Clinical trial NCT03523793: Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy
Official title: Health System Implementation of Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Low Back Pain
Keywords: Outpatient Physical Therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy Research
name: Brooks Rehabilitation
First posted: 2018-05-14
Enrollment: 1441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cross-sectional stepped wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will investigate implementation of a process to enhance Clinical Practice Guideline (CPG) adherence to limit unwarranted variability in initial treatment decisions with high potential for providing more effective and efficient physical therapy management for patients with neck and low back pain.

Detailed description: Effective implementation of CPGs to augment initial clinical decision making during physical therapy management of patients with spine related musculoskeletal pain will have several important goals: 1) improve patient pain and disability outcomes, 2) limit over utilization of physical therapy services, and 3) increase adherence to limit unwarranted variation in clinical practice. This proposed pilot study proposal will test if a multifaceted intervention strategy for implementation of neck and low back CPG meets these goals and provide necessary data for larger system wide implementation efforts.

Specific Aim 1: Determine if physical therapy clinics that receive neck and low back pain (LBP) clinical practice guideline (CPG) training are associated with improved patient outcomes compared to those that have not received training. Neck and LBP specific disability and pain intensity will be assessed at intake, on a weekly basis and at discharge (Specific Aim 1a). Secondary patient outcomes will consist of patient satisfaction scores (Specific Aim 1b). Statistical analyses will evaluate for temporal effects of training considering the stepped wedge study design.

Specific Aim 2: Determine if multifaceted interventions for CPG implementation positively impacts physical therapist beliefs, attitudes, knowledge and behaviors over time. CPG adherence (by clinicians) will be indirectly assessed using quantitative and qualitative methods consisting of: 1) clinician checklists, 2) clinician questionnaires, 3) quality indicators, and 4) total proportion outcome measure assessments (Specific Aim 2).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Receiving outpatient physical therapy for a diagnosis covered in previously published CPGs for neck or LBP
* Able to read and comprehend English language (necessary for completion of self-report e-forms)

Exclusion Criteria:

* Any diagnosis indicating systemic involvement
* Widespread chronic pain syndrome
* Neuropathic pain syndromes
* Neurological disorders.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 68 weeks
measure: Neck Disability Index (NDI)
timeFrame: 68 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 68 weeks
Secondary outcomes:
measure: Rehabilitation Outpatient Division Patient Satisfaction Survey
timeFrame: 68 weeks
measure: Evidence-Based Practice Questionnaire (EBPQ)
timeFrame: 68 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Brooks Rehabilitation
state: Florida
Study officials:
affiliation: University of Florida; Brooks Rehabilitation
name: Jason Beneciuk, DPT,PhD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beneciuk JM, Osborne R, Hagist MB, Crittenden J, Buzzanca KE, Gao H, Wu SS. American Physical Therapy Association Clinical Practice Guideline Implementation for Neck and Low Back Pain in Outpatient Physical Therapy: A Nonrandomized, Cross-sectional Stepped-Wedge Pilot Study. J Orthop Sports Phys Ther. 2022 Feb;52(2):113-123. doi: 10.2519/jospt.2022.10545.