Using brief reflections to capture and evaluate end-user engagement: a case example using the COMPASS study.

BACKGROUND: Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct. METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of "brief reflections" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources. RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible. CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .

Healthcare use and out-of-pocket costs for rural family caregivers and care recipients in a randomized controlled trial.

BACKGROUND: Rural family caregivers (FCGs) in the United States often experience high economic costs. This randomized controlled trial compared a transitional palliative care intervention (TPC) to support FCGs of seriously ill care recipients (CRs) to an attention control condition. We evaluated the TPC's effect on healthcare use and out-of-pocket spending for both FCGs and CRs. METHODS: TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months or CR death to collect self-reported healthcare utilization (e.g., outpatient, emergency department, and hospital), out-of-pocket healthcare spending (e.g., deductibles and coinsurance), and health-related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRRs) were estimated using negative binomial regressions. RESULTS: The study included 282 FCG-CR dyads across three U.S. states. Follow-up over the 6-month period was shortened by high CR mortality rates across both arms (29%), but was similar across arms. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% confidence interval [CI] = 0.56-0. 99). Total out-of-pocket spending was not significantly different for TPC versus control. Across both groups, mean out-of-pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56-0.89). CONCLUSIONS: This study contributes to evidence that palliative care interventions reduce the number of nights in the hospital for seriously ill patients. Yet, overall rural FCGs and seriously ill CRs experience substantial out-of-pocket economic costs in the 6 months following hospitalization. Transitional care intervention design should consider impacts on patient and caregiver spending. CLINICALTRIALS: gov # is NCT03339271.

Evidence Map of Non-Pharmacological Dementia Care Partner Interventions Implemented in the US: Gaps and Impact Opportunities.

There are 200+ tested interventions for care partners (family, friends, and fictive kin) of people living with dementia (PLWD). But these interventions do not systematically cover relevant settings. Nor do these interventions affect all relevant outcomes that matter to people and healthcare systems. We present an evidence map of settings and outcomes from translated interventions to identify gaps. Of 190 studies identified, 31 unique interventions were retained in the evidence map. Identified setting gaps included studies set solely in hospitals/medical centers or set in multiple settings. Identified outcome gaps included interventions that improved care partner beliefs about providing care, care partner negative coping strategies, PLWD resources (e.g., social support), and PLWD coping strategies. Armed with an understanding of present gaps, we call on researchers to fill the identified gaps to ensure systematic coverage of settings and evaluation of outcomes that matter to people and healthcare systems.

Using Hybrid Effectiveness Studies to Facilitate Implementation in Community-Based Settings: Three Case Studies in Dementia Care Research.

The pipeline from discovery to testing and then implementing evidence-based innovations in real-world contexts may take 2 decades or more to achieve. Implementation science innovations, such as hybrid studies that combine effectiveness and implementation research questions, may help to bridge the chasm between intervention testing and implementation in dementia care. This paper describes hybrid effectiveness studies and presents 3 examples of dementia care interventions conducted in various community-based settings. Studies that focus on outcomes and implementation processes simultaneously may result in a truncated and more efficient implementation pipeline, thereby providing older persons, their families, health care providers, and communities with the best evidence to improve quality of life and care more rapidly. We offer post-acute and long-term care researchers considerations related to study design, sampling, data collection, and analysis that they can apply to their own dementia and other chronic disease care investigations.

Admission Cognition and Function Predict Change in Physical Function Following Skilled Nursing Rehabilitation.

OBJECTIVES: Many older adults are discharged from skilled nursing facilities (SNFs) at functional levels below those needed for safe, independent home and community mobility. There is limited evidence explaining this insufficient recovery. The purpose of this secondary analysis was to determine predictors of physical function change following SNF rehabilitation. DESIGN: Secondary analysis of a prospective observational cohort study. SETTING AND PARTICIPANTS: Across 4 SNFs, data were collected from 698 adults admitted for physical rehabilitation following an acute hospitalization. METHODS: Physical function recovery was evaluated as change from admission to discharge in Short Physical Performance Battery (SPPB) scores (N = 698) and gait speed (n = 444). Demographic and clinical characteristics collected at admission served as potential predictors of physical function change. Following imputation, a standardized model selection estimator was calculated for predictors per physical function outcome. Predictor estimates and 95% CIs were calculated for each outcome model. RESULTS: Higher cognitive scores [standardized ß (ßSTD) = 0.11, 95% CI: 0.0004, 0.20] and higher activities of daily living (ADL) independence at admission (ßSTD = 0.22, 95% CI: 0.05, 0.34) predicted greater SPPB change; higher SPPB scores at admission (ßSTD = -0.26, 95% CI: -0.35, -0.14) predicted smaller SPPB change. Higher ADL independence at admission (ßSTD = 0.17, 95% CI: 0.01, 0.37) predicted greater gait speed change; faster gait speed at admission (ßSTD = -0.30, 95% CI: -0.44, -0.15) predicted smaller gait speed change. CONCLUSIONS AND IMPLICATIONS: Admission cognition, ADL independence, and physical function predicted physical function change following post-hospitalization rehabilitation. Inverse findings for admission physical function and ADL independence predictors suggest independence with ADL is not necessarily aligned with mobility-related function. Findings highlight that functional recovery is multifactorial and requires comprehensive assessment throughout SNF rehabilitation.

Implementation Costs of Technology-Enhanced Transitional Palliative Care for Rural Caregivers.

OBJECTIVES: Compared to urban family caregivers (FCG), rural FCG experience greater burdens accessing coordinated care for their loved ones during and after hospitalization. The impact of technology-enhanced transitional palliative care (TPC) on caregiver outcomes is currently being evaluated in a randomized control trial. This study evaluates resource use and health system costs of this FCG-focused TPC intervention and potential Medicare reimbursement mechanisms. METHODS: Rural caregivers of hospitalized patients were randomized into an 8-week intervention consisting of video visits conducted by a registered nurse certified in palliative care, supplemented with phone calls and texts (n = 215), or attentional control. Labor costs were estimated for a registered nurse and compared to scenario analyses using a nurse practitioner or social worker wages. Medicare reimbursement scenarios included Transitional Care Management (TCM) and Chronic Care Management (CCM) CPT codes. RESULTS: In the base case, TPC cost was $395 per FCG facilitated by a registered nurse, compared to $337 and $585 if facilitated by a social worker or nurse practitioner, respectively. Mean Medicare reimbursement in the TCM-only scenario was $322 and $260 for high or moderate complexity patients, respectively. Reimbursement in the CCM only scenario was $348 and $274 for complex and non-complex patients, respectively. Reimbursement in the TCM+CCM scenario was $496 and $397, for high/complex and moderate/non-complex patients, respectively. CONCLUSION: TPC is a feasible, low cost and sustainable strategy to enhance FCG support in rural areas. Potential reimbursement mechanisms are available to offset the costs to the health system for providing transitional palliative care to caregivers of patients recently hospitalized.

Costs of implementing a multi-site facilitation intervention to increase access to medication treatment for opioid use disorder.

BACKGROUND: The United States has been grappling with the opioid epidemic, which has resulted in over 75,000 opioid-related deaths between April 2020 and 2021. Evidence-based pharmaceutical interventions (buprenorphine, methadone, and naltrexone) are available to reduce opioid-related overdoses and deaths. However, adoption of these medications for opioid use disorder has been stifled due to individual- and system-level barriers. External facilitation is an evidence-based implementation intervention that has been used to increase access to medication for opioid use disorder (MOUD), but the implementation costs of external facilitation have not been assessed. We sought to measure the facility-level direct costs of implementing an external facilitation intervention for MOUD to provide decision makers with estimates of the resources needed to implement this evidence-based program. METHODS: We performed a cost analysis of the pre-implementation and implementation phases, including an itemization of external facilitation team and local site labor costs. We used labor estimates from the Bureau of Labor and Statistics, and sensitivity analyses were performed using labor estimates from the Veterans Health Administration (VHA) Financial Management System general ledger data. RESULTS: The average total costs for implementing an external facilitation intervention for MOUD per site was $18,847 (SD 6717) and ranged between $11,320 and $31,592. This translates to approximately $48 per patient with OUD. Sites with more encounters and participants with higher salaries in attendance had higher costs. This was driven mostly by the labor involved in planning and implementation activities. The average total cost of the pre-implementation and implementation activities were $1031 and $17,816 per site, respectively. In the sensitivity analysis, costs for VHA were higher than BLS estimates likely due to higher wages. CONCLUSIONS: Implementing external facilitation to increase MOUD prescribing may be affordable depending on the payer's budget constraints. Our study reported that there were variations in the time invested at each phase of implementation and the number and type of participants involved with implementing an external facilitation intervention. Participant composition played an important role in total implementation costs, and decision makers will need to identify the most efficient and optimal number of stakeholders to involve in their implementation plans.

Applying i-PARIHS to Identify Emerging Innovations in Hospital Discharge Decision Making in Response to System Stress: A Qualitative Study.

Background: The purpose of this qualitative study was to use a Learning Health System approach to identify factors influencing the emergence of innovation in rehabilitation hospital discharge decision-making during the Coronavirus 2019 (COVID-19) pandemic. Methods: Rehabilitation clinicians were recruited from the Veterans Affairs Health Care System and participated in individual semi-structured interviews guided by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. Data were analyzed using a rapid qualitative, deductive team-based approach informed by directed content analysis. Results: Twenty-three rehabilitation clinicians representing physical (N = 11) and occupational therapy (N = 12) participated in the study. Three primary themes were generated: (1) Recipients: innovations emerged as approaches to communicating discharge recommendations changed (in-person to virtual) and strong patient/family preferences to discharge to the home challenged collaborative goal setting; (2) Context: the ability of rehabilitation clinicians to innovate and the form of innovations were influenced by the broader hospital system, interdisciplinary team dynamics, and policy fluctuations; (3) Innovation: emerging innovations in discharge processes included perceived increases in team collaboration, shifts in caseload prioritization, and alternative options for post-acute care. Conclusions: Our findings reinforce that rehabilitation clinicians developed innovative strategies to quickly adapt to multiple systems-level factors that were changing in the face of the COVID-19 pandemic. Future research is needed to assess the impact of innovations, remediate unintended consequences, and evaluate the implementation of promising innovations to respond to emerging healthcare delivery needs more rapidly.

Post-COVID-19 Syndrome Clinical Pathway for the US Veterans Health Administration.

The Department of Veterans Health Affairs (VHA) has launched 22 multispecialty post-COVID-19 clinics across the US for the growing number of veterans experiencing long-term sequelae after acute COVID-19 infection. While evidence-based treatments for this syndrome are under investigation, there is a critical need to establish and disseminate clinical pathways (CPWs) based on knowledge and experience gained in those clinics. This VHA CPW is intended to guide primary care clinicians who care for patients experiencing dyspnea and/or cough during post-COVID-19 syndrome (PCS), which includes symptoms and abnormalities persisting or present beyond 12 weeks of the onset of acute COVID-19. This effort will help guide and standardize the care of veterans across the VHA, improve health outcomes, and effectively utilize health care resources. This article summarizes our stepwise diagnostic approach for patients presenting with PCS dyspnea and/or cough in primary care; it also highlights teleconsultation and telerehabilitation as opportunities to reach those in rural areas or with transportation barriers and improve reach for specialized services.

Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities: An Effectiveness-Implementation Hybrid Type 1 Clinical Trial Protocol.

OBJECTIVE: Skilled nursing facility rehabilitation is commonly required to address hospital-associated deconditioning among older adults with medical complexity. In skilled nursing facilities, standard-of-care rehabilitation focuses on low-intensity interventions, which are not designed to sufficiently challenge skeletal muscle and impart functional improvements. In contrast, a high-intensity resistance training approach (IntenSive Therapeutic Rehabilitation for Older NursinG homE Residents; i-STRONGER) in a single-site pilot study resulted in better physical function among patients in skilled nursing facilities. To extend this work, an effectiveness-implementation hybrid type 1 design, cluster-randomized trial will be conducted to compare patient outcomes between 16 skilled nursing facilities utilizing i-STRONGER principles and 16 Usual Care sites. METHODS: Clinicians at i-STRONGER sites will be trained to deliver i-STRONGER as a standard of care using an implementation package that includes a clinician training program. Clinicians at Usual Care sites will continue to provide usual care. Posttraining, changes in physical performance (eg, gait speed, Short Physical Performance Battery scores) from patients' admission to discharge will be collected over a period of 12 months. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework will be used to evaluate i-STRONGER effectiveness and factors underlying successful i-STRONGER implementation. Effectiveness will be evaluated by comparing changes in physical function between study arms. Reach (proportion of patients treated with i-STRONGER), adoption (proportion of clinicians utilizing i-STRONGER), implementation (i-STRONGER fidelity), and maintenance (i-STRONGER sustainment) will be concurrently quantified and informed by clinician surveys and focus groups. IMPACT: This effectiveness-implementation hybrid type 1 cluster-randomized trial has the potential to shift rehabilitation care paradigms in a nationwide network of skilled nursing facilities, resulting in improved patient outcomes and functional independence. Furthermore, evaluation of the facilitators of, and barriers to, implementation of i-STRONGER in real-world clinical settings will critically inform future work evaluating and implementing best rehabilitation practices in skilled nursing facilities.

Strategies to Bridge Equitable Implementation of Telehealth.

During the COVID-19 pandemic, the rapid scaling of telehealth limited the extent to which proactive planning for equitable implementation was possible. The deployment of telehealth will persist in the postpandemic era, given patient preferences, advances in technologies, growing acceptance of telehealth, and the potential to overcome barriers to serve populations with limited access to high-quality in-person care. However, aspects and unintended consequences of telehealth may leave some groups underserved or unserved, and corrective implementation plans that address equitable access will be needed. The purposes of this paper are to (1) describe equitable implementation in telehealth and (2) integrate an equity lens into actionable equitable implementation.

What Contributes to Sustainability? Examining Access to Medications for Opioid Use Disorder in Low-Adopting VHA Facilities.

BACKGROUND: Successful implementation can increase the availability of evidence-based treatments but continued patient access can be threatened if there is not deliberate focus on sustainment. Real-world examples are needed to elucidate contributors to sustainability. OBJECTIVE: We examined sustainability of outcomes of a study which tested a 12-month external facilitation intervention. The study evaluated change in access to medications for opioid use disorder (MOUD) in Veterans Health Administration (VHA) facilities in the lowest quartile of MOUD prescribing. DESIGN: Convergent mixed-methods design. PARTICIPANTS: Thirty-nine providers and leaders from eight VHA facilities. APPROACH: Thirty-minute post-implementation telephone interviews explored whether barriers identified pre-implementation were successfully addressed, the presence of any new challenges, helpfulness of external facilitation, and plans for sustaining MOUD access. Interviews were analyzed using a rapid turn-around approach. VHA administrative data were used to characterize the facilities and assess their ratio of patients with an OUD diagnosis receiving MOUD (MOUD/OUD ratio) at the end of a 9-month sustainability period. KEY RESULTS: Commonly reported contributors to sustained MOUD access included national attention on the opioid epidemic, accountability created by study participation, culture shift in MOUD acceptability, leadership support, and plans to build on initial progress. Frequently reported barriers included staffing issues and lack of MOUD-devoted time; the need to overhaul existing policies, practices, and/or processes; and fear and anxiety about MOUD prescribing. All facilities either maintained MOUD/OUD ratio improvement (n = 2) or further improved (n = 6) at the end of sustainability. Facilities with the highest and lowest ratio at the end of sustainability used a team-based approach to MOUD delivery; however, organizational setting differences may have impacted overall MOUD access. CONCLUSIONS: Ensuring stable and consistent staff, and sufficient time dedicated to MOUD are critical to sustaining access to evidence-based treatment in low-adopting facilities. This study highlights the importance of investing in local, system-level changes to improve and sustain access to effective treatments.

A Methodological Approach for Documenting Multi-Component Interventions Targeting Family Caregivers.

Managing the complex care needs of seriously ill patients transitioning from hospital to home can have detrimental effects on family caregivers (FCG). Multi-component interventions tailored to FCG needs are most effective at reducing caregiver burden, distress, and depression. However, gaps exist in determining best methods to assess, document, and analyze intervention components for FCGs. Common methods used to capture patient data during transitions in care may not be appropriate or allowed for FCG needs. As such, we present a methodological approach for electronically capturing, reporting, and analyzing multiple intervention components. This approach uses a standardized terminology and pathway for tailoring intervention components in real time while evaluating intervention effects across time. We use examples from a randomized controlled trial to illustrate the benefits of the current approach for analyzing the effectiveness of multi-component interventions in the context of caregiving research.

Population- and Community-Based Interventions to Prevent Suicide.

Background: Suicide is estimated to account for 1.4% of deaths worldwide, making it among the leading causes of premature death. Public health approaches to reduce suicide have the potential to reach individuals across the spectrum of suicide risk. Aims: To review the effectiveness of newer community-based or population-level suicide prevention strategies. Methods: We conducted a systematic review of literature published from January 2010 to November 2020 to evaluate the effectiveness of community- and population-level interventions. The US Center for Disease Control framework was used for grouping studies by strategy. Results: We included 56 publications that described 47 unique studies. Interventions that reduce access to lethal means, implement organizational policies and culture in police workplace settings, and involve community screening for depression may reduce suicide deaths. It is unclear if other interventions such as public awareness and education campaigns, crisis lines, and gatekeeper training prevent suicide. Evidence was inconsistent for community-based, multistrategy interventions. The most promising multistrategy intervention was the European Alliance Against Depression. Limitations: Most eligible studies were observational and many lacked concurrent control groups or adjustment for confounding variables. Conclusions: Community-based interventions that may reduce suicide deaths include reducing access to lethal means, implementing organizational policies in workplace settings, screening for depression, and the multistrategy European Alliance Against Depression Program. Evidence was unclear, inconsistent, or lacking regarding the impact of many other single- or multistrategy interventions on suicide deaths.

Healthcare quality measures in implementation research: advantages, risks and lessons learned.

Implementation studies evaluate strategies to move evidence-based practices into routine clinical practice. Often, implementation scientists use healthcare quality measures to evaluate the integration of an evidence-based clinical practice into real-world healthcare settings. Healthcare quality measures have standardized definitions and are a method to operationalize and monitor guideline-congruent care. Implementation scientists can access existing data on healthcare quality measures through various sources (e.g. operations-calculated), or they can calculate the measures directly from healthcare claims and administrative data (i.e. researcher-calculated). Implementation scientists need a better understanding of the advantages and disadvantages of these methods of obtaining healthcare quality data for designing, planning and executing an implementation study. The purpose of this paper is to describe the advantages, risks and lessons learned when using operations- versus researcher-calculated healthcare quality measures in site selection, implementation monitoring and implementation outcome evaluation. A key lesson learned was that relying solely on operations-calculated healthcare quality measures during an implementation study poses risks to site selection, accurate feedback on implementation progress to stakeholders, and the integrity of study results. A possible solution is using operations-calculated quality measures for monitoring of evidence-based practice uptake and researcher-calculated measures for site section and outcomes evaluation. This approach provides researchers greater control over the data and consistency of the measurement from site selection to outcomes evaluation while still retaining measures that are familiar and understood by key stakeholders whom implementation scientists need to engage in practice change efforts.

A Learning Health System Approach to Long COVID Care.

Background: Global initiatives to mitigate COVID-19 transmission have shifted health system priorities to management of patients with prolonged long COVID symptoms. To better meet the needs of patients, clinicians, and systems, a learning health system approach can use rapid-cycle methods to integrate data and real-world experience to iteratively evaluate and adapt models of long COVID care. Observations: Employees in the Veterans Health Administration formed a multidisciplinary workgroup. We sought to develop processes to learn more about this novel long COVID syndrome and innovative long COVID care models that can be applied within and outside of our health care system. We describe our workgroup processes and goals to create a mechanism for cross-facility communication, identify gaps in care and research, and cocreate knowledge on best practices for long COVID care delivery. Conclusions: The learning health system approach will be critical in reimagining health care service delivery after the COVID-19 pandemic.