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Intervention content and delivery (40)
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Intervention development (3)
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To develop the [intervention]
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Focus group [] to identify the range of possible interventions
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Intervention components (3)
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One of the subsidiary aims is to find out what “support as usual” means
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Identify components of the intervention which contribute to its effectiveness
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Describe “usual care” for this patient group
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Models, mechanisms and underlying theory development (1)
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To better understand women’s decisions regarding [intervention]
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Feasibility and acceptability of intervention in practice (8)
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Examine acceptability of [intervention] for those over 75 and to ascertain the views of various stakeholders
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Treatment acceptability and usefulness of intervention
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Assess the acceptability of the intervention to patients and healthcare providers
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Explore factors associated with success or failure of the intervention: feasibility, acceptability of different models of [intervention]
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Intervention fidelity, reach & dose (3)
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Identify patients’ reasons for completing or not completing [intervention]
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Gain insights into reasons for poor uptake and lack of adherence
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Compliance with intervention
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Intervention implementation (2)
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[Healthcare professionals]: experiences of learning and applying new [intervention], their impressions of the ‘climate’ within the group and the impact of the group on the wider service. Managers: Understanding of service policies and practices for [treatment group] – perceived influence that [this type of trial] have had on the clinical practice within each of the services
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Assess the impact of the new [intervention] on the [] workforce, other ‘key’ stakeholders and national leads
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Generic acceptability / implementation (7)
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Identify factors (organisational, professional and patient related) that influence successful implementation
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Views of [healthcare professionals] concerning implementation of the service. Understand how the intervention worked in practice
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Experiences and views about the intervention (11)
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Main trial – assess experience of receiving [intervention]
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To qualitatively explore participants’ experiences of the two [interventions]
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Explore patients’ views and experiences of [intervention]
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Understand how patients make sense of their treatment and recovery and whether there are any differences in experience between the two treatment groups
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Service users: experiences of participating in [intervention]
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Patient experiences about the process and effects of [intervention]
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Unclear (2)
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Identify additional factors influencing the uptake of [intervention] and the way it is used
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Explore how [intervention] influences beliefs and behaviours
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Trial design, conduct and processes (14)
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Recruitment and retention (3)
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Development of training programme with individual feedback for staff involved in recruitment
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Start-up: assess parent and clinician attitudes to recruitment methods
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Reasons for rates of recruitment to the trial
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Trial participation (4)
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To ascertain the impact of the trial on participants
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Start-up: assess parent and clinician attitudes to participation
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Understand why some [participants] consent to randomisation or express strong preferences for a particular treatment
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Acceptability of trial in principle (1)
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Explore attitudes towards a possible [] type of randomised trial; focus groups with patients to explore their attitudes towards the proposed trial
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Acceptability of trial in practice (2)
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Understand the reasons for acceptance or refusal of randomization
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Ethical conduct (2)
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Ethical and practical issues of consent and assent e.g., merits and problems associated with a number of models of consent, feasibility and acceptability of taking advance consent / assent for research trial procedures
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Consent and assent
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Public and patient involvement (1)
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Phase 1: engage service users and carers in driving the research process, and to elicit views of NHS services
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Unclear (1)
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The empirical investigation of the social organisation, production and effects of the RCT in practice
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Outcomes (5)
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Breadth of outcomes (2)
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Ensure the most relevant [outcome] factors are assessed by the questionnaires
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To access important aspects of [] care not reflected in standardised measures of clinical outcomes
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Variation of outcomes (2)
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To examine the perspectives of participant and professional stakeholders using qualitative methods. This is important to understand and explain any differences in outcome between intervention sites
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Phase 2: Determine user's and carers' views on the process and effects of [intervention] compared with the views of those who received the attention control
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Unclear (1)
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Start-up: assess parent and clinician attitudes to outcomes
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Measures of process and outcome (2)
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Completion of measures (1)
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Ensure the feasibility of daily assessment
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Development of measures (1)
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Look at ways of asking about [outcome measures]. Ensure that the most relevant [outcome measures] are assessed by the questionnaires
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Target condition (3)
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Experience of the disease, health behaviour and beliefs (3)
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Main trial: explore parent and clinician attitudes and knowledge to [health behaviour]
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Explore issues related to [disease]
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Unclear (3)
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Unclear (3)
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Understanding of the processes underlying the changes in patients’ beliefs and attitudes
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A qualitative assessment of patient and carer perceptions
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Process evaluation: perceived impact of the intervention on outcomes
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