CFF Patient Registry: reducing gaps in clinical practice

In the words of management guru Peter Drucker, ‘if you can't measure it, you can't manage it.’ The US CFF recognised the critical role of data collection and measurement in QI early on and thus created a patient registry in 1966.5 The registry data have evolved over the years from a few variables on vital status to allow for a better understanding of the natural history of disease to a comprehensive database that gives healthcare providers and researchers the information they need to develop care guidelines, improve delivery of care and identify eligible patients for clinical trials. The US CFF Patient Registry now includes detailed annual and encounter-based data on over 300 unique variables running the gamut from active pulmonary therapies to sputum microbiology to pulmonary function test results to CF-related comorbidities for each of its more than 26 000 participants.3

In 2003, the US CFF developed a secure internet-based portal (Port CF) to allow for the timely entry of encounter-based data and to serve as a vehicle to disseminate care guidelines and deliver patient alerts and clinical reminders at the point-of-care where it impacts on care the most. In 2006, the US CFF made centre-specific performance indicators transparent to the public and this was promoted as an initiative to ‘accelerate the rate of improvement’ in CF care through benchmarking. Top-performing centres are used as models of best practice with the hope of cross-pollinating successful processes to other centres, and thus reducing national variability in practice patterns and outcomes. The information gleaned from this project was disseminated in several ways including a step-by-step QI guidebook entitled ‘Action Guide for Accelerating the Rate of Improvement in Cystic Fibrosis Care’. An example of some of the tools and methods employed in QI is provided in box 1.

In addition to providing the guide, the US CFF also launched a series of action-oriented training programs entitled Learning and Leadership Collaboratives to increase the capacity for QI across the CF clinical care network. Each centre participating in one of the Learning and Leadership Collaboratives performed a QI project over the course of a year. One example noting the impact of QI is the change in lung function in children at the Akron Ohio CF centre after implementing a QI project to standardise the management of acute pulmonary exacerbation (figure 1).

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Figure 1

The two figures denote the year-to-year change in the median forced expiratory volume in one second (FEV₁) per cent predicted from 2004 to 2005 compared with other centres in the USA. The blue bar represents the Akron centres median FEV₁% predicted in 2004 and the red bar denotes the median FEV₁% predicted in 2005. The green bar represents the National centre level average. The remaining bars represent all other CFF accredited paediatric CF centres. Reproduced with permission from Dr Nathan Kraynack. CF, cystic fibrosis; CFF, CF Foundation.

There are several examples of how the US CFF Patient Registry has been used by CF centres to motivate QI. In 1998, the Northern New England Cystic Fibrosis Consortium (NNECFC) noticed significant variation in its screening rates for CF-related diabetes (16–78%) and the overall rate was 17% below the national average.8 Following a 3-year QI initiative that involved feedback of data to clinicians, patient education about CF-related diabetes, and clinic system changes to trigger annual blood work and tracking of results, the NNECFC reduced variation in its centres to 71–90%, and the overall rate was 4% above the national average. In another example, the Children's Memorial Hospital in Chicago was able to reduce rates of nutritional failure by documenting nutritional status at every clinic visit and targeting those patients at the highest risk for nutritional failure with a customised self-management plan.9

CFF TDN: improving research processes

CQI has not been restricted to clinical care in CF. The CFF TDN, with 77 clinical sites across the USA, has employed the same CQI approach employed in the clinical arena to improve quality and efficiency in the conduct of clinical trials in CF. During the past 3 years, the US CFF has invested in the development of a web-based database system to collect study-related metrics from sites participating in CF clinical trials. Data are captured on time for IRB approval, contract approval, site activation (approval to enrolment), time to first patient enrolled and number of patients enrolled. These data have been used by the CFF TDN to initiate a benchmarking process (with funding from the US National Institutes of Health—NCRR UL1 RR025014) to identify and evaluate high performing centres based primarily on efficient study start-up and measures of enrolment performance. Given the challenges of conducting clinical research, clear pathways to successful and efficient conduct of clinical trials are needed. The results from this project will be available in the fall of 2011.

Overcoming inertia: QI implementation

Although the success story of CQI in CF may be considered unique as CF is an orphan disease affecting young people, and has been well supported by a patient foundation, there are several key lessons that can be learnt. CQI in healthcare must be approached systematically with redesign of processes and strategic planning of the change process to help overcome inertia related to the status quo. The initiative requires a champion that can articulate a vision and galvanise the collective buy-in of a multidisciplinary team towards a common goal. It requires data collection and measurement to identify opportunities for improvement and to provide instant feedback following implementation of the QI initiative. Timely feedback is crucial to reinforcing good behaviour and facilitating the reiterative nature of CQI. Finally, the collected data should be transparent to facilitate benchmarking and identification of best practices, which captures the true essence of CQI.