Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy

University of Florida

Status: Completed

Conditions: Neck Pain; Low Back Pain

Treatments: Other: Standard Care; Behavioral: Clinical Practice Guideline Implementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03523793

0045970 (710850-6) (Other Identifier)

00000775 (Other Grant/Funding Number)

IRB201800569

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,441 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,441 participants in 2 patient groups

Physical Therapists - CPG

Experimental group

Description:

Cross-sectional stepped wedge design with 16 physical therapy clinics (including approximately 40 physical therapists) being allocated to one of 4 sequences that differ in CPG implementation time (each sequence consisting of 4 clinics). This proposed study will be conducted over 68 weeks, with the initial 12 weeks serving as a baseline washout phase (before any clinic has received training), then 4 clinics crossing over from standard care (control) to CPG and decision support tool implementation (intervention) approximately every 8 weeks until week 44 when all 4 sequences (16 clinics) have completed training.

Treatment:

Behavioral: Clinical Practice Guideline Implementation

Physical Therapists - Control

Active Comparator group

Description:

This proposed study will be conducted over 68 weeks, with the initial 12 weeks serving as a baseline washout phase (before any clinic has received training), then 4 clinics crossing over from standard care (control) to CPG and decision support tool implementation (intervention) approximately every 8 weeks until week 44 when all 4 sequences (16 clinics) have completed training.

Treatment:

Other: Standard Care