Is staff consistency important to parents’ satisfaction in a longitudinal study of children at risk for type 1 diabetes: the TEDDY study

Background Participants’ study satisfaction is important for both compliance with study protocols and retention, but research on parent study satisfaction is rare. This study sought to identify factors associated with parent study satisfaction in The Environmental Determinants of Diabetes in the Young (TEDDY) study, a longitudinal, multinational (US, Finland, Germany, Sweden) study of children at risk for type 1 diabetes. The role of staff consistency to parent study satisfaction was a particular focus. Methods Parent study satisfaction was measured by questionnaire at child-age 15 months (5579 mothers, 4942 fathers) and child-age four years (4010 mothers, 3411 fathers). Multiple linear regression analyses were used to identify sociodemographic factors, parental characteristics, and study variables associated with parent study satisfaction at both time points. Results Parent study satisfaction was highest in Sweden and the US, compared to Finland. Parents who had an accurate perception of their child’s type 1 diabetes risk and those who believed they can do something to prevent type 1 diabetes were more satisfied. More educated parents and those with higher depression scores had lower study satisfaction scores. After adjusting for these factors, greater study staff change frequency was associated with lower study satisfaction in European parents (mothers at child-age 15 months: − 0.30,95% Cl − 0.36, − 0.24, p < 0.001; mothers at child-age four years: -0.41, 95% Cl − 0.53, − 0.29, p < 0.001; fathers at child-age 15 months: -0.28, 95% Cl − 0.34, − 0.21, p < 0.001; fathers at child-age four years: -0.35, 95% Cl − 0.48, − 0.21, p < 0.001). Staff consistency was not associated with parent study satisfaction in the US. However, the number of staff changes was markedly higher in the US compared to Europe. Conclusions Sociodemographic factors, parental characteristics, and study-related variables were all related to parent study satisfaction. Those that are potentially modifiable are of particular interest as possible targets of future efforts to improve parent study satisfaction. Three such factors were identified: parent accuracy about the child’s type 1 diabetes risk, parent beliefs that something can be done to reduce the child’s risk, and study staff consistency. However, staff consistency was important only for European parents. Trial registration NCT00279318.

Barriers and facilitators to facility HIV self-testing in outpatient settings in Malawi: a qualitative study

Background Facility HIV self-testing (HIVST) within outpatient departments can increase HIV testing coverage by facilitating HIVST use in outpatient waiting spaces while clients wait for routine care. Facility HIVST allows for the majority of outpatients to test with minimal health care worker time requirements. However, barriers and facilitators to outpatients’ use of facility HIVST are still unknown. Methods As part of a cluster randomized trial on facility HIVST in Malawi, we conducted in-depth interviews with 57 adult outpatients (> 15 years) who were exposed to the HIVST intervention and collected observational journals that documented study staff observations from facility waiting spaces where HIVST was implemented. Translated and transcribed data were analyzed using constant comparison analysis in Atlas.ti. Results Facility HIVST was convenient, fast, and provided autonomy to outpatients. The strategy also had novel facilitators for testing, such as increased motivation to test due to seeing others test, immediate support for HIVST use, and easy access to additional HIV services in the health facility. Barriers to facility HIVST included fear of judgment from others and unwanted status disclosure due to lack of privacy. Desired changes to the intervention included private, separate spaces for kit use and interpretation and increased opportunity for disclosure and post-test counseling. Conclusions Facility HIVST was largely acceptable to outpatients in Malawi with novel facilitators that are unique to facility HIVST in OPD waiting spaces. Trial registration The parent trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.

Conducting a Cluster RCT on Medication Safety in Nursing Units Overtaxed by the COVID-19 Pandemic

Medication errors continue to harm many hospitalized patients. In other high-risk industries, voluntary incident reporting is widely used to improve safety. Reporting is widely used in hospitals, but not as effectively. This AHRQ-funded cluster RCT will assess the effects of the SAFE Loop, which includes five enhancements in incident reporting implemented on hospital nursing units. Analyses will compare changes in nurses’ attitudes toward reporting, event reporting rates, report quality, and medication event rates between intervention and control arms. The COVID-19 pandemic has created both obstacles and opportunities. The intervention requires study staff to engage nursing unit directors, attend daily nursing “huddles”, and train overtaxed front-line nurses in a geographic area greatly impacted by COVID-19 surges. This created uncertainty around the best time to start the trial. Conversely, we have collected unique data on the implications of COVID-19 for medication safety while testing our instruments during the trial preparation phase.

The participatory turn in health and medicine: The rise of the civic and the need to ‘give back’ in data-intensive medical research

What has been called the “participatory turn” in health and medicine refers to a general shift from paternalistic and hierarchical, to more collaborative and egalitarian relationships between medical experts and patients/research participants; a shift from what the pragmatic sociologists Boltanski and Thévenot (2006) call a “domestic” to a “civic” order of worth. Critical scholarship on the participatory turn tends to emphasize discrepancies between ideals of equality and empowerment, and practices of increased individual responsibility and disempowerment. In this paper, we depart from this critical literature by suspending evaluation about authentic and inauthentic ideals and practices. Instead, we explore the issues and challenges that arise in the process of ensuring that ideal and practice align in what we call a civic-participatory style of doing medical research. Drawing on interviews and observations carried out with medical researchers, coordinators and assessors in a longitudinal cohort study called the Personalized Parkinson’s Project (PPP), we show that for study staff it is often unclear how they can meet the demands of reciprocity towards research participants that are presupposed by civic-participatory ideals. In particular, in the context of a study whose aim is the creation of a comprehensive dataset comprised of clinical, environmental and lifestyle data that study participants generously “give” over a period of 2 years, we observed a persistent concern on the part of study staff regarding what and how to “give back”. As we show, study staff negotiate and resolve this tension through recourse to creative workarounds and innovative ways of giving back, including frequent project and scientific updates, newsletters, the designation of personal assessors and pampering Event Days. The paper makes a contribution to the critical literature on the participatory turn by showing the utility of the orders of worth framework in probing the challenges and workarounds that emerge in settings where an incumbent style of organizing medical research (here, the 'civic') comes to challenge practices hitherto organized according to a wholly different logic (in this case, the 'domestic')—without making assumptions about the (in)authenticity of such ideals and practices. Moreover, we contend that this framework offers new tools for evaluating participatory research projects in the form of “good” or “successful” civic–domestic compromises.

Surgical safety checklist audits may be misleading! Improving the implementation and adherence of the surgical safety checklist: a quality improvement project

Despite good quality evidence for benefits with its use, challenges have been encountered in the correct and consistent implementation of the surgical safety checklist (SSC). Previous studies of the SSC have reported a discrepancy between what is documented and what is observed in real time. A baseline observational audit at our institution demonstrated compliance of only 3.5% despite a documented compliance of 100%. This project used quality improvement principles of identifying the problem and designing strategies to improve staff compliance with the SSC. These included changing the SSC from paper-based to a reusable laminated form, a broad multidisciplinary education and marketing campaign, targeted coaching and modifying the implementation in response to ongoing staff feedback. Five direct observational audits were undertaken over four Plan–Do–Study–Act cycles to capture real-time information on staff compliance. Two staff surveys were also undertaken. Compliance with the SSC improved from 3.5% to 63% during this study. Staff reported they felt the new process improved patient safety and that the new SSC was easily incorporated into their workflow. Improving compliance with the SSC requires deep engagement with and cooperation of surgical, anaesthesia and nursing teams and understanding of their work practices and culture. The prospective observational audit highlighted an initial 3.5% compliance rate compared with 100% based on an audit of the patient notes. Relying solely on a retrospective paper-based model can lead to hospitals being unaware of significant safety and quality issues. While in-person prospective observations are more time-consuming and resource-consuming than retrospective audits, this study highlights their potential utility to gain a clear picture of actual events. The significant variation between documented and observed data may have considerable implications for other retrospective studies which rely on human-entered data for their results.

Speaker, tell me a joke: The feasibility of using smart speaker technology for health and well-being in an older adult population (Preprint)

BACKGROUND Although smart speaker technology is poised to help improve the health and well-being of older adults through offering services such as music, medication reminders, and connection to others, more research is needed to determine how older adults from lower socioeconomic position (SEP) accept and use this technology. OBJECTIVE The purpose of this study is to serve as a feasibility study for using smart speakers for improving the health and well-being of older low SEP adults. METHODS Forty nine adults between the age of 65 to 85 who lived in a subsidized housing community were recruited to take part in a three-month study. Participants had a smart speaker into their home and were given a brief orientation to its use. Over the course of the study, participants were given weekly check-in calls to help assist with any problems and newsletters with tips on how to use the speaker. Participants received a pretest and posttest to gauge comfort with technology, well-being, and perceptions of and use of the speaker. Study staff also maintained detailed process notes of interactions with participants over the course of the study, including a log of all issues reported. RESULTS At the end of the study period, 38% of the participants indicated using the speaker daily, and 38% reported using it several times per week. Seventy-two percent of the participants indicated that they wanted to continue using the speaker after the end of the study. The majority (63%) indicated that the speaker was useful, and approximately half of participants felt that the speaker gave them another voice to talk to (51%) and connected them with the outside world (47%). Although common uses were using the speaker for weather, music, and news, fewer reported using it for health-related questions. Despite initial challenges participants experienced with framing questions to the speaker, additional explanation by study staff addressed these issues in the first weeks of the study. CONCLUSIONS Results from this study indicate that there is promise for smart speaker technology with older low SEP adults, particularly to connect them to music, news, and reminders. Future studies will need to provide more up-front training on query formation, as well as develop and promote more specific options for older adults, particularly in the area of health and well-being. INTERNATIONAL REGISTERED REPORT RR2-10.2196/jmir.4375

Study protocol: a pilot randomised waitlist-controlled trial of a dyadic mobile health intervention for black sexual-minority male couples with HIV in the USA

IntroductionHIV care engagement is lower among black sexual-minority men relative to other racial/ethnic groups of sexual-minority men. Being in a primary relationship is generally associated with more successful HIV care engagement across various populations. However, among black sexual-minority men, the association between primary relationship status and HIV-related outcomes is inconsistent across the HIV care continuum. Given the ubiquity of mobile technology access and use among racial/ethnic minority communities, leveraging mobile technology for HIV care engagement appears a promising intervention strategy. This paper outlines the protocol of the LetSync study, a pilot randomised controlled trial of a mobile health app intervention developed using the Framework of Dyadic HIV Care Engagement to improve care-engagement outcomes among black sexual-minority male couples living with HIV.Methods and analysisEighty black sexual-minority men in couples (n=160) will be enrolled to pilot test the LetSync app. At least one member of each dyad must be both HIV-positive and self-identify as black/African-American. Couples will be randomised to either a waitlist-control arm or an intervention that uses relationship-based approach to improve HIV care engagement. We will assess feasibility and acceptability of trial procedures and intervention protocols based on predefined metrics of feasibility and acceptability. Execution of the study will yield the opportunity to conduct analyses to test the measurement and analysis protocol on antiretroviral therapy adherence by comparing the intervention and waitlist-control arms on self-reported and biological (hair sample) measures of adherence.Ethics and disseminationStudy staff will obtain electronic consent from all participants. This study has been approved by the University of California (UCSF) Institutional Review Board. Study staff will work with the Community Advisory Board at the UCSF Center for AIDS Prevention Studies Board to disseminate results to participants and the community via open discussions, presentations, journal publications and/or social media.Trial registration numberNCT04951544.

The Internet-Based Conversational Engagement Clinical Trial (I-CONECT) in Socially Isolated Adults 75+ Years Old: Randomized Controlled Trial Protocol and COVID-19 Related Study Modifications

Background: Increasing social interactions through communication technologies could offer a cost-effective prevention approach that slows cognitive decline and delays the onset of Alzheimer's disease. This paper describes the protocol of an active project named “Internet-based conversational engagement clinical trial (I-CONECT)” (ClinicalTrials.gov: NCT02871921). The COVID-19 pandemic related protocol modifications are also addressed in the current paper.Methods: I-CONECT is a multi-site, assessor-blind, randomized controlled behavioral intervention trial (RCT). We aim to randomize 320 socially isolated adults 75+ years old [160 Caucasian and 160 African American participants, 50:50 split between those with normal cognition and mild cognitive impairment (MCI)] recruited from the community to either the video chat intervention group or the control group (1:1 allocation). Those in the video chat group receive a computer and Internet service for the duration of the study, which they use to video chat with study staff for 30 min/day 4×/week for 6 months (high dose), and then 2×/week for an additional 6 months (maintenance dose). Both video chat and control groups have a brief (about 10 min) telephone check-in with study staff once per week. The primary outcome is the change in global cognitive function measured by Montreal Cognitive Assessment (MoCA) from baseline to 6 months. Secondary outcomes include changes in cognition in memory and executive function domains, emotional well-being measured by NIH Toolbox emotional battery, and daily functional abilities assessed with the Revised Observed Tasks of Daily Living (OTDL-R). Eligible participants have MRIs at baseline and 6 months. Participants contribute saliva for genetic testing (optional consent), and all video chats, weekly check-in calls and neuropsychological assessment sessions are recorded for speech and language analysis. The pandemic halted research activities and resulted in protocol modifications, including replacing in-person assessment with remote assessment, remote deployment of study equipment, and revised targeted sample size.Discussion: This trial provides user-friendly hardware for the conversational-based intervention that can be easily provided at participants' homes. The trial aspires to use age and culture-specific conversational materials and a related platform developed in this trial for enhancing cognitive reserve and improving cognitive function.

Barriers to recruitment, retention and intervention delivery in a randomized trial among patients with firearm injuries

Background We discuss barriers to recruitment, retention, and intervention delivery in a randomized controlled trial (RCT) of patients presenting with firearm injuries to a Level 1 trauma center. The intervention was adapted from the Critical Time Intervention and included a six-month period of support in the community after hospital discharge to address recovery goals. This study was one of the first RCTs of a hospital- and community-based intervention provided solely among patients with firearm injuries. Main text Barriers to recruitment included limited staffing, coupled with wide variability in length of stay and admission times, which made it difficult to predict the best time to recruit. At the same time, more acutely affected patients needed more time to stabilize in order to determine whether eligibility criteria were met. Barriers to retention included insufficient patient resources for stable housing, communication and transportation, as well as limited time for patients to meet with study staff to respond to follow-up surveys. These barriers similarly affected intervention delivery as patients who were recruited, but had fewer resources to help with recovery, had lower intervention engagement. These barriers fall within the broader context of system avoidance (e.g., avoiding institutions that keep formal records). Since the patient sample was racially diverse with the majority of patients having prior criminal justice system involvement, this may have precluded active participation from some patients, especially those from communities that have been subject to long and sustained history of trauma and racism. We discuss approaches to overcoming these barriers and the importance of such efforts to further implement and evaluate hospital-based violence intervention programs in the future. Conclusion Developing strategies to overcome barriers to data collection and ongoing participant contact are essential to gathering robust information to understand how well violence prevention programs work and providing the best care possible for people recovering from injuries. Trial registration ClinicalTrials.govNCT02630225. Registered 12/15/2015.

Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders

Background Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and appropriately accounted for. Building on earlier work, we embedded social science research within an ongoing malaria human infection study in coastal Kenya to understand the study benefits and burdens experienced by study stakeholders in this low-resource setting and assess the wider implications for future research planning and policy. Methods Data were collected using qualitative research methods, including in-depth interviews (44), focus group discussions (10) and non-participation observation. Study participants were purposively selected (key informant or maximal diversity sampling), including volunteers in the human infection study, study staff, community representatives and local administrative authorities. Data were collected during and up to 18 months following study residency, from sites in Coastal and Western Kenya. Voice recordings of interviews and discussions were transcribed, translated, and analysed using framework analysis, combining data- and theory-driven perspectives. Findings Physical, psychological, economic and social forms of benefits and burdens were experienced across study stages. Important benefits for volunteers included the study compensation, access to health checks, good residential living conditions, new learning opportunities, developing friendships and satisfaction at contributing towards a new malaria vaccine. Burdens primarily affected study volunteers, including experiences of discomfort and ill health; fear and anxiety around aspects of the trial process, particularly deliberate infection and the implications of prolonged residency; anxieties about early residency exit; and interpersonal conflict. These issues had important implications for volunteers’ families, study staff and the research institution’s reputation more widely. Conclusion Developing ethically and scientifically strong HIS relies on grounded accounts of volunteers, study staff and the wider community, understood in the socioeconomic, political and cultural context where studies are implemented. Recognition of the diverse, and sometimes perverse, nature of potential benefits and burdens in a given context, and who this might implicate, is critical to this process. Prior and ongoing stakeholder engagement is core to developing these insights.