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Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial.

Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial.

Authors :
Choudhry, Niteesh K.
Fontanet, Constance P.
Ghazinouri, Roya
Fifer, Sheila
Archer, Kristin R.
Haff, Nancy
Butterworth, Susan W.
Deogun, Harvinder
Block, Shannon
Cooper, Angelina
Sears, Ellen
Goyal, Parul
Coronado, Rogelio A.
Schneider, Byron J.
Hsu, Eugene
Milstein, Arnold
Source :
Contemporary Clinical Trials. Dec2021, Vol. 111, pN.PAG-N.PAG. 1p.
Publication Year :
2021

Abstract

Low back and neck pain (together, spine pain) are among the leading causes of medical visits, lost productivity, and disability. For most people, episodes of spine pain are self-limited; nevertheless, healthcare spending for this condition is extremely high. Focusing care on individuals at high-risk of progressing from acute to chronic pain may improve efficiency. Alternatively, postural therapies, which are frequently used by patients, may prevent the overuse of high-cost interventions while delivering equivalent outcomes. The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure) trial is a cluster-randomized multi-center pragmatic clinical trial designed to evaluate the clinical effectiveness and healthcare utilization of two interventions for primary care patients with acute and subacute spine pain. The study was conducted at 33 primary care clinics in geographically distinct regions of the United States. Individuals ≥18 years presenting to primary care with neck and/or back pain of ≤3 months' duration were randomized at the clinic-level to 1) usual care, 2) a risk-stratified, multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care. The trial's two primary outcomes are change in function at 3 months and spine-related spending at one year. 2971 individuals were enrolled between June 2017 and March 2020. Follow-up was completed on March 31, 2021. The SPINE CARE trial will determine the impact on clinical outcomes and healthcare costs of two interventions for patients with spine pain presenting to primary care. Trial registration number: NCT03083886 [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
15517144
Volume :
111
Database :
Academic Search Index
Journal :
Contemporary Clinical Trials
Publication Type :
Academic Journal
Accession number :
154073277
Full Text :
https://doi.org/10.1016/j.cct.2021.106602