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.

Chronic Pain / therapy Health Expenditures Humans Treatment Outcome
Back pain Health services research Primary care

Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
12 2021
Historique:
received: 26 04 2021
revised: 14 10 2021
accepted: 17 10 2021
pubmed: 25 10 2021
medline: 1 4 2022
entrez: 24 10 2021
Statut: ppublish

Résumé

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. NCT03083886.

Sections du résumé

BACKGROUND
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.
METHODS
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.
DISCUSSION
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.

Identifiants

DOI: 10.1016/j.cct.2021.106602 PMID: 34688915
pubmed: 34688915
pii: S1551-7144(21)00338-4
doi: 10.1016/j.cct.2021.106602
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT03083886']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

106602

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

Auteurs

Niteesh K Choudhry (NK)

Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: nkchoudhry@bwh.harvard.edu.

Constance P Fontanet (CP)

Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

Roya Ghazinouri (R)

Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

Sheila Fifer (S)

Clinical Excellence Research Center, Stanford University School of Medicine, Palo Alto, CA, USA.

Kristin R Archer (KR)

Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

Nancy Haff (N)

Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

Susan W Butterworth (SW)

Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, USA.

Harvinder Deogun (H)

HonorHealth Clinical Research Institute, Scottsdale, Arizona, USA.

Shannon Block (S)

Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

Angelina Cooper (A)

HonorHealth Clinical Research Institute, Scottsdale, Arizona, USA.

Ellen Sears (E)

Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

Parul Goyal (P)

Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

Rogelio A Coronado (RA)

Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Physical Medicine and Rehabilitation, Osher Center for Integrative Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.

Byron J Schneider (BJ)

Department of Physical Medicine & Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA.

Eugene Hsu (E)

Clinical Excellence Research Center, Stanford University School of Medicine, Palo Alto, CA, USA.

Arnold Milstein (A)

Clinical Excellence Research Center, Stanford University School of Medicine, Palo Alto, CA, USA.

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Classifications MeSH

questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Manifestations neurologiques › Douleur chronique › Design of the Spine Pain Intervention to...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › Dépenses de santé › Design of the Spine Pain Intervention to...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Design of the Spine Pain Intervention to...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Design of the Spine Pain Intervention to...