Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?

Mitchell, Eleanor; Sprange, Kirsty; Treweek, Shaun; Nixon, E.

doi:10.1186/s13063-022-06417-3

Cited by 2 publications

(2 citation statements)

References 22 publications

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“…We recommend engaging with organisations early and tailoring study information to highlight the potential benefits of trial participation to each user group. Understanding the needs and values of stakeholders is viewed as critical for successful recruitment into a trial 27. A recent Delphi study recommended making clear to prospective participants not only the potential benefits and harms of trial participation but how these compare with what would happen if the participant did not take part in the trial 28…”

Section: Discussionmentioning

confidence: 99%

“…Understanding the needs and values of stakeholders is viewed as critical for successful recruitment into a trial. 27 A recent Delphi study recommended making clear to prospective participants not only the potential benefits and harms of trial participation but how these compare with what would happen if the participant did not take part in the trial. 28 To minimise any risk to patients from the absence of CDS, participants suggested additional monitoring for adverse safety events by pharmacists and systems.…”

Section: Discussionmentioning

confidence: 99%

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Qualitative study of challenges with recruitment of hospitals into a cluster controlled trial of clinical decision support in Australia

Baysari,

Van Dort,

Stanceski

et al. 2024

BMJ Open

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ObjectiveTo identify barriers to hospital participation in controlled cluster trials of clinical decision support (CDS) and potential strategies for addressing barriers.DesignQualitative descriptive design comprising semistructured interviews.SettingFive hospitals in New South Wales and one hospital in Queensland, Australia.ParticipantsSenior hospital staff, including department directors, chief information officers and those working in health informatics teams.Results20 senior hospital staff took part. Barriers to hospital-level recruitment primarily related to perceptions of risk associated with not implementing CDS as a control site. Perceived risks included reductions in patient safety, reputational risk and increased likelihood that benefits would not be achieved following electronic medical record (EMR) implementation without CDS alerts in place. Senior staff recommended clear communication of trial information to all relevant stakeholders as a key strategy for boosting hospital-level participation in trials.ConclusionHospital participation in controlled cluster trials of CDS is hindered by perceptions that adopting an EMR without CDS is risky for both patients and organisations. The improvements in safety expected to follow CDS implementation makes it challenging and counterintuitive for hospitals to implement EMR without incorporating CDS alerts for the purposes of a research trial. To counteract these barriers, clear communication regarding the evidence base and rationale for a controlled trial is needed.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Qualitative study of challenges with recruitment of hospitals into a cluster controlled trial of clinical decision support in Australia

Baysari,

Van Dort,

Stanceski

et al. 2024

BMJ Open

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The Resilience Hub approach for addressing mental health of health and social care workers during the COVID-19 pandemic: a mixed-methods evaluation

Varese,

Allsopp,

Carter

et al. 2024

Health Soc Care Deliv Res

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Background Resilience Hubs provide mental health screening, facilitation of access and direct provision of psychosocial support for health and social care keyworkers in England affected by the coronavirus disease 2019 pandemic. Aim To explore implementation of the Hubs, including characteristics of staff using the services, support accessed, costing data and a range of stakeholder perspectives on the barriers and enablers to Hub use and implementation of staff well-being support within the context of the pandemic. Design Mixed-methods evaluation. Setting Four Resilience Hubs. Methods Findings were integrated via mixed-method case studies, including: analyses of Hub mental health screening (N = 1973); follow-up questionnaire data (N = 299) on service use and health status of Hub clients; economic information provided by the Hubs; 63 interviews with Hub staff, wider stakeholders, Hub clients and keyworkers who did not use the Hubs. Results Findings were consistent across Hubs and workstreams. Most Hub clients were NHS staff. Under-represented groups included men, keyworkers from minority ethnic communities, care homes and emergency services staff. Clients reported comorbid mental health needs across multiple domains (anxiety; depression; post-traumatic stress; alcohol use; functioning). Their health status was lower than population norms and relevant pre-pandemic data. Several factors predicted higher needs, but having pre-pandemic emotional well-being concerns was one of the most robust predictors of higher need. Sixty per cent of participants who completed follow-up questionnaires reported receiving mental health support since Hub screening, most of which was directly or indirectly due to Hub support. High levels of satisfaction were reported. As in many services, staffing was the central component of Hub cost. Hubs were predominantly staffed by senior clinicians; this staffing model was consistent with the generally severe difficulties experienced by clients and the need for systemic/team-based working. Costs associated with health and social care use for Hub clients were low, which may be due to barriers to accessing support in general. Enablers to accessing Hubs included: a clear understanding of the Hubs, how to self-refer, and managerial support. Barriers included confusion between Hubs and other support; unhelpful beliefs about job roles, unsupportive managers, negative workplace cultures and difficulties caused by systemic issues. Some keyworkers highlighted a perceived need for further diversity and cultural competency training to improve reach to under-represented communities. Other barriers for these groups included prior negative experiences of services, structural inequalities and stigma. Some wider stakeholders had concerns around growing waiting times for Hub-provided therapy, and insufficient data on Hub usage and outcomes. Feedback was otherwise very positive. Limitations Main limitations included lack of comparative and pre-pandemic/baseline data, small numbers from under-represented groups limiting fine-grained analysis, and participant self-selection. Conclusions Findings highlighted the value of the Hub model of outreach, screening, support navigation and provision of direct support during the coronavirus disease 2019 pandemic, and as a potential model to respond to future crises. The research provided recommendations to improve Hub promotion, equality/diversity/inclusion access issues, management of specialist resources and collection of relevant data on Hub outcomes and activities. Broader recommendations for the primary prevention of mental health difficulties across the health and care system are made, as individual support offers should be an adjunct to, not a replacement for, resolutions to systemic challenges. Research recommendations are made to conduct more robust evaluations of the clinical and cost-effectiveness of the Hubs, using larger data sets and comparative data. Study registration This study is registered as researchregistry6303. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR132269) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 29. See the NIHR Funding and Awards website for further award information.

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Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?

Cited by 2 publications

References 22 publications

Qualitative study of challenges with recruitment of hospitals into a cluster controlled trial of clinical decision support in Australia

Qualitative study of challenges with recruitment of hospitals into a cluster controlled trial of clinical decision support in Australia

The Resilience Hub approach for addressing mental health of health and social care workers during the COVID-19 pandemic: a mixed-methods evaluation

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