary care based multidisciplinary intervention to usual care in these settings.

This intervention brings together elements often available in health plans but organized in a less integrated fashion, and it will ensure flexibility in implementation to best fit individual clinic environments and the needs of chronic pain patients on long-term opiate therapy.

Being tested
Interdisciplinary pain program
Keywords
Pain management, Opioid use, Pragmatic, Collaborative care, Primary care
Medical subject headings
Agnosia

What participants receive

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

  • Interdisciplinary pain programBehavioural

    Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.

Study groups in NCT01888146
Study groupRoleWhat they receive
Interdisciplinary pain programExperimentalInterdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.
Receives: Behavioral: Interdisciplinary pain program
Treatment as usualNo interventionPatients in this arm will receive care as usual and utilize services as they currently exist in the health plan system.

What is being measured

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

  1. Brief Pain Inventory

    Reliable and valid tool that measures patients' pain intensity and functional interference.

    Measured: Collected every 3 months for 1 year

Secondary outcomes (1)
  1. Health care utilization and cost

    Primary care and specialty care services

    Measured: Collected every 3 months for 1 year

Timeline

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

  1. First posted27 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

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
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01888146
Sponsor's protocol ID
1UH2AT007788-01
Acronym
PPACT-UH2
Status last verified
Dec 2015
First submitted
16 May 2013
Last updated
23 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Interdisciplinary pain program in people with Chronic Non-malignant Pain, run by Kaiser Permanente at 1 site in United States.

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 7 inclusion and 0 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 23 Dec 2015. 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 United States. 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?

Brief Pain Inventory (time frame: Collected every 3 months for 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Dec 2015.

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