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Implementation Challenges: Lessons Learned from a Large Pragmatic Trial

This article discusses the challenges and lessons learned from the implementation of targeted interventions for chronic low back pain in a large pragmatic trial. It explores the use of psychologic and physical therapy interventions, as well as the enrollment and data capture strategies within primary care settings.

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Implementation Challenges: Lessons Learned from a Large Pragmatic Trial

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  1. Implementation Challenges: Lessons Learned from a Large Pragmatic Trial Joel Stevans, PhD, DC Assistant Professor, Department of Physical Therapy Senior Implementation Scientist, Health Policy Institute University of Pittsburgh

  2. Targeted Interventions to Prevent Chronic Low Back Pain (LBP) Anthony Delitto, PT, PhD, FAPTA Principal Investigator Professor and Dean, School of Health and Rehabilitation Sciences University of Pittsburgh Robert Saper, MD, MPH Co-Principal Investigator Associate Professor, Department of Family Medicine Director of Integrative Medicine Boston University Patient-Centered Outcomes Research Institute (PCORI) Award PCS-1402-10867 PCORnet Study Identification Number: C11-2016-0001

  3. Acknowledgements • TARGET Trial Site Principal Investigators • Anthony Delitto, PT, PhD, FAPTA, University of Pittsburgh • Robert Saper, MD, MPH, Boston Medical Center • Gerard Brennan, PT, PhD, Intermountain Healthcare • David Morrisette, PT, PhD, Medical University of South Carolina • Stephen Wegener, PhD, Johns Hopkins University • TARGET Trial Study Team

  4. Back Pain is a Well Known Problem • It is highly prevalent and extremely costly • Most common type of pain & the second most common reason for doctor visits • Management is becoming more discordant with guidelines • Overuse of opioid prescribing • Overuse of diagnostic imaging (MR, CT, x-ray) • Early specialty escalation • Underuse of non-pharmacologic interventions

  5. Targeted LBP Interventions in Primary Care Psychologic obstacles to recovery Enhanced package of care Physical obstacles to recovery Face-to-face conservative treatment Low risk of chronicity Advice, reassurance & medication https://startback.hfac.keele.ac.uk/

  6. Psychologically Informed Physical Therapy • Improve physical function through tailored stretching, strengthening, and aerobic exercises • Address psychosocial obstacles to recovery through education, coaching, graded exercise • Fear-avoidance behaviors and beliefs • Catastrophizing

  7. Multisite, Pragmatic, Cluster Randomized, Controlled Trial • Health delivery systems • UPMC • Boston Medical Center • Intermountain Healthcare • Johns Hopkins University • Medical University of South Carolina • Cluster randomized 88 primary care practices • 46 in the intervention group • 42 in the control group

  8. Assess for Eligibility Baseline Measures Chronic LBP Questionnaire STarT Back Tool Oswestry LBP Disability Questionnaire – Chronic LBP Exclude Observational Cohort RCT Cohort Acute LBP – Low/Medium Risk Acute LBP – High Risk GBC GBC + PIPT Follow - up Measure 6 - Month Follow - up Measures 6 - Month Follow - up Measures PT Checklist Chronic LBP Questionnaire Chronic LBP Questionnaire Oswestry Oswestry 12 - Month Follow - up Measures 12 - Month Follow - up Measures Resource Utilization Resource Utilization Secondary Aims Primary and Secondary Aims GBC = Guideline Based Care and PIPT = Psychologically Informed Physical Therapy

  9. Enrollment Strategy Two-part interdependent process • Quality improvement (QI) enrollment • Clinic personnel identifies LBP patients • Baseline data collection • High-risk patients receive immediate PIPT referral in the intervention clinics • Research enrollment • Informed consent - web, paper, telephonic (at 6 mo.) or point-of-care • Follow-up assessments - web, paper & telephonic follow-up at 6 months

  10. Implementation Strategy within Primary Care • Rely on administrative staff to identify and screen patients • Appointment schedulers • Front desk / check-in staff • Rooming staff (e.g., medical assistants, nurses) • Leverage technology to facilitate the process • Staff and provider training • Audit and feedback reports with facilitation • Financial incentives (2 systems)

  11. Data Capture at Point-of-Care • Responsibility of each study site • Develop mechanisms to collect patient-reported information • Tablet • Direct entry • Patient portal • Patient navigator • Integrate baseline data into the EMR • Automated scoring with best practice alerts in the EMR • Pend PIPT referral for high-risk patients in intervention clinics

  12. Prospective Workflow Physicians Rooming Staff Front Desk Staff Central or Clinic Based Appointment Schedulers • Pend PIPT Orders • Sign PIPT Orders • Identify & Screen Patients

  13. Retrospective Workflow Physicians Rooming Staff Front Desk Staff Central or Clinic Based Appointment Schedulers • Sign PIPT Orders • Identify Patients, Screen and Pend PIPT Orders Patient Navigator

  14. Pathway to Physical Therapy

  15. Identification and Screening by Site Data subject to final reconciliation with each site

  16. High Risk PIPT/PT Referrals by Site Data subject to final reconciliation with each site

  17. Enrollment Strategy Two-part interdependent process • Quality improvement (QI) enrollment • Clinic personnel identifies LBP patients • Baseline data collection • High-risk patients receive immediate PIPT referral in the intervention clinics • Research enrollment • Informed consent - web, paper, telephonic (at 6 mo.) or point-of-care • Follow-up assessments - web, paper & telephonic follow-up at 6 months

  18. Enrollment Strategy Two-part interdependent process • Quality improvement (QI) enrollment • Clinic personnel identifies LBP patients • Baseline data collection • High-risk patients receive immediate PIPT referral in the intervention clinics • Research enrollment • Informed consent - web, paper, telephonic (at 6 mo.) or point-of-care • Follow-up assessments - web, paper & telephonic follow-up at 6 months

  19. Consent & Six Month Follow-up

  20. Summary • Barriers at virtually every level • Organizational • Individual • Technological • Substantial variability • Policies and procedures • Infrastructure (e.g., EMR) • Technological capabilities • Resources

  21. Summary • Contextual environment cannot be ignored • Research & operations • Clarity on core versus adaptable components • The fuel for change • Alignment with organizational priorities • Leadership engagement • PCORI funding • Must constantly tend the garden • Audit & feedback • Reinforcement & retraining

  22. Questions

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