Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000404
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
1999-11-03
Brief Title:
Effects of Comprehensive Care for Knee OA
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Effects of Comprehensive Care for Knee Osteoarthritis OA
Status:
COMPLETED
Status Verified Date:
2013-04
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:
We will study 300 people with knee osteoarthritis OA who receive their medical care from a large health maintenance organization HMO in Indianapolis Our study will evaluate a comprehensive plan for treatment of knee OA by primary care physicians Primary care physicians will provide standard care for knee OA to half of the study participants 150 people and will use the comprehensive treatment plan guidelines to treat the other half The comprehensive plan includes careful use of medications along with non-drug approaches such as patient education exercise and social support People who participate in the study will receive care for knee OA for 1 year We will measure the results outcomes of treatment at the start of the study and at 3 months 6 months and 12 months after patients join the study The results we will measure include joint pain physical function drug side effects quality of life satisfaction with OA care and the cost of medical care
Detailed Description:
Anticipating trends toward generalism in medicine the rheumatology community has begun to set forth guidelines for managing osteoarthritis OA These guidelines emphasize a comprehensive approach toward nondrug treatment eg patient education exercise social support and a conservative approach to drug management to minimize the side effects of nonsteroidal anti-inflammatory drugs NSAIDs Unfortunately few primary care physicians provide conservative comprehensive care for OA as promoted in the recent rheumatology literature Also although researchers have studied individual elements of a comprehensive approach to OA care and largely validated them in isolation no research support exists to suggest that uniformly adopting OA care guidelines will result in better patient outcomes andor reduced costs of care
In this project we will implement in a controlled fashion and evaluate a comprehensive plan for treating patients with knee OA by primary care physicians in a managed care environment Comprehensive care for knee OA will be guided by a procedure designed to introduce and reinforce a an array of nondrug self-care procedures intended to combat joint pain and preserve function and b a stepped protocol for drug management of knee pain that minimizes the risk of adverse side effects of NSAIDs
Participants will be 300 patients with a confirmed clinical diagnosis of knee OA who receive their medical care in a large health maintenance organization HMO in Indianapolis Indiana We will randomly allocate geographically discrete offices of the HMOs to experimental OA care by algorithm or control routine OA care conditions 150 subjectsgroup Patients who enroll in the study at each location will receive care for knee OA for 1 year under the guidelines specified by random assignment
We will measure outcomes at baseline and 3 months 6 months and 12 months after enrollment and outcomes will include joint pain physical function drug side effects quality of life ie general health status satisfaction with OA care and direct costs of medical care We think that comprehensive care as guided by our algorithms will result in significant improvement in knee pain physical function and patient satisfaction and lower direct costs compared to care delivered under routine circumstances
In this project we will implement in a controlled fashion and evaluate a comprehensive plan for treating patients with knee OA by primary care physicians in a managed care environment Comprehensive care for knee OA will be guided by a procedure designed to introduce and reinforce a an array of nondrug self-care procedures intended to combat joint pain and preserve function and b a stepped protocol for drug management of knee pain that minimizes the risk of adverse side effects of NSAIDs
Participants will be 300 patients with a confirmed clinical diagnosis of knee OA who receive their medical care in a large health maintenance organization HMO in Indianapolis Indiana We will randomly allocate geographically discrete offices of the HMOs to experimental OA care by algorithm or control routine OA care conditions 150 subjectsgroup Patients who enroll in the study at each location will receive care for knee OA for 1 year under the guidelines specified by random assignment
We will measure outcomes at baseline and 3 months 6 months and 12 months after enrollment and outcomes will include joint pain physical function drug side effects quality of life ie general health status satisfaction with OA care and direct costs of medical care We think that comprehensive care as guided by our algorithms will result in significant improvement in knee pain physical function and patient satisfaction and lower direct costs compared to care delivered under routine circumstances
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-021 | US NIH GrantContract | None | httpsreporternihgovquickSearchP60AR020582 |
| P60AR020582 | NIH | None | None |