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Comparative Study
. 2018 Oct 19;19(1):569.
doi: 10.1186/s13063-018-2929-4.

A protocol for the process evaluation of a multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission

Petra Mäkelä  1   2 , Mary Godfrey  3 , Andrea Cradduck-Bamford  4 , Graham Ellis  5 , Sasha Shepperd  6   7
Affiliations
Comparative Study

A protocol for the process evaluation of a multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission

Petra Mäkelä et al. Trials. .

Abstract

Background: Attempts to design services to support the delivery of healthcare closer to home have taken various forms as countries respond to an increase in hospital admission rates for older people, who are at risk of hospital-acquired morbidity, prolonged lengths of stay and readmission. Evidence to support the development of these services is limited. We are conducting a process evaluation, alongside a UK multi-site randomised trial, to understand the contexts and practices of implementing geriatrician-led admission avoidance hospital at home services and to explore ways that the intervention might be effective, under what conditions, for whom, and how it differs from inpatient care.

Methods: We are interviewing patients and their caregivers, from sites that are purposively sampled from participating National Health Service (NHS) trusts across the UK. We are also visiting sites to observe local processes and discuss the establishment and running of services with a range of multidisciplinary staff, managers, commissioners, primary care and social services representatives. We aim to interview approximately 36 patients and their caregivers with experience of hospital at home or inpatient services; 12 at each of three sites. We will use a content analysis approach to explore data across participants, services and sites.

Discussion: This process evaluation will enable evaluation of implementation processes prior to knowing trial outcomes. We encompass domains of reach, delivery, change, context and response to the intervention by patients, their carers, health professionals and the health system.

Trial registration: ISRCTN60477865 . Registered on 10 March 2014. Trial sponsor: University of Oxford. Version 3.1, registered on 14 June 2016.

Keywords: Admission avoidance; Comprehensive Geriatric Assessment; Hospital at home; Process evaluation.

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Conflict of interest statement

Ethics approval and consent to participate

The design of this process evaluation is included within the ethics application and overall protocol for the RCT [21]. Ethical approval for the trial was given by the Research Ethics Committee England, Wales and Northern Ireland (14/WA/1081) and Scotland (14/SS/1046). Participants who meet the inclusion criteria and verbally agree to participate are asked to sign a consent form. If a participant has difficulty completing the consent form due to visual impairment or frailty, but is capable of informed consent, a witness signature is sought from a next of kin or medical professional not working within the trial team to confirm the consent process was appropriately performed. We are recruiting adult participants with cognitive impairment/dementia who are unable to consent for themselves. We consider that this is necessary because, if recruitment is restricted to patients with capacity, such a restriction would lead to an unrepresentative study sample. The consent process takes into account the implications of the Mental Capacity Act (2005) in England, Wales and Northern Ireland and the Adults with Incapacity Act (2000) in Scotland. A relative, friend or Independent Mental Capacity Advocate is involved in making a decision in the best interests of individuals if they do not have capacity to give consent. If necessary, this consultee consent is taken verbally over the phone and the paperwork sent to the consultee to be signed to record consent. We reassess capacity at follow-up visits and re-consent a participant if their capacity changes between baseline and follow-up. Participants, or their representatives, are asked to sign and date the latest approved version of the Informed Consent Form before any trial-specific procedures are performed. The trial manager ensures that all sites are aware of any amendments.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Process evaluation overview
Fig. 2
Fig. 2
Simplified logic model for Comprehensive Geriatric Assessment (CGA)
See this image and copyright information in PMC

References

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