Evaluating the PRASE intervention: a multi-centre, cluster, wait list design, randomised controlled trial with a qualitative process evaluation

Project Lead: Laura Sheard (laura.sheard@bthft.nhs.uk)

Objective: To assess the efficacy of the PRASE patient safety intervention in achieving patient safety improvements over a 12 month period.

Method:
Trial: A multi-centre, cluster, wait list randomised controlled trial of a patient safety intervention with a qualitative process evaluation. The trial methods consists of three stages:

i) Measurement
Over a 2-3 week period, 25 patients per ward complete the 48 item PMOS questionnaire, and report any safety concerns (or specific positive experiences of care) using the PIRT incident reporting tool. Patients will be given a choice of whether they would prefer to self-complete the questionnaire or have it facilitated by the researcher. There are three measurement periods – at baseline, 6 months and 12 months.

ii) Feedback
Information for each ward is collated and presented to the ward in the form of a ‘Feedback Report’. PMOS questionnaire scores are shown graphically using a traffic light system to allow staff to see easily which areas they are performing in well, and those areas perhaps in need of improvement.

iii) Action planning and change
Ward staff form an Action Planning Team and identify areas to target for improvement based on patient feedback detailed in the report. The APT is facilitated by a PRASE researcher. Nominated people within the APT takes responsibility for delivering the action plan.

Process Evaluation:
The key elements of the process evaluation are:

• Analysis of documented action plans
• In depth ethnographic observation of the APM
• Structured interviews with key members of the APM
• Detailed fieldworker diaries

Patient recruitment and on-going engagement for the current projects
Three Trusts are taking part in this study: Harrogate & District NHS Foundation Trust, Calderdale & Huddersfield NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust. At the end of the first phase of data collection, 800 participants were recruited in total. It is projected that 800 participants will also be recruited in each of the two remaining data collection phases meaning the overall total for the trial will be 2400 patients.

(September 2011 – December 2014)

Project Lead: Professor Gerry Armitage, gerrard.armitage@bdct.nhs.uk

Rationale
Patients can be an important source of knowledge in reducing avoidable harm and improving care. However, we rarely have the means to share this information and may feel uncertain in doing so. Patients with renal (kidney) failure regularly require complex care in a range of environments but little is known about giving them the option to report on quality and safety and whether this is beneficial. Renal patient view (RPV) is a web-based electronic patient record that gives information to patients with kidney disease about their diagnosis, treatment, and latest blood tests – accessible from any networked computer. This study will further develop RPV through the embedding of a patient-led reporting scheme, to identify factors affecting quality and safety in renal services.

Research Question to be addressed
Can an electronic, patient-led reporting scheme increase the information available to improve the quality and safety of healthcare?

Methods of investigation:
Agree objectives for a Renal Patient View (RPV) based reporting scheme and identify common contributory factors that impact upon quality and safety and consider how these are best reported using patient and staff focus groups. Ratify all of these using a joint services panel (including patients), and patient-led steering group

Adapt existing RPV technology and clinical governance processes in the study settings to accommodate a patient-initiated reporting scheme, pilot the scheme and collect a range of qualitative data from patients and staff to assess utilisation, and corroborate the patient report data with existing forms of quality/safety data

Following analysis of pilot data, implement the scheme across the study settings and survey patients and staff on the implementation process, acceptability, feasibility, and sustainability. We will also examine patient experience as a function of the scheme together and report on a concurrent cost analysis.

Funding sources
NIHR Research for Patient Benefit

The Team: Richard Thomson, Susan Hrisos (based at the University of Newcastle)

Reflecting the growing international interest in involving patients in safety initiatives, several campaigns have been implemented that aim to promote patients’ proactive contributions to their own safety. Examples include the SPEAK UP campaign in the USA and Please Ask in the UK, as well as specific examples such as the NPSA “Clean your hands” campaign. However, concerns have been raised about the acceptability of such approaches to patients and possible unintended consequences such as patients’ loss of trust in, or experience of, care. The extent to which patients have been involved or consulted in the development of such approaches is unclear and there is little evidence of any theoretical underpinning. Project 3 will address this major gap by developing theoretically grounded, patient-informed and fully piloted interventions that aim to promote active patient involvement. The study will adopt the MRC Framework for developing and evaluating complex interventions and will focus on three priority areas for patient safety: hospital acquired infection; medicines reconciliation and patient deterioration.

Aim of the project:
To develop an intervention(s) that supports patients to work collaboratively with healthcare professionals to improve safety and reduce the risk of harm.

The Team: Zoë Thompson, Vikram Jha, Naomi Quinton, Jools Symons

Aim of the project:
This project focuses on patient involvement in delivering a short patient safety educational intervention to F1 doctors. The intervention involves patient safety champions delivering personal narratives of harm or error during care and co-facilitating discussion on safety issues. The project aims to study the impact of this intervention and also develop a model of patient involvement in educational research.

Project Lead: Professor Gerry Armitage, gerrard.armitage@bdct.nhs.uk

Persons with Parkinson’s disease (PD) require sensitive, responsive care to sustain quality of life. Combined locomotor, cognitive and affective problems severely restrict daily activities, especially if associated with the considerable burden of dementia (Lang, 1998). An American study found that 5-10 % of those with PD are cared for in residential settings (Mitchell, 1996). Whilst effective care planning is essential in such settings (Rantz 2001), it has been shown that care processes could be better structured (Mozley et al 2004). It is also known that key aspects of residential care such as medicines management may be problematic (Barnes et al 2006). Additionally, recent communications received by the PDS from close family have suggested their relative’s care lacks specialist knowledge and anticipation of needs (PDS, 2006). The ad hoc nature of care provision for people with PD in residential care was further highlighted by a systematic review (Armitage & Ziegler 2007) illustrating the need for further research.

Aim of the project:
To examine the care planning process of people with PD and the views of their principle informal carer (close relative) on the effectiveness of the interventions, specific to PD, offered in a range of residential care settings from 4 local health authorities across England.

Method:
An exploratory, qualitative study.

4 Local Authorities (LAs) will be randomly selected and from the LA lists we will randomly select at least 10 care home facilities.

Qualitative interviews with up to 40 relatives of people with PD and (if recommended and feasible) the person with PD, will be undertaken. The associated care plan will be concurrently analysed, and if the data from this requires further development, the formal carer responsible for the care plan will also be interviewed.

Analysis:
A qualitative analysis of both the care plans and interviews will be performed and their relative coherence explored.

Project Lead: Dr Angela Grange, angela.grange@bthft.nhs.uk

Aim of the project:
To design and test the feasibility and validity of a patient record for planned stays in hospital.

Design: Pilot study

To inform an understanding of patient concerns patients coming into hospital for elective surgery patients will complete a diary throughout their patient journey.

The themes will be used to develop a patient record which will be tested for validity and to investigate if it is feasible as a documentation tool.

Views of users will be explored via in depth interviews and healthcare professionals by focus group.

Settings: Surgical wards in hospital reflecting a broad spread of specialties where elective procedures take place: general surgery, gynaecology, urology, orthopaedics.

Subjects: Twenty patient diaries by patients with planned elective admissions of anticipated stays of between 1 and 8 nights, testing of patient record on fifty patients from the same surgical specialties.

Project Lead: Professor Ian Watt, Ian.Watt@hyms.ac.uk

Aims of the Project:

• To develop a conceptual framework relating to patient involvement in patient safety, including a typology of mechanisms by which patients might contribute to their own safety.
• To identify the strategies which have been considered or used to encourage patients to get involved in their care with a view to enhancing their safety, and to assess the effectiveness of these.
• To investigate how the various types of reporting systems that have been developed to improve patient safety have solicited, received and used reports from patients and their representatives.
• To determine patients’ awareness of and concerns about health care safety.
• To identify situations and ways in which patients or their representatives have acted to help secure their own safety.
• To elicit patients’ views about the various roles they might play to ensure their own safety, about interventions to encourage or support them in playing those roles, and about their potential contribution to safety reporting systems.
• To develop and carry out an initial development assessment of an intervention to promote patient involvement in patient safety.

Method:
The objectives will be achieved in three main phases, each of which will build on the previous work. The first phase will comprise a focused set of literature reviews, summarising current knowledge of patient roles, interventions and the potential for patients to contribute to reporting systems. The second phase will involve primary research (individual interviews and focus groups) with the objectives of generating new knowledge about patients’ views on their role in and experiences of safety in healthcare settings. The third phase will involve the development and piloting of potential patient involvement strategies in clinical settings informed by the conceptual model developed in phases 1 and 2.