NCT03162952

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,025

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2011

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

7.3 years

First QC Date

February 16, 2017

Last Update Submit

April 11, 2019

Conditions

Keywords

Chronic pain

Outcome Measures

Primary Outcomes (1)

  • Project 1 Clinical Appropriateness

    Measuring appropriateness rate of manipulation for chronic back pain

    4 years

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chiropractic physicians Chiropractic patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAND Corporation

Santa Monica, California, 90407, United States

Location

Related Publications (1)

  • Herman PM, Edgington SE, Sorbero ME, Hurwitz EL, Goertz CM, Coulter ID. Visit Frequency and Outcomes for Patients Using Ongoing Chiropractic Care for Chronic Low-Back and Neck Pain: An Observational Longitudinal Study. Pain Physician. 2021 Jan;24(1):E61-E74.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ian D Coulter, PhD

    RAND Cororation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

May 22, 2017

Study Start

September 30, 2011

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations