- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03523793
Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy
Health System Implementation of Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy Settings
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Jacksonville, Florida, United States, 32216
- Brooks Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical Therapists - CPG
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.
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The Study team will use several methods from the implementation strategy taxonomy of the Effective Practice and Organization of Care (EPOC) classification system to improve our likelihood for successful neck and low back pain implementation consisting of: 1) educational materials, workshops and outreach visits from trainers; 2) external consultant testimonials; 3) iterative quality improvement processes (including ongoing analysis of clinician feedback to improve process); 4) routine collection of patient reported outcomes to engage discussion among clinician groups and outpatient division leaders) and 5) local organization consensus process (including feedback from key outpatient division stakeholders).
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Active Comparator: Physical Therapists - Control
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.
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Considering the stepped wedge design with a 12-week washout phase, clinics will be providing standard physical therapy prior to receiving clinical practice guideline training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index (ODI)
Time Frame: 68 weeks
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The Oswestry Disability Index (ODI), which has 10 items that assesses how low back pain affects common daily activities.
The ODI has a range of 0% "no disability due to low back pain" to 100% "completely disabled due to low back pain", with higher scores indicating higher disability from low back pain.
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68 weeks
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Neck Disability Index (NDI)
Time Frame: 68 weeks
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The Neck Disability Index (NDI), which has 10 items that assesses how neck pain affects common daily activities.
The NDI has a range of 0% "no disability due to neck pain" to 100% "completely disabled due to neck pain", with higher scores indicating higher disability from neck pain.
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68 weeks
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 68 weeks
|
Numeric Pain Rating Scale (NPRS) Pain intensity will be rated using a NPRS, ranging from "0" (no pain) to "10" (worst pain imaginable).
Patients will be asked to rate their current pain intensity, as well as their best and worst level of pain intensity over the past 24 hours.
These 3 pain ratings will averaged and used as the NPRS variable in this study.
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68 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rehabilitation Outpatient Division Patient Satisfaction Survey
Time Frame: 68 weeks
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To assess overall therapy experience and explanations provided by therapist.
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68 weeks
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Evidence-Based Practice Questionnaire (EBPQ)
Time Frame: 68 weeks
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The Evidence-Based Practice Questionnaire (EBPQ) to assess clinician beliefs, attitudes, knowledge and self-reported behaviors regarding evidence-based practice and clinical practice guidelines.
Responses range from Strongly Agree to Strongly Disagree.
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68 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jason Beneciuk, DPT,PhD,MPH, University of Florida; Brooks Rehabilitation
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201800569
- 0045970 (710850-6) (Other Identifier: University of Pittsburgh)
- 00000775 (Other Grant/Funding Number: Foundation for Physical Therapy)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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