Ignite Creation Date:
2024-05-06 @ 8:15 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02697435
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2016-02-12
Brief Title:
Making Better Lives Patient-Focused Care for Low Back Pain LBP
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP
Status:
COMPLETED
Status Verified Date:
2019-07
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:
None
Brief Summary:
Back pain is a huge problem for millions of Americans including nearly 11 million Veterans Our older Veterans suffer the most Citizens spend billions of dollars yet consistently get poor results Primary Care Providers are often tasked with diagnosing and treating Chronic Low Back Pain even though they are often undereducated in the field These PCPs often use advanced imaging usually MRIs to guide care These images often show degenerative disc disease and other common pathologies in older adults even those who are pain free which can lead to misdiagnosis and treatment The investigators believe that Chronic Low Back Pain is a syndrome a final common pathway for the expression of multiple contributors that often lie outside the spine itself For example hip osteoarthritis knee pain and even anxiety could all lessen back pain if addressed and treated probably
Investigators will measure participants low back pain-associated disability with the well-validated RMDQ Data will be collected at baseline and monthly via telephone The investigators hypothesize that veterans who receive PCCET will experience significantly greater reduction in low back pain-associated disability than those who receive IAUC at six months
Investigators will also measure participants low back pain with the 0-10 Numeric Rating Scale for Pain Data will be collected at baseline and monthly via telephone The investigators hypothesize that veterans who receive PCCET will experience significantly greater reduction in low back pain than those who receive IAUC at six months
The goal of this study is to compare patients treated with usual care which usually starts with imaging versus patients who are treated by trained geriatricians who know how to recognize and address 11 key conditions that commonly drive pain and disability in older adults The investigators believe that older patients who receive care tailored to their needs by educated PCPs will ultimately have less back pain and more importantly better quality of life
Investigators will measure participants low back pain-associated disability with the well-validated RMDQ Data will be collected at baseline and monthly via telephone The investigators hypothesize that veterans who receive PCCET will experience significantly greater reduction in low back pain-associated disability than those who receive IAUC at six months
Investigators will also measure participants low back pain with the 0-10 Numeric Rating Scale for Pain Data will be collected at baseline and monthly via telephone The investigators hypothesize that veterans who receive PCCET will experience significantly greater reduction in low back pain than those who receive IAUC at six months
The goal of this study is to compare patients treated with usual care which usually starts with imaging versus patients who are treated by trained geriatricians who know how to recognize and address 11 key conditions that commonly drive pain and disability in older adults The investigators believe that older patients who receive care tailored to their needs by educated PCPs will ultimately have less back pain and more importantly better quality of life
Detailed Description:
Nearly half of our 22 million US military Veterans are age 65 and older and within this population low back pain is common costly and often disabling The prevalence of low back pain in those 85 the most vulnerable and fastest growing segment of society is estimated at 44 Chronic low back pain CLBP ie present for 6 months or more is associated with the overwhelming majority of healthcare resource utilization and personal suffering Treating back problems cost Americans more than 30 billion in 2007- up from 16 billion in 1997 in 2007 dollars Despite these staggering data there is no evidence that the care of patients with CLBP has improved and the use of invasive potentially morbid and often ineffective interventions eg epidural corticosteroid injections and spine surgery continues to skyrocket Primary care providers PCP who are tasked with treating CLBP without adequate education often use advanced imaging most commonly magnetic resonance imaging MRI to guide care Imaging-identified pathology eg degenerative disc and facet disease bulging discs is ubiquitous in older adults even in those that are pain-free It is not surprising therefore that imaging-guided treatments often lead to suboptimal outcomes and potential morbidity In contrast to how CLBP is often conceptualized and treated the investigators conceptualize CLBP as a syndrome that is a final common pathway for the expression of multiple contributors that often lie outside the spine itself for example hip osteoarthritis fibromyalgia syndrome and anxiety Treating CLBP and ameliorating disability in older adults necessitates addressing multiple conditions and risk factors however the expertise to evaluate and treat all of the disorders that can contribute to CLBP typically resides in multiple specialty silos making a comprehensive approach to treating CLBP difficult to implement
Through the support of a 2-year Rehab RD Merit Review pilot award the investigators have laid the essential foundation for delivering more comprehensive and patient-centric care to older Veterans with CLBP The investigators have
1 synthesized through a modified Delphi process evidence on evaluating and treating 11 key conditions that commonly drive pain and disability in older adults with CLBP
2 created algorithms to be used in the clinical setting to treat these 11 conditions
3 successfully trained geriatrician providers in a practical structured assessment of the 11 conditions and
4 validated the prevalence of these conditions specifically in older Veterans
In the current application the investigators are proposing a 2-site pilot study to explore the impact of delivering patient-centered comprehensive evaluation and treatment PCCET as compared with imaging-associated usual care IAUC to older Veterans with CLBP In addition to examining whether PCCET is more effective than IAUC for reducing pain and functional limitations when delivered by geriatricians in 2 VA medical centers the investigators will evaluate PCCETs impact on health-related quality of life and health care utilization The investigators also will collect data to identify barriers and facilitators to implementing PCCET from the perspective of patients and providers
Through the support of a 2-year Rehab RD Merit Review pilot award the investigators have laid the essential foundation for delivering more comprehensive and patient-centric care to older Veterans with CLBP The investigators have
1 synthesized through a modified Delphi process evidence on evaluating and treating 11 key conditions that commonly drive pain and disability in older adults with CLBP
2 created algorithms to be used in the clinical setting to treat these 11 conditions
3 successfully trained geriatrician providers in a practical structured assessment of the 11 conditions and
4 validated the prevalence of these conditions specifically in older Veterans
In the current application the investigators are proposing a 2-site pilot study to explore the impact of delivering patient-centered comprehensive evaluation and treatment PCCET as compared with imaging-associated usual care IAUC to older Veterans with CLBP In addition to examining whether PCCET is more effective than IAUC for reducing pain and functional limitations when delivered by geriatricians in 2 VA medical centers the investigators will evaluate PCCETs impact on health-related quality of life and health care utilization The investigators also will collect data to identify barriers and facilitators to implementing PCCET from the perspective of patients and providers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRO 1653 | OTHER_GRANT | RRD | None |