Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01888146
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2013-05-16
Brief Title:
Pain Program for Active Coping Training
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Collaborative Care for Chronic Pain in Primary Care
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPACT-UH2
Brief 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 eg depression sleep problems that is feasible and sustainable within the primary care setting
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None