Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.
Armitage, Gerry R.
KeywordHospital patients; Patient safety; Safety management; Medical error; Patient participation; PRASE patient safety intervention
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AbstractBackground Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. Methods/design A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period. The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience. The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. Methods: fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection of key data about intervention wards. Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework. Discussion This study will be one of the largest patient safety trials ever conducted, involving 32 hospital wards. The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level. Incorporating the ‘patient voice’ is critical if patient feedback is to be situated as an integral part of patient safety improvements.
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CitationSheard L, O’Hara J, Armitage G, Wright J, Cocks K, McEachan RRC, Watt I and Lawton R (2014) Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial. Trials. 15: 420.
Link to publisher’s versionhttp://dx.doi.org/10.1186/1745-6215-15-420
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Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reportingWard, J.K.; McEachan, R.R.C.; Lawton, R.; Armitage, Gerry R.; Watt, I.S.; Wright, J.; Yorkshire Quality Safety Research Group (2011)BACKGROUND: Patients have the potential to provide a rich source of information on both organisational aspects of safety and patient safety incidents. This project aims to develop two patient safety interventions to promote organisational learning about safety - a patient measure of organisational safety (PMOS), and a patient incident reporting tool (PIRT) - to help the NHS prevent patient safety incidents by learning more about when and why they occur. METHODS: To develop the PMOS 1) literature will be reviewed to identify similar measures and key contributory factors to error; 2) four patient focus groups will ascertain practicality and feasibility; 3) 25 patient interviews will elicit approximately 60 items across 10 domains; 4) 10 patient and clinician interviews will test acceptability and understanding. Qualitative data will be analysed using thematic content analysis.To develop the PIRT 1) individual and then combined patient and clinician focus groups will provide guidance for the development of three potential reporting tools; 2) nine wards across three hospital directorates will pilot each of the tools for three months. The best performing tool will be identified from the frequency, volume and quality of reports. The validity of both measures will be tested. 300 patients will be asked to complete the PMOS and PIRT during their stay in hospital. A sub-sample (N = 50) will complete the PMOS again one week later. Health professionals in participating wards will also be asked to complete the AHRQ safety culture questionnaire. Case notes for all patients will be reviewed. The psychometric properties of the PMOS will be assessed and a final valid and reliable version developed. Concurrent validity for the PIRT will be assessed by comparing reported incidents with those identified from case note review and the existing staff reporting scheme. In a subsequent study these tools will be used to provide information to wards/units about their priorities for patient safety. A patient panel will provide steering to the research. DISCUSSION: The PMOS and PIRT aim to provide a reliable means of eliciting patient views about patient safety. Both interventions are likely to have relevance and practical utility for all NHS hospital trusts.
Ethnicity and primary care. A comparative study of doctor-patient relationship, perceived health, symptomatology, and use of general practitioner services by Asian and white patients, and the Bradford general practitioners' attitudes towards these patients.Baker, Mark R.; Kernohan, Elizabeth E.M.; Ahmad, Waqar I-U. (University of BradfordPostgraduate School of Studies in Biomedical Sciences, 2009-10-02)Britain's Asians are a young population and their socio-economic status is low, with racial disadvantage in housing, employment, education and health. Research on their health has usually not been conducted in its socio-economic and demographic context and there is little on their use of primary care. Three studies were conducted to investigate their relationship with primary care in Bradford. A study of general practice attenders of white/British, Pakistani and Indian origin confirmed the demographic and socio-economic differences between the groups. The former had higher rates of alcohol and cigarette consumption. For Pakistanis and Indians, fluency and literacy in English was poor. Ethnic and linguistic match between doctor and patient was more important in patients' choice of doctor than the doctor's sex. Differential employment status of Asian and white/British accounted for some of the differences in health. A study of general practice attendance showed similar rates of surgery consultations between Asians and Non-Asians; the latter made greater use of domiciliary services. Both these studies were conducted in an inner Bradford health centre with an Asian male, a white male and a white female doctor. Bradford GPs were found to perceive that Asian patients made greater use of surgery and domiciliary consultations; attended more often for trivial complaints; and had lower compliance rates than Non-Asians. These perceptions were not supported by objective data. Better qualified GPs had a smaller, and Asian doctors had a greater proportion of Asian patients on their lists. Research, and action on Asians' health, needs to take account of their poorer socio-economic status.
Evaluation of novel tool to ensure asthma and COPD patients use the approved inhalation technique when they use an inhaler. Clinical pharmacy studies investigating the impact of novel inhalation technique training devices and spacers on the inspiratory characteristics, disease control and quality of life of patients when using their inhalers.Chrystyn, Henry; Smythe, James W.; Ammari, Wasem G.S. (University of BradfordBradford School of Pharmacy, 2010-09-01)Many respiratory patients misuse their inhaler. Although training improves their inhaler technique, patients do forget the correct inhaler use with time. In the current work, three clinical studies investigated novel tools designed with feedback mechanisms to ensure patients use the correct inhalation method when using their inhaler. Research Ethics Committee approval was obtained and all the participants signed an informed consent form. In the first study, the recruited asthmatic children (n=17) and adults (n=39) had their metered dose inhaler (MDI) technique assessed. Those who attained the recommended inhalation flow rate (IFR) of < 90 l/min through their MDI formed the control group. Whilst those who had a poor MDI technique with an IFR ¿ 90 l/min were randomized into either the verbal counselling (VC) group; or the 2ToneTrainer (2TT) group that, in addition to the verbal training, received the 2ToneTrainer MDI technique training device equipped with an audible feedback mechanism of correct inhalation flow. All the participants were assessed on two occasions (6 weeks apart) for their inhalation flow rate, asthma control and quality of life. The study showed that the 2ToneTrainer tool was as efficient as verbal training in improving and maintaining the asthmatic patients¿ MDI technique, particularly using the recommended slow inhalation flow through the MDI. Although statistically insignificant, potential improvement in quality of life was demonstrated. The 2ToneTrainer tool has the advantage of being available to the patients all the time to use when they are in doubt of their MDI technique. In the second research study, the inhalation profiles of asthmatic children (n=58) and adults (n=63), and of COPD patients (n=63) were obtained when they inhaled through the novel Spiromax dry powder inhaler (DPI) which was connected to an electronic pressure change recorder. From these inspiratory profiles; the peak inhalation flow, inhalation volume and inhalation acceleration rate were determined. The variability (23% - 58%) found in these inhalation profile parameters among various patient groups would be expected in all DPIs. The effect of the inhalation acceleration rates and volumes on dose emission characteristics from DPIs should be investigated. Attention, though, should be paid to the patients¿ realistic inhalation profile parameters, rather than the recommended Pharmacopoeial optimal inhalation standard condition, when evaluating the in-vitro performance of DPIs. Finally, in preschool asthmatic children, the routine use of the current AeroChamber Plus spacer (n=9) was compared with that of a novel version; the AeroChamber Plus with Flow-Vu spacer (n=10) over a 12-week period. The Flow-Vu spacer has a visual feedback indicator confirming inhalation and tight mask-face seal. The study showed that the new AeroChamber Plus with Flow-Vu spacer provided the same asthma control as the AeroChamber Plus in preschool children and maintained the same asthma-related quality of life of their parents. However, the parents preferred the new Flow-Vu spacer because its visual feedback indicator of inhalation reassured them that their asthmatic children did take their inhaled medication sufficiently.