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by Gabriela Ferreira Siano, Camila Stefanie Fonseca de Oliveira, Felipe Gaia de Sousa, Suzane Lilian Beier, Adriane Pimenta da Costa-Val
Animal welfare encompasses the overall well-being of an animal, spanning both its physical and mental health, assessable through potential measurements. It stands in contrast to mistreatment, which involves actions, direct or indirect, that endanger an animal’s well-being. This study sought to appraise the factors influencing the Brazilian population’s understanding of dog welfare and mistreatment. The survey questions were adapted from the Animal Welfare Examination Protocol, utilized by veterinarians to evaluate suspected passive abuse cases in dogs. Out of 1377 responses, 1353 were valid and analyzed. Among the 19 assessed indicators, 15 demonstrated an adequate response rate surpassing 90% of all 1353 responses. However, for three questions related to comfort, a smaller yet notable percentage of responses were only minimally adequate. Moreover, in one question within the comfort assessment, 186 participants (13.74%) provided inadequate responses. This implies that these people could potentially subject animals to a state of low Animal Welfare. Lack of knowledge emerged as a potential root of passive abuse, specifically negligence. In the assessment of nutritional indicators, water supply and quality received unanimous adequate responses. In evaluating comfort perceptions, significant associations were noted between gender, dog ownership, family income, and responses regarding resting surface. Regarding health indicators, the majority responded appropriately. Female gender and dog ownership correlated with providing the appropriate response, while not owning a dog was associated with minimally adequate responses. In the context of comfort indicators, "Hitting the Dog" also demonstrated an association with gender, with females tending towards appropriate responses. Given the lack of significant correlation between educational levels and the most suitable responses, it underscores the urgency of implementing environmental education programs in schools with a focus on animal protection.by Nafiseh Ghassab-Abdollahi, Haidar Nadrian, Elnaz Shaseb, Narges Kheirollahi, Mina Hashemiparast
BackgroundOlder adults with polypharmacy are more prone to medication errors. People with low educational attainment have more difficulties in taking their medications.
ObjectivesThis study aimed to identify the extent of medication self-administration errors (MSEs) and the contributing factors among illiterate and low-literate community-dwelling older adults with polypharmacy.
MethodThe present cross-sectional study was conducted among people aged 60 and above. The data were collected using the sociodemographic, clinical, and Belief about Medicines Questionnaires (BMQ). To determine the extent of MSE, a medication error checklist was used. The negative binomial hierarchical regression model in the five blocks was performed.
ResultsThe final sample size was 276 people. The frequency of MSEs in the last 6 months was 69.2%. Sixteen percent of participants had made four or more mistakes. The most common MSEs were forgetting, improper taking of medications with food, improper timing, incorrect dosage (lower dose), and forgetting the doctor’s instructions. Near 18% of participants reported adverse events following their mistakes. The significant predictors of MSEs were being completely illiterate (p = 0.021), the higher number of doctor visits per year (p = 0.014), irregularly seeing doctors (p Conclusion
Despite the high prevalence of MSEs among older patients, practical strategies to deal with them at their homes have not been established among health systems. MSE as a multifactorial event can be caused by a collection of internal and external factors. Further studies to identify the role of patients, clinicians, procedures, and systems in developing MSEs as interconnected components are needed.
International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.
Systematic review.
Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.
All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.
Search results were independently screened by at least two reviewers and data were extracted into a proforma.
38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.
International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.
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To examine family planning through the community’s perception, belief system and cultural impact; in addition to identifying the determining factors for family planning uptake.
A descriptive exploratory study.
Three communities were selected from three local government areas, each in the three senatorial districts in Ekiti State.
The study was conducted among young unmarried women in the reproductive age group who were sexually active as well as married men and women in the reproductive age group who are currently living with their partners and were sexually active.
Eight focus group discussions were conducted in the community in 2019 with 28 male and 50 female participants. The audio recordings were transcribed, triangulated with notes and analysed using QSR NVivo V.8 software. Community perception, beliefs and perceptions of the utility of family planning, as well as cultural, religious and other factors determining family planning uptake were analysed.
The majority of the participants had the perception that family planning helps married couple only. There were diverse beliefs about family planning and mixed reactions with respect to the impact of culture and religion on family planning uptake. Furthermore, a number of factors were identified in determining family planning uptake—intrapersonal, interpersonal and health system factors.
The study concluded that there are varied reactions to family planning uptake due to varied perception, cultural and religious beliefs and determining factors. It was recommended that more targeted male partner engagement in campaign would boost family planning uptake.
by Levi Matthies, Hendrik Amir-Kabirian, Medhanie T. Gebrekidan, Andreas S. Braeuer, Ulrike S. Speth, Ralf Smeets, Christian Hagel, Martin Gosau, Christian Knipfer, Reinhard E. Friedrich
In Neurofibromatosis type 1 (NF1), peripheral nerve sheaths tumors are common, with cutaneous neurofibromas resulting in significant aesthetic, painful and functional problems requiring surgical removal. To date, determination of adequate surgical resection margins–complete tumor removal while attempting to preserve viable tissue–remains largely subjective. Thus, residual tumor extension beyond surgical margins or recurrence of the disease may frequently be observed. Here, we introduce Shifted-Excitation Raman Spectroscopy in combination with deep neural networks for the future perspective of objective, real-time diagnosis, and guided surgical ablation. The obtained results are validated through established histological methods. In this study, we evaluated the discrimination between cutaneous neurofibroma (n = 9) and adjacent physiological tissues (n = 25) in 34 surgical pathological specimens ex vivo at a total of 82 distinct measurement loci. Based on a convolutional neural network (U-Net), the mean raw Raman spectra (n = 8,200) were processed and refined, and afterwards the spectral peaks were assigned to their respective molecular origin. Principal component and linear discriminant analysis was used to discriminate cutaneous neurofibromas from physiological tissues with a sensitivity of 100%, specificity of 97.3%, and overall classification accuracy of 97.6%. The results enable the presented optical, non-invasive technique in combination with artificial intelligence as a promising candidate to ameliorate both, diagnosis and treatment of patients affected by cutaneous neurofibroma and NF1.Regular clinical reviews of people with COPD provide an opportunity to optimise management and are recommended in national and international guidelines. However, there are limited data about the relationship between having an annual review and other aspects of care quality, which might influence decision-making by healthcare professionals and commissioners.
Using data from 74 827 people with COPD completing the Asthma+Lung UK COPD Patient Passport, between 2014 and 2022, we conducted adjusted logistic regression (adjusting for year) and compared receipt of key items of care between those reporting that they had had an annual review (65.3%) and those who did not (34.7%). To further capture patient experience, we also analysed 4228 free-text responses to the 2021 Asthma+Lung UK annual COPD survey to the question ‘What is the one thing that could improve your COPD care?’
We found that the absence of an annual review was associated with significantly worse COPD care across all domains studied; in particular, inhaler training (yes: 80.8% vs no: 38.4%, adjusted OR (AOR): 8.18, 95% CI (7.89 to 8.47), having a written care plan (89.6% vs 56.9%, AOR 6.68 (95% CI 6.35 to 7.05) and medication knowledge (72.6% vs 33.6%, AOR 5.73 (95% CI 5.51 to 5.96). Thematic analysis of the 2021 COPD survey responses identified three areas to improve care: (1) access and support from healthcare services, (2) improved treatment effectiveness and (3) interaction between COPD and the social environment.
Failure to deliver annual COPD reviews is associated with worse patient-reported experience of care quality. In parallel, people with COPD express a desire for greater support and access to healthcare services.
The vast majority of the 300 000 pregnancy-related deaths every year occur in South Asia and sub-Saharan Africa. Increased access to quality antepartum and intrapartum care can reduce pregnancy-related morbidity and mortality worldwide. We used a population-based cross-sectional cohort design to: (1) examine the sociodemographic risk factors and structural barriers associated with pregnancy care-seeking and institutional delivery, and (2) investigate the influence of residential distance to the nearest primary health facility in a rural population in Mali.
A baseline household survey of Malian women aged 15–49 years was conducted between December 2016 and January 2017, and those who delivereda baby in the 5 years preceding the survey were included. This study leverages the baseline survey data from a cluster-randomised controlled trial to conduct a secondary analysis. The outcomes were percentage of women who received any antenatal care (ANC) and institutional delivery; total number of ANC visits; four or more ANC visits; first ANC visit in the first trimester.
Of the 8575 women in the study, two-thirds received any ANC in their last pregnancy, one in 10 had four or more ANC visits and among those that received any ANC, about one-quarter received it in the first trimester. For every kilometre increase in distance to the nearest facility, the likelihood of the outcomes reduced by 5 percentage points (0.95; 95% CI 0.91 to 0.98) for any ANC; 4 percentage points (0.96; 95% CI 0.94 to 0.98) for an additional ANC visit; 10 percentage points (0.90; 95% CI 0.86 to 0.95) for four or more ANC visits; 6 percentage points (0.94; 95% CI 0.94 to 0.98) for first ANC in the first trimester. In addition, there was a 35 percentage points (0.65; 95% CI 0.56 to 0.76) decrease in likelihood of institutional delivery if the residence was within 6.5 km to the nearest facility, beyond which there was no association with the place of delivery. We also found evidence of increase in likelihood of receiving any ANC care and its intensity increased with having some education or owning a business.
The findings suggest that education, occupation and distance are important determinants of pregnancy and delivery care in a rural Malian context.
This Phase 1b study was designed to evaluate the safety and efficacy of pravibismane, a novel broad-spectrum topical anti-infective, in managing moderate or severe chronic diabetic foot ulcer (DFU) infections. This randomized, double-blind, placebo-controlled, multicenter study consisted of 39 individuals undergoing pravibismane treatment and 13 individuals in the placebo group. Assessment of safety parameters included clinical observations of tolerability and pharmacokinetics from whole blood samples. Pravibismane was well-tolerated and exhibited minimal systemic absorption, as confirmed by blood concentrations that were below the lower limit of quantitation (0.5 ng/mL) or in the low nanomolar range, which is orders of magnitude below the threshold of pharmacological relevance for pravibismane. Pravibismane treated subjects showed approximately 3-fold decrease in ulcer size compared to the placebo group (85% vs. 30%, p = 0.27). Furthermore, the incidence of ulcer-related lower limb amputations was approximately 6-fold lower (2.6%) in the pooled pravibismane group versus 15.4% in the placebo group (p = 0.15). There were no treatment emergent or serious adverse events related to study drug. The initial findings indicate that topical pravibismane was safe and potentially effective treatment for improving recovery from infected chronic ulcers by reducing ulcer size and facilitating wound healing in infected DFUs (ClinicalTrials.gov Identifier NCT02723539).
Commentary on: Wong S, Müller A. Nurses' use of pro re nata medication in adult acute mental healthcare settings: An integrative review. Int J Ment Health Nurs. 2023 Apr 6. doi: 10.1111/inm.13148. Epub ahead of print.
This literature review provides synthesised evidence to evaluate and improve the clinical practice of pro re nata (PRN) medication in mental healthcare organisations. Further research focused on exploring grey literature would offer additional perspectives and broaden the current clinical practices of PRN utilisation.
PRN refers to unscheduled medication used to manage acute symptoms. PRN is commonly used in mental healthcare, but literature suggests that its use is not always based on evidence. This review offers knowledge for developing evidence-based PRN practice. The nurses play a crucial role in PRN administration, including assessing patients’ needs for medication, following prescribed indications and instructions, as...
Diabetic Foot Ulcers (DFUs) are a major complication of diabetes, often leading to amputation. Understanding the relationship between haematological inflammatory markers and the incidence of amputation in DFU patients with infectious complications is crucial for improving management and outcomes. This retrospective study, conducted from May 2020 to October 2022, involved 109 patients with DFUs, categorised into amputation (AM) and non-amputation (NAM) groups. Patients were evaluated for various factors, including demographic data, DFU duration, and blood parameters such as haemoglobin A1c (HbA1c), haemoglobin (Hb), albumin (ALB), white blood cell count (WBC), erythrocyte sedimentation rate (ESR), procalcitonin (PCT), C-reactive protein (CRP), platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and lymphocyte-to-monocyte ratio (LMR). Statistical analyses were performed using independent sample t-tests, Mann–Whitney U test and logistic regression. The univariate analysis showed no significant difference in BMI, DM duration or DFU duration between groups. However, significant differences were noted in PCT, Hb, ESR, ALB, HbA1c and WBC levels, and in inflammatory ratios (NLR, PLR and LMR). Multivariate logistic regression identified CRP, NLR and PLR as independent risk factors for amputation. The study highlights CRP, PLR and NLR as key independent risk factors for amputation in patients with DFUs. These easily obtainable markers from routine blood tests can effectively aid in predicting the risk of osteomyelitis and amputation, enhancing clinical decision making and patient care strategies.
To develop a reflection method for community nurses and certified nursing assistants to support the implementation of the Dutch Informal Care guideline in daily care.
Design-based research.
A design group and four test groups of community nurses and nursing assistants were formed to develop a reflection method that aligns with the needs and preferences of its end-users. The design and test group meetings were video recorded. The video data were iteratively discussed and analysed thematically to adapt and refine the method and to identify its key features.
A final reflection method was developed. Five main themes were identified from the analysis: the group, reflective triggers, knowledge about the guidelines, the coach and preconditions. The themes are linked to nine key features representing the building blocks of the reflection method. The key features are group size, participants with different (educational) backgrounds, pairs of participants, expressing thoughts, video feedback, reflection game, making the connection with the guideline, coaching as a process facilitator and meeting organizational and contextual conditions for implementation.
An evidence- and practice-based reflection method for community nurses and certified nursing assistants is developed to support the implementation. By involving community nurses and certified nursing assistants, the method closely matches their needs and preferences. Critical elements of the reflection method are a game element, video feedback and working in pairs in a group of participants from different (educational) backgrounds. Guidance is needed to make the transfer from theory to practice.
A reflection method for community nurses and certified nursing assistants was developed to enhance care work according to guideline recommendations, aiming to improve the care provided by informal caregivers.
The COREQ guideline was used.
This reflection method was developed in close collaboration with all stakeholders during the entire study.
To explore the postoperative kinesophobia of patients after percutaneous coronary intervention (PCI) and its related factors.
Percutaneous coronary intervention is an effective method to treat coronary heart disease (CHD), and cardiac rehabilitation is an important auxiliary method after PCI. However, the compliance of patients with cardiac rehabilitation after PCI is not good, among which kinesophobia is an important influencing factor.
A descriptive cross-sectional design was implemented, and the high-quality reporting of the study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology Statement.
In total, 351 inpatients who underwent PCI in three tertiary grade-A hospitals in China were selected by convenient sampling method. We use one-way ANOVA and multiple linear regression analysis to determine the relevant related factors.
The kinesophobia of patients after PCI was negatively correlated with chronic illness resource utilization and sense of personal mastery, and positively correlated with illness perception. Education level, clinical classification of CHD, exercise habits, chronic illness resource utilization, illness perception and sense of personal mastery entered the regression equation, which could explain 78.1% of the total variation.
The level of kinesiophobia of patients after PCI is high. Education level, clinical classification of CHD, exercise habits, chronic illness resource utilization, illness perception and sense of personal mastery are the related factors of kinesiophobia of patients after PCI.
By reducing the level of exercise fear of patients after PCI, patients are more likely to accept and adhere to the cardiac rehabilitation plan, thus improving their prognosis and improving their quality of life.
The patient underwent PCI in the research hospital. Researchers screen them according to the inclusion criteria and invite them to participate in this study. If they meet the requirements, participants will answer the research questionnaire face to face after signing the informed consent form.
Treatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent pain stimuli. This is suspected to render affected individuals less likely to respond to conventional therapies. Endotherapy or surgical decompression is offered to patients with pancreatic duct obstruction. However, the response to treatment is unpredictable. Pancreatic quantitative sensory testing (P-QST), an investigative technique of standardised stimulations to test the pain system in CP, has been used for phenotyping patients into three mutually exclusive groups: no central sensitisation, segmental sensitisation (pancreatic viscerotome) and widespread hyperalgesia suggestive of supraspinal central sensitisation. We will test the predictive capability of the pretreatment P-QST phenotype to predict the likelihood of pain improvement following invasive treatment for painful CP.
This observational clinical trial will enrol 150 patients from the University of Pittsburgh, Johns Hopkins and Indiana University. Participants will undergo pretreatment phenotyping with P-QST. Treatment will be pancreatic endotherapy or surgery for clearance of painful pancreatic duct obstruction. Primary outcome: average pain score over the preceding 7 days measured by Numeric Rating Scale at 6 months postintervention. Secondary outcomes will include changes in opioid use during follow-up, and patient-reported outcomes in pain and quality of life at 3, 6 and 12 months after the intervention. Exploratory outcomes will include creation of a model for individualised prediction of response to invasive treatment.
The trial will evaluate the ability of P-QST to predict response to invasive treatment for painful CP and develop a predictive model for individualised prediction of treatment response for widespread use. This trial was approved by the University of Pittsburgh Institutional Review Board. Data and results will be reported and disseminated in conjunction with National Institutes of Health policies.
Prescribing long-term opioid therapy is a nuanced clinical decision requiring careful consideration of risks versus benefits. Our goal is to understand patient, provider and context factors that impact the decision to prescribe opioids in patients with cancer.
We conducted a secondary analysis of the raw semistructured interview data gathered from 42 prescribers who participated in one of two aligned concurrent qualitative studies in the USA and Australia. We conducted a two-part analysis of the interview: first identifying all factors influencing long-term prescribing and second open coding-related content for themes.
Factors that influence long-term opioid prescribing for cancer-related pain clustered under three key domains (patient-related, provider-related and practice-related factors) each with several themes. Domain 1: Patient factors related to provider–patient continuity, patient personality, the patient’s social context and patient characteristics including racial/ethnic identity, housing and socioeconomic status. Domain 2: Provider-related factors centred around provider ‘personal experience and expertise’, training and time availability. Domain 3: Practice-related factors included healthcare interventions to promote safer opioid practices and accessibility of quality alternative pain therapies.
Despite the differences in the contexts of the two countries, providers consider similar patient, provider and practice-related factors when long-term prescribing opioids for patients with cancer. Some of these factors may be categorised as cognitive biases that may intersect in an already disadvantaged patient and exacerbate disparities in the treatment of their pain. A more systematic understanding of these factors and how they impact the quality of care can inform appropriate interventions.
by Clemens Brunner, Philip Schadenbauer, Nele Schröder, Roland H. Grabner, Stephan E. Vogel
Determining if a sequence of numbers is ordered or not is one of the fundamental aspects of numerical processing linked to concurrent and future arithmetic skills. While some studies have explored the neural underpinnings of order processing using functional magnetic resonance imaging, our understanding of electrophysiological correlates is comparatively limited. To address this gap, we used a three-item symbolic numerical order verification task (with Arabic numerals from 1 to 9) to study event-related potentials (ERPs) in 73 adult participants in an exploratory approach. We presented three-item sequences and manipulated their order (ordered vs. unordered) as well as their inter-item numerical distance (one vs. two). Participants had to determine if a presented sequence was ordered or not. They also completed a speeded arithmetic fluency test, which measured their arithmetic skills. Our results revealed a significant mean amplitude difference in the grand average ERP waveform between ordered and unordered sequences in a time window of 500–750 ms at left anterior-frontal, left parietal, and central electrodes. We also identified distance-related amplitude differences for both ordered and unordered sequences. While unordered sequences showed an effect in the time window of 500–750 ms at electrode clusters around anterior-frontal and right-frontal regions, ordered sequences differed in an earlier time window (190–275 ms) in frontal and right parieto-occipital regions. Only the mean amplitude difference between ordered and unordered sequences showed an association with arithmetic fluency at the left anterior-frontal electrode. While the earlier time window for ordered sequences is consistent with a more automated and efficient processing of ordered sequential items, distance-related differences in unordered sequences occur later in time.by Pablo Marino Corrêa Nascimento, Luiz Fernando Rodrigues Junior, Mauro Felippe Felix Mediano, Valéria Gonçalves da Silva, Bernardo Rangel Tura, Fabio César Sousa Nogueira, Gilberto Domont, Adriana Bastos Carvalho, Antônio Carlos Campos de Carvalho, Taís Hanae Kasai-Brunswick, Claudio Tinoco Mesquita, Humberto Villacorta Junior, Helena Cramer Veiga Rey
Sarcopenia, a clinical syndrome primarily associated with reduced muscle mass in the elderly, has a negative impact on quality of life and survival. It can occur secondarily to other diseases such as heart failure (HF), a complex clinical syndrome with high morbidity and mortality. The simultaneous occurrence of these two conditions can worsen the prognosis of their carriers, especially in the most severe cases of HF, as in patients with reduced left ventricular ejection fraction (LVEF). However, due to the heterogeneous diagnostic criteria for sarcopenia, estimates of its prevalence present a wide variation, leading to new criteria having been recently proposed for its diagnosis, emphasizing muscle strength and function rather than skeletal muscle mass. The primary objective of this study is to evaluate the prevalence of sarcopenia and/or dynapenia in individuals with HF with reduced LVEF according to the most recent criteria, and compare the gene and protein expression of those patients with and without sarcopenia. The secondary objectives are to evaluate the association of sarcopenia and/or dynapenia with the risk of clinical events and death, quality of life, cardiorespiratory capacity, ventilatory efficiency, and respiratory muscle strength. The participants will answer questionnaires to evaluate sarcopenia and quality of life, and will undergo the following tests: handgrip strength, gait speed, dual-energy X-ray absorptiometry, respiratory muscle strength, cardiopulmonary exercise, as well as genomic and proteomic analysis, and dosage of N-terminal pro-B-type natriuretic peptide and growth differentiation factor-15. An association between sarcopenia and/or dynapenia with unfavorable clinical evolution is expected to be found, in addition to reduced quality of life, cardiorespiratory capacity, ventilatory efficiency, and respiratory muscle strength.Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.
To assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI at 1 year post discharge, focusing on the potential impact of age, frailty, and disease severity.
Routinely collected outcome data on 1207 patients admitted with confirmed COVID-19 related SARI across all three secondary care sites in our NHS trust over 3 months were assessed in this retrospective cohort study. Of those surviving 1 year, we prospectively collected 36-item short form (SF-36) HRQoL questionnaires, comparing three age groups (
Overall mortality was 46.5% in admitted patients. In our SF-36 cohort (n=169), there was a significant reduction in all HRQoL domains versus normative data; the most significant reductions were in the physical component (pemotional component (physical well-being versus CFS (the correlation coefficient=–0.37, p
There was a significant reduction in all SF-36 domains at 1 year. Poor CFS at admission was associated with a significant and prolonged impact on physical parameters at 1 year. Age had little impact on the severity of HRQoL, except in the domains of physical functioning and the overall physical component.
SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).
The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.
The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.
ClinicalTrials.gov: NCT05533918 and
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