Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol

The Function QUERI program will implement and evaluate three innovative, evidence-based clinical programs that fill gaps in current clinical care for Veterans at risk for functional decline and disability and will be conducted in VA medical centers throughout the national VA Health Care System. Guided by the International Classification of Functioning, Disability and Health [7], Function QUERI’s clinical programs directly address known stressors and contextual factors that influence functional ability and independence. The three clinical programs will be implemented as QI projects, and the evaluation will be conducted as human subjects research approved by the Durham VA Health Care System Institutional Review Board.

The first of the three Function QUERI projects evaluates the implementation and features of Group PT, a group-based physical therapy program to improve access to therapy for Veterans with knee osteoarthritis (OA). With a lifetime risk of 45% and rising overall prevalence [8, 9], knee OA is one of the most common chronic health conditions and a leading cause of pain and disability among adults [10‐16]. Despite evidence that PT improves knee OA pain, disability, and other key outcomes [17‐22], PT is underutilized [23]. Group PT is designed to enhance efficiency of care by providing more contact hours of care per patient with fewer total clinician hours, compared to traditional individual PT. The program involves six 1-h, weekly, group-based sessions comprising up to 10 patient participants. At patients’ first session, a physical therapist conducts a brief evaluation and administers baseline functional tests and questionnaires; functional tests and questionnaires are repeated at the last session. At each session, the physical therapist leads the group in strengthening and stretching exercises, as well as brief education and discussion modules. Patients are instructed to perform assigned exercises at home. Results from a trial demonstrated similar outcomes between Group PT and traditional individual PT for knee OA, but the Group PT program has a lower cost [24]. Group PT is a 1-year project that takes place in a single site to evaluate key outcomes of sustainability and ways to improve the reach of the program for wider dissemination. It also serves as a case study for the CONNECT implementation intervention, the experiences of which will inform refinements to CONNECT trainings and content for application in other Function QUERI projects.

Project 2 evaluates the implementation of assisted early mobility for hospitalized older veterans (STRIDE), a supervised walking program for hospitalized older Veterans focused on maintaining musculoskeletal strength and mobility during hospitalization, a highly vulnerable time for development of disability. A key contributor to hospital-associated disability is immobility during hospitalization [25]. While fewer than 5% of patients have physician orders for bed rest, hospitalized older adults spend only 4% of their time standing or walking [26]. The hazards of immobility in the hospital have been recognized for more than 2 decades [27]. Previously developed hospital mobility interventions have demonstrated the potential of inpatient walking to prevent declines in mobility during hospital stays and to reduce hospital lengths of stay [28‐34], but there are currently no VA system-wide approaches to address this important gap in clinical care. Adapted from a mobility program tested in three non-VA hospitals that led to reduced hospital lengths of stay [35], STRIDE is designed for patients aged > 60 and consists of a one-time gait and balance assessment conducted by a physical therapist, followed by daily supervised walks by a recreation therapy assistant for the duration of the hospital stay [36]. Clinical demonstration of STRIDE conducted at the Durham VA Health Care System (VAHCS) resulted in a greater likelihood of discharge to home (than to skilled nursing or rehabilitation) among STRIDE participants compared to clinically similar patients receiving usual care (92 vs 74%, p = 0.007) [36]. Based on the cumulative evidence on early mobility, positive staff, and patient assessments of STRIDE, it was established as a permanent clinical service at the Durham VAHCS and has the potential to become a system-wide approach to address hospital-associated disability in the VHA. Function QUERI’s STRIDE implementation is a multi-year project that will be implemented across eight participating VAMCs.

Project 3 examines the implementation of helping invested family members improve veterans experiences study (iHI-FIVES) to promote function and independence through skills training and support for caregivers of Veterans with cognitive and/or functional limitations. The Veterans Health Administration (VHA) has the most extensive system of home and community-based services of any health care system in the USA and yet about two-thirds of the 5.5 million Veterans who receive care in the home receive it exclusively from family and friends. Caregivers allow Veterans to avoid or delay nursing home entry [37], but caregiving can result in high rates of caregiver burden, depression, cost, and health risk to Veterans themselves. Caregivers commonly report unmet needs for caregiver skills training [38], which can reduce negative consequences of caregiving, increase quality of care, and optimize patient independence [39‐44]. HI-FIVES is a multi-modal training program that occurs after a Veteran’s referral to home and community-based services. Its training sessions address standardized and caregiver-selected topics such as increasing Veteran function and independence, caregiver injury prevention and self-care, communicating with providers, and navigating the VHA [45]. Caregivers are encouraged to create action items to apply the skills learned, including incorporating the use of relaxation techniques into their busy lives. Results from the HI-FIVES trial (NCT01777490) found that HI-FIVES significantly increased Veteran and caregiver’s experience of VA care. The trial yielded limited effects on increasing patient days at home, which may be explained by the trial’s limitation of being underpowered to detect statistically significant differences (due to larger than expected variance). Thus, a larger sample size is needed to detect true differences in days at home, the primary outcome. Based on the results to date, the VA National Program Office on Caregiver Support is promoting HI-FIVES for wide-scale dissemination. Function QUERI will capitalize on this effort and support the implementation of HI-FIVES (iHI-FIVES) project by facilitating the rollout of caregiver trainings across eight participating VAMC sites and evaluating the program, with its increased enrollment for definitive retesting on a larger sample (n ≥ 400) in this hybrid type III effectiveness-implementation design. Caregiver Support Program staff and Geriatrics and Extended Care Services staff will be recruited to offer iHI-FIVES.

As described in Table 1, Function QUERI’s three clinical programs promote a shared goal of optimizing physical function and independence among Veterans while potentially delaying the onset of costly disability. An important challenge and consideration is understanding optimal methods to disseminate these promising programs more widely and in a sustained way. Our initial program experience suggests that inter-professional relationships and team dynamics are the key determinants to the success of new hospital-based clinical programs that require collaborative processes involving multiple disciplines. Indeed, a major reason for clinical care gaps in this population is poor communication and coordination among the many interdisciplinary providers involved in their care. Implementing new programs in diverse settings requires buy-in and cooperation among many different service lines, and a one-size-fits-all approach is rarely effective.

Providing expertise in implementation science, organizational behavior, and quantitative and qualitative analyses, our implementation core serves as an essential bridge across all Function QUERI projects. The implementation facilitation component of the core will develop and facilitate the implementation activities for Group PT, STRIDE, and iHI-FIVES with participating sites. The data and analytic component of the core will develop survey and interview instruments, establish common measurement of team characteristics and outcomes across projects (when possible), and evaluate the impact of teams on implementation and programmatic outcomes. Organizing the projects through this implementation core provides economies of scale and minimizes variation in processes and effort across projects and the participating sites. Implementation core activities are described in more detail below.

Our program of work is informed by Grol and Wensing’s Implementation of Change Model (IoC) [46] and the Consolidated Framework for Implementation Research (CFIR) [46, 47] which, in combination, provide a comprehensive approach to implementing new clinical programs, from development through execution, evaluation, and dissemination. Specifically, the IoC model describes a process of implementation, beginning with the identification of practices (i.e., clinical programs) to address gaps in care for patients with (or at-risk for) impaired function and independence, defining targets for improvement, developing and executing implementation strategies, and continuous evaluation and adaptation of implementation to improve processes and outcomes. IoC is consistent with tenets of complexity science, acknowledging that implementation processes in complex systems require flexible and iterative approaches and constant monitoring and assessment [46, 48]; IoC is thus an appropriate framework to guide the development and execution of Function QUERI’s implementation strategies (described in more detail below). Evaluation and dissemination approaches are informed by the CFIR, which is a macro-level model of implementation that describes a comprehensive taxonomy of operationally defined domains influencing implementation. Each CFIR domain is informed by an array of theoretical constructs from various disciplines. We adapted CFIR to inform our evaluation of team-based implementation strategies for Function QUERI’s complex clinical programs.

We use our program’s nested model of team function and performance (Fig. 1) to guide our evaluation of implementation, which draws from complexity science [4, 48], organizational theories on change and team behaviors, and the CFIR. Our model posits that the successful implementation of clinical programs is a function of team structure, team processes (i.e., CFIR’s inner setting), the environmental context (i.e., outer setting), and the prescribed work characteristics of our innovative clinical programs. Altogether, these factors affect providers’ engagement, interactions, and work activities, which collectively affect the ability of teams to accomplish their goals. Understanding the relationships among clinical program characteristics, team processes, team characteristics, and environmental contexts is critical to implementing and evaluating programs for Veterans at risk for functional decline and loss of independence.

The Function QUERI’s program goals are to assess (1) the effectiveness of the clinical programs and (2) the impact of CONNECT and team characteristics on clinical program implementation. The remainder of this paper focuses on the design of our evaluation of teams and CONNECT. Details on evaluations of clinical program effectiveness (i.e., patient outcomes) are available at clinicaltrials.​gov (STRIDE no. NCT03300336 and iHI-FIVES no. NCT03474380).

With assistance from our VA operation partners and marketing clinical programs through VAMC clinical conferences and national meetings, we will recruit sites on a volunteer basis. We will assess eligibility of sites to determine if they meet project-specific criteria that includes adequate sample size for evaluation. Specifically, STRIDE sites must have a minimum inpatient average daily census of 20 general medicine patients per day and iHI-FIVES sites must commit to conducting two rounds of iHI-FIVES training sessions every 6 months.

Evaluation of team and CONNECT impacts on implementation will employ a mixed methods design. Guided by our nested model of team function and performance in implementation, the implementation core will develop and collect common measures from primary and secondary data sources to evaluate team processes and characteristics, program characteristics, environmental context, and implementation outcomes. The data used to evaluate team and CONNECT impacts on clinical program implementation will be obtained from several sources, including provider/staff surveys and interviews, patient surveys and interviews, patient electronic medical record abstraction, and VA administrative data for patient encounters and VAMC performance measures. Since all projects’ clinical programs utilize staff from existing care teams, inpatient wards, and service lines, Function QUERI will assess team characteristics and function before and after CONNECT training and program implementation. Sample measures and associated data sources are displayed in Table 2.

Team characteristics and processes will be primarily assessed using the Team Development Measure (TDM©), a 31-item questionnaire, which characterizes teams’ stage of development and the degree to which groups have the characteristics of highly effective teamwork in place [70, 71]. The TDM© is ideally suited for Function QUERI’s evaluation of teams because it has been tested in a variety of healthcare settings and maintains psychometric strength when applied to a range of group membership sizes. Items from the TDM© also cluster to reflect the four key dimensions of team function: communication, role clarity, cohesion, and goal and means clarity [70]. This will enable the implementation core to (1) assess baseline and post-implementation changes in dimensions of team function, (2) identify variations in team strengths and weaknesses within and across clinical programs at participating sites, and (3) assess the dimensionality (e.g., one summative measure of team function or multiple measures of team function) and predictive power of team function on implementation and program outcomes to inform future implementation efforts.

The implementation core will supplement the TDM© with additional survey and interview questions identified from the literature on healthcare teams [72]. These additional items describe other important features of teams, including size, composition, and the degree to which team membership spans boundaries (e.g., clinical, professional). We will also describe team communication channels (internal, external), decision-making, and establishment of routines.

Implementation outcomes are the intermediate result of deliberate action in implementing new practices/services [73]. They serve as indicators of implementation processes that are the pre-condition for attainment of intended clinical and system-level change (i.e., program outcomes such as reductions in admission to nursing homes). This distinction is important, as it provides more specificity of the mechanisms underlying implementation successes or failures [73]. Given the overall goals of Function QUERI and the goals of our operational partners, we will focus on three main types of implementation outcomes: penetration, fidelity, and cost. Penetration of clinical programs is generally defined as proportion of eligible patients and/or caregivers who received clinical program services (e.g., referrals to iHI-FIVES). Fidelity will be assessed via measures that describe patient/caregiver engagement (e.g., patient attendance for Group PT, caregivers’ attendance for iHI-FIVES), dose, and adherence to the protocol (e.g., STRIDE participants with at least one supervised walk). To assess budget impacts, we will assess costs related to program implementation and program delivery at each site, as well as patient-level resource utilization.

Function QUERI’s evaluation of implementation will focus on examining the impact of teams and the CONNECT implementation strategy, within and across projects. We will use a quantitatively driven simultaneous design (QUAN + qual) in which quantitative data constitute the core component and are collected in parallel with qualitative data [74, 75]. These two methods will be used to answer related questions, in that quantitative data will be used to evaluate implementation effectiveness and qualitative data to understand how implementation processes (including team processes) and environmental context related to implementation outcomes. Data integration will involve embedding qualitative process data within the quantitative outcomes data (for example, in a matrix format in which program sites are arranged from high to low penetration) to evaluate the relationship between implementation outcomes and process for both implementation strategies (e.g., REP alone vs. REP + CONNECT).

To assess the relationship between teams and implementation outcomes, we will examine how fidelity and penetration outcomes change over time by team measures. For example, prior work [70] has demonstrated that items from the TDM© reflect team communication, role clarity, cohesion, and goal and means clarity. Survey items from the larger team survey may cluster to reflect other dimensions of team function, which will enable Function QUERI to examine predictive power of team characteristics on implementation and program outcomes. Pre- and post-implementation survey administration will also enable assessment of temporal changes in team function. Specifically, prior experience suggests that baseline team structure and communication effectiveness modifies the impact of CONNECT, with highly functioning or dysfunctional teams receiving less benefit. Thus, by capturing baseline team measures, we will be able to assess for this effect. Furthermore, if we find that the implementation strategy REP + CONNECT improves implementation outcomes compared to REP alone, we will examine whether team measures mediate or moderate this effect following methods of MacKinnon [76] and Kraemer [76, 77].

We anticipate that sites randomized to implementation via REP + CONNECT will achieve higher rates of implementation effectiveness (e.g., higher penetration, fidelity) than sites receiving REP alone. To evaluate the impact of CONNECT on clinical program implementation, penetration, fidelity, and cost outcomes will be assessed only in the post-implementation period and primary analyses will be conducted on implementation outcomes observed in the first post-implementation period to avoid potential confounding with time since implementation. We will use appropriate logistic or linear mixed regression models [78‐81], where the main predictor of interest will be REP vs. REP + CONNECT adjusting for clustering of VAMC with either a random effect or by conditioning.

Organization-specific context and processes are likely to affect both implementation and program outcomes. Our quantitative findings will be complemented by additional analyses of context sensitivity and qualitative data from semi-structured interviews with key informants at participating sites. Responses will be coded and analyzed at individual and team levels, using both a priori labels of facility context, team processes and implementation outcomes, and data-derived labels to develop site-level case memo summaries of contextual factors and team processes. From this coded data, we will identify and visually display emergent themes in a matrix, with columns reflecting implementation outcomes (i.e., fidelity and penetration) arranged from high to low, to illustrate patterns in contextual factors and team processes according to implementation outcomes. For example, we will develop a matrix to compare reports of implementation processes and outcomes between REP alone and REP + CONNECT sites. The rows of the matrix will reflect a priori implementation measures, and the columns will reflect whether responses are from REP or REP + CONNECT sites.

Utilizing a similar approach across projects, we will perform budget impact analysis for STRIDE and iHI-FIVES multi-site projects to frame affordability to the VHA [82]. Depending on the evaluation results of STRIDE and iHI-FIVES implementation projects, budget impacts will particularly focus on comparing total costs by the implementation strategy of REP alone vs. REP + CONNECT. Since CONNECT is expected to be more time-intensive and expensive than REP, it is critical to consider the relative gains (if any) to both team function and patient outcomes from adding CONNECT training to REP. For these projects, we will also consider variability in budgetary impact by site (e.g., costs may differ by low versus high penetration sites or by team composition). We will calculate the budget impacts of the clinical programs and compare them to each program’s value. The value will be defined in light of all of the evaluation evidence. For example, the value may be framed as total budget impact per unit gain in patient function or as total budget impact compared to the clinical team’s narrative on how a program benefited patients. We will also consider framing budgetary impact against different domains, such as total costs by site or costs per Veteran participant. The Function QUERI investigators leading the clinical programs will work with the implementation core and VA operational partners to develop appropriate comparisons.

The Function QUERI set an ambitious and important agenda to explore ways to effectively disseminate and implement innovative evidence-based clinical programs across the VA health system. There is a significant amount of work that presents challenges and opportunities. First, conducting the implementation and evaluation, with an a prior stepped-wedge design in ever changing real-world settings, forces Function QUERI to delicately balance considerations of study design and voluntary participation in implementing clinical programs. To this end, our use of REP to work with sites in a systematic and standardized way is a great strength in facilitating local adaptations to optimize implementation. Second, our selection of volunteer sites may limit heterogeneity in our sample. However, there is a great deal to learn about implementation processes and adaptations in real-world settings to inform continuous improvement and to the likelihood of effective uptake and sustainability of valuable clinical intervention. Third, our measurement approach involves significant effort in primary data collection of patient and provider surveys, interviews, and extraction of secondary administrative/clinical data with attention to common measures across three contextually disparate clinical contexts. The challenges of data collection and management may be outweighed by the opportunity to generate a broader, nuanced understanding of implementation in hospital settings and to facilitating effective interdisciplinary team function across VA settings.

Function QUERI will achieve an immediate impact on the VHA by providing access to evidence-based clinical services for a large group of vulnerable Veterans at risk for functional decline and loss of independence. A long-term impact will be to enhance VA’s capacity for clinical innovation through development and testing of an implementation intervention (CONNECT) to enhance uptake of evidence-based programs in interdisciplinary teams. To this end, the Function QUERI program will specify dimensions of team characteristics and function that enhance capacity for clinical innovation and uptake of evidence-based programs. Synthesizing findings within and across projects, we will translate implementation findings to identify the contextual factors and components from CONNECT that improve team processes and function to optimize future wide-scale implementation of VA clinical programs.