Browsing by Author "Sperber, Nina"

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    Adapting to CONNECT: modifying a nursing home-based team-building intervention to improve hospital care team interactions, functioning, and implementation readiness.
    (BMC health services research, 2022-07) Wang, Virginia; D'Adolf, Joshua; Decosimo, Kasey; Robinson, Katina; Choate, Ashley; Bruening, Rebecca; Sperber, Nina; Mahanna, Elizabeth; Van Houtven, Courtney H; Allen, Kelli D; Colón-Emeric, Cathleen; Damush, Teresa M; Hastings, Susan N

    Background

    Clinical interventions often need to be adapted from their original design when they are applied to new settings. There is a growing literature describing frameworks and approaches to deploying and documenting adaptations of evidence-based practices in healthcare. Still, intervention modifications are often limited in detail and justification, which may prevent rigorous evaluation of interventions and intervention adaptation effectiveness in new contexts. We describe our approach in a case study, combining two complementary intervention adaptation frameworks to modify CONNECT for Quality, a provider-facing team building and communication intervention designed to facilitate implementation of a new clinical program.

    Methods

    This process of intervention adaptation involved the use of the Planned Adaptation Framework and the Framework for Reporting Adaptations and Modifications, for systematically identifying key drivers, core and non-core components of interventions for documenting planned and unplanned changes to intervention design.

    Results

    The CONNECT intervention's original context and setting is first described and then compared with its new application. This lays the groundwork for the intentional modifications to intervention design, which are developed before intervention delivery to participating providers. The unpredictable nature of implementation in real-world practice required unplanned adaptations, which were also considered and documented. Attendance and participation rates were examined and qualitative assessment of reported participant experience supported the feasibility and acceptability of adaptations of the original CONNECT intervention in a new clinical context.

    Conclusion

    This approach may serve as a useful guide for intervention implementation efforts applied in diverse clinical contexts and subsequent evaluations of intervention effectiveness.

    Trial registration

    The study was registered at ClinicalTrials.gov ( NCT03300336 ) on September 28, 2017.
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    Establishing the value of genomics in medicine: the IGNITE Pragmatic Trials Network.
    (Genetics in medicine : official journal of the American College of Medical Genetics, 2021-03-29) Ginsburg, Geoffrey S; Cavallari, Larisa H; Chakraborty, Hrishikesh; Cooper-DeHoff, Rhonda M; Dexter, Paul R; Eadon, Michael T; Ferket, Bart S; Horowitz, Carol R; Johnson, Julie A; Kannry, Joseph; Kucher, Natalie; Madden, Ebony B; Orlando, Lori A; Parker, Wanda; Peterson, Josh; Pratt, Victoria M; Rakhra-Burris, Tejinder K; Ramos, Michelle A; Skaar, Todd C; Sperber, Nina; Steen-Burrell, Kady-Ann; Van Driest, Sara L; Voora, Deepak; Wiisanen, Kristin; Winterstein, Almut G; Volpi, Simona; IGNITE PTN

    Purpose

    A critical gap in the adoption of genomic medicine into medical practice is the need for the rigorous evaluation of the utility of genomic medicine interventions.

    Methods

    The Implementing Genomics in Practice Pragmatic Trials Network (IGNITE PTN) was formed in 2018 to measure the clinical utility and cost-effectiveness of genomic medicine interventions, to assess approaches for real-world application of genomic medicine in diverse clinical settings, and to produce generalizable knowledge on clinical trials using genomic interventions. Five clinical sites and a coordinating center evaluated trial proposals and developed working groups to enable their implementation.

    Results

    Two pragmatic clinical trials (PCTs) have been initiated, one evaluating genetic risk APOL1 variants in African Americans in the management of their hypertension, and the other to evaluate the use of pharmacogenetic testing for medications to manage acute and chronic pain as well as depression.

    Conclusion

    IGNITE PTN is a network that carries out PCTs in genomic medicine; it is focused on diversity and inclusion of underrepresented minority trial participants; it uses electronic health records and clinical decision support to deliver the interventions. IGNITE PTN will develop the evidence to support (or oppose) the adoption of genomic medicine interventions by patients, providers, and payers.
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    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 D

    Background

    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 ).
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    Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program.
    (Trials, 2020-10) Hastings, Susan N; Stechuchak, Karen M; Choate, Ashley; Mahanna, Elizabeth P; Van Houtven, Courtney; Allen, Kelli D; Wang, Virginia; Sperber, Nina; Zullig, Leah; Bosworth, Hayden B; Coffman, Cynthia J

    Background

    Stepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs.

    Methods

    Based on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals.

    Results

    Site recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3 months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6-8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled).

    Conclusions

    Future studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a "ramp-up" period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out.

    Trial registration

    ClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.
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    Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials.
    (BMC musculoskeletal disorders, 2012-04) Allen, Kelli D; Bosworth, Hayden B; Brock, Dorothea S; Chapman, Jennifer G; Chatterjee, Ranee; Coffman, Cynthia J; Datta, Santanu K; Dolor, Rowena J; Jeffreys, Amy S; Juntilla, Karen A; Kruszewski, Jennifer; Marbrey, Laurie E; McDuffie, Jennifer; Oddone, Eugene Z; Sperber, Nina; Sochacki, Mary P; Stanwyck, Catherine; Strauss, Jennifer L; Yancy, William S

    Background

    Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care.

    Methods / design

    One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed.

    Discussion

    Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings.

    Trial registration

    NCT01130740 (VA); NCT 01435109 (NIH).
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    Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol.
    (Implementation science : IS, 2018-04) Wang, Virginia; Allen, Kelli; Van Houtven, Courtney H; Coffman, Cynthia; Sperber, Nina; Mahanna, Elizabeth P; Colón-Emeric, Cathleen; Hoenig, Helen; Jackson, George L; Damush, Teresa M; Price, Erika; Hastings, Susan N
    BACKGROUND:Successful implementation of new clinical programs depends on effectively establishing, reorganizing, or enhancing team structures and processes to coordinate the work of individuals who are interdependent in their tasks, manage relationships, and share responsibility for outcomes. However, a one-size-fits-all approach is rarely effective. In partnership with VA national clinical leaders and local clinical champions, the Optimizing Function and Independence VA Quality Enhancement Research Initiative program (Function QUERI) will evaluate efforts to implement team-based clinical programs for Veterans at risk for functional decline and disability. METHODS:Function QUERI will implement and evaluate three innovative, evidence-based clinical programs in VA medical centers: (1) a group physical therapy program for knee osteoarthritis (Group PT); (2) assisted early mobility for hospitalized older veterans (STRIDE), a supervised walking program for hospitalized older veterans; and (3) implementation of helping invested family members improve veteran experiences study (iHI-FIVES), a skills training program for caregivers of disabled Veterans. A common reason for clinical care gaps in these populations is poor communication and coordination among the many interdisciplinary providers involved in their care. To facilitate the implementation of the clinical programs, Function QUERI will evaluate the impact of complexity science-based implementation intervention to promote team readiness (CONNECT), an implementation intervention designed as a bundle of interaction-oriented activities to promote team function and readiness for change, on the implementation of clinical programs across multiple sites. The evaluation will use a mixed methods design. Group PT is a local, single-site quality improvement project where a modified CONNECT intervention will be tested to inform the remaining program implementation projects. For STRIDE and iHI-FIVES projects, we will randomize participating sites to implement the clinical program, with the CONNECT intervention or not, and will use a stepped-wedge cluster randomized trial design. DISCUSSION:Function QUERI will translate its findings across its projects to identify the contextual factors and components from CONNECT that improve team processes and function to optimize effective implementation for future rollout of VA clinical programs. Synthesizing findings within and across projects, we will specify dimensions of team characteristics and function that enhance capacity for clinical innovation and uptake of evidence-based programs. TRIAL REGISTRATION:NCT03300336 Registered September 28, 2017, NCT03474380 Registered March 15, 2018.