Browsing by Author "Ballengee, Lindsay A"
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Item Open Access Group physical therapy for knee osteoarthritis: protocol for a hybrid type III effectiveness-implementation trial.(Implementation science communications, 2023-10) Webb, Sara; Drake, Connor; Coffman, Cynthia J; Sullivan, Caitlin; Sperber, Nina; Tucker, Matthew; Zullig, Leah L; Hughes, Jaime M; Kaufman, Brystana G; Pura, John A; Anderson, Livia; Hastings, Susan N; Van Houtven, Courtney H; Abbate, Lauren M; Hoenig, Helen; Ballengee, Lindsay A; Wang, Virginia; Allen, Kelli DBackground
Knee osteoarthritis (OA) is a leading cause of chronic pain and disability and one of the most common conditions treated in outpatient physical therapy (PT). Because of the high and growing prevalence of knee OA, there is a need for efficient approaches for delivering exercise-based PT to patients with knee OA. A prior randomized controlled trial (RCT) showed that a 6-session Group Physical Therapy Program for Knee OA (Group PT) yields equivalent or greater improvements in pain and functional outcomes compared with traditional individual PT, while requiring fewer clinician hours per patient to deliver. This manuscript describes the protocol for a hybrid type III effectiveness-implementation trial comparing two implementation packages to support delivery of Group PT.Methods
In this 12-month embedded trial, a minimum of 16 Veterans Affairs Medical Centers (VAMCs) will be randomized to receive one of two implementation support packages for their Group PT programs: a standard, low-touch support based on Replicating Effective Programs (REP) versus enhanced REP (enREP), which adds tailored, high-touch support if sites do not meet Group PT adoption and sustainment benchmarks at 6 and 9 months following launch. Implementation outcomes, including penetration (primary), adoption, and fidelity, will be assessed at 6 and 12 months (primary assessment time point). Additional analyses will include patient-level effectiveness outcomes (pain, function, satisfaction) and staffing and labor costs. A robust qualitative evaluation of site implementation context and experience, as well as site-led adaptations to the Group PT program, will be conducted.Discussion
To our knowledge, this study is the first to evaluate the impact of tailored, high-touch implementation support on implementation outcomes when compared to standardized, low-touch support for delivering a PT-based intervention. The Group PT program has strong potential to become a standard offering for PT, improving function and pain-related outcomes for patients with knee OA. Results will provide information regarding the effectiveness and value of this implementation approach and a deeper understanding of how healthcare systems can support wide-scale adoption of Group PT.Trial registration
This study was registered on March 7, 2022 at ClinicalTrials.gov (identifier NCT05282927 ).Item Open Access Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial.(Pain medicine (Malden, Mass.), 2020-12) George, Steven Z; Coffman, Cynthia J; Allen, Kelli D; Lentz, Trevor A; Choate, Ashley; Goode, Adam P; Simon, Corey B; Grubber, Janet M; King, Heather; Cook, Chad E; Keefe, Francis J; Ballengee, Lindsay A; Naylor, Jennifer; Brothers, Joseph Leo; Stanwyck, Catherine; Alkon, Aviel; Hastings, Susan NBackground
Coordinated efforts between the National Institutes of Health, the Department of Defense, and the Department of Veterans Affairs have built the capacity for large-scale clinical research investigating the effectiveness of nonpharmacologic pain treatments. This is an encouraging development; however, what constitutes best practice for nonpharmacologic management of low back pain (LBP) is largely unknown.Design
The Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) trial is an embedded pragmatic cluster-randomized trial that will examine the effectiveness of two different care pathways for LBP. Sixteen primary care clinics will be randomized 1:1 to receive training in delivery of 1) an integrated sequenced-care pathway or 2) a coordinated pain navigator pathway. Primary outcomes are pain interference and physical function (Patient-Reported Outcomes Measurement Information System Short Form [PROMIS-SF]) collected in the electronic health record at 3 months (n=1,680). A subset of veteran participants (n=848) have consented to complete additional surveys at baseline and at 3, 6, and 12 months for supplementary pain and other measures.Summary
AIM-Back care pathways will be tested for effectiveness, and treatment heterogeneity will be investigated to identify which veterans may respond best to a given pathway. Health care utilization patterns (including opioid use) will also be compared between care pathways. Therefore, the AIM-Back trial will provide important information that can inform the future delivery of nonpharmacologic treatment of LBP.Item Open Access Introduction of a psychologically informed educational intervention for pre-licensure physical therapists in a classroom setting.(BMC medical education, 2020-10-23) Ballengee, Lindsay A; Covington, J Kyle; George, Steven ZBACKGROUND:There is an increasing need for physical therapists to address psychosocial aspects of musculoskeletal pain. Psychologically informed practice is one way to deliver this type of care through the integration of biopsychosocial interventions into patient management. An important component of psychologically informed practice is patient centered communication. However, there is little research on how to effectively implement patient centered communication into pre-licensure training for physical therapists. METHODS:Thirty Doctor of Physical Therapy (DPT) students took part in an educational intervention that consisted of one 4-h didactic teaching session and three 1-h experiential learning sessions. Prior to the first session, students performed an examination of a standardized patient with chronic low back pain and were assessed on psychologically informed physical therapy (PIPT) adherent behaviors via a rating scale. Students also completed the Pain Attitudes and Beliefs Scale (PABS-PT). After the last experiential session, students evaluated another standardized patient and were reassessed on PIPT adherent behaviors. Students retook the PABS-PT and qualitative data was also collected. RESULTS:After the educational intervention, students had positive changes in their pain attitudes and belief scores indicating a stronger orientation toward a psychosocial approach to patient care (p < 0.05). Additionally, after the intervention, students showed improvements in their adherence to using PIPT behaviors in their simulated patient interactions (p < 0.05). Qualitatively, students reported a high acceptability of the educational intervention with common themes indicating improved confidence with treating and communicating with complex patients. CONCLUSION:Students had attitudes and beliefs shift towards a more psychosocial orientation and demonstrated improved PIPT behaviors in simulated patient interactions after a brief educational intervention. Future research should investigate best practices for implementation of psychologically informed physical therapy for licensed clinicians.Item Open Access Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial.(Clinical trials (London, England), 2023-06) Ballengee, Lindsay A; King, Heather A; Simon, Corey; Lentz, Trevor A; Allen, Kelli D; Stanwyck, Catherine; Gladney, Micaela; George, Steven Z; Hastings, S NicoleBackground/aims
Embedded pragmatic clinical trials are increasingly recommended for non-pharmacological pain care research due to their focus on examining intervention effectiveness within real-world settings. Engagement with patients, health care providers, and other partners is essential, yet there is limited guidance for how to use engagement to meaningfully inform the design of interventions to be tested in pain-related pragmatic clinical trials. This manuscript aims to describe the process and impacts of partner input on the design of two interventions (care pathways) for low back pain currently being tested in an embedded pragmatic trial in the Veterans Affairs health care system.Methods
Sequential cohort design for intervention development was followed. Engagement activities were conducted with 25 participants between November 2017 and June 2018. Participants included representatives from multiple groups: clinicians, administrative leadership, patients, and caregivers.Results
Partner feedback led to several changes in each of the care pathways to improve patient experience and usability. Major changes to the sequenced care pathway included transitioning from telephone-based delivery to a flexible telehealth model, increased specificity about pain modulation activities, and reduction of physical therapy visits. Major changes to the pain navigator pathway included transitioning from a traditional stepped care model to one that offers care in a feedback loop, increased flexibility regarding pain navigator provider type, and increased specificity for patient discharge criteria. Centering patient experience emerged as a key consideration from all partner groups.Conclusion
Diverse input is important to consider before implementing new interventions in embedded pragmatic trials. Partner engagement can increase acceptability of new care pathways to patients and providers and enhance uptake of effective interventions by health systems.Trial registration
NCT#04411420. Registered on 2 June 2020.