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Table 2 Description of interventions in phase 2

From: Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions

Abbreviated name for trial Aim of trial Setting and wider context Nature of intervention Nature of control intervention(s)
Phase 2: Multiple explanatory case study
Aim: To seek empirical support for the theoretical propositions and assess likely validity across multiple trial types and contexts
Trial 1: Waiting list To determine whether patients and their partners who receive an extended home-based programme of pre-cardiac surgery education and support demonstrate equal or greater benefit compared with those who receive a short hospital- based programme NHS Health Board covering a large geographical area with no cardiac surgery. Contract with a neighbouring Health Board for cardiac surgery. Mixed urban/rural, affluent/ deprived population, with a range of GP practices (single-handed to group practices) Education and support intervention for patients on waiting list for coronary artery bypass surgery, delivered over six months with alternate monthly home and practice nurse visits One-off three-hour education and support class delivered in hospital setting for patients in the same target group, soon after joining the waiting list
Trial 2: Information To evaluate the benefits of a new information leaflet given to parents/guardians when their child is discharged from hospital following a benign febrile convulsion Paediatric unit in large teaching hospital in Scotland An information leaflet for parents of children with benign febrile convulsions, designed to meet current standards of written information An information leaflet for the same target group, not designed to meet current standards of written information
Trial 3: Exercise To determine the acceptability and effects of an aerobic exercise intervention during radiotherapy for localised prostate cancer on fatigue Cancer centre in Scotland Exercise intervention to reduce fatigue in patients undergoing four weeks of radiotherapy for prostate cancer. One to one session with physiotherapist for tailored exercise instruction A weekly phone call with a clinical nurse specialist. No specific exercise guidance
Trial 4: CBT To assess the relative efficacy in routine practiceof clinical nurse specialists providing cognitive-behaviour therapy for psychotic patients suffering from chronic, distressing symptoms only partially relieved by medication Hospital and community psychiatric services in a large Health Board in Scotland Twenty sessions of cognitive behavioural therapy, delivered over nine months, for patients with medication-resistant psychotic symptoms Two controls: 1) usual psychiatric care 2) twenty supportive psychotherapy sessions
Trial 5: Guidelines To determine the effectiveness of a national guideline in improving quality of life in epilepsy sufferers. To evaluate the effectiveness of two different implementation strategies for this guideline General practices in a large Health Board area in Scotland Interactive workshops, structured record sheets and specialist nurse facilitation to improve the management of epilepsy through clinical guidelines Two controls: 1) guideline only sent to GP practices 2) interactive workshops and structured record sheets but no specialist nurse input
Trial 6: Sleep To examine the impact of disorders of initiating and maintaining sleep on mothers’ mental health. To evaluate the cost effectiveness of a tailored sleep programme, provided by health visitors, in improving the mother’s mental health and the child’s sleep disorder Fifteen GP practices within a large Health Board area in Scotland parents for children’s sleep Tailored behavioural intervention programme delivered to disorders by a health visitor over six weekly sessions Two controls: 1) information booklet only 2) waiting list for programme
Carers To evaluate the effectiveness of a community mental health nurse (CMHN)-led intervention in supporting carers who look after a person who is diagnosed with schizophrenia. The intervention was compared with support that is normally offered to carers by CMHNs Two Health Board areas in Scotland. Recruitment also took place through local carer support groups Supportive intervention to meet the needs of carers of people with schizophrenia, delivered at home over twelve weeks by nurses trained to provide a carer-focused intervention Supportive intervention to same target group, delivered over twelve weeks by nurses not trained to provide a carer-focused intervention
  1. CMHN, community mental health nurse; GP, general practitioner; NHS, National Health Service.