RAND Center of Excellence for the Study of Appropriateness of Care in CAM (CERC)
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|ClinicalTrials.gov Identifier: NCT03162952|
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : April 16, 2019
|Condition or disease|
|Chronic Low Back Pain Chronic Neck Pain|
The primary objective of this Center of Excellence is:
Develop and refine methods for the study of the appropriateness of care in CAM.
This Center of Excellence will have four Projects.
- Project 1: Clinician Based Appropriateness
- Project 2: Outcomes Based Appropriateness
- Project 3: Patient Preferences Appropriateness
- Project 4 : Resource Utilization Based Appropriateness
Because much of CAM faces the challenge of limited evidence], and because these methods are well-established, we will have as our core project
Project 1: Clinician-Based Appropriateness the application of the RAND approach to the determination of appropriate care for Manipulation/Mobilization (M/M) for chronic .low back pain (CLBP) and chronic cervical pain (CCP). This approach uses a mixed (CAM and non-CAM) panel of expert clinicians to interpret syntheses of all available data on safety, efficacy and effectiveness and clinical experience to apply these data to the question of care appropriateness for low back and cervical M/M. This approach has been applied successfully to M/M for low back pain and a literature review and expert panel was previously done for M/M for cervical manipulation.
The main objectives of the core project (Project 1) are to develop a set of ratings of the appropriateness of M/M for chronic low back and chronic neck pain across various patient presentations, to be used in the determination of the prevalence of appropriate and inappropriate care in a national sample of these patients, and to provide feedback to the research community regarding the patient presentations where substantial uncertainty remains as to the appropriateness of M/M. We will also, however, in the Resource Utilization project examine M/M in relationship to other forms of a non-invasive therapy for cervical pain to get comparative ratings of appropriateness.
Objectives of the Other Center Projects. The other projects in the Center each add to the RAND-based method in different ways by exploring the broader dimensions of appropriateness which may be applicable for CAM as well as health care in general. Project 2 (Outcomes Based Appropriateness) will examine the patient-assessed outcomes which, in part, contribute to the determination of appropriateness made by patients. Its objectives include developing CAM-sensitive PROMIS measures for patients using manipulation/mobilization for CLBP and CCP and to analyze data collected from a national study of chiropractic patients with CLBP and that can be used to evaluate appropriateness of their care from the patient's perspective. Given the prevalence of patient self-referral in CAM and the health system-wide focus on patient-centered care, Project 3 (Patient Preference Appropriateness) will examine how patient preferences affect what is considered to be appropriate care. Objectives here include understanding how CLBP and CCP patients decide to use M/M and determining what they believe is appropriate care. Finally, given the high proportion of out-of-pocket costs in CAM and the dramatic rise of healthcare costs in general, Project 4 (Resource Utilization Based Appropriateness) will examine how cost affects both which care is most appropriate and the appropriate course of care once implemented. Objectives here include providing data on the relative cost-effectiveness of care options for CLBP and CCP to the Appropriateness Panel (Project 1) to see if cost data changes their ratings, and analyzing data from our national sample to begin to understand the characteristics of an appropriate course of care once M/M is chosen.
|Study Type :||Observational|
|Actual Enrollment :||2025 participants|
|Official Title:||RAND Center of Excellence for the Study of Appropriateness of Care in CAM|
|Actual Study Start Date :||September 30, 2011|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
- Project 1 Clinical Appropriateness [ Time Frame: 4 years ]Measuring appropriateness rate of manipulation for chronic back pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162952
|United States, California|
|Santa Monica, California, United States, 90407|
|Principal Investigator:||Ian D Coulter, PhD||RAND Cororation|