Browsing by Author "Allen, Kelli D"
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Item Open Access A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.(Annals of internal medicine, 2016-01) Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene ZBackground
Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused.Objective
To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes.Design
Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740).Setting
Department of Veterans Affairs Medical Center in Durham, North Carolina.Participants
30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis.Intervention
The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record.Measurements
The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes.Results
At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ.Limitation
The study was conducted in a single Veterans Affairs medical center.Conclusion
The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis.Primary funding source
Department of Veterans Affairs, Health Services Research and Development Service.Item Open Access A feasibility study to develop and test a Spanish patient and provider intervention for managing osteoarthritis in Hispanic/Latino adults (PRIMO-Latino).(Pilot and feasibility studies, 2018-01) Corsino, Leonor; Coffman, Cynthia J; Stanwyck, Catherine; Oddone, Eugene Z; Bosworth, Hayden B; Chatterjee, Ranee; Jeffreys, Amy S; Dolor, Rowena J; Allen, Kelli DBackground
Arthritis affects approximately 50 million adults in the USA. Hispanics/Latinos have a higher prevalence of arthritis-attributed activity limitations primarily related to osteoarthritis (OA). Hispanic/Latinos are less likely to receive hip replacement independent of health care access, and they are less likely to receive knee replacement. There have been few interventions to improve OA treatment among the Hispanic/Latino population in the USA. In our study, we aimed to develop and test a telephone delivered culturally appropriate Spanish behavioral intervention for the management of OA in Hispanic/Latino adults.Methods
We conducted a feasibility study in an academic health center and local community in Durham, North Carolina. We enrolled self-identified Spanish speaking overweight/obese adults (≥ 18) with OA of the knee and/or hip under the care of a primary health care provider. The 12-month patient intervention focused on physical activity, weight management, and cognitive behavioral pain management skills. The patient intervention was delivered via telephone with calls scheduled twice per month for the first 6 months, then monthly for the last 6 months (18 sessions). The one-time provider intervention included delivery of patient-specific OA treatment recommendations, based on patients' baseline data and published guidelines. The primary measures were metrics of feasibility, including recruitment and intervention delivery. We also assessed pain, stiffness, and function using the Spanish-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Results
A total of 1879 participants were identified for potential enrollment. Of those, 1864 did not meet inclusion criteria, were not able to be reached or refused. Fifteen participants enrolled in the intervention. The mean number of phone calls completed was 14.7. Eighty percent completed more than 16 calls. The mean WOMAC baseline score (SD) was 39 (20); mean improvement in WOMAC scores between baseline and 12 months, among 11 participants who completed the study, was - 13.27 [95% CI, - 25.09 to - 1.46] points.Conclusion
Recruitment of Hispanics/Latinos, continues to be a major challenge. A Spanish-based telephone delivering lifestyle intervention for OA management in Hispanic/Latino adults is feasible to deliver and may lead to improved OA symptoms. Future research is needed to further test the feasibility and effectiveness of this type of intervention in this segment of the population.Trial registration
NCT01782417.Item Open Access Accelerating Implementation of Virtual Care in an Integrated Health Care System: Future Research and Operations Priorities.(Journal of general internal medicine, 2021-08) Lewinski, Allison A; Sullivan, Caitlin; Allen, Kelli D; Crowley, Matthew J; Gierisch, Jennifer M; Goldstein, Karen M; Gray, Kaileigh; Hastings, Susan N; Jackson, George L; McCant, Felicia; Shapiro, Abigail; Tucker, Matthew; Turvey, Carolyn; Zullig, Leah L; Bosworth, Hayden BBackground
Virtual care is critical to Veterans Health Administration (VHA) efforts to expand veterans' access to care. Health care policies such as the Veterans Access, Choice, and Accountability (CHOICE) Act and the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act impact how the VHA provides care. Research on ways to refine virtual care delivery models to meet the needs of veterans, clinicians, and VHA stakeholders is needed.Objective
Given the importance of virtual approaches for increasing access to high-quality VHA care, in December 2019, we convened a Think Tank, Accelerating Implementation of Virtual Care in VHA Practice, to consider challenges to virtual care research and practice across the VHA, discuss novel approaches to using and evaluating virtual care, assess perspectives on virtual care, and develop priorities to enhance virtual care in the VHA.Methods
We used a participatory approach to develop potential priorities for virtual care research and activities at the VHA. We refined these priorities through force-ranked prioritization and group discussion, and developed solutions for selected priorities.Results
Think Tank attendees (n = 18) consisted of VHA stakeholders, including operations partners (e.g., Office of Rural Health, Office of Nursing Services, Health Services Research and Development), clinicians (e.g., physicians, nurses, psychologists, physician assistants), and health services researchers. We identified an initial list of fifteen potential priorities and narrowed these down to four. The four priorities were (1) scaling evidence-based practices, (2) centralizing virtual care, (3) creating high-value care within the VHA with virtual care, and (4) identifying appropriate patients for virtual care.Conclusion
Our Think Tank took an important step in setting a partnered research agenda to optimize the use of virtual care within the VHA. We brought together research and operations stakeholders and identified possibilities, partnerships, and potential solutions for virtual care.Item Open Access 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 NBackground
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.Item Open Access Association of Burden and Prevalence of Arthritis With Disparities in Social Risk Factors, Findings From 17 US States.(Preventing chronic disease, 2022-02) Rethorn, Zachary D; Rethorn, Timothy J; Cook, Chad E; Sharpe, Jason A; Hastings, S Nicole; Allen, Kelli DIntroduction
Social risks previously have been associated with arthritis prevalence and costs. Although social risks often cluster among individuals, no studies have examined associations between multiple social risks within the same individual. Our objective was to determine the association between individual and multiple social risks and the prevalence and burden of arthritis by using a representative sample of adults in 17 US states.Methods
Data are from the 2017 Behavioral Risk Factor Surveillance System. Respondents were 136,432 adults. Social risk factors were food insecurity, housing insecurity, financial insecurity, unsafe neighborhoods, and health care access hardship. Weighted χ2 and logistic regression analyses, controlling for demographic characteristics, measures of socioeconomic position, and other health conditions examined differences in arthritis prevalence and burden by social risk factor and by a social risk index created by summing the social risk factors.Results
We observed a gradient in the prevalence and burden of arthritis. Compared with those reporting 0 social risk factors, respondents reporting 4 or more social risk factors were more likely to have arthritis (adjusted odds ratio [AOR], 1.92; 95% CI, 1.57-2.36) and report limited usual activities (AOR, 2.97; 95% CI, 2.20-4.02), limited work (AOR, 2.72; 95% CI, 2.06-3.60), limited social activities (AOR, 3.10; 95% CI, 2.26-4.26), and severe joint pain (AOR, 1.86; 95% CI, 1.44-2.41).Conclusion
Incremental increases in the number of social risk factors were independently associated with higher odds of arthritis and its burden. Intervention efforts should address the social context of US adults to improve health outcomes.Item Open Access Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management.(BMC musculoskeletal disorders, 2014-12) Allen, Kelli D; Bosworth, Hayden B; Chatterjee, Ranee; Coffman, Cynthia J; Corsino, Leonor; Jeffreys, Amy S; Oddone, Eugene Z; Stanwyck, Catherine; Yancy, William S; Dolor, Rowena JBackground
The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics.Methods
Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants' Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants' Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation.Results
Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from "rural" to "small city"), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%).Conclusions
Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation.Trial registration
Clinical trial registration number
NCT 01435109.Item Open Access Differences in osteoarthritis self-management support intervention outcomes according to race and health literacy.(Health education research, 2013-06) Sperber, Nina R; Bosworth, Hayden B; Coffman, Cynthia J; Lindquist, Jennifer H; Oddone, Eugene Z; Weinberger, Morris; Allen, Kelli DWe explored whether the effects of a telephone-based osteoarthritis (OA) self-management support intervention differed by race and health literacy. Participants included 515 veterans with hip and/or knee OA. Linear mixed models assessed differential effects of the intervention compared with health education (HE) and usual care (UC) on pain (Arthritis Impact Measurement Scales-2 [AIMS2] and Visual Analogue Scale), function (AIMS2 mobility and walking/bending), affect (AIMS2) and arthritis self-efficacy by: (i) race (white/non-white), (ii) health literacy (high/low) and (iii) race by health literacy. AIMS2 mobility improved more among non-whites than whites in the intervention compared with HE and UC (P = 0.02 and 0.008). AIMS2 pain improved more among participants with low than high literacy in the intervention compared with HE (P = 0.05). However, we found a differential effect of the intervention on AIMS2 pain compared with UC according to the combination of race and health literacy (P = 0.05); non-whites with low literacy in the intervention had the greatest improvement in pain. This telephone-based OA intervention may be particularly beneficial for patients with OA who are racial/ethnic minorities and have low health literacy. These results warrant further research designed specifically to assess whether this type of intervention can reduce OA disparities.Item Open Access Early Mobility in the Hospital: Lessons Learned from the STRIDE Program.(Geriatrics (Basel, Switzerland), 2018-12) Hastings, Susan Nicole; Choate, Ashley L; Mahanna, Elizabeth P; Floegel, Theresa A; Allen, Kelli D; Van Houtven, Courtney H; Wang, VirginiaImmobility during hospitalization is widely recognized as a contributor to deconditioning, functional loss, and increased need for institutional post-acute care. Several studies have demonstrated that inpatient walking programs can mitigate some of these negative outcomes, yet hospital mobility programs are not widely available in U.S. hospitals. STRIDE (assiSTed eaRly mobIlity for hospitalizeD older vEterans) is a supervised walking program for hospitalized older adults that fills this important gap in clinical care. This paper describes how STRIDE works and how it is being disseminated to other hospitals using the Replicating Effective Programs (REP) framework. Guided by REP, we define core components of the program and areas where the program can be tailored to better fit the needs and local conditions of its new context (hospital). We describe key adaptations made by four hospitals who have implemented the STRIDE program and discuss lessons learned for successful implementation of hospital mobility programs.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 Group physical therapy for veterans with knee osteoarthritis: study design and methodology.(Contemporary clinical trials, 2013-03) Allen, Kelli D; Bongiorni, Dennis; Walker, Tessa A; Bartle, John; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Hansen, Gloria; Jennings, Caroline; Lindquist, Jennifer H; Oddone, Eugene Z; Senick, Margaret J; Sizemore, John C; St John, Jamie; Hoenig, HelenPhysical therapy (PT) is a key component of treatment for knee osteoarthritis (OA) and can decrease pain and improve function. Given the expected rise in prevalence of knee OA and the associated demand for treatment, there is a need for models of care that cost-effectively extend PT services for patients with this condition. This manuscript describes a randomized clinical trial of a group-based physical therapy program that can potentially extend services to more patients with knee OA, providing a greater number of sessions per patient, at lower staffing costs compared to traditional individual PT. Participants with symptomatic knee OA (n = 376) are randomized to either a 12-week group-based PT program (six 1 h sessions, eight patients per group, led by a physical therapist and physical therapist assistant) or usual PT care (two individual visits with a physical therapist). Participants in both PT arms receive instruction in an exercise program, information on joint care and protection, and individual consultations with a physical therapist to address specific functional and therapeutic needs. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and the secondary outcome is the Short Physical Performance Test Protocol (objective physical function). Outcomes are assessed at baseline and 12-week follow-up, and the primary outcome is also assessed via telephone at 24-week follow-up to examine sustainability of effects. Linear mixed models will be used to compare outcomes for the two study arms. An economic cost analysis of the PT interventions will also be conducted.Item Open Access Group Versus Individual Physical Therapy for Veterans With Knee Osteoarthritis: Randomized Clinical Trial.(Physical therapy, 2016-05) Allen, Kelli D; Bongiorni, Dennis; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Lindquist, Jennifer H; Oddone, Eugene Z; Hoenig, HelenBackground
Efficient approaches are needed for delivering nonpharmacological interventions for management of knee osteoarthritis (OA).Objective
This trial compared group-based versus individual physical therapy interventions for management of knee OA.Design and methods
Three hundred twenty patients with knee OA at the VA Medical Center in Durham, North Carolina, (mean age=60 years, 88% male, 58% nonwhite) were randomly assigned to receive either the group intervention (group physical therapy; six 1-hour sessions, typically 8 participants per group) or the individual intervention (individual physical therapy; two 1-hour sessions). Both programs included instruction in home exercise, joint protection techniques, and individual physical therapist evaluation. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range=0-96, higher scores indicate worse symptoms), measured at baseline, 12 weeks, and 24 weeks. The secondary outcome measure was the Short Physical Performance Battery (SPPB; range=0-12, higher scores indicate better performance), measured at baseline and 12 weeks. Linear mixed models assessed the difference in WOMAC scores between arms.Results
At 12 weeks, WOMAC scores were 2.7 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% confidence interval [CI]=-5.9, 0.5; P=.10), indicating no between-group difference. At 24 weeks, WOMAC scores were 1.3 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-4.6, 2.0; P=.44), indicating no significant between-group difference. At 12 weeks, SPPB scores were 0.1 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-0.5, 0.2; P=.53), indicating no difference between groups.Limitations
This study was conducted in one VA medical center. Outcome assessors were blinded, but participants and physical therapists were not blinded.Conclusions
Group physical therapy was not more effective than individual physical therapy for primary and secondary study outcomes. Either group physical therapy or individual physical therapy may be a reasonable delivery model for health care systems to consider.Item Open Access Identifying Family and Unpaid Caregivers in Electronic Health Records: Descriptive Analysis.(JMIR formative research, 2022-07) Ma, Jessica E; Grubber, Janet; Coffman, Cynthia J; Wang, Virginia; Hastings, S Nicole; Allen, Kelli D; Shepherd-Banigan, Megan; Decosimo, Kasey; Dadolf, Joshua; Sullivan, Caitlin; Sperber, Nina R; Van Houtven, Courtney HBackground
Most efforts to identify caregivers for research use passive approaches such as self-nomination. We describe an approach in which electronic health records (EHRs) can help identify, recruit, and increase diverse representations of family and other unpaid caregivers.Objective
Few health systems have implemented systematic processes for identifying caregivers. This study aimed to develop and evaluate an EHR-driven process for identifying veterans likely to have unpaid caregivers in a caregiver survey study. We additionally examined whether there were EHR-derived veteran characteristics associated with veterans having unpaid caregivers.Methods
We selected EHR home- and community-based referrals suggestive of veterans' need for supportive care from friends or family. We identified veterans with these referrals across the 8 US Department of Veteran Affairs medical centers enrolled in our study. Phone calls to a subset of these veterans confirmed whether they had a caregiver, specifically an unpaid caregiver. We calculated the screening contact rate for unpaid caregivers of veterans using attempted phone screening and for those who completed phone screening. The veteran characteristics from the EHR were compared across referral and screening groups using descriptive statistics, and logistic regression was used to compare the likelihood of having an unpaid caregiver among veterans who completed phone screening.Results
During the study period, our EHR-driven process identified 12,212 veterans with home- and community-based referrals; 2134 (17.47%) veteran households were called for phone screening. Among the 2134 veterans called, 1367 (64.06%) answered the call, and 813 (38.1%) veterans had a caregiver based on self-report of the veteran, their caregiver, or another person in the household. The unpaid caregiver identification rate was 38.1% and 59.5% among those with an attempted phone screening and completed phone screening, respectively. Veterans had increased odds of having an unpaid caregiver if they were married (adjusted odds ratio [OR] 2.69, 95% CI 1.68-4.34), had respite care (adjusted OR 2.17, 95% CI 1.41-3.41), or had adult day health care (adjusted OR 3.69, 95% CI 1.60-10.00). Veterans with a dementia diagnosis (adjusted OR 1.37, 95% CI 1.00-1.89) or veteran-directed care referral (adjusted OR 1.95, 95% CI 0.97-4.20) were also suggestive of an association with having an unpaid caregiver.Conclusions
The EHR-driven process to identify veterans likely to have unpaid caregivers is systematic and resource intensive. Approximately 60% (813/1367) of veterans who were successfully screened had unpaid caregivers. In the absence of discrete fields in the EHR, our EHR-driven process can be used to identify unpaid caregivers; however, incorporating caregiver identification fields into the EHR would support a more efficient and systematic identification of caregivers.Trial registration
ClincalTrials.gov NCT03474380; https://clinicaltrials.gov/ct2/show/NCT03474380.Item Open Access Implementation of a group physical therapy program for Veterans with knee osteoarthritis.(BMC musculoskeletal disorders, 2020-02) Allen, Kelli D; Sheets, Brandon; Bongiorni, Dennis; Choate, Ashley; Coffman, Cynthia J; Hoenig, Helen; Huffman, Kim; Mahanna, Elizabeth P; Oddone, Eugene Z; Van Houtven, Courtney; Wang, Virginia; Woolson, Sandra; Hastings, Susan NBACKGROUND:A previous randomized clinical trial found that a Group Physical Therapy (PT) program for knee osteoarthritis yielded similar improvements in pain and function compared with traditional individual PT. Based on these findings the Group PT program was implemented in a Department of Veterans Affairs Health Care System. The objective of this study was to evaluate implementation metrics and changes in patient-level measures following implementation of the Group PT program. METHODS:This was a one-year prospective observational study. The Group PT program involved 6 weekly sessions. Implementation metrics included numbers of referrals and completed sessions. Patient-level measures were collected at the first and last PT sessions and included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; self-report of pain, stiffness and function (range 0-96)) and a 30-s chair rise test. RESULTS:During the evaluation period, 152 patients were referred, 80 had an initial session scheduled, 71 completed at least one session and 49 completed at least 5 sessions. The mean number of completed appointments per patient was 4.1. Among patients completing baseline and follow-up measures, WOMAC scores (n = 33) improved from 56.8 (SD = 15.8) to 46.9 (SD = 14.0); number of chair rises (n = 38) completed in 30 s increased from 10.4 (SD = 5.1) to 11.9 (SD = 5.0). CONCLUSIONS:Patients completing the Group PT program in this implementation phase showed clinically relevant improvements comparable to those observed in the previous clinical trial that compared group and individual PT for knee osteoarthritis. These results are important because Group PT can improve efficiency and access compared with individual PT. However, there were some limitations with respect to attendance and completion rates, and program adaptations may be needed to optimize these implementation metrics. Larger, longer-term studies are required to more fully evaluate the effectiveness of this program.Item Open Access 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 JBackground
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.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 Mandated caregiver training in the Veterans Health Administration: Caregiver inquiry informs national dissemination.(The Gerontologist, 2022-11) Sperber, Nina R; Boucher, Nathan; Hughes, Jaime M; Bruening, Rebecca; Zullig, Leah L; Decosimo, Kasey; Tucker, Matthew; Christensen, Leah A; Allen, Kelli D; Hastings, Susan N; Van Houtven, Courtney HBackground and objectives
A minority of family caregivers receive training, with implications for their own and their recipient's outcomes. Federal policy has supported implementation and expansion of caregiver training and support. The Department of Veterans Affairs (VA) has developed a national Caregiver Support Program and collaborated with VA health services researchers to explore caregivers' acceptance of an evidence-based training program in preparation for system-wide dissemination.Research design and methods
This approach entailed a convergent mixed-methods design, which involved separate analyses of quantitative and qualitative data. Survey questions based on the Kirkpatrick model for training evaluation measured caregivers' reaction and learning and interview questions elicited caregivers' reports about the value of the program for them.Results
Most caregivers reported satisfaction with the training when responding to survey questions, although qualitative interviews revealed caveats suggesting need to hone the best timing and specific group of caregivers for maximal benefit.Discussion and implications
Our findings indicate that understanding program-user fit may be particularly critical when implementing training for caregivers as they come to the program at different points along their caregiving journey, needing differing types and intensities of support. While a general program may appeal to policymakers aiming to scale caregiver training within a large, heterogeneous system, there may be shortcomings in terms of end-user acceptance and subsequent downstream outcomes such as reach and ultimately program effectiveness. Good, iterative communication flow between program developers and policymakers facilitates this understanding and, in turn, decisions about scaling.Item Open Access Participant evaluation of a telephone-based osteoarthritis self-management program, 2006-2009.(Preventing chronic disease, 2012-01) Sperber, Nina R; Bosworth, Hayden B; Coffman, Cynthia J; Juntilla, Karen A; Lindquist, Jennifer H; Oddone, Eugene Z; Walker, Tessa A; Weinberger, Morris; Allen, Kelli DIntroduction
Self-management support interventions can help improve osteoarthritis outcomes but are underused. Little is known about how participants evaluate the helpfulness of these programs. We describe participants' evaluations of a telephone-based, osteoarthritis self-management support intervention that yielded improved outcomes in a clinical trial.Methods
Participants were 140 people in the intervention arm of the trial who completed an end-of-trial survey. We used mixed methods to describe participants' perceived helpfulness of the program and its components. We compared ratings of helpfulness according to participant characteristics and analyzed themes from open-ended responses with a constant comparison approach. We calculated Pearson correlation coefficients between perceived helpfulness and changes in pain, function, affect, and self-efficacy.Results
The average rating of overall helpfulness on a scale from 1 to 10 was 7.6 (standard deviation, 2.3), and more than 80% of participants agreed that each component (phone calls, educational material, setting goals and action plans) was helpful. Participants had better perceived helpfulness ratings than their counterparts if they were nonwhite, had limited health literacy, had no college education, had perceived inadequate income, were older, had a spouse or were living together in a committed relationship, and had greater symptom duration and less pain. Ratings of helpfulness increased with greater improvement in outcomes. Participants frequently mentioned the health educator's calls as being helpful for staying on task with self-management behaviors.Conclusion
Participants viewed this intervention and each of its components as helpful for improving osteoarthritis symptoms. In addition to the improvements in objective outcomes seen in the clinical trial, these results provide further support for the dissemination of self-management support interventions.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.Item Open Access 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 SBackground
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).Item Open Access Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.(Annals of internal medicine, 2017-03) Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena JBackground
A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions.Objective
To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes.Design
Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109).Setting
10 Duke University Health System community-based primary care clinics.Participants
537 outpatients with symptomatic hip or knee osteoarthritis.Intervention
The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers.Measurements
The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups.Results
No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care.Limitations
The study involved 1 health care network. Data on provider referrals were not collected.Conclusion
Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care.Primary funding source
National Institute of Arthritis and Musculoskeletal and Skin Diseases.