Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01345409
Status:
COMPLETED
Last Update Posted:
2016-12-23
First Post:
2011-04-28
Brief Title:
Acupuncture and Chiropractic Care for Chronic Pain in an Integrated Health Plan
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Acupuncture and Chiropractic Care for Chronic Pain in an Integrated Health Plan
Status:
COMPLETED
Status Verified Date:
2016-12
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:
Relief
Brief Summary:
Recent research examines many types of complementary and alternative CAM therapies However real-world use of CAM has been largely overlooked
This project consists of four discrete sets of project activities that largely follow one another chronologically
Phase1 uses information from the EMR patient electronic medical records to identify unique clusters of patients with CMP chronic musculoskeletal pain their care within the health plan and to examine how those in unique clusters may have different uses for AC acupuncture and chiropractic services andor differential outcomes associated with such care
Phase 2 will conduct a survey of CMP patients from KPNW Kaiser Permanente Northwest region to establish a broad sample of patients and their use of out-of-plan CAM services
Phase 3 will collect qualitative data focus groups and individual interviews from KP members KP providers and acupuncturists and chiropractors from the community to examine KP providers decision to recommend AC services AC services delivered to KP patients and patients decisions to pursue and retain CAM care A secondary purpose is to have KP members with CMP review planned assessment instruments to improve understandability of the instruments They will provide feedback on relevancy any notable omissions of domains important in patients decision to use CAM services for pain treatment They will also provide insight to broader health and quality of life outcomes associated with such CAM treatments
Phase 4 is a prospective cohort study to evaluate health servicescosts and broader clinical and functional outcomes associated with the receipt of AC relative to carefully matched comparison participants receiving traditional CMP services
This project consists of four discrete sets of project activities that largely follow one another chronologically
Phase1 uses information from the EMR patient electronic medical records to identify unique clusters of patients with CMP chronic musculoskeletal pain their care within the health plan and to examine how those in unique clusters may have different uses for AC acupuncture and chiropractic services andor differential outcomes associated with such care
Phase 2 will conduct a survey of CMP patients from KPNW Kaiser Permanente Northwest region to establish a broad sample of patients and their use of out-of-plan CAM services
Phase 3 will collect qualitative data focus groups and individual interviews from KP members KP providers and acupuncturists and chiropractors from the community to examine KP providers decision to recommend AC services AC services delivered to KP patients and patients decisions to pursue and retain CAM care A secondary purpose is to have KP members with CMP review planned assessment instruments to improve understandability of the instruments They will provide feedback on relevancy any notable omissions of domains important in patients decision to use CAM services for pain treatment They will also provide insight to broader health and quality of life outcomes associated with such CAM treatments
Phase 4 is a prospective cohort study to evaluate health servicescosts and broader clinical and functional outcomes associated with the receipt of AC relative to carefully matched comparison participants receiving traditional CMP services
Detailed Description:
Substantial recent research examines the efficacy and biological basis of many types of complementary and alternative CAM therapies However real-world use of CAM has been largely overlooked despite calls for CAM therapies to be studied in the manner in which they are practiced and urging high prioritization for research that includes clinical outcomes cost-effectiveness and the decision-making process for patients and providers There is therefore heightened need for enriched understanding-particularly given CAMs growing popularity which fortunately offers stores of new data for research Recent studies suggests that Americans seek CAM treatments far more often for chronic musculoskeletal pain CMP than for any other condition Among CAM treatments for CMP acupuncture and chiropractic AC care are among those with the highest acceptance by physician groups and the best evidence to support their use Further recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain-despite their high costs potential adverse effects and modest efficacy-suggests the need to evaluate the outcomes associated with promising non-pharmacologicalnon-surgical CAM treatments for CMP which are often well accepted by patients and increasingly used in the community
This study responds to the NCCAM program announcement PAR-08-045 Outcomes Cost-Effectiveness and the Decision Making Process to Use CAM
Because this project consists of four discrete sets of project activities that largely follow one another chronologically the investigators plan to submit separate IRQs to cover each set of project activities as follows
Phase1 Retrospective study using information from the EMR to identify unique clusters of patients with CMP their trajectories of care within the health plan and to examine how those in unique clusters may have differing propensities for the use of AC services andor differential outcomes associated with such care The IRQ for this study has been submitted Phase 2 The administration of an out-of-plan CAM survey to determine from a broad sample of KP members their use of such services
Phase 3 The collection of qualitative data focus groups and individual interviews from KP members KP providers and acupuncturists and chiropractors from the community to examine KP providers decision to recommend AC services AC services delivered to KP patients and patients decisions to pursue and retain CAM care A secondary purpose is to have KP members with CMP review planned assessment instruments for phase 4 of the study to provide feedback on relevancy any notable omissions of domains important in patients decision to use CAM services for pain treatment and broader health and quality of life outcomes associated with such CAM treatments as well as to review understandability of the assessment instruments
Phase 4 A prospective cohort study to evaluate health servicescosts and broader clinical and functional outcomes associated with the receipt of AC relative to carefully matched comparison participants receiving traditional CMP services
This study responds to the NCCAM program announcement PAR-08-045 Outcomes Cost-Effectiveness and the Decision Making Process to Use CAM
Because this project consists of four discrete sets of project activities that largely follow one another chronologically the investigators plan to submit separate IRQs to cover each set of project activities as follows
Phase1 Retrospective study using information from the EMR to identify unique clusters of patients with CMP their trajectories of care within the health plan and to examine how those in unique clusters may have differing propensities for the use of AC services andor differential outcomes associated with such care The IRQ for this study has been submitted Phase 2 The administration of an out-of-plan CAM survey to determine from a broad sample of KP members their use of such services
Phase 3 The collection of qualitative data focus groups and individual interviews from KP members KP providers and acupuncturists and chiropractors from the community to examine KP providers decision to recommend AC services AC services delivered to KP patients and patients decisions to pursue and retain CAM care A secondary purpose is to have KP members with CMP review planned assessment instruments for phase 4 of the study to provide feedback on relevancy any notable omissions of domains important in patients decision to use CAM services for pain treatment and broader health and quality of life outcomes associated with such CAM treatments as well as to review understandability of the assessment instruments
Phase 4 A prospective cohort study to evaluate health servicescosts and broader clinical and functional outcomes associated with the receipt of AC relative to carefully matched comparison participants receiving traditional CMP services
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