Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324857
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2006-05-09
Brief Title:
Educational Intervention for Knee Pain
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Knee Replacement Disparity A Randomized Controlled Intervention
Status:
COMPLETED
Status Verified Date:
2018-09
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:
The purpose of this study is to demonstrate the efficacy of interventions to improve understanding of knee replacement risks benefits and expected outcomes among AA primary care patients increase willingness to consider knee replacement among AA primary care patients and increase primary care referral rates for surgical consideration for AA patients who meet the indications for knee replacement
Detailed Description:
The proposed project represents the next phase in a trajectory of VA research designed to eliminate racial disparities in the utilization of knee joint replacement - an effective treatment option for end-stage knee osteoarthritis OA Numerous studies have documented the existence of marked racial disparities in the utilization of knee joint replacement in OA African-Americans AA are two to five times less likely than white patients to receive knee joint replacement for lower extremity OA Our prior work has shown that compared to white patients AA patients expect worse outcomes from this treatment and consequently are less willing to consider joint replacement even when clinically indicated and recommended by a physician Patient willingness an attitudinal disposition modifiable with education and counseling has emerged as a key patient-level mediator in the utilization of elective medical procedures such as knee joint replacement
The short-term goals of this randomized controlled trial are to demonstrate the efficacy of interventions to improve understanding of knee joint replacement risks benefits and expected outcomes among AA primary care patients increase willingness to consider knee joint replacement among AA primary care patients and increase primary care referral rates for surgical consideration for AA patients who meet the indications for knee joint replacement We will test a multi-faceted intervention consisting of a knee OA decision aid video developed by the Foundation for Informed Medical Decision Making alone or in combination with individually tailored patient counseling using Motivational Interviewing versus an attention control The long-term objective is to reduce or eliminate the racial gap in the utilization of knee joint replacement The central hypothesis of this proposal is that the scientifically accurate high quality patient-centered information on knee arthritis and joint replacement provided by the knee OA decision aid alone or in combination with motivational interviewing will improve patient understanding of knee joint replacement outcomes increase patient willingness to consider knee joint replacement and consequently lead to higher rates of referral for surgical consideration when clinically indicated With increased referral rates currently a major bottleneck in the path to joint replacement more AA patients will receive recommendations for surgery thus potentially reducing racial differences in the utilization of this procedure This proposal is innovative because it is the first patient-centered evidence-based VA intervention trial to use a decision aid alone or in combination with motivational interviewing to intervene on a well-documented and marked racial disparity in joint replacement that exists within and outside the VA health care system
Primary Specific Aims
1 To examine the effectiveness of the proposed intervention strategies DA alone MI alone or a combined DAMI to improve willingness to consider knee joint replacement when clinically indicated among AA primary care patients
2 To examine the effectiveness of the proposed intervention strategies on patient expectations of knee joint replacement risksbenefits among AA primary care patients
3 To examine the effectiveness of the proposed intervention strategies in increasing primary care referrals for surgical evaluation of AA patients with knee OA
Secondary Specific Aim To examine the effectiveness of the proposed intervention strategies to increase AA patient likelihood of receiving knee joint replacement within 12 months of the intervention
A randomized controlled factorial design will be utilized to examine the effectiveness of knee OA decision aid andor MI compared with attention control on select key patient-centered and process of care outcomes We will recruit approximately 600 AA primary care patients 150 at the VAPHS 150 at the LSCDVAMC and 300 at the PVAMC who meet the American College of Rheumatology clinical indications for knee joint replacement and randomize them into either intervention arms or attention control We will assess patient expectations willingness and referral to joint replacement We will also collect qualitative data on doctor-patient communication following the intervention or control so that we can assess in the future whether or not the interventions impact study outcomes through improved quality of communication This study will provide hard evidence needed to improve quality of care for African-American VA patients who have end-stage knee OA a major cause of disability and functional decline in VA elderly patients
The short-term goals of this randomized controlled trial are to demonstrate the efficacy of interventions to improve understanding of knee joint replacement risks benefits and expected outcomes among AA primary care patients increase willingness to consider knee joint replacement among AA primary care patients and increase primary care referral rates for surgical consideration for AA patients who meet the indications for knee joint replacement We will test a multi-faceted intervention consisting of a knee OA decision aid video developed by the Foundation for Informed Medical Decision Making alone or in combination with individually tailored patient counseling using Motivational Interviewing versus an attention control The long-term objective is to reduce or eliminate the racial gap in the utilization of knee joint replacement The central hypothesis of this proposal is that the scientifically accurate high quality patient-centered information on knee arthritis and joint replacement provided by the knee OA decision aid alone or in combination with motivational interviewing will improve patient understanding of knee joint replacement outcomes increase patient willingness to consider knee joint replacement and consequently lead to higher rates of referral for surgical consideration when clinically indicated With increased referral rates currently a major bottleneck in the path to joint replacement more AA patients will receive recommendations for surgery thus potentially reducing racial differences in the utilization of this procedure This proposal is innovative because it is the first patient-centered evidence-based VA intervention trial to use a decision aid alone or in combination with motivational interviewing to intervene on a well-documented and marked racial disparity in joint replacement that exists within and outside the VA health care system
Primary Specific Aims
1 To examine the effectiveness of the proposed intervention strategies DA alone MI alone or a combined DAMI to improve willingness to consider knee joint replacement when clinically indicated among AA primary care patients
2 To examine the effectiveness of the proposed intervention strategies on patient expectations of knee joint replacement risksbenefits among AA primary care patients
3 To examine the effectiveness of the proposed intervention strategies in increasing primary care referrals for surgical evaluation of AA patients with knee OA
Secondary Specific Aim To examine the effectiveness of the proposed intervention strategies to increase AA patient likelihood of receiving knee joint replacement within 12 months of the intervention
A randomized controlled factorial design will be utilized to examine the effectiveness of knee OA decision aid andor MI compared with attention control on select key patient-centered and process of care outcomes We will recruit approximately 600 AA primary care patients 150 at the VAPHS 150 at the LSCDVAMC and 300 at the PVAMC who meet the American College of Rheumatology clinical indications for knee joint replacement and randomize them into either intervention arms or attention control We will assess patient expectations willingness and referral to joint replacement We will also collect qualitative data on doctor-patient communication following the intervention or control so that we can assess in the future whether or not the interventions impact study outcomes through improved quality of communication This study will provide hard evidence needed to improve quality of care for African-American VA patients who have end-stage knee OA a major cause of disability and functional decline in VA elderly patients
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