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RAND Center of Excellence for the Study of Appropriateness of Care in CAM (CERC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03162952
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
RAND

Brief Summary:
The RAND approach to appropriateness makes it feasible to take the best of what is known from research and apply it-using the expertise of experienced clinicians-over the wide range of patients and presentations seen in real-world clinical practice. The major limitation of the RAND approach, however, is that it still utilizes a limited definition of appropriateness; one that relies heavily on safety, efficacy and effectiveness. Until now the RAND method has not included patient preferences or resource utilization effectiveness. These are both serious absences. In the past decade we have seen an evolution in outcome measures from clinician based objective measures to patient-centered and subjective measures. The development of Patient Based Outcome Assessments (PBOA); Patient Reported Outcomes Measurement Information System (PROMIS) and the recent establishment of Patient-Centered Outcomes Research Institute (PCORI) all contest to the growing importance of the patient's perspective in determining outcomes and therefore also appropriateness. In the Center, we propose to advance appropriateness methods by adding three additional dimensions to the RAND appropriateness methods: patient outcomes, patient preferences and cost

Condition or disease
Chronic Low Back Pain Chronic Neck Pain

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 2025 participants
Observational Model: Cohort
Time Perspective: Other
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



Primary Outcome Measures :
  1. Project 1 Clinical Appropriateness [ Time Frame: 4 years ]
    Measuring appropriateness rate of manipulation for chronic back pain



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chiropractic physicians Chiropractic patients
Criteria

Inclusion Criteria:

  • Current chiropractic patient over 21 years with chronic low back pain and chronic cervical pain.
  • They must have had the pain for 3 months.

Exclusion Criteria:

  • Under 21, non-specific chronic low back pain or cervical pain, personal injury case able to access the project on line.

Information from the National Library of Medicine

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


Locations
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United States, California
RAND Corporation
Santa Monica, California, United States, 90407
Sponsors and Collaborators
RAND
University of California, Los Angeles
Investigators
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Principal Investigator: Ian D Coulter, PhD RAND Cororation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT03162952    
Other Study ID Numbers: 1U19AT007912-10 REVISED
1U19AT007912 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RAND:
Chronic pain
Additional relevant MeSH terms:
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Low Back Pain
Neck Pain
Back Pain
Pain
Neurologic Manifestations