- Amirta Benning, programme manager1,
- Maisoon Ghaleb, lecturer in pharmacy practice/patient safety23,
- Anu Suokas, translational research facilitator4,
- Mary Dixon-Woods, professor of medical sociology5,
- Jeremy Dawson, research fellow6,
- Nick Barber, professor of the practice of pharmacy2,
- Bryony Dean Franklin, professor of medication safety and director, centre for medication safety and service quality27,
- Alan Girling, senior research fellow1,
- Karla Hemming, senior research fellow1,
- Martin Carmalt, consultant physician8,
- Gavin Rudge, data scientist1,
- Thirumalai Naicker, honorary research associate1,
- Ugochi Nwulu, senior research associate/coordinator9,
- Sopna Choudhury, research associate1,
- Richard Lilford, professor of clinical epidemiology1
- 1School of Health and Population Sciences, University of Birmingham, Edgbaston, West Midlands B15 2TT, UK
- 2Department of Practice and Policy, School of Pharmacy, University of London, London WC1N 1AX
- 3School of Pharmacy, University of Hertfordshire, Hatfield, Hertfordshire AL10 9AB
- 4Arthritis Research UK Pain Centre, Academic Rheumatology, Clinical Sciences Building, City Hospital, Nottingham NG5 1PB
- 5Department of Health Sciences, University of Leicester, Leicester LE1 7RH
- 6Work and Organisational Psychology Group, Aston Business School, Aston University, Aston Triangle, Birmingham B4 7ET
- 7Imperial College Healthcare NHS Trust, St Mary’s Hospital, London W2 1NY
- 8Royal Orthopaedic Hospital, Bristol Road South, Northfield, Birmingham B31 2AP
- 9Clinical Investigation Unit, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham B15 2TH
- Correspondence to: R J Lilford
- Accepted 12 October 2010
Objectives To conduct an independent evaluation of the first phase of the Health Foundation’s Safer Patients Initiative (SPI), and to identify the net additional effect of SPI and any differences in changes in participating and non-participating NHS hospitals.
Design Mixed method evaluation involving five substudies, before and after design.
Setting NHS hospitals in the United Kingdom.
Participants Four hospitals (one in each country in the UK) participating in the first phase of the SPI (SPI1); 18 control hospitals.
Intervention The SPI1 was a compound (multi-component) organisational intervention delivered over 18 months that focused on improving the reliability of specific frontline care processes in designated clinical specialties and promoting organisational and cultural change.
Results Senior staff members were knowledgeable and enthusiastic about SPI1. There was a small (0.08 points on a 5 point scale) but significant (P<0.01) effect in favour of the SPI1 hospitals in one of 11 dimensions of the staff questionnaire (organisational climate). Qualitative evidence showed only modest penetration of SPI1 at medical ward level. Although SPI1 was designed to engage staff from the bottom up, it did not usually feel like this to those working on the wards, and questions about legitimacy of some aspects of SPI1 were raised. Of the five components to identify patients at risk of deterioration—monitoring of vital signs (14 items); routine tests (three items); evidence based standards specific to certain diseases (three items); prescribing errors (multiple items from the British National Formulary); and medical history taking (11 items)—there was little net difference between control and SPI1 hospitals, except in relation to quality of monitoring of acute medical patients, which improved on average over time across all hospitals. Recording of respiratory rate increased to a greater degree in SPI1 than in control hospitals; in the second six hours after admission recording increased from 40% (93) to 69% (165) in control hospitals and from 37% (141) to 78% (296) in SPI1 hospitals (odds ratio for “difference in difference” 2.1, 99% confidence interval 1.0 to 4.3; P=0.008). Use of a formal scoring system for patients with pneumonia also increased over time (from 2% (102) to 23% (111) in control hospitals and from 2% (170) to 9% (189) in SPI1 hospitals), which favoured controls and was not significant (0.3, 0.02 to 3.4; P=0.173). There were no improvements in the proportion of prescription errors and no effects that could be attributed to SPI1 in non-targeted generic areas (such as enhanced safety culture). On some measures, the lack of effect could be because compliance was already high at baseline (such as use of steroids in over 85% of cases where indicated), but even when there was more room for improvement (such as in quality of medical history taking), there was no significant additional net effect of SPI1. There were no changes over time or between control and SPI1 hospitals in errors or rates of adverse events in patients in medical wards. Mortality increased from 11% (27) to 16% (39) among controls and decreased from 17% (63) to 13% (49) among SPI1 hospitals, but the risk adjusted difference was not significant (0.5, 0.2 to 1.4; P=0.085). Poor care was a contributing factor in four of the 178 deaths identified by review of case notes. The survey of patients showed no significant differences apart from an increase in perception of cleanliness in favour of SPI1 hospitals.
Conclusions The introduction of SPI1 was associated with improvements in one of the types of clinical process studied (monitoring of vital signs) and one measure of staff perceptions of organisational climate. There was no additional effect of SPI1 on other targeted issues nor on other measures of generic organisational strengthening.
We thank Michael D L Morgan, Martyn R Partridge, and Philip W Ind for their expertise and contribution in the development of the forms for the explicit case note review; Janet Willars for conducting strategic/senior interviews and for helping to facilitate focus groups; Dale Webb, Louise Thomas, and Simona Arena for their insight into the implementation of SPI; Peter Chilton for his assistance in the preparation of this manuscript; and Frank Davidoff, Peter Pronovost, Tim Hofer, and M Clare Derrington for comments on the manuscript.
Contributors: AB, MD-W, JD, NB, and RL designed the study and submitted the grant proposal. RL was chief investigator. AB, NB, RL, MG, and BDF designed the forms and methods for explicit review of case notes. AB, RL, and UN designed the semistructured forms for holistic review of case notes and methods for data extraction. AB and UN were responsible for the case note review collection. MG and BDF conducted the explicit review of case notes, and AG analysed the data. MC and TN conducted the holistic review of case notes, and KH analysed the data. UN and MG designed the database for case note review. GR and AB created the queries for data extraction. MD-W supervised the study of senior staff and qualitative study. KH and SC performed quantitative analysis of the qualitative data from the stakeholder interviews. AS carried out the ethnographic fieldwork. MD-W and AS analysed the qualitative data. JD was responsible for all aspects of the staff and patient surveys. All authors contributed to the final manuscript. RL is guarantor.
Funding: This study was funded by the Health Foundation and NPSA and sponsored for research governance purposes by the University of Birmingham. The study was designed independently by the researchers and was awarded after competitive tender. The researchers acted independently but worked collaboratively with the funder. The researchers independently collected, analysed, and interpreted the data and independently wrote this article. The funders were given the opportunity to provide comments before submission. All researchers had the opportunity to access participants’ anonymised data.
Competing interest: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare financial support for the study by the Health Foundation, additional funding for the explicit case note review in control hospitals and the holistic case note review study from the National Patient Safety Agency, funding for KH from the National Institute for Health Research Collaborations for Leadership in Applied Health Research and Care for Birmingham and Black Country, and AG by the Engineering and Physical Sciences Research Council, Multidisciplinary Assessment Technology Centre for Healthcare programme. The Centre for Medication Safety and Service Quality is affiliated with the Centre for Patient Safety and Service Quality at Imperial College Healthcare NHS Trust, which is funded by the National Institute of Health Research; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work
Ethical approval: Each substudy had its own ethical approval. The staff and patient surveys were approved by the North West multi-centre research ethics committee and each site granted access to their data. The stakeholder interviews, ethnography and case note review sub-studies were approved by Trent multi-centre research ethics committee. Informed consent was elicited from interview participants and focus groups. Informed consent was not required for the case note review as there was no direct contact with participants and notes were anonymised by participating hospitals. Local research governance was followed at each site.
Data sharing: no additional data available, but see full report.6
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