- 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.
Since the publication of two key reports in 2000,1 2 increased efforts, attention, and resources have been given to patient safety, but by 2005 progress was reported as frustratingly slow.3 There is now keen interest in finding ways to make more sustained improvements. Approaches to patient safety that aim to intervene at an organisational level and that actively engage workers in the management of risk are argued to be especially promising for providing solutions to the problems of patient safety.4 5 The Health Foundation’s Safer Patients Initiative (SPI) was an important example of such an approach.
The Safer Patients Initiative programme
The Health Foundation selected four hospitals (table 1⇓), one in each country of the United Kingdom, to participate in the first phase of SPI (SPI1).6 The Health Foundation (a British charity dedicated to improving the quality of healthcare) invested £775 000 (€900 000, $1.2m) in each hospital. SPI1 ran from January 2005 to September 2006 inclusive and was intended to embed and spread thereafter. The Health Foundation issued a request for applications to conduct an independent evaluation of the SPI1 intervention. We report on the results of this evaluation.
SPI1 set out to secure improvements in patient safety7 8 9 and covered a range of aims (box 1), which included a 50% reduction in adverse events.10 Mentored by the Institute for Healthcare Improvement (IHI), based in the United States, it had several features similar to the well publicised US “Saving 100,000 lives campaign.”11 12 The intervention consisted of many components (box 1), some generic (aimed at strengthening the organisation as a whole) and others targeted at specific high risk clinical issues. The generic components sought to promote patient safety as an organisational priority, increase the effectiveness of senior leadership in relation to safety, engender a culture of safety, and instil knowledge of the principles of safe practice among staff. The targeted components of SPI1 focused on improving the reliability of specific frontline care processes in designated clinical areas (general wards, critical care, perioperative care, and management of medicines).
Box 1: Key generic and specific elements of the Safer Patients Initiative
General aim: “to avoid unnecessary harm, pain or suffering as a result of error in medical interventions”
Generic improvement to reduce adverse events
Build a culture of safety and good leadership
Train to enable organisations to identify problems and develop and evaluate methods to reduce risk
Foster an understanding of the principles of safe practice
Approach used in SPI
Collaborative residential learning sessions with the Institute for Healthcare Improvement (IHI) faculty to train “change agents” who would lead implementation in their hospitals
Instruction in use of control charts
Web based learning and site visits from IHI expert faculty
Know-how for Plan-Do-Study-Act (PDSA) cycles
Electronic facility for information sharing—for example, to share results of PDSA cycles
Leadership projected in part by management walk rounds
Participation in safety culture surveys
Formation of a collaborative learning community
Identify and respond to deteriorating patients to reduce need for “crash calls” and avoidable mortality
Approach used in SPI
Review of 50 deaths carried out by hospital staff
Tools for monitoring patients’ condition and for triggering action, such as forms to record vital signs and other salient information (such as early warning score system (EWSS))
Promote the use of risk (severity) scores
Establish a rapid response team
Reduce medication errors
Approach used in SPI
Assessment of medication safety by involving staff in failure mode effects analysis (FMEA); educating staff to identify and remedy weak links in medication practice from prescribing to administration and monitoring
Tool to identify and measure rates of adverse events
Tool to reduce adverse events from treatment with anticoagulants
Education to improve “medicine reconciliation,” to ensure that medicines that patients were taking before admission were not inadvertently omitted or altered after admission
Communication between staff to reduce adverse events/mortality
Approach used in SPI
Situation background assessment recommendation (SBAR) tool to ensure that information is communicated in a structured way
Safety briefings; briefings at shift changes to ensure staff members are aware of relevant information for patients
Infection control including for meticillin resistant Staphylococcus aureus (MRSA)
Approach used in SPI
Perioperative antibiotics to reduce infection at surgical site
Catheter insertion and maintenance drill to prevent central line infections in intensive care
Following the tenets of a package of ventilator guidelines (bundles) to reduce ventilator acquired pneumonia, venous thromboembolism, and stress ulcers in intensive care units
Improvements in hand hygiene—for example, by training and use of posters
From each hospital, 15-20 “change agents” participated in four learning sessions run by the IHI to gain knowledge and expertise in how to change practice, measure the effects, and sustain safety improvements.7 8 9 Change agents were charged with leading change by facilitating the implementation of SPI1 in their hospitals. They also formed a virtual community that shared data, tools, expertise, and experience; participated in conference calls and electronic mailing lists; and uploaded monthly progress reports through a project intranet.
SPI1 hospitals received site visits and technical assistance from the IHI over the course of the programme, and staff members in participating hospitals were asked to take part in surveys of safety culture managed by the IHI. Changes in clinical processes were supported by learning materials (such as care “bundles,” collections of carefully packaged evidence based standards directed at a particular condition or clinical scenario) (box 1). The intention was to encourage compliance with the tenets of safe and effective care by using Plan-Do-Study-Act (PDSA) cycles, where changes are first implemented on a small scale and tested and refined before being rolled out on a larger scale. The programme strongly emphasised the role of measurement in improving patient safety. Staff members were expected to upload time series process data (such as compliance with prophylaxis for deep vein thrombosis) to the project intranet to create run charts—graphs to help people visualise changes on selected measures over time. Monitoring of care processes through these charts was seen as important for guiding local improvement activities and evaluating their impact.
We evaluated changes in a range of end points relevant to patient safety over time and whether these changes could be attributed to SPI1 in the four participating hospitals. We used a controlled design to identify whether SPI1 had any additional effect (that is, net of any overall trends in hospital safety over the same period).
We have reported here on the methods used and the main findings based on SQUIRE guidelines.13 Further details are available in the full online report.6 The evaluation of the rollout of SPI to other hospitals (SPI2) is available in a companion paper.14
Framework for evaluation
The study was a “mixed method” evaluation15 16 because it combined qualitative and quantitative data and involved many “levels” in the organisation, “from boardroom to patient.”15 16 17 18 19 This type of evaluation is particularly suitable for service delivery/management interventions that are not likely to yield the type of conclusive results characteristic of evaluations of treatments based on measurement of outcomes on patients.20 Mixed method evaluation draws on the idea of “triangulation,” where confidence in the findings increases when observations of one type are corroborated by other types of evidence. This follows a tradition in the philosophy of science.15 16 17 18 19 Figure 1 shows the framework for the evaluation⇓.
The evaluation comprised five substudies to investigate key aims of the initiative (table 2⇓).
Improvement of leadership and engagement of leaders and staff—Semistructured interviews were conducted to assess knowledge and enthusiasm for the initiative among 60 senior members of staff in the four SPI1 hospitals.
Improvement in culture of safety and “transformative” effects—Before and after surveys of staff attitudes in control and SPI1 hospitals were conducted by means of a validated questionnaire to assess staff morale, attitudes, and aspects of culture (the NHS National Staff Survey).
Informing, educating, and motivating frontline clinical staff—Qualitative studies comprising ethnographic observations on acute medical wards, interviews, and focus groups in SPI1 hospitals were conducted to obtain direct access to staff behaviour and views, and to add depth of understanding.
Impact on processes of clinical care—To identify any improvements, we measured error rates in control and SPI1 hospitals by means of explicit (criterion based) and separate holistic reviews of case notes. The study group comprised patients aged 65 or over who had been admitted with acute respiratory disease: this is a high risk group to whom many evidence based guidelines apply and hence where significant effects were plausible.
Improving outcomes of care—We reviewed case notes to identify adverse events and mortality and assessed any improvement in patients’ experiences by using a validated measure of patients’ satisfaction (the NHS patient survey).
Data were collected in the four SPI1 intervention hospitals and 18 control hospitals. For economy, the control hospitals comprised nine that would later participate in the second phase of SPI (SPI2) but were pre-intervention at the time of this study. A further nine controls were added that would also form the controls for the SPI2 hospitals.14 All 18 control hospitals were located in England (thereby providing access to the NHS staff and patient surveys).
Use of before and after observations across control and SPI1 sites enabled us to compare rates of change across control and SPI1 hospitals over time. This approach, known as the “difference in difference” method,18 is particularly suitable for identifying temporal variations in outcomes that are not due to exposure to the intervention that is being evaluated, and is used to take into account the effect of events other than the particular intervention of interest that occur over the intervention period.
Interviews with strategic/senior staff
Using semistructured telephone interviews with 60 hospital staff members in strategic/senior positions across the four hospitals, we investigated how far participants understood and expressed enthusiasm for the SPI1. A researcher (JW, see acknowledgments) conducted the interviews, which were tape recorded and transcribed. Data analysis was first based on the constant comparative method that was used to generate thematic categories into which participants’ accounts could be categorised.21 Three independent reviewers then scored the responses of hospital participants on a 1-10 scale for level of knowledge and level of enthusiasm.
The National NHS Staff Survey questionnaire was used at two time points to measure variables such as staff morale, attitudes, and aspects of “culture” that might be affected by the generic strengthening of organisational systems that SPI1 intended to achieve. Eleven of the 28 survey questions (table 3⇓)22 23 24 25 26 were identified as likely to be of relevance. Questionnaires were sent to all staff members in the four SPI1 hospitals, including the three hospitals outside England that did not routinely participate in the National NHS Staff Survey. In each of the 18 control hospitals, a simple random sample of 850 staff members was used; at this sample size, an average 60% response rate would yield 95% confidence intervals of no greater than 10% for all scores in a single organisation. Further detail about the questionnaire is available from www.nhsstaffsurveys.com, and further detail about the evaluation is in the full report.6 Statistical analyses were adjusted for age, sex, ethnic background, occupational group, length of service, and management status.
One author (AS) undertook three rounds of data collection. Between April and September 2006, she visited one medical ward in each of the four hospitals for one week. She undertook around 150 hours of ethnographic observations and 47 interviews with different types of ward staff, focusing on general issues relating to patient safety and SPI1. The wards were selected on the basis that they would treat many of the patients whose case notes would be reviewed (see below), but not on the basis that SPI1 “change agents” (see box 1) were necessarily active on these wards. From April to June 2007, shortly after the intervention phase, a second week-long visit to each ward involved a further round of ethnographic observations (around 150 hours) and 41 interviews. A third visit involving three focus groups at each site (one at study ward level, one involving people with responsibilities for patient safety/SPI1, and one at strategic level) was used to feed back preliminary findings and to ask staff for their reflections on SPI1. These were carried out in May-July 2008 by two of the authors (AS and UG) and one researcher (JW).
Data analysis of interviews was based on the constant comparative method,21 facilitated by the use of NVivo software. For focus groups and ethnographic field notes, simple coding procedures were used to categorise the data thematically.
Quality of care/error rates in patients with acute respiratory disease on medical wards
Using case note review, we assessed quality of care using standards based on established guidelines wherever possible. We reviewed case notes from patients with similar clinical conditions across the SPI1 and control hospitals so that we could compare like with like. Case note review is resource intensive and thus must be selective. We focused on patients aged over 65 with acute respiratory disease (community acquired pneumonia, exacerbation of asthma, or chronic obstructive pulmonary disease) admitted to medical wards (one in each participating hospital) (box 2). The review assessed processes targeted by SPI1 (such as quality of observations to detect deteriorating patients) and those that might be expected to improve if there was an overall shift in organisational systems and culture toward patient safety (such as improved medical histories).
Box 2: Rationale for focus on patients aged over 65 admitted with acute respiratory disease
It was important to focus on an issue where all four SPI1 hospitals would be implementing a specific SPI intervention (intensive care was excluded partly for this reason)
There is a high incidence of comorbidities in people aged over 65, making this a high risk and hence a potentially error-rich population in which an effective organisational patient safety intervention might yield detectable improvements. Improving recognition and response to acute deterioration was a specific target of the SPI (see box 1), and patients admitted with acute respiratory disease are at high risk of such deterioration27 28
There was evidence that monitoring and medication practice was suboptimal in NHS hospitals, thus providing sufficient room for improvements to be detected with samples of affordable size29
A single set of case notes could be used to assess end points targeted by several SPI interventions (see box 1), specifically including management of patients at risk of deterioration and prescribing errors
Case notes from the 18 control and four SPI1 hospitals were collected from two periods of six months, which we termed epochs. Epoch 1 (October 2003 to March 2004) was before the intervention and epoch 2 (October 2006 to March 2007) was after.
We aimed to analyse 100 sets of case notes from each SPI1 hospital per epoch (800 in total) and 15 from each control hospital per epoch (540 in total). This would give 80% power to detect a 13 percentage point improvement in error rates from a baseline of 70% at P=0.05 (see full report for further details).6 For each set of case notes, the admissions of interest were photocopied, anonymised, and digitised and the year of admission was removed to ensure blinding to epoch. These processes were completed before reviewing. Review was both explicit (criterion based) and implicit (holistic) because each method identifies a different spectrum of errors.30
Criterion based review—Qualified pharmacists (MG and BDF) conducted explicit reviews according to predefined criteria relating to deterioration of the patient; medical history taking; compliance with evidence based care; and prescribing errors (table 4⇓). To control for any learning or fatigue effects, or both, in reviewers, case notes were scrambled to ensure that they were not reviewed entirely in series. Agreement on prescribing error between observers35 was evaluated by assigning one in 10 sets of case notes to both reviewers, who assessed cases in batches, blinded to each other’s assessments, but compared and discussed results after each batch. Data were collected on the adequacy of masking of patients’ names, hospital, and epoch. All analyses were adjusted for patient level covariates of age and sex. We used cubic polynomials in the time of review to adjust for learning/fatigue effects in the review process.
Holistic review—Holistic review was not part of the original protocol (for either SPI1 or SPI2) but was carried out after a suggestion by the late Vin McLoughlin (a director of the Health Foundation) in November 2007 at a project progress meeting. A specialist in general medicine (MC) holistically evaluated each set of case notes to identify errors in the care of patients and adverse events. To measure reliability between observers,35 an experienced trainee in respiratory medicine (TN) independently re-evaluated a subset of these case notes (n=91). Error was defined, according to Reason, as “a failure to complete a planned action as it was intended or adoption of an incorrect plan.”36 The results, adjusted for age and sex, are presented as the average number of errors per 100 patients; a patient could have more than one error. Errors were categorised as relating to diagnosis on admission; hospital acquired infection; technical/management; medication/maintenance/test results; clinical reasoning; and discharge information.37 38 39 40 41 Reviewers also gave an overall rating of the quality of care.6
Adverse events—The holistic review of case notes identified adverse events related to healthcare, which were reported as a rate of total adverse events per 100 patients. An adverse event was defined as “an unintended injury or complication which results in disability, death or prolonged hospital stay and which is caused by healthcare management.”38 Reviewers classified adverse events (including those resulting in death) by degree of preventability (on the balance of probabilities). Adjustments were made for age and sex.
Mortality—Overall adjusted (or crude) hospital mortality rates for all four SPI1 hospitals were not available because of difficulty accessing this information from the non-English countries. Overall mortality was unlikely to be a useful measure for this study as it is an insensitive marker of avoidable mortality,42 creating a high risk of a false negative result in a study with only four intervention hospitals.43 We therefore compared mortality rates across epochs among patients in medical wards whose case notes had been included in the case note review. Adjustments were made for age, sex, and number of comorbidities.
Patients’ satisfaction—An emphasis on safety can make staff and patients feel valued.44 We used a survey based on the questionnaire used in the National NHS Acute Inpatient Survey in England (www.nhssurveys.org) to obtain evidence of such a “halo effect” on patients’ experiences. The dates of the surveys of patients were aligned with the dates of staff surveys.6 Five scores were identified for analysis: three related to overall satisfaction scores and two to cleanliness. Data in the control arm were available only at the level of the organisation (hospital), not at the level of the individual clinical directorate (medicine, surgery, etc). Thus the analysis was conducted at the organisational level throughout. In the SPI1 arm, organisation level scores were formed by averaging all respondents’ scores in each hospital.
We used generalised linear mixed models for formal statistical analyses. Fixed effects were included for the difference in levels before the intervention between control and SPI1 hospitals (“baseline comparisons”); the change over time in control hospitals between the period before (epoch 1) and after (epoch 2) the intervention; and the effect of SPI1, interpreted as the discrepancy between the temporal changes experienced over the two epochs in the control and SPI1 hospitals. The impact of intraclass correlation in before and after studies is lower than for cross sectional studies.18 45 Nevertheless, we took into account the effect of hospital level clustering by including random effects for each hospital.
We used logistic models for binary responses; Poisson models for adverse events and general care errors; negative binomial models for medication errors (per recorded prescription); and normal models in all other cases. No adjustments were made for multiple comparisons, but we used 99% confidence intervals throughout and significance was set at P<0.01. Agreement between observers was tested with the intraclass correlation coefficient for rating scales and the κ statistic for dichotomous judgments. All models were fitted in Stata v10.
Senior/strategic staff interviews
Interviews with senior/strategic hospital staff in the SPI1 hospitals showed that they were mainly positive about SPI1 and had considerable enthusiasm for the initiative and its principles. Only seven of the 60 participants were unable to describe SPI1 accurately or in detail.8 Even though there was a broadly shared understanding of the programme’s theory of change (what the intervention was intended to achieve and with what methods), there was less evidence of an explicit and shared organisational theory of change (what was needed to make the programme work at an organisational level and how programme implementation could be optimised). Despite their enthusiasm, hospital staff members expressed multiple concerns about the ambitious reach of the programme, whether resources would be equal to the demands, and whether resistance might be encountered at the “sharp end”46 where staff care for patients. Strategies for overcoming such difficulties were not clear in the accounts of stakeholders.
The quantitative analysis found that 73% scored above 5 (out of 10) on the knowledge scale and 83% scored above 5 (out of 10) on the enthusiasm scale (fig 2⇓). Correlations between knowledge and enthusiasm across the three raters were 0.61, 0.69, and 0.91. Reliability between raters was medium to high, with intraclass correlations of 0.55 for knowledge and 0.65 for enthusiasm.
There was no significant difference in response rates between control and SPI1 hospitals at baseline, and the hospitals were broadly similar with respect to morale, attitudes, and culture of the hospital staff at baseline. Table 3⇑ shows the changes in control and SPI1 hospitals on each of 11 scores, along with the differences between groups. The difference was significant for only one of the 11 scores (organisational climate) (P<0.01), favouring the SPI1 hospitals over controls. There was a modest effect size for the difference in change between the control and SPI1 hospitals after covariates were taken into account: 0.08 points on a 5 point scale where there was a range at baseline of 0.50 points between hospitals.
The focus groups in four medical wards across the four sites agreed that the senior staff members in the hospitals were committed and enthusiastic about SPI1, made a significant strategic contribution, gave weight to the initiative, and generally set a good example for staff.
“If these guys aren’t behind it very quickly your clinical directors and . . . other directors, you know [other] senior people start to fall by the wayside and so I think that’s absolutely paramount having the top guys leading the way, so I think that has been one of the big successes.”
The involvement of the IHI in SPI1 was seen as crucial in lending credibility and support to the initiative and was much valued as a source of knowledge and expertise.
Ethnographic observations suggested that medical wards were pressurised settings, often coping with multiple demands and limited resources.47 The impact of SPI1 at the sharp end of medical wards was mostly difficult to detect, except in relation to improved monitoring of patients’ vital signs and use of early warning score track-and-trigger systems to detect and respond to possible deterioration.
Despite the enthusiasm and support at the strategic level or “blunt end,” medical ward staff, for the most part, tended either to know relatively little about SPI1 procedures, practices, and principles, or viewed them as handed down (top down) rather than something they were involved in developing (bottom up). There was little evidence that frontline medical ward staff perceived a sense of ownership over the initiative. The perception existed among some that SPI1 had allowed a small number of people to become an elite group with enhanced career prospects, while others were left feeling excluded.
“SPI was a select group of twenty people . . . you’re starting off in small areas and of course the by-product of that is that you’ve got a small group dealing with those small areas so there is, although we may not like it, there is a perception in some parts of the organisation that SPI is a, an elite entity.”
The gap between the strategic level view and what was happening at the sharp end was evident in several different ways. For example, “leadership walk rounds” were discussed enthusiastically in the leadership focus groups, but some staff members at the sharp end thought that the process was disappointing and might even have undermined SPI1 because it sometimes seemed to show a failure to connect senior management with the wards in meaningful ways.
“Well he came around and spoke to a few people and just asked about any concerns. He said he was interested to know how the nursing staff felt and he wanted to know one thing that he could take back to the rest of the board about any issues that nursing staff had. Afterwards they sent a letter to say thanks but you never hear any . . . well we haven’t heard anything more than that so.”
Several PDSA “success stories” were reported in the focus groups. Few of the frontline ward staff members interviewed, however, seemed aware of PDSA cycles. Somewhere between the blunt end and the sharp end, the model of participative engagement on which SPI1 was based had got rather lost, at least in relation to medical wards. There were several important influences that determined the extent to which SPI1 interventions became embedded on these wards. One example was intensity of the “dose” of SPI1 given to the wards. The activities of SPI1 change agents were dispersed throughout hospitals, and they might have focused their efforts on the more well defined clinical areas (such as the intensive care unit) that were the subject of clinical processes targeted by SPI1.
“The ward aspect was one of the more difficult areas to implement because it wasn’t as sort of specific, as confined, whereas the other areas perhaps were confined to theatres or ICU. [The ward] was much more . . . nebulous and covered a much bigger area . . . than perhaps other parts of the SPI.”
A further issue was legitimacy. Sometimes staff simply did not see particular interventions as being scientifically legitimate.
“Something that appears on the surface very simple, like the definition of a surgical infection, caused an absolute riot.”
Scientific legitimacy debates were, perhaps paradoxically, exacerbated by the use of PDSA cycles. Some clinical staff members reported seeing the run-chart data collected during the cycles as unreliable and lacking in credibility and therefore as not providing enough of a prompt for change. Claims of problematic evidence, however, might have been used strategically as a means of resisting change and reinforcing inertia. Legitimacy issues also arose when staff members did not recognise that the problem being tackled was a “real” one requiring a particular response, or they did not consider that the resources that would be required to implement the intervention were legitimate in light of other priorities and pressures. We observed further barriers to adopting safety initiatives, including the instability of teams caused by rotating and agency staff, meaning it was difficult to sustain a collective knowledge and faith in SPI1 over time.
Positive impacts of SPI1 included increased managerial recognition and focus on patient safety and the promotion of a systematic approach. One of the major lessons learnt was the scale of resources and organisational support required to make patient safety initiatives work. There was a perception that hospitals had underestimated this and been too ready to assume that something that worked in a defined clinical area (such as intensive care units) would easily transfer to other environments or would spontaneously spread. Hospitals reported that they had begun to devise strategies for future implementation, which included engaging senior clinicians and encouraging local ownership.
Quality of care/error rates in patients with acute respiratory disease on medical wards
Explicit review of case notes
The smallest SPI1 hospital in our sample could not provide the target numbers of case notes, leading to a slight shortfall in the intended SPI1 sample size of 400 sets of case notes in each epoch: 381 in epoch 1 and 380 in epoch 2. Control hospitals yielded 236 sets of case notes in epoch 1 and 240 sets in epoch 2. Baseline comparisons across all 1237 sets showed no significant differences between the control and SPI1 hospitals for any of the explicit review measures (table 4) assessed against the predetermined criteria.
Compliance in recording patients’ observations at both six and 12 hours after admission improved markedly between the two epochs, and this was significant for all but one of eight possible items. Both control and SPI1 hospitals improved, though the improvement was greater in SPI1 hospitals (table 5⇓); this difference in difference was significant only for the recording of respiratory rate at 12 hours. There was also a considerable increase over time in use of the CURB (confusion/urea/respiratory rate/blood pressure) score in patients with pneumonia, but these differences were not significant between control and SPI1 hospitals, and the point estimate favoured controls (table 6⇓).
There were many prescribing errors, but these were mostly minor (table 7⇓). There were no significant effects of SPI1 either over time or in favour of SPI in quality of prescribing (error rate ratio (estimated from population averaged negative binomial model) 1.2, 0.9 to 1.8; P=0.138).
The quality of observations, risk assessment, and prescribing were SPI1 targets (box 1), but we also sought evidence of a “halo effect” that might be evidence of a general strengthening of the system. There was no evidence of improvement in adherence to various tenets of safe evidence based practice (table 6⇑) either over time or in SPI1 hospitals in particular. Compliance with certain standards (such as use of steroids when indicated) was already high (over 85%) at baseline in both sets of hospitals, leaving little room for further improvement. The quality of history taking remained stable over time in both control and SPI1 hospitals (table 8⇓).
A comparison of the prescribing error results showed substantial35 agreement between the two observers, with a κ of 0.71 and 0.70 in epochs 1 and 2, respectively. For some items—notably prescribing errors (table 7) and recording of exercise tolerance and chest pain (table 8)—the time in the sequence when the review of the case notes was conducted made a significant contribution to the recorded outcome. The propensity to record prescribing error first improved (taken as learning) and then declined (taken as fatigue). Adjustment for these effects was made in the analysis of these and all other items (see full report for further information on tests for homogeneity of end points among control and SPI1 hospitals, and effects of patient age on the quality of care6). Despite masking of all case notes in the hospital records department, and again at the Birmingham “centre” (see methods), the reviewer was able to discern the patient’s name in 4% (42) of cases; hospital of origin in 1% (11) of cases; and epoch in 14% (158) of cases.
Holistic review of case notes
In the four SPI1 hospitals, 390 and 381 sets of case notes from epoch 1 and epoch 2, respectively, were holistically reviewed. For the 18 control hospitals, numbers were 243 and 246, respectively (range 8-15 cases per hospital). The total number of case notes (1260) is slightly different to the number in the explicit review because not all notes had been sent for both types of review when the study “closed.” Both reviewers assessed 91 sets of case notes; measures of reliability between them were, as expected for holistic reviews,30 low (κ=0.15, SE 0.08).
A total of 425 errors were identified. The most common categories of errors related to diagnosis, assessment, or admission or to poor clinical reasoning. From epoch 1 to 2, error rates declined from 44.4 to 42.3 in control hospitals and from 29.7 to 24.4 in the SPI1 hospitals. The difference in changes across control and SPI1 hospitals was not significant (rate ratio 0.87, 99% confidence interval 0.52 to 1.44; P=0.48).
The holistic review of the 1260 case notes identified 56 adverse events across all epochs and hospitals, giving an overall adverse event rate of about four per 100 patients treated. Agreement between raters in identification of adverse events was somewhat higher than agreement in identification of errors by holistic review (κ=0.25). The adverse event rate increased from 2.9 to 4.8 per 100 patients in control hospitals and declined from 6.2 to 3.7 among SPI1 hospitals. This difference in changes across control and SPI1 hospitals was not significant (rate ratio 0.40, 0.09 to 1.84; P=0.12).
In about a quarter (16) of the adverse events, there existed strong or certain evidence that the event was preventable (box 3). At around 1.3% (16/1260), this is a somewhat lower rate of preventable adverse events than reported for hospital inpatients elsewhere.40
Box 3: Preventable adverse events identified as being strongly* or certainly preventable in the 1260 case notes reviewed in the holistic review
Patient given oxygen and became unrousable from CO2 retention, required admission to intensive care unit
Patient lost consciousness because of hypoglycaemia caused by overdose of insulin to control hyperkalaemia (patient died)
Supraventricular tachycardia in patient with untreated hypokalaemia (patient died)
Wrong choice of antibiotic for severe community acquired pneumonia (patient died)
Patient’s breathlessness deteriorated because nurses omitted scheduled use of nebuliser
Patient sent home with severe uninvestigated anaemia†
Patient started on treatment for hyperthyroidism, despite equivocal test result (and in wrong dose)
Bronchospasm could have been avoided or lessened had β blocker been stopped
Patient lost consciousness because of hypoglycaemia caused by overdose of insulin to control hyperkalaemia*
Delay in administration of vitamin K leading to haematoma
Patient’s breathlessness increased, requiring transfer to high dependency unit, after failure to administer prescribed antibiotics
Patient’s collapse caused by adrenal crisis because corticosteroids were not prescribed for patient with known Addison’s disease (patient died)
Failure to treat MRSA; general practitioner not informed on discharge. No absolute evidence of harm but high risk
Severe anaemia not investigated and general practitioner not informed†
Bronchospasm could have been avoided or lessened had β blocker been stopped
Failure to inform general practitioner of the risk of CO2 retention†
*More likely than not (>50%) on balance of probabilities.
†No absolute evidence of harm in these cases but patients were discharged in clear danger and this influenced reviewer.
The mortality rate among patients admitted to medical wards was high, at over 14% (178 deaths across 1237 sets of case notes included in the explicit review), but there were no significant differences between control and SPI1 hospitals in the adjusted mortality rates. The baseline comparisons showed no significant differences between control and SPI1 hospitals nor was there significant evidence of temporal change in the control hospitals (table 9⇓). When we adjusted figures for age, sex, and number of comorbidities in the analysis of mortality rates the odds ratios were 1.9 (99% confidence interval 0.6 to 5.6; P=0.149) for the baseline comparison, 1.4 (0.7 to 2.9; P=0.274) for the change in control hospitals, and 0.5 (0.2 to 1.4; P=085) for the effect of SPI1. There was no significant effect of sex or number of comorbidities on mortality, but the odds of death increased by 8% (5% to 11%) per year of patient age (P<0.001). Few of the deaths were attributable to error. In two cases, the reviewer thought that the death was definitely caused by the error (untreated documented hyperkalaemia, failure to recognise adrenal crisis) and in two further cases that it was more likely than not that death could have been averted (wrong choice of antibiotic, insulin overdose).
The response rate for the first survey was 54% (1961/3624) in the four SPI1 hospitals; for the second it was 51% (1720/3397). In the 18 control hospitals there was a greater fall, from 63% (9563/15274) to 56% (8590/15300). At baseline there were no significant differences between control and SPI1 hospitals on any of the scores. Only one of the patient satisfaction scores (cleanliness of bathrooms) showed a significantly different change (favouring SPI1) (table 10⇓).
Phase one of the Safer Patients Initiative (SPI1) was generally greeted enthusiastically at the strategic level (blunt end) in participating hospitals. Ethnographic observations and interviews, however, suggested that staff at the sharp end of medical wards generally had only a vague idea of the intervention, and that, with the exception of patient monitoring, few had direct experience of most of its components. Only one of the 11 dimensions on the staff survey changed significantly between groups; this occurred on an item relating to organisational climate, which favoured the SPI. Quantitative evaluation showed a significant effect in favour of SPI1 in respect of only one clinical process. This exception was in relation to the aim of improving observation of acutely ill patients, where recording of respiratory rate improved significantly more in SPI1 than in control hospitals. This quantitative finding was consistent with the qualitative observations.
During the study there was a general improvement in the quality of the monitoring of vital signs among both control and SPI1 hospitals; there was improvement in all eight of the required measurements of vital signs over the first 12 hours after admission (and this was significant in all but one case). The magnitude of the improvement in monitoring respiratory rate from before to after the intervention was greater than the magnitude of the difference between control and SPI1 hospitals. Likewise there was a sharp improvement over time in use of formal risk scoring for patients with pneumonia. These findings are all consistent with a general (temporal) improvement in the quality of monitoring for sick patients in the NHS over the study period.
We observed several clinical processes that were not specific SPI1 targets but might have been expected to improve if the overall goal of strengthening the system and achieving cultural and organisational realignments around safety had been achieved on medical wards. There was no significant difference between control and SPI1 hospitals over time. For some measures—such as use of corticosteroids in patients with chronic obstructive pulmonary disease and asthma—practice was already good at baseline and there was little room for further improvement. There was, however, also no change in other measures of quality of care, even when there was greater room for improvement. The holistic review corroborated findings from the criterion based explicit review, showing no consistent trends in either errors or adverse events in medical wards treating patients with acute respiratory disease in control versus SPI1 hospitals.
Strengths and weaknesses
Our study had several strengths, including use of a predefined protocol, selected competitively, for evaluating SPI1. We quantified safety practices and used independent reviewers who made observations across multiple hospitals. Breaking the link between reviewer and hospital removes vested interest and ensures that any measurement error is systematic, thereby reducing risk of bias in comparisons between institutions. Reviewers were masked (as further insurance against observer bias), and we quality assured the masking process. We measured learning/fatigue effects (not just variation between observations)30 to ensure that comparisons were not biased over time. Qualitative and quantitative observations across the different levels of hospitals enabled “triangulation”48 of data collection and interpretation. We used a before and after controlled design and “difference in difference” approach to quantitative measurements.15 With some notable exceptions49 50 most quality improvement reports lack contemporaneous controls, thus denying the ability to be confident in determining whether any changes can be attributed to the intervention.
These strengths mean that this evaluation adds to the science of evaluating large scale, complex quality improvement interventions that defy rigorous assessment with single method or single measure designs. Our approach dealt with the problems of data quality and other biases associated with using hospitals’ own SPI1 run-charts, which are not designed for research purposes. A separate study has shown that data are not collected in a consistently defined way and tend to have missing values.51
One limitation of our study is that it was non-randomised. Results might have been biased against SPI1 because SPI1 hospitals might have had less room for improvement, and controls might have had higher than average performance, particularly as half were also selected as future SPI2 intervention sites. The staff survey and explicit review, however, showed similar performance at baseline, while adverse events and error rates detected on holistic review were equivocal (favouring the control hospitals in one domain and the SPI1 hospitals in another).
Results might have been biased in favour of SPI1 because SPI1 sites were selected, not chosen at random (the reverse of the possible bias mentioned above), and agreement to participate in the evaluation could have had a differentially motivating effect in SPI1 hospitals than in control hospitals (a form of the Hawthorne effect that could not be avoided by randomisation). These potential biases against controls would have been scientifically more worrisome had the results not been mostly null.
What is already known on this topic
There is keen interest in finding ways of making healthcare safer for patients, and there are many examples of successful interventions targeted at specific clinical problems, such as hospital acquired infections
There are few formal summative evaluations of attempts to generate systematic organisation-wide improvements in the safety of care
Most evaluations of patient safety and quality improvement efforts lack contemporaneous controls
What this study adds
Quality of monitoring of sick patients improved in control hospitals and in hospitals participating in the Safer Patients Initiative, but control hospitals did not improve as much as intervention hospitals; there was a small improvement in staff attitudes to organisational climate in intervention hospitals
On a range of other measures and outcomes related to patient safety, there was no additive effect attributable to the Safer Patients Initiative
Qualitative and quantitative findings of the evaluation of the Safer Patients Initiative were convergent
Cite this as: BMJ 2011;342:d195
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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