Clinical Directors Network

Abstract Home health aides and attendants (HHAs) frequently provide care to adults with heart failure (HF), but many lack training and confidence, and cannot quickly reach their nurse supervisors when they need help. In partnership with one of the largest home care agencies in New York, NY, we conducted a pilot randomized control trial (RCT) to test an education and communication-based intervention among 105 HHAs caring for HF patients. HHAs were randomized to: a) HF training (control) or b) HF training plus mHealth app that allowed HHAs to message nurses in real-time (intervention) and followed for 90 days. Main outcomes: 1) feasibility 2) acceptability and 3) effectiveness (primary outcomes: HF knowledge Caregiver Self-Efficacy (SE), secondary outcome: self-reported preventable 911calls). Data on patient outcomes (ED visits, hospitalizations) were collected. Mixed effects models were used to compare trajectory of all outcomes between and within study arms. Qualitative data was analyzed thematically. The presentation will focus on the findings of the RCT, including completion and retention rates, feasibility and acceptability of the intervention, and HHA and patient outcomes. Overall, we found that training improved HHAs’ HF knowledge and caregiving SE, with the largest gains among those with lowest baseline scores. The chat feature (intervention) did not significantly improve primary outcomes but did reduce preventable 911 calls (secondary outcome). Fewer ED visits occurred among patients cared for by intervention arm HHAs. The findings can inform the design of a future large-scale trial, and how to better support and integrate HHAs providing care HF care.

As the 8 patient partners serving on the PCORnet® Steering Committee, we stand at the forefront of a transformative movement in clinical research. PCORnet® Network Partners have been pioneers in integrating patient voices into every aspect of the research process, and we applaud the progress in operationalizing the Patient-Centered Outcomes Research Institute’s (PCORI) Framework for Patient Engagement and for leading the way as funders to change how to effectively involve patients and other interested parties in research. However, we believe that now is the time to amplify our efforts and call for a fundamental shift in how health research is conducted across the board. This commentary serves as both a reflection on our journey and a rallying cry for deeper, more authentic patient engagement and partnership in clinical research. The landscape of clinical research has undergone significant changes over the past decade, with patient engagement emerging as a cornerstone of patient-centered outcomes research. This shift is evidenced by major funding agencies now requiring patient engagement and a growing body of literature demonstrating improved study quality, recruitment, and relevance when patients are engaged as partners. As patient partners participating in PCORnet®, we have been at the forefront of this evolution, witnessing firsthand the progress made and the challenges and learnings that remain. Drawing on our experiences and evidence from the literature, we propose strategies to enhance patient involvement across all stages of research. We introduce and explore the concept that clinical research should be “careful, kind, and connected.” Our reflections underscore that meaningful patient involvement is essential for advancing health outcomes and achieving a truly patient-partnered research ecosystem.

ObjectiveApproaches to randomized clinical trial (RCT) implementation greatly changed during the COVID-19 pandemic as clinical trials transitioned to largely virtual implementation; virtual RCT implementation may continue in the future. Without careful consideration, virtual RCTs may exacerbate the historical under-representation of women, the elderly, and racial and ethnic minorities that has occurred in past clinical trials. The following study presents an approach to virtualizing an RCT for an mHealth intervention.Materials and MethodsParticipants for the trial were recruited from Federally Qualified Health Centers in medically underserved areas of the New York City metropolitan area. Recruitment began in January 2020 but was paused in March 2020 due to the COVID-19 pandemic’s onset. The research team developed a virtual protocol for recruitment, onboarding, and study implementation.ResultsStudy participants were predominantly from immigrant, low-income, and racial and ethnic minority groups. Our virtualization approach included an easier-to-understand consent form, expanded virtual training materials, and greater one-on-one attention during training. Our approach did not lead to significant changes in the population we recruited into the study or introduce additional biases and restriction.DiscussionOur study represents an early investigation into how the change from in-person clinical trial recruitment and study implementation to virtual during the COVID-19 pandemic may impact recruitment of participants from medically underserved communities into RCTs.ConclusionThis approach may be used in future trials testing mHealth and other technological interventions without exacerbating the under-representation of medically underserved populations.

ImportanceHealth care workers (HCW) faced chronic stress during the COVID-19 pandemic and were at high risk of illness, death and burnout.ObjectiveTo understand the experiences of and assess the acceptability and usability of the “Stress First Aid” (SFA) intervention for HCWs.DesignWe used a mixed methods approach to conduct: (1) a quantitative post-intervention survey of experiences with the SFA intervention within a cluster randomized controlled trial (cRCT); and (2) a qualitative descriptive analysis. The intervention was rolled out over three waves from March 2021 – October 2022 simultaneously with the sites’ COVID-19 response.SettingOur team engaged and recruited eight pairs of hospitals and six pairs of Federally Qualified Health Centers (FQHCs), balanced across region, including nine states, and matched on size, type, and COVID-19 burden.ParticipantsA total of 862 HCWs received the SFA intervention and completed both the pre- and post-intervention surveys (FQHC n = 245 and hospital n = 617). For the qualitative analysis, among HCWs who agreed to be contacted for a post-intervention interview, we purposively sampled a subset of 35 HCWs balanced by site, gender, age, race/ethnicity and HCW type.InterventionSFA is an evidence-informed intervention adapted to mitigate the psychosocial impact of COVID-19 on HCWs through individual peer support actions.Main Outcome(s) and Measure(s)Quantitative measures are binary indicators of agreement with 6 questions about experiences with the SFA intervention. For the qualitative analysis, we utilized a semi-structured interview protocol to provide additional context on experience with SFA and how SFA affects HCW well-being.ResultsBetween 48.2 and 59.4% of HCWs agreed or strongly agreed that they: found SFA helpful (48.2%), felt comfortable supporting colleagues (59.4%), would recommend SFA (51.2%), and would continue to use SFA principles (57.2%). Non-White HCWs (particularly Black HCWs), those in assistant/technician positions and those who reported attending a greater number of booster sessions were more likely to agree with positive statements about SFA experiences.Conclusions and RelevanceGiven the continued resurgence of public health emergencies, its lasting effects on HCWs, and related emerging challenges, we expect there to be a continued need for support of patient-facing HCWs.Clinical trial registrationClinical Trials.gov Number: NCT04723576 Registered on 01/22/2021 Clinicaltrials.govNCT04723576.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12913-025-13268-6.

Abstract Background Hybrid effectiveness-implementation designs evaluate the effectiveness and implementation of interventions. We retrospectively evaluated the implementation of a stepped-wedge cluster randomized controlled trial (RCT) of a facilitated telemedicine model (experimental) integrated into opioid treatment programs (OTPs) compared to offsite referral (control) for hepatitis C virus (HCV) treatment. We compared organizational and implementation characteristics associated with an HCV cure and with high healthcare delivery satisfaction. Methods We used the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM)-QuEST framework to guide data collection and evaluation. We evaluated the clinical effectiveness outcome (HCV cure) and patient centered outcomes (changes between in-person and telemedicine patient satisfaction questionnaire subscales: time spent with doctor, interpersonal manner, accessibility and convenience, and general satisfaction). We combined patient and organization-level information to conduct a configurational comparative method of coincidence analysis (CNA) to identify strategy configurations associated with each outcome. We also utilized the random forest method to identify the most important variables and reran the CNA analysis. For contextual interpretation, we discussed stakeholders’ perceptions of the findings through focus group discussions. Results Using RE-AIM-QuEST, in terms of reach, the RCT enrolled 96.5% of the original projected sample. We found that low patient load per provider or counselor, site liaison presence, and approaches that promoted case manager integration into site workflows, were associated with increased clinical effectiveness. When evaluating organization factors associated with high satisfaction with healthcare delivery, we found that approaches that promote communication, patient and staff education, and site liaison presence were important in the facilitated telemedicine arm. In the referral arm, additional important factors identified included the ability of the case manager to explain the referral process and OTP affiliation with a university. In terms of telemedicine implementation, free-standing sites and low patient volume were associated with high satisfaction. In the referral arm, university affiliation was an important factor. Conclusions Factors associated with communication, addressing participants’ concerns, and case manager integration within OTP workflows are important for successful implementation of facilitated telemedicine. Using these combinations may be important for expanding and evaluating HCV treatment uptake and for understanding successful implementation of telemedicine-based interventions in underserved populations. Trial registration Clintrials.gov registration number NCT02933970; Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals - Full Text View - ClinicalTrials.gov

Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. ClinicalTrials.gov Identifier: NCT02933970.

Abstract In the past 15 years, research activities focusing on the interlinkages between climate change and human mobility have intensified. At the same time, an increasing number of actors and processes have sought to address human mobility in the context of climate change from a policy perspective. Hitherto, research has been limited in terms of geographical preferences as well as conceptual and methodological focus areas. This paper argues that to address the evolving policy space, future research on climate change in the context of human mobility needs to become more differentiated, integrated and generalized. This includes concerted efforts to better integrate researchers from the global South, improved cross‐linkages between different datasets, approaches and disciplines, more longitudinal and comparative studies and development of innovative qualitative and quantitative methods.

In this paper, we describe two case studies of research projects that attempt to scale up HCI research beyond traditional small evaluation studies. The first of these projects focused on evaluating an interactive web application for promoting problem-solving in self-management of type 2 diabetes mellitus (T2DM) in a randomized clinical trial; the second one included deployment in the wild of a smartphone app that provided individuals with T2DM with personalized predictions for changes in blood glucose levels in response to meals. We highlight lessons learned during these two projects and describe four different design considerations important for large scale studies. These include designing for longevity, diversity, adoption, and abandonment. We then discuss implications for future research that targets large scale deployment studies.