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Ayer — Octubre 2nd 2025Tus fuentes RSS

Assessing the Effectiveness of Interventions Implemented by Nurses to Reduce Medication Administration Errors in Hospitalised Acute Adult Patient Settings: Systematic Review and Meta‐Analysis

ABSTRACT

Background

Medication administration errors are high-risk patient safety issues that could potentially cause harm to patients, thereby delaying recovery and increasing length of hospital stay with additional healthcare costs. Nurses are pivotal to the medication administration process and are considered to be in the position to recognize and prevent these errors. However, the effectiveness of interventions implemented by nurses to reduce medication administration errors in acute hospital settings is less reported.

Aim

To identify and quantify the effectiveness of interventions by nurses in reducing medication administration errors in adults' inpatient acute hospital.

Methods

A systematic review and meta-analysis was conducted up to 03/24. Six databases were searched. Study methodology quality assessment was conducted using the Joanna Briggs Institute (JBI) critical appraisal tools, and data extraction was conducted. Meta-analysis was performed to combine effect sizes from the studies, and synthesis without meta-analysis was adopted for studies that were not included in the meta-analysis to aggregate and re-examine results from studies.

Results

Searches identified 878 articles with 26 studies meeting the inclusion criteria. Five types of interventions were identified: (1) educational program, (2) workflow smart technologies, (3) protocolised improvement strategy, (4) low resource ward-based interventions, and (5) electronic medication management. The overall results from 14 studies included in meta-analysis showed interventions implemented by nurses are effective in reducing medication administration errors (Z = 2.15 (p = 0.03); odds ratio = 95% CI 0.70 [0.51, 0.97], I 2 = 94%). Sub-group analysis showed workflow smart technologies to be the most effective intervention compared to usual care. Findings demonstrate that nurse-led interventions can significantly reduce medication administration errors compared to usual care. The effectiveness of individual interventions varied, suggesting a bundle approach may be more beneficial. This provides valuable insights for clinical practice, emphasizing the importance of tailored, evidence-based approaches to improving medication safety.

Reporting Method

PRISMA guided the review and JBI critical appraisal tools were used for quality appraisal of included studies.

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Responsiveness and the minimal clinically important difference of the Chelsea Critical Care Physical Assessment tool (CPAx) in critically ill, mechanically ventilated adults: a study protocol for a prospective, multicentre, cohort study

Por: Eggmann · S. · Paton · M. · Villinger · C. · Bradley · S. · Hellings · T. · Hills · A. · Venetz · P. · Broadley · T. · Charles-Nelson · A. · Hodgson · C.
Introduction

The use of invasive life support in patients with a prolonged critical illness clearly saves lives but carries substantial risks, including intensive care unit-acquired weakness (ICUAW) and long-term disability. Early mobilisation might improve outcomes, yet the evidence is conflicting and complicated by the lack of a responsive outcome measurement to detect change in critically ill patients’ physical function and activity. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for patients at risk of ICUAW. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated.

Methods and analysis

The primary objective of this prospective, international, multicentre, longitudinal cohort study is to investigate responsiveness and to establish the MCID of the CPAx during the ‘intensive care unit (ICU) period’, from ICU baseline to ICU discharge, and ‘hospital period’, from ICU to hospital discharge. Adults with any critical illness who are mechanically ventilated for at least 72 hours, expected to remain in ICU (≥48 hours) and being treated by a physiotherapist are eligible for study inclusion. Functional measurements, including the CPAx and a global rating of change (GRC) scale, will be collected during routine physiotherapy. Responsiveness will be evaluated primarily using the GRC as an anchor to distinguish changed from unchanged/deteriorated patients (criterion validity). As such, the magnitude of change will be analysed with receiver operating characteristics. Additionally, construct validity will be explored with correlation coefficients and effect sizes to confirm/reject a priori formulated hypotheses. MCID will be investigated with anchor-based and distribution-based methods. We plan to recruit 120 patients across three sites in Australia and Switzerland.

Ethics and dissemination

Ethical approval has been obtained from each local ethics committee (Canton of Bern, Switzerland (2024-00346), Monash Health, Australia (HREC/106143/MonH-2024-438474(v3)), the Alfred, Australia (490/24)). The results will be disseminated through international/national conferences, peer-reviewed journals and social media. The high quality, rigorous testing of the CPAx could benefit researchers, clinicians and patients.

Trial registration number

NCT06419699.

Evaluating the health and well-being effects of increasing biodiversity within multiple small parks in Edinburgh, UK: a protocol for a mixed-methods, longitudinal, pre-post natural experiment

Por: Malden · S. · McDougall · C. W. · Ward Thompson · C. · Wendelboe-Nelson · C. · Ross-Perez · A. · Clemens · T. · Mason · S. · Villegas-Diaz · R. · Hoadley · A. · Hunter · A. · Jepson · R. · Williams · A. J.
Introduction

Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.

Methods and analysis

This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.

Ethics and dissemination

This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.

Isolation and characterization of a <i>Chlamydia muridarum tc0237</i> mutant from a genetic screen that is attenuated in epithelial cells

by Kaylee R. Jacobs, Caleb M. Ardizzone, Arkaprabha Banerjee, Evelyn Toh, Xiaoli Zhang, David E. Nelson

Chlamydia are obligate intracellular bacterial pathogens that infect a wide range of vertebrate hosts. Despite having highly conserved genomes, closely related Chlamydia species can exhibit distinct host and tissue tropisms. The host tropisms of the human pathogen Chlamydia trachomatis and the closely related mouse pathogen Chlamydia muridarum are influenced by their ability to evade host immune responses, particularly those mediated by interferon gamma. However, there is evidence that tissue tropism is driven by additional poorly understood host and Chlamydia factors. In this study, we used a forward genetic approach to investigate the mechanisms that mediate C. muridarum tissue tropism. We conducted a tropism screen using a randomly mutagenized C. muridarum library and murine cell lines representing different tissues. We identified a mutant isolate whose growth was restricted in murine rectal and oviduct epithelial cells in an interferon gamma-independent manner. This phenotype was mapped to a missense mutation in tc0237, a gene that mediates the affinity of C. muridarum for cultured human epithelial cells. Our analysis of growth dynamics showed that the tc0237 mutant exhibits a developmental delay in rectal epithelial cells. Together, these results suggest that TC0237 plays a role in C. muridarum tissue tropism.

Primary care patients presenting with unexpected weight loss in Australian general practices: replication of a diagnostic accuracy study

Por: Lee · A. · de Mendonca · L. · McCarthy · D. · Nelson · C. · Rafiq · M. · Venning · B. · Chima · S. · Daly · D. · Fishman · G. · Kearney · C. · Hunter · B. · Lim · F. S. · Manski-Nankervis · J.-A. · Nicholson · B. D. · Emery · J. · Martinez-Gutierrez · J.
Objective

We calculate positive predictive values (PPVs) of patients presenting with unexpected weight loss (UWL) being diagnosed with cancer within 6 months, using data from a population of Australian primary care patients to replicate results from a previous UK study.

Design

A diagnostic accuracy study involving calculation of the PPV for any cancer using retrospective data from routinely collected electronic healthcare records. The index date is defined as the first recorded UWL presentation and the reference standard is cancer diagnosis within 6 months of the index date.

Setting

This study uses primary care data from the Patron primary care database, linked to hospital admissions data and the Victorian Cancer Registry. We include only patients who presented to their General Practitioners (GPs) at least once between 1 July 2007 and 1 February 2022.

Participant

Patients were included if they were at least 18 years of age at the index date, had no previous diagnosis of cancer or previous weight loss intervention, including being prescribed medications for weight loss. 13 306 patients out of a primary care population of 1 791 051 patients were identified that met the eligibility criteria.

Results

When stratified by age, sex and smoking status, we found PPVs lower than those derived in a previous UK primary care study, though still above 3% for male non-smokers over 60, female smokers over 70 and all males over 70. Patients from ages 60–79 with at least one abnormal blood test result had PPVs consistently above 3%, while overall, patients with abnormal blood test results have PPVs of up to 35%.

Conclusion

We confirmed that many PPVs, while consistently below those derived in the UK study, are above clinically significant thresholds and increasing with age and the number of different abnormal blood test results.

Barriers and facilitators of HIV pre-exposure prophylaxis (PrEP) uptake and use in Canada: a scoping review protocol

Por: Chabikuli · A. · Chakraborty · D. · Ziegler · C. · Djiadeu · P. · Mgbatogu · K. · Ifeanacho · E. · Ajiboye · O. · Lo Hog Tian · J. · Odhiambo · J. · Nelson · L. E. · Rourke · S. B. · Ajiboye · W.
Introduction

Despite extensive efforts in HIV prevention, significant barriers to accessing interventions such as HIV pre-exposure prophylaxis (PrEP) persist in Canada. Although PrEP has demonstrated efficacy in preventing HIV transmission, various structural, social and systemic factors continue to impede its widespread adoption and use. These factors influence the uptake (acceptance and access) and use (adherence and retention) of PrEP. The purpose of this scoping review is to examine the existing body of evidence regarding the barriers and facilitators to uptake and use of PrEP in Canada. By identifying these factors, the review aims to inform future research, policy development and interventions to improve PrEP access and its integration into HIV prevention strategies in Canada.

Methods and analysis

This scoping review will focus on studies involving HIV-seronegative individuals in Canada who are either eligible for or currently using PrEP as an HIV prevention option. The review will consider barriers and facilitators within services, programmes, policies or practices related to HIV prevention in Canada. Eligible studies will include experimental, quasi-experimental, observational or qualitative designs. Studies that do not address PrEP or HIV prevention, or that involve populations not aligned with the inclusion criteria, will be excluded. The review will involve searching a range of key databases, including MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Scopus, Web of Science and TRIP, with no language restrictions, and focusing on publications from 2016 onward. Two independent reviewers will screen titles and abstracts, followed by full-text assessment and data extraction, using Covidence. Data will be analysed narratively, with a specific focus on subgroup analyses of key populations. The findings will be synthesised to provide an overview of the key themes, trends, and evidence gaps identified within the existing literature.

Ethics and dissemination

This piece of research will not involve human participants and will solely use already published data. Consequently, ethics approval is not necessary. The findings will be disseminated through peer-reviewed journal articles and conference presentations and may be of relevance to governmental health agencies and local HIV/AIDS service organisations.

Trial registration

The protocol has been registered on Open Science Framework registries at https://doi.org/10.17605/OSF.IO/69WJA.

A Multinational Observational Study of Nurse Work Wellbeing: A Research Protocol for the Caring Science International Collaborative

ABSTRACT

Background

Work wellbeing, also known as workplace wellbeing, is a global concern for nurses, particularly because excessive stress and exhaustion contribute to burnout.

Objective

The Caring Science International Collaborative (CSIC), an international research network, empirically investigates nurse work wellbeing using the Profile of Caring, a psychometrically validated and reliable instrument.

Framework

The CSIC framework defines wellbeing intrinsically—as caring and clarity—and extrinsically—as the social and technical resources needed to work efficiently and effectively. The Profile of Caring explains 80% of work wellbeing in nursing without bias across 10 countries.

Study Design

This research protocol describes an international multicenter observational study that measures nurse work wellbeing using the Profile of Caring and other concepts and outcomes measures.

Depressive disorders in children: recent prevalence and future directions

Por: Nelson · K. M. · Wilson · S.

Commentary on: Spoelma MJ, Sicouri GL, Francis DA, Songco AD, Daniel EK, Hudson JL. Estimated prevalence of depressive disorders in children from 2004 to 2019: A systematic review and meta-analysis. JAMA Pediatrics. 2023;177(10):1017–1027.

Implications for practice and research

  • Clinical practice with young children benefits from knowledge about the prevalence of depressive disorders in childhood and that the well-established sex differences seen for depression in adulthood may not appear until adolescence.

  • Further research is needed to address possible changes in the prevalence of childhood depressive disorders around the world and following the COVID-19 pandemic, and whether these changes are differentially distributed across individuals and communities.

  • Context

    Depression in childhood is a long-documented public health concern.1 A large body of research has considered prevalence rates of depression in children around the world, given its relevance for lifespan mental health and well-being. Meta-analytic research...

    Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT

    Por: Poolman · M. · Wright · S. · Hendry · A. · Goulden · N. · Holmes · E. · Byrne · A. · Perkins · P. · Hoare · Z. · Nelson · A. · Hiscock · J. · Hughes · D. A. · OConnor · J. · Foster · B. · Reymond · L. · Lewis · P. · Wee · B. · Roberts · R. · Parkinson · A. · Roberts · S. · Wilkinson · C.
    Objectives

    To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.

    Design

    We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1:1 allocation ratio, using convergent mixed methods.

    Setting

    Home-based care without 24/7 paid care provision, in three UK sites.

    Participants

    Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before the approach, including a known history of substance abuse or carer ability to be trained to competency.

    Intervention

    Intervention-group carers received training by local nurses using a manualised training package.

    Primary outcome measures

    Quantitative data were collected at baseline and 6–8 weeks post-bereavement and via carer diaries. Interviews with carers and healthcare professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.

    Secondary outcome measures

    The secondary outcome measure was time to symptom relief, calculated using data items from the carer diary, after the patient had died.

    Results

    In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting >30% of eligible dyads. The expected recruitment target (50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced (30% (6/20) usual care and 80% (16/20) intervention). The feasibility criterion of >40% retention was, therefore, considered not met. A total of 12 carers (intervention, n=10; usual care, n=2) and 20 healthcare professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The intervention group had a considerably shorter time to medication administration than the usual-care group (median time to administer medication in intervention=5 min, usual-care=105 min). Intervention group carers felt confident in administering medication. Healthcare professional support was sought by intervention group carers in 24 out of 147 (16.3%) medication administration entries. The context of the feasibility study was not ideal, as district nurses were overstretched, unfamiliar with research methods and possibly not in equipoise. A disparity in readiness to consider the intervention was demonstrated between carers, who were uniformly enthusiastic, and healthcare professionals who were not. Findings confirmed methodological and ethics issues pertaining to researching the last days of life care.

    Conclusion

    The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring healthcare professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.

    Trial registration number

    ISRCTN11211024.

    Work Wellbeing of Nurses in MENA Countries: A Cross‐Sectional Comparative Secondary Analysis of Jordan, Israel, and Türkiye

    ABSTRACT

    Background

    Global research on nurse work wellbeing (WWB) has produced internationally-informed outcome models, yet few studies examine how these models apply within specific countries. Understanding WWB in the national context is essential to shape effective, locally relevant nursing policies and practices.

    Objectives

    To explore WWB characteristics among hospital nurses in the Middle East and North Africa (MENA) and identify country-specific opportunities to improve nurse WWB.

    Methods

    A secondary analysis was conducted using WWB data from nurses in Jordan, Israel, and Türkiye, extracted from a broader 9-country study (2022–2023) involving 2546 nurses. The original study employed the 35-item Profile of Caring instrument to measure a 9-factor model of WWB. This analysis used descriptive statistics and linear regression to examine country-specific patterns among MENA nurses (n = 429).

    Results

    Data from Jordan (n = 136), Israel (n = 175), and Türkiye (n = 118) revealed statistically significant differences (p < 0.001) across five of nine WWB factors by country. Country, as a variable, predicted 33% of the variance of caring-for-self and 20% of caring-of-manager, with Türkiye and Jordan reporting the lowest scores, respectively. Country explained 18% of satisfaction with professional growth and 16% in autonomy, with Türkiye scoring lowest on both. Fifteen percent of participative management was predicted by country, with both Türkiye and Jordan having lower scores than Israel.

    Linking Evidence to Action

    Findings inform country-specific policy and operational improvements to support nurse WWB: strengthening manager-staff engagement, fostering self-care among nurses and caring and communicative behaviors from managers, supporting professional development, and enhancing autonomy and role clarity.

    Job Satisfaction as a Factor in Nursing Staff's Work Wellbeing and Retention: A Comparative Study of Central and Eastern Europe and Other Global Regions

    ABSTRACT

    Background

    Prior international collaborative studies indicated that job satisfaction, a factor of nursing work wellbeing (WWB), is closely linked to retention, with notable cross-country differences. However, limited regional comparisons, especially between Central and Eastern Europe (CEE), North America, and the Middle East and North Africa (MENA), restrict understanding of nurse wellbeing and retention regional impacts, limiting tailored strategy development.

    Aims

    This secondary analysis study compared the effects of region on nursing WWB and job satisfaction factors in CEE, MENA, and North America, aiming to identify those CEE region-specific predictors associated with and effects on job satisfaction and, in turn, WWB.

    Methods

    CEE (n = 1616), MENA (n = 1562), and North America (n = 1386) data were analyzed using descriptive and linear regression analytics (p < 0.001). The CEE sample included nursing staff from Croatian (n = 301), Polish (n = 215), Serbian (n = 489), and Slovenian (n = 611) nurses and nursing assistants. Six job satisfaction factors were examined: coworkers, patient care, participative management, autonomy, professional growth, and organizational rewards.

    Results

    The CEE region reported statistically significant lower mean scores and negative effects across all six job satisfaction factors compared to MENA and North America. Satisfaction with coworkers had the largest effect within the CEE region when compared to MENA and North America (ϐ = −0.26), while satisfaction with participative management had the smallest regional effect (ϐ = −0.10). Findings informed operational discussions for CEE-targeted retention interventions.

    Linking Evidence to Action

    Job satisfaction subscale factors facilitate the identification of empirically- and theoretically-informed operational actions to improve CEE nursing job satisfaction as an important factor of WWB and contribute to nursing retention.

    Deepening Empirical Understandings of Nurse Work Well‐Being: Using Mixed Methods Including Path Analysis to Create Contextualized Outcome Models

    ABSTRACT

    Background

    This 2022–2023 study across nine countries builds on a 2019–2021 ten-country study exploring nurse work well-being (WWB) and its associated outcomes. WWB, as assessed using the Profile of Caring (PoC) survey, is conceptualized as a multifactorial construct encompassing caring for self, caring of manager, clarity of role/system, and job satisfaction.

    Aims

    To explore relationships between WWB and staff outcomes by evaluating the PoC construct validity within an international nursing population in the post-pandemic context.

    Methods

    Nursing staff (n = 2546) from 128 facilities participated. Mixed methods, including thematic analysis, descriptive statistics, regression analyses, and path analysis, were employed to develop a WWB outcome model. Reliability was assessed with Cronbach's alpha, and construct validity was assessed through exploratory factor analysis.

    Results

    The final model had good model fit, explaining 76% of nurse WWB. Feeling rewarded for work well done, total direct effect had a positive relationship with job satisfaction (β = 0.415, p = < 0.001) and a negative effect on intent to leave (β = −0.242, p = 0.003). Job satisfaction total direct effect negatively related to intent to leave (β = −0.584, p = < 0.001). Relationship direction, strength, and significance varied by country. Caring of manager explained one-third of WWB. Job satisfaction subscales explained intent to leave (25.2%). The PoC showed high reliability (Cronbach's alpha ≥ 0.80), and robust construct validity was confirmed through exploratory factor analysis (KMO = 0.950, factor loadings ≥ 0.40).

    Linking Evidence to Action

    Conclusions suggest that understanding job satisfaction and intent to leave predictors is complex, requiring complex models to globally and contextually explain nurse WWB outcomes.

    Active group-based performing arts interventions in Parkinsons disease: an updated systematic review and meta-analysis

    Por: Barnish · M. S. · Reynolds · S. E. · Nelson-Horne · R. V.
    Objectives

    To assess the evidence for active group-based performing arts interventions for people with Parkinson’s disease (PD).

    Setting

    Scholarly literature (published in English) from any country or countries (last search February 2025). This systematic review was not registered and received no funding.

    Data sources

    Five bibliographic databases: AMED (Ebsco), APA PsycINFO (Ovid), CINAHL (Ebsco), EMBASE (Ovid) and MEDLINE (Ovid), plus supplementary searches.

    Primary and secondary outcome measures

    Eligible studies used a quantitative design to assess the benefit of active group-based performing arts interventions on quality of life, functional communication, speech, motor function and cognitive status in PD. The risk of bias was assessed using the SURE, University of York Centre for Reviews and Dissemination and Newcastle-Ottawa Scale checklists. Data were synthesised using narrative synthesis and random-effects meta-analysis.

    Results

    A total of 94 studies were included: 2453 people with PD (mean age 68 years, 55% male) from 18 countries. Narrative synthesis supported nine combinations of performing arts modalities and outcome domains, including a benefit for dance on motor function (supported by 50 out of 54 studies), dance on quality of life (supported by 24 out of 37 studies) and singing on speech (supported by 17 out of 20 studies). Meta-analysis supported five combinations of performing art modalities, comparators and outcomes, including a clinically significant benefit for PD-specific dance versus usual care PDQ-39, MD –7.81, 95% CI –11.87 to –3.75 and tango-based dance versus usual care on UPDRS-III, MD –9.89, 95% CI –16.65 to –3.13.

    Conclusions

    Evidence from both the narrative synthesis and the meta-analysis supports a benefit for some combinations of performing arts modalities and outcomes. Limitations of the evidence base included differences in comparators and outcomes, heterogeneity, lack of control arms and male underrepresentation. Future studies should compare the effectiveness of different performing arts modalities, assess functional communication and consider clinical significance.

    Randomised controlled trial of a psychosocial digital health application to promote coping for caregivers of patients undergoing haematopoietic stem cell transplantation: a study protocol for the BMT-CARE app

    Por: Willis · K. D. · Barata · A. · Freese · M. · Applebaum · A. J. · Nelson · A. · Traeger · L. N. · Horick · N. K. · Rabideau · D. J. · Temel · J. S. · Greer · J. A. · Jacobs · J. M. · El-Jawahri · A.
    Introduction

    Caregivers of patients undergoing haematopoietic stem cell transplantation (HSCT) experience tremendous psychological distress before, during and after HSCT. However, few interventions are tailored to the protracted needs of these caregivers while considering scalability and accessibility. We previously developed an evidence-based intervention for caregivers of patients undergoing HSCT that improved quality of life (QOL), caregiving burden and mood. We have since adapted this clinician-delivered intervention into a self-administered, digital health application (BMT-CARE app) and are currently evaluating the effect of this intervention on QOL in caregivers of patients receiving HSCT.

    Methods and analysis

    The study design is a non-blinded randomised controlled trial of a digital health intervention for caregivers of patients undergoing HSCT at the Massachusetts General Hospital Cancer Center. We are enrolling and randomising 125 caregivers to receive the BMT-CARE app or usual care in a 1:1 assignment, stratifying by transplant type (autologous vs allogeneic). Caregivers assigned to the BMT-CARE app complete five self-guided modules designed to improve coping and stress management prior to and up to 60 days post-HSCT. The modules include interactive, gamified features and video vignettes to optimise engagement. Participants complete questionnaires at baseline and days 10, 60 and 100 post-HSCT. The primary outcome is comparison of QOL at day 60 post-HSCT. Secondary outcomes include caregiver burden, anxiety and depression symptoms, as well as post-traumatic stress symptoms. We are also exploring the usability of the BMT-CARE app to inform refinements prior to future testing.

    Ethics and dissemination

    The study is funded by the Leukemia and Lymphoma Society and approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #22–634 v.1.5). The results of this study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be disseminated at scientific meetings and in peer-reviewed journals.

    Trial registration number

    NCT05709912; Pre-results.

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