Implementation outcomes from a multi-site stepped wedge cluster randomized family caregiver skills training trial.

OBJECTIVE: To assess whether a team collaboration strategy (CONNECT) improves implementation outcomes of a family caregiver skills training program (iHI-FIVES). DATA SOURCES AND STUDY SETTING: iHI-FIVES was delivered to caregivers at eight Veterans Affairs (VA) medical centers. Data sources were electronic health records, staff surveys, and interviews. STUDY DESIGN: In a stepped wedge cluster randomized trial, sites were randomized to a 6-month time interval start date for iHI-FIVES launch. Sites were then randomized 1:1 to either (i) CONNECT, a team collaboration training strategy plus Replicating Effective Programs (REP), brief technical support training for staff, or (ii) REP only (non-CONNECT arm). Implementation outcomes included reach (proportion of eligible caregivers enrolled) and fidelity (proportion of expected trainings delivered). Staff interviews and surveys assessed team function including communication, implementation experience, and their relation to CONNECT and iHI-FIVES implementation outcomes. DATA COLLECTION/EXTRACTION METHODS: The sample for assessing implementation outcomes included 571 Veterans referred to VA home- and community-based services and their family caregivers eligible for iHI-FIVES. Prior to iHI-FIVES launch, staff completed 65 surveys and 62 interviews. After the start of iHI-FIVES, staff completed 52 surveys and 38 interviews. Mixed methods evaluated reach and fidelity by arm. PRINCIPAL FINDINGS: Fidelity was high overall with 88% of expected iHI-FIVES trainings delivered, and higher among REP only (non-CONNECT) compared with CONNECT sites (95% vs. 80%). Reach was 18% (average proportion of reach across eight sites) and higher among non-CONNECT compared with CONNECT sites (22% vs. 14%). Qualitative interviews revealed strong leadership support at high-reach sites. CONNECT did not influence self-reported team function. CONCLUSIONS: A team collaboration strategy (CONNECT), added to REP, required more resources to implement iHI-FIVES than REP only and did not substantially enhance reach or fidelity. Leadership support was a key condition of implementation success and may be an important factor for improving iHI-FIVES reach with national expansion.

Adaptations and early adoption of a family caregiver intervention in the Veterans Affairs Health Care System: A multimethod pragmatic approach for national scaling.

OBJECTIVE: To examine the relationship between site-level adaptation and early adoption of Caregivers Finding Important Resources, Support, and Training (FIRST) training during national implementation across diverse Veteran Health Administration (VA) medical centers. DATA SOURCES AND STUDY SETTING: We enrolled and evaluated 25 VA medical centers (VAMCs). Along with administrative data on site characteristics, we examined site-reported data on adaptations and intervention adoption, defined as ≥4 training classes delivered to ≥5 caregivers at 6 months from April through October 2022. STUDY DESIGN: A type III hybrid implementation-effectiveness cluster randomized controlled trial, randomized VAMCs 1:1 to receive foundational (low-touch) implementation support (n = 12) or the addition of enhanced (high-touch) implementation support (n = 13). DATA COLLECTION/EXTRACTION METHODS: At key implementation phases, VAMCs were asked to report adaptations including content, contextual modifications (format, setting, personnel, and population), and training of providers. We describe site-level adaptations by arm and by organizational characteristics that included VAMC complexity level, staffing, rurality, and organizational readiness to change. We used qualitative comparative analysis to identify unique adaptations that contributed to intervention adoption at 6 months. PRINCIPAL FINDINGS: VAMCs randomized to receive enhanced support reported slightly more adaptations than those randomized to foundational support. At 6 months, VAMCs with two or more adaptations adopted Caregivers FIRST at a higher rate than those with fewer adaptations (90% vs. 44%). Staffing adaptations (e.g., who delivered the intervention), format and content (e.g., modified delivery pace), and referring provider training were unique adaptations to adopting sites. CONCLUSIONS: Site-level adaptations were diverse and occurred more frequently in sites with early adoption of Caregivers FIRST. Future research should identify best practices of supporting and monitoring intervention adaptation. Understanding the role of adaptation in early adoption success could assist other healthcare systems in implementing interventions for caregivers.

A stepped wedge cluster randomized trial to evaluate the effectiveness of a multisite family caregiver skills training program.

OBJECTIVE: To assess the effects of an evidence-based family caregiver training program (implementation of Helping Invested Families Improve Veteran Experiences Study [iHI-FIVES]) in the Veterans Affairs healthcare system on Veteran days not at home and family caregiver well-being. DATA SOURCES AND STUDY SETTING: Participants included Veterans referred to home- and community-based services with an identified caregiver across 8 medical centers and confirmed family caregivers of eligible Veterans. STUDY DESIGN: In a stepped wedge cluster randomized trial, sites were randomized to a 6-month time interval for starting iHI-FIVES and received standardized implementation support. The primary outcome, number of Veteran "days not at home," and secondary outcomes, changes over 3 months in measures of caregiver well-being, were compared between pre- and post-iHI-FIVES intervals using generalized linear models including covariates. DATA COLLECTION/EXTRACTION METHODS: Patient data were extracted from the electronic health record. Caregiver data were collected from 2 telephone-based surveys. PRINCIPAL FINDINGS: Overall, n = 898 eligible Veterans were identified across pre-iHI-FIVES (n = 327) and post-iHI-FIVES intervals (n = 571). Just under one fifth (17%) of Veterans in post-iHI-FIVES intervals had a caregiver enroll in iHI-FIVES. Veteran and caregiver demographics in pre-iHI-FIVES intervals were similar to those in post-iHI-FIVES intervals. In adjusted models, the estimated rate of days not at home over 6-months was 42% lower (rate ratio = 0.58 [95% confidence interval: 0.31-1.09; p = 0.09]) post-iHI-FIVES compared with pre-iHI-FIVES. The estimated mean days not at home over a 6-month period was 13.0 days pre-iHI-FIVES and 7.5 post-iHI-FIVES. There were no differences between pre- and post-iHI-FIVES in change over 3 months in caregiver well-being measures. CONCLUSIONS: Reducing days not at home is consistent with effectiveness because more time at home increases quality of life. In this study, after adjusting for Veteran characteristics, we did not find evidence that implementation of a caregiver training program yielded a reduction in Veteran's days not at home.

Enhancing team communication to improve implementation of a supervised walking program for hospitalized veterans: Evidence from a multi-site trial in the Veterans Health Administration.

INTRODUCTION: The timely translation of evidence-based programs into real-world clinical settings is a persistent challenge due to complexities related to organizational context and team function, particularly in inpatient settings. Strategies are needed to promote quality improvement efforts and implementation of new clinical programs. OBJECTIVE: This study examines the role of CONNECT, a complexity science-based implementation intervention to promote team readiness, for enhancing implementation of the 'Assisted Early Mobility for Hospitalized Older Veterans' program (STRIDE), an inpatient, supervised walking program. DESIGN: We conducted a stepped-wedge cluster randomized trial using a convergent mixed-methods design. Within each randomly assigned stepped-wedge sequence, Veterans Affairs Medical Centers (VAMCs) were randomized to receive standardized implementation support only or additional training via the CONNECT intervention. Data for the study were obtained from hospital administrative and electronic health records, surveys, and semi-structured interviews with clinicians before and after implementation of STRIDE. SETTING: Eight U.S. VAMCs. PARTICIPANTS: Three hundred fifty-three survey participants before STRIDE implementation and 294 surveys after STRIDE implementation. Ninety-two interview participants. INTERVENTION: CONNECT, a complexity-science-based intervention to improve team function. MAIN OUTCOME MEASURES: The implementation outcomes included STRIDE reach and fidelity. Secondary outcomes included validated measures of team function (i.e., team communication, coordination, role clarity). RESULTS: At four VAMCs randomized to CONNECT, reach was higher (mean 12.4% vs. 3.8%), and fidelity was similar to four non-CONNECT VAMCs. VAMC STRIDE delivery teams receiving CONNECT reported improvements in team function domains, similar to non-CONNECT VAMCs. Qualitative findings highlight CONNECT's impact and the influence of team characteristics and contextual factors, including team cohesion, leadership support, and role clarity, on reach and fidelity. CONCLUSION: CONNECT may promote greater reach of STRIDE, but improvement in team function among CONNECT VAMCs was similar to improvement among non-CONNECT VAMCs. Qualitative findings suggest that CONNECT may improve team function and implementation outcomes but may not be sufficient to overcome structural barriers related to implementation capacity.

"I've been doing this for years": the COVID-19 pandemic and family caregiver isolation and loneliness.

Background: Family caregivers are family members or friends of care recipients who assist with activities of daily living, medication management, transportation, and help with finances among other activities. As a result of their caregiving, family caregivers are often considered a population at risk of experiencing increased stress, isolation, and loneliness. During the COVID-19 pandemic in the US, social isolation and decrease in social activities were a top concern among older adults and their family caregivers. Using secondary analysis of survey data as part of a multi-site implementation trial of a caregiver skills training program, we describe differences in caregiver experiences of loneliness before and during the COVID-19 pandemic. Methods: Health and wellbeing surveys of family caregivers were collected on 422 family caregivers of veterans before and during COVID-19. Logistic regression modeling examined whether the loneliness differed between caregiver groups pre vs during COVID-19, using the UCLA 3-item loneliness measure. Rapid directed qualitative content analysis of open-ended survey questions was used to explore the context of how survey responses were affected by the COVID-19 pandemic. Results: There were no significant differences in loneliness between caregivers pre vs during COVID-19. In open-ended responses regarding effects of COVID-19, caregivers described experiencing loneliness and social isolation; why they were unaffected by the pandemic; and how caregiving equipped them with coping strategies to manage negative pandemic-related effects. Conclusion: Loneliness did not differ significantly between pre vs during COVID-19 caregivers. Future research could assess what specific characteristics are associated with caregivers who have resiliency, and identify caregivers who are more susceptible to experiencing loneliness. Understanding caregiver loneliness could assist other healthcare systems in developing and implementing caregiver support interventions.

Understanding veterans' experiences with lung cancer and psychological distress: A multimethod approach.

Psychological distress while coping with cancer is a highly prevalent and yet underrecognized and burdensome adverse effect of cancer diagnosis and treatment. Left unaddressed, psychological distress can further exacerbate poor mental health, negatively influence health management behaviors, and lead to a worsening quality of life. This multimethod study primarily focused on understanding veterans' psychological distress and personal experiences living with lung cancer (an underrepresented patient population). In a sample of 60 veterans diagnosed with either nonsmall cell lung cancer (NSCLC) or small cell lung cancer (SCLC), we found that distress is common across clinical psychology measures of depression (37% [using the Patient Health Questionnaire, PHQ-9 measure]), anxiety (35% [using the Generalized Anxiety Disorder, GAD-7 measure]), and cancer-related posttraumatic stress (13% [using the Posttraumatic Stress Symptom Checklist measure]). A total of 23% of the sample endorsed distress scores on two or more mental health screeners. Using a broader cancer-specific distress measure (National Comprehensive Cancer Network), 67% of our sample scored above the clinical cutoff (i.e., ≥ 3), and in the follow-up symptom checklist of the National Comprehensive Cancer Network measure, a majority endorsed feeling sadness (75%), worry (73%), and depression (60%). Qualitative analysis with a subset of 25 veterans highlighted that psychological distress is common, variable in nature, and quite bothersome. Future research should (a) identify veterans at risk for distress while living with lung cancer and (b) test supportive mental health interventions to target psychological distress among this vulnerable veteran population. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Evaluating Therapeutic Inertia in Two Telehealth Interventions for Type 2 Diabetes: Secondary Analyses of a Randomized Trial.

Introduction: Although therapeutic inertia is a known driver of suboptimal type 2 diabetes control, little is known about how to combat this phenomenon. We analyzed randomized trial data to determine whether a comprehensive telehealth intervention was more effective than a less structured telehealth approach (telemonitoring and care coordination) at promoting treatment intensification in poorly controlled diabetes. Methods: Patients with poorly controlled type 2 diabetes were randomized 1:1 to telemonitoring/care coordination or a comprehensive telehealth intervention, which included an active, study provider-guided medication management component. Prospectively collected medication lists were used to determine whether treatment intensification occurred for each patient during 3-month intervals throughout the study period. To examine between-arm differences in treatment intensification over time, we fit a generalized estimation equation model. In each arm, hemoglobin A1c levels at the beginning and end of each 3-month interval were used to distinguish between therapeutic inertia and potentially appropriate nonintensification of treatment. Results: The mean, model-estimated likelihood of treatment intensification during 3-month intervals was 61.3% in the comprehensive telehealth group versus 48.6% for telemonitoring/care coordination (odds ratio 1.7, 95% confidence interval 1.2-2.2; p = 0.0007), with no evidence that treatment effect varied over time (p = 0.54). Treatment intervals with observed therapeutic inertia were more common in the telemonitoring/care coordination arm than the comprehensive telehealth arm (116/300, 39% vs. 57/275, 21%). Conclusions: A comprehensive telehealth approach that integrated protocol-guided medication management increased treatment intensification and reduced therapeutic inertia compared with a less structured telehealth approach. The studied approaches may serve as examples of how systems might use telehealth to combat therapeutic inertia. Clinical Trial Registration: ClinicalTrials.gov NCT03520413.

Diabetes distress in Veterans with type 2 diabetes mellitus: Qualitative descriptive study.

Diabetes distress (DD) is a negative psychosocial response to living with type 2 diabetes mellitus (T2DM). We sought insight into Veterans' experiences with DD in the context of T2DM self-management. The four domains in the Diabetes Distress Scale (i.e. regimen, emotional, interpersonal, healthcare provider) informed the interview guide and analysis (structural coding using thematic analysis). The mean age of the cohort (n = 36) was 59.1 years (SD 10.4); 8.3% of patients were female and 63.9% were Black or Mixed Race; mean A1C was 8.8% (SD 2.0); and mean DDS score was 2.4 (SD 1.1), indicating moderate distress. Veterans described DD and challenges to T2DM self-management across the four domains in the Diabetes Distress Scale. We found that (1) Veterans' challenges with their T2DM self-management routines influenced DD and (2) Veterans experienced DD across a wide range of domains, indicating that clinical interventions should take a "whole-person" approach.Trial Registration: NCT04587336.

Evaluation of strategies to support implementation of a hospital walking program: protocol for a type III effectiveness-implementation hybrid trial.

BACKGROUND: STRIDE is a supervised walking program designed to address the negative consequences of immobility during hospitalization for older adults. In an 8-hospital stepped wedge randomized controlled trial, STRIDE was associated with reduced odds of hospital discharge to skilled nursing facility. STRIDE has the potential to become a system-wide approach to address hospital-associated disability in Veteran's Affairs; however, critical questions remain about how best to scale and sustain the program. The overall study goal is to compare the impact of two strategies on STRIDE program penetration (primary), fidelity, and adoption implementation outcomes. METHODS: Replicating Effective Programs will be used as a framework underlying all implementation support activities. In a parallel, cluster randomized trial, we will use stratified blocked randomization to assign hospitals (n = 32) to either foundational support, comprised of standard, low-touch activities, or enhanced support, which includes the addition of tailored, high-touch activities if hospitals do not meet STRIDE program benchmarks at 6 and 8 months following start date. All hospitals begin with foundational support for 6 months until randomization occurs. The primary outcome is implementation penetration defined as the proportion of eligible hospitalizations with ≥ 1 STRIDE walks at 10 months. Secondary outcomes are fidelity and adoption with all implementation outcomes additionally examined at 13 and 16 months. Fidelity will be assessed for STRIDE hospitalizations as the percentage of eligible hospital days with "full dose" of the program, defined as two or more documented walks or one walk for more than 5 min. Program adoption is a binary outcome defined as ≥ 5 patients with a STRIDE walk or not. Analyses will also include patient-level effectiveness outcomes (e.g., discharge to nursing home, length of stay) and staffing and labor costs. We will employ a convergent mixed-methods approach to explore and understand pre-implementation contextual factors related to differences in hospital-level adoption. DISCUSSION: Our study results will dually inform best practices for promoting successful implementation of an evidence-based hospital-based walking program. This information may support other programs by advancing our understanding of how to apply and scale-up national implementation strategies. TRIAL REGISTRATION: This study was registered on June 1, 2021, at ClinicalTrials.gov (identifier NCT04868656 ).