Process evaluation embedded within a randomised trial of caregiver training after stroke

Objectives and brief methodology

Stroke remains a major health problem in the 21st century with incident rates of 1.65 per 1000 population for first ever stroke. Shorter hospital stays mean caregivers will play an increasingly important role in the care and continued rehabilitation of patients after stroke. Caregivers identify information and the skills training required to implement physical care as the most important of pre-discharge needs. The process evaluation ran alongside a multi-centre cluster randomised trial of a caregiver training programme (TRACS).

An intervention (The London Stroke Carer Training Course, LSCTC) was tested in a single centre and was effective in decreasing burden, anxiety and depression for the caregiver, improving psychological outcomes for patients and reducing overall costs.  The TRACS cluster RCT tested the effectiveness of the LSCTC in a much larger sample of stroke units (n=18) and compared this with usual care in a further group of stroke units (n=18). The process evaluation focused on the implementation of the LSCTC, how staff, patients and caregivers understood and engaged with the intervention and their perceptions of whether this contributed to caregivers’ ability to support stroke survivors at home.

The aims of this study are to:

Comprehend the context in which formal and informal training is provided for caregivers after stroke in both intervention and control stroke units participating in the TRACS trial
Understand patients’, caregivers’ and staff’s experience of the formal and informal training process
Understand patients’ and caregivers’ subjective views of the benefits of formal and informal training
Provide data to assist in interpretation of the TRACS trial outcomes.
Observations of day-to-day stroke unit practice, multidisciplinary team and family meetings, together with instances of formal and informal caregiver training were undertaken in 10 of 36 TRACS trial centres (6 intervention and 4 control units). Documentary analysis supplemented the observational data. Semi-structured interviews were conducted with patients and caregivers three months after discharge (n = 37 pairs). Interviews with patients and caregivers explored their in-hospital experiences and their perceptions of receiving information and formal or informal preparation for caring for the patient at home following discharge.

Multidisciplinary team members from eight of the 10 stroke units (n = 53), participated in semi-structured interviews soon after recruitment to the TRACS cluster randomised controlled trial closed. These interviews explored team members’ experiences and perceptions of providing information about stroke and their participation in formal or informal caregiver training in hospital.

Results and impact of research

The TRACS cluster randomised controlled trial demonstrated no clinical or statistical differences between groups on the primary outcomes of functional independence (patients), or caregiver burden. Similarly, for the range of secondary outcomes measured at 6 and

12 months, no clinical or statistical differences were evident. Thus, the outcomes seen in the early single-centre trial were not replicated in TRACS. The process evaluation findings are important in contributing to an understanding of the possible reasons for the TRACS study outcomes.

The process evaluation found that contextual factors including the organisational history and team relationships within stroke units, external policy drivers, and service development initiatives, impinged on implementation of the caregiver training programme (the LSCTC)  in unintended ways that could not have been predicted through focus on how staff worked individually and collectively with caregivers and with patients at unit level. Factors that facilitated or impeded the effectiveness of the cascade training model used, whether and how stroke unit teams made sense of and engaged individually and collectively with a complex caregiver training intervention, and what impact these factors had on embedding the intervention in routine stroke unit practice were identified.

We concluded that, where implementation of complex interventions depends on multiple providers (in this case a wide range of stroke unit team members), time needs to be invested in reaching agreement on who will take responsibility for delivery of specific components and in determining how implementation and its effectiveness will be monitored. This goes beyond concern with intervention fidelity; explicit consideration also needs to be given to the implementation process in terms of how programme change can be effected at organisational, practice, and service delivery levels. In this study, Normalization Process

Theory’s constructs proved helpful in identifying vulnerable features of implementation processes in respect of the work involved in embedding complex interventions such as the LSCTC.

The process evaluation has provided insight into factors which influenced the design, implementation and delivery of the TRACS LSCTC training programme. Any future decision to develop and implement a TRACS-LSCTC like intervention on a national basis needs to take account of our findings, which go beyond reporting on the fidelity of intervention implementation. Incorporating patient and caregiver experiences and perceptions ensured that the research moved beyond reporting on objective measures of the effectiveness of the intervention.


July 2008 to December 2011

Research Outputs

Forster A, Dickerson J, Young J, Patel A, Kalra L, Nixon J, Smithard D, Knapp M, Holloway I, Anwar S, Farrin A. A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis. The Lancet 2013

Clarke DJ, Godfrey M, Hawkins R, Sadler E. Harding G, Forster A, McKevitt C, Dickerson J, Farrin AJ. Implementing a training intervention to support caregivers after stroke: a process evaluation examining the initiation and embedding of programme change. Implementation Science (in press).

Clarke D, Hawkins R, Sadler E, Harding G, Forster A, McKevitt C, Godfrey M, Dickerson J, Farrin A. Training caregivers after stroke: process evaluation of the implementation of the London Stroke Caregiver Training Course (LSCTC) in a pragmatic cluster randomised controlled trial. International Journal of Stroke 2012; 7:48.

Clarke D, Hawkins R, Sadler E, Harding G, Forster A, McKevitt C, Godfrey M, Monaghan J, Farrin A. Interdisciplinary health research: perspectives from a process evaluation research team. Qual Prim Care 2012; 20(3):179-189.

Further information

For further information please contact Professor Anne Forster on 01274 383446 or by email.

This summary is independent research funded by the National Institute for Health and Care Research (Research for Patient Benefit Programme Grant, Process evaluation embedded within a randomised trial of caregiver training after stroke, PB-PG-0407-13308). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.