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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523793
Recruitment Status : Active, not recruiting
First Posted : May 14, 2018
Last Update Posted : June 18, 2020
Sponsor:
Collaborators:
Center on Health Services Training and Research (CoHSTAR)
Brooks Rehabilitation
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Neck Pain Low Back Pain Behavioral: Clinical Practice Guideline Implementation Other: Standard Care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1672 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cross-sectional stepped wedge design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Health System Implementation of Clinical Practice Guidelines for Neck and Low Back Pain in Outpatient Physical Therapy Settings
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: Clinical Practice Guideline Implementation
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).

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.
Other: Standard Care
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.




Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 68 weeks ]
    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.

  2. Neck Disability Index (NDI) [ Time Frame: 68 weeks ]
    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.

  3. 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.


Secondary Outcome Measures :
  1. Rehabilitation Outpatient Division Patient Satisfaction Survey [ Time Frame: 68 weeks ]
    To assess overall therapy experience and explanations provided by therapist.

  2. Evidence-Based Practice Questionnaire (EBPQ) [ Time Frame: 68 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523793


Locations
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United States, Florida
Brooks Rehabilitation
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
University of Florida
Center on Health Services Training and Research (CoHSTAR)
Brooks Rehabilitation
Investigators
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Principal Investigator: Jason Beneciuk, DPT,PhD,MPH University of Florida; Brooks Rehabilitation
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03523793    
Other Study ID Numbers: IRB201800569
0045970 (710850-6) ( Other Identifier: University of Pittsburgh )
00000775 ( Other Grant/Funding Number: Foundation for Physical Therapy )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Outpatient Physical Therapy
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms