Observational studyTrials2017
Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity.
Observational study in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed.
- Trial
- Process evaluation of a pragmatic feasibility trial on smokeless tobacco cessation intervention delivered in dental hospitals.BMC public health · 2024Trial
- Just-in-Time Adaptive Interventions: Where Are We Now and What Is Next?Annual review of psychology · 2026Review
- Outcomes of Restrictive Practice Review Meetings in an Acute Mental Health Unit: A Retrospective Before-and-After Study.International journal of mental health nursing · 2025Article
- Conducting qualitative research on acute mental health inpatient wards: Lessons from the field.PloS one · 2025Article
- Exploring the Safewards Programme to Reduce Restrictive Practices in Residential Aged Care: Protocol for a Pilot and Feasibility Study.Health expectations : an international journal of public participation in health care and health policy · 2024Article
- Patient responsiveness as a safewards fidelity indicator: a qualitative interview study on an acute psychiatric in-patient ward.BMC health services research · 2024Article
- Safewards: An integrative review of the literature within inpatient and forensic mental health units.International journal of mental health nursing · 2022Review
- Exploring factors that influence success when introducing "The Safewards Model" to an acute adolescent ward: A qualitative study of staff perceptions.Journal of child and adolescent psychiatric nursing : official publication of the Association of Child and Adolescent Psychiatric Nurses, Inc · 2022Article
- Recruiting and retaining participants in three randomised controlled trials of psychological interventions conducted on acute psychiatric wards: top ten tips for success.BJPsych open · 2022Article
- Implementation fidelity, attitudes, and influence: a novel approach to classifying implementer behavior.Implementation science communications · 2022Article
- Safewards Secure: A Delphi study to develop an addition to the Safewards model for forensic mental health services.Journal of psychiatric and mental health nursing · 2022Article
- Interventions to reduce self-harm on in-patient wards: systematic review.BJPsych open · 2021Article
- Mental health nurses experience of the introduction and practice of the Safewards model: a qualitative descriptive study.BMC nursing · 2021Article
- Contextual Barriers and Enablers to Safewards Implementation in Victoria, Australia: Application of the Consolidated Framework for Implementation Research.Frontiers in psychiatry · 2021Article
- Safewards: Changes in conflict, containment, and violence prevention climate during implementation.International journal of mental health nursing · 2020Article
- Article
- Improving inappropriate medication and information transfer at hospital discharge: study protocol for a cluster RCT.Implementation science : IS · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundUnderstanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity not only affects the validity of trial findings, but also because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice. Participant observation methods have been identified as being particularly valuable in studies of fidelity, yet are rarely used. This study aimed to use these methods to explore the quality of implementation of a complex intervention (Safewards) on mental health wards during a cluster randomised controlled trial. Specific aims were firstly to describe the different ways in which the intervention was implemented, and secondly to explore the contextual factors moderating the quality of intervention delivery, in order to inform 'real world' implementation of the intervention.
methodsSafewards was implemented on 16 mental health wards in England. We used Research Assistants (RAs) trained in participant observation to record qualitative observational data on the quality of intervention delivery (n = 565 observations). At the end of the trial, two focus groups were conducted with RAs, which were used to develop the coding framework. Data were analysed using thematic analysis.
resultsThere was substantial variation in intervention delivery between wards. We observed modifications to the intervention which were both fidelity consistent and inconsistent, and could enhance or dilute the intervention effects. We used these data to develop a typology which describes the different ways in which the intervention was delivered. This typology could be used as a tool to collect qualitative observational data about fidelity during trials. Moderators of Safewards implementation included systemic, interpersonal, and individual factors and patient responses to the intervention.
conclusionsOur study demonstrates how, with appropriate training in participant observation, RAs can collect high-quality observational data about the quality of intervention delivery during a trial, giving a more complete picture of 'fidelity' than measurements of adherence alone.
trial registrationISRCTN registry; IRSCTN38001825 . Registered 29 August 2012.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.