Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial
Introduction Low back pain (LBP) is a key source of medical costs and disability, impacting over 31 million Americans at any given time and resulting in US$100–US$200 billion per year in total healthcare costs. LBP is one of the leading causes of ambulatory care visits to US physicians; problematica...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-03-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/3/e097133.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850209623055794176 |
|---|---|
| author | Shelby D Reed Adam P Goode Rowena J Dolor Barcey T Levy Stacie A Salsbury Christine Goertz Hrishikesh Chakraborty Samuel Broderick Kelley Ryan Sharon Settles Shoshana Hort Elizabeth A Chrischilles Stacie Kasper James E Stahl Chandra Almond Zacariah Shannon Debra Harris Jeanette Daly Patricia Winokur Jon D Lurie |
| author_facet | Shelby D Reed Adam P Goode Rowena J Dolor Barcey T Levy Stacie A Salsbury Christine Goertz Hrishikesh Chakraborty Samuel Broderick Kelley Ryan Sharon Settles Shoshana Hort Elizabeth A Chrischilles Stacie Kasper James E Stahl Chandra Almond Zacariah Shannon Debra Harris Jeanette Daly Patricia Winokur Jon D Lurie |
| author_sort | Shelby D Reed |
| collection | DOAJ |
| description | Introduction Low back pain (LBP) is a key source of medical costs and disability, impacting over 31 million Americans at any given time and resulting in US$100–US$200 billion per year in total healthcare costs. LBP is one of the leading causes of ambulatory care visits to US physicians; problematically, these visits often result in treatments such as opioids, surgery or advanced imaging that can lead to more harm than benefit. The American College of Physicians (ACP) Guideline for Low Back Pain recommends patients receive non-pharmacological interventions as a first-line treatment. Roadmaps exist for multidisciplinary collaborative care that include well-trained primary contact clinicians with specific expertise in the treatment of musculoskeletal conditions, such as physical therapists and doctors of chiropractic, as first-line providers for LBP. These clinicians, sometimes referred to as primary spine practitioners (PSPs) routinely employ many of the non-pharmacological approaches recommended by the ACP guideline, including spinal manipulation and exercise. Important foundational work has demonstrated that such care is feasible and safe, and results in improved physical function, less pain, fewer opioid prescriptions and reduced utilisation of healthcare services. However, this treatment approach for LBP has yet to be widely implemented or tested in a multisite clinical trial in real-world practice.Methods and analysis The Implementation of the American College of Physicians Guideline for Low Back Pain trial is a health system-embedded pragmatic cluster-randomised trial that will examine the effect of offering initial contact with a PSP compared with usual primary care for LBP. Twenty-six primary care clinics within three healthcare systems were randomised 1:1 to PSP intervention or usual primary care. Primary outcomes are pain interference and physical function using the Patient-Reported Outcomes Measurement Information System Short Forms collected via patient self-report among a planned sample of 1800 participants at baseline, 1, 3 (primary end point), 6 and 12 months. A subset of participants enrolled early in the trial will also receive a 24-month assessment. An economic analysis and analysis of healthcare utilisation will be conducted as well as an evaluation of the patient, provider and policy-level barriers and facilitators to implementing the PSP model using a mixed-methods process evaluation approach.Ethics and dissemination The study received ethics approval from Advarra, Duke University, Dartmouth Health and the University of Iowa Institutional Review Boards. Study data will be made available on completion, in compliance with National Institutes of Health data sharing policies.Trial registration number NCT05626049. |
| format | Article |
| id | doaj-art-e6ef14d9e2ed49b4b34fd6316e52c114 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e6ef14d9e2ed49b4b34fd6316e52c1142025-08-20T02:09:58ZengBMJ Publishing GroupBMJ Open2044-60552025-03-0115310.1136/bmjopen-2024-097133Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trialShelby D Reed0Adam P Goode1Rowena J Dolor2Barcey T Levy3Stacie A Salsbury4Christine Goertz5Hrishikesh Chakraborty6Samuel Broderick7Kelley Ryan8Sharon Settles9Shoshana Hort10Elizabeth A Chrischilles11Stacie Kasper12James E Stahl13Chandra Almond14Zacariah Shannon15Debra Harris16Jeanette Daly17Patricia Winokur18Jon D Lurie19Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USADuke University School of Medicine, Durham, North Carolina, USADepartment of Medicine, Duke University School of Medicine, Durham, North Carolina, USAFamily and Community Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USAPalmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, Iowa, USADuke University School of Medicine, Durham, North Carolina, USADuke Clinical Research Institute, Duke University, Durham, North Carolina, USADuke Clinical Research Institute, Duke University, Durham, North Carolina, USADuke Clinical Research Institute, Duke University, Durham, North Carolina, USADuke Clinical Research Institute, Duke University, Durham, North Carolina, USADepartment of Medicine, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USACollege of Public Health, Department of Epidemiology, The University of Iowa, Iowa City, Iowa, USAFamily and Community Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USADepartment of Medicine, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USADuke Clinical Research Institute, Duke University, Durham, North Carolina, USAPalmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, Iowa, USADuke Clinical Research Institute, Duke University, Durham, North Carolina, USAFamily and Community Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USAInternal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USAMedicine, Orthopaedics, Health Policy, and Clinical Practice, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USAIntroduction Low back pain (LBP) is a key source of medical costs and disability, impacting over 31 million Americans at any given time and resulting in US$100–US$200 billion per year in total healthcare costs. LBP is one of the leading causes of ambulatory care visits to US physicians; problematically, these visits often result in treatments such as opioids, surgery or advanced imaging that can lead to more harm than benefit. The American College of Physicians (ACP) Guideline for Low Back Pain recommends patients receive non-pharmacological interventions as a first-line treatment. Roadmaps exist for multidisciplinary collaborative care that include well-trained primary contact clinicians with specific expertise in the treatment of musculoskeletal conditions, such as physical therapists and doctors of chiropractic, as first-line providers for LBP. These clinicians, sometimes referred to as primary spine practitioners (PSPs) routinely employ many of the non-pharmacological approaches recommended by the ACP guideline, including spinal manipulation and exercise. Important foundational work has demonstrated that such care is feasible and safe, and results in improved physical function, less pain, fewer opioid prescriptions and reduced utilisation of healthcare services. However, this treatment approach for LBP has yet to be widely implemented or tested in a multisite clinical trial in real-world practice.Methods and analysis The Implementation of the American College of Physicians Guideline for Low Back Pain trial is a health system-embedded pragmatic cluster-randomised trial that will examine the effect of offering initial contact with a PSP compared with usual primary care for LBP. Twenty-six primary care clinics within three healthcare systems were randomised 1:1 to PSP intervention or usual primary care. Primary outcomes are pain interference and physical function using the Patient-Reported Outcomes Measurement Information System Short Forms collected via patient self-report among a planned sample of 1800 participants at baseline, 1, 3 (primary end point), 6 and 12 months. A subset of participants enrolled early in the trial will also receive a 24-month assessment. An economic analysis and analysis of healthcare utilisation will be conducted as well as an evaluation of the patient, provider and policy-level barriers and facilitators to implementing the PSP model using a mixed-methods process evaluation approach.Ethics and dissemination The study received ethics approval from Advarra, Duke University, Dartmouth Health and the University of Iowa Institutional Review Boards. Study data will be made available on completion, in compliance with National Institutes of Health data sharing policies.Trial registration number NCT05626049.https://bmjopen.bmj.com/content/15/3/e097133.full |
| spellingShingle | Shelby D Reed Adam P Goode Rowena J Dolor Barcey T Levy Stacie A Salsbury Christine Goertz Hrishikesh Chakraborty Samuel Broderick Kelley Ryan Sharon Settles Shoshana Hort Elizabeth A Chrischilles Stacie Kasper James E Stahl Chandra Almond Zacariah Shannon Debra Harris Jeanette Daly Patricia Winokur Jon D Lurie Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial BMJ Open |
| title | Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial |
| title_full | Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial |
| title_fullStr | Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial |
| title_full_unstemmed | Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial |
| title_short | Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial |
| title_sort | implementation of the american college of physicians guideline for low back pain impact lbp protocol for a healthcare systems embedded multisite pragmatic cluster randomised trial |
| url | https://bmjopen.bmj.com/content/15/3/e097133.full |
| work_keys_str_mv | AT shelbydreed implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT adampgoode implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT rowenajdolor implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT barceytlevy implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT stacieasalsbury implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT christinegoertz implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT hrishikeshchakraborty implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT samuelbroderick implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT kelleyryan implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT sharonsettles implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT shoshanahort implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT elizabethachrischilles implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT staciekasper implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT jamesestahl implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT chandraalmond implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT zacariahshannon implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT debraharris implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT jeanettedaly implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT patriciawinokur implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial AT jondlurie implementationoftheamericancollegeofphysiciansguidelineforlowbackpainimpactlbpprotocolforahealthcaresystemsembeddedmultisitepragmaticclusterrandomisedtrial |