French national team responsible for transposing of the US CF LLC

A French national team was formed comprising the lead physician at the Nantes-Roscoff Center of Expertise, his assistant, a parent of an adolescent with CF (an engineer by training), a physiotherapist and the head of information and communication system projects. The physician, physiotherapist and parent had been trained in a quality course at TDIMA, and had visited several CF centers involved in the CF LLCs for years [12]. The physician in charge of the French national therapeutic patient education program (TPE) and director of the pediatric CF center in Nantes, was closely associated with the team and led its testing at her center. This team is hereinafter referred to as the “national team”. Due to its composition, the national team included two main features unique to French CF model of care: 1) the CF therapeutic patient education program, validated in 2005 by the French health authorities and structured according to developmental stages in children and needs in terms of management of complication in adults (http://etp.centre-reference-muco-nantes.fr), and 2) respiratory physiotherapy care, delivered to patients at home according to the French National Diagnosis and Treatment Protocol and reimbursed by the French national health insurance system. The national team also strongly emphasized the involvement of patients and parents in the QIP at each center. A recruitment procedure was put in place to identify in the patient caseload at each center individuals with CF or parents of children with CF who were motivated, available, at ease in their relationships with professionals, capable of self-expression in a group, able to communicate via Internet with the team. The patient or parent was enlisted as a full member of the local quality improvement team and their travel expenses were reimbursed by the patient organization Vaincre la Mucoviscidose.

Transposition of the US CF LLC into a first version of the PHARE-M LLC

The Pilot PHARE-M LLC1 (September 2011 – June 2012)

The PHARE-M LLC1 enrolled 7 volunteer centres, including four CF centers from the two national French national Centers of Expertise of Nantes-Roscoff and Lyon, thanks to close professional networking. A multidisciplinary “quality improvement team” was formed at each center included a physician leader, four to five professionals and a parent or a patient. Vaincre la Mucoviscidose agreed to reimburse the travel fees of the teams – including those of the patients/parents – and give each center a grant covering a 0,20 FTEs for a nurse for 1 year, corresponding to the extra time required for data analysis and teamwork management.

Four Face-to-face LLC meetings were organized. At these meetings, theoretical presentations of the method illustrated with examples drawn from the American teams were alternated with practical exercises by the French center teams. Each team analyzed its patient outcomes and selected a theme for improvement for a target patient population. Patient data was available for each center from the 2009 Patient Registry report by center; however, some indicators presented weaknesses such as body mass index (BMI) being expressed for children as an absolute value and not as a percentile or Z-score. This forced the teams to collect specific data from their patient electronic records. The teams were offered Action Guide tools (satisfaction surveys, activity analysis grids, communication tools, etc.) and took advantage of the opportunity to adapt them to their setting. International experiences published in the literature were presented [15, 16] and the teams were reminded of CF care guidelines [17]. Each team identified actions to redesign its processes, in line with its theme for improvement, to be tested according to successive PDSA cycles. The teams’ satisfaction and suggestions were recorded at each meeting and an overall score was displayed on the PHARE-M website.

Assessments of the pilot PHARE-M LLC1

The PHARE-M being an innovative approach to QI in France, some key stakeholders were dubious as to its applicability in the French CF care network. The head of the Nantes-Roscoff Center of Expertise asked a Mines-Nantes School sociological researcher to perform a first assessment of the program to analyse the factors for its success and barriers to its adoption, and the patient organization asked a consulting a firm to perform a second assessment to inform its decision as to whether to continue to fund the program.

The first assessment took place during LLC1. The assessor participated as an observer during two web meetings and the third Face-to-Face meeting. The assessment included familiarization with PHARE-M documents, interviews with a panel of professionals and patients/parents on the quality improvement teams, an interview with the members of the national team, an interview with the Director of TDIMA, and a visit to one site. All interviews and focus groups were recorded and fully transcribed. The data was exploited (coding, categorization), processed (analysis, validity) and interpreted according to the standard thematic content analysis protocol (Miles & Huberman [18]). This was followed by manual grouping and counting within an analysis framework with the following dimensions: process applicability (terminology, formalization, tools, distance web meetings); incorporation of patients and parents (roles, time spent, barriers); national/regional coordination (roles, nature of support, incorporation mechanisms); process adoption (perceived benefits and costs, working atmosphere, engagement, acquisitions); and impact (operation, working practices, cooperation with the stakeholders). The report was submitted in July 2012 for consideration to adjust the PHARE-M LLC2.

The second assessment was contracted at the end of LLC1 to evaluate the effectiveness of this QI method in France, and to perform a comparative analysis between aims and outcomes achieved (efficiency) and between actions performed and expenses (efficacy). The study methodology included: familiarization with the PHARE-M documents and the literature on CF (French National Diagnosis and Treatment Protocol, French National Registry, etc.); investigations into four engaged CFC sites (Versailles, Lyon pediatric, Reims, and Roscoff) with professionals and patients/parents; telephone interviews with the members of the national team and patients/parents. The report was submitted during the October 2012 meeting of the board of directors of the patient organization, and the decision as to whether to continue funding was voted on in December 2012.

Main adjustments in the PHARE-M LLC2

Following these two assessments, the national team made adjustments to the program, thus further customizing the second version of the PHARE-M (see below). The patient organization continued to fund the travel fees of the teams and the extra-time worked by a referent professional on the team at each center. No funding was allocated to the national team for intensive coaching of the teams at each center.

Inter-regional rollout of the PHARE-M LLC2 (September 2012 – June 2013)

A second PHARE-M LLC session was planned to enroll the centers in the two French inter-regions of Rhône-Alpes-Auvergne and Grand-Ouest belonging to the regional care network of the two CF Centers of Expertise of Nantes-Roscoff and Lyon that could not have been included in the first session.

The teams also requested that a “post-PHARE-M cycle” be established to maintain a focus on quality improvement and have CFCs continue to exchange experiences after the LLC until they achieved their goal for improvement (two to 3 years after the training year). This was discussed with the patient organization for purposes of obtaining additional funding to organize an annual CQI meeting at a CF center for benchmarking and sustaining QI work.

Standardization and sustainability of the PHARE-M

The growing difficulty of enlisting new CFCs and the risk of jeopardizing patient organization funding led the national team to conceive of different avenues for perpetuating the PHARE-M and its rollout throughout the CF network.

First, a research project was drawn up in an attempt to respond to the recurrent request for evidence of the PHARE-M’s positive impact on patient outcomes. The PHARE-M Performance project was submitted at a call for projects by the French Ministry of Health in February 2012. The project was selected by the Ministry on 5 December 2012 and funded for a three-year study. Its protocol combined a quasi-experimental evaluation of the effectiveness of the program to change patient outcomes over the course of 3 years with a process evaluation [20]. Following a realistic approach, the latter was designed to understand what works, for whom and under which circumstances (context) [21]. The success of the PHARE-M performance project at this call for projects was seen as a means to give credibility and recognition to the PHARE-M as well as funding to the national team for further interventional research.

Second, systematic efforts were made to incorporate the PHARE-M’s into hospital accreditation process. The announcement of certain professional practice evaluation (EPP) actions for improvement and the participation of a hospital quality engineer on the quality improvement team at several centers were actively sought to improve the acceptability of the program in hospitals alongside more traditional certification methods.

Finally, continuing professional development in the field of hospital continuing education, which started in 2013 [22–24], offered an opportunity to standardize the PHARE-M into a hospital continuing education program without modifying its content or curriculum except to have it take place during a calendar year (January through December). Recognition by the hospital continuing education authority of the PHARE-M as a CPD program was sought as it was key to further roll-out.

Results of PHARE-M LLC1 & LLC2

Seven centers volunteered to test and propose improvements to the program in the PHARE-M LLC1: four pediatric centers (Lyon, Nantes, Paris Robert Debré, and Versailles), one adult CFC (Lyon), and two pediatric teams at mixed centers (Reims and Roscoff) following up a total of about 1200 patients out of the 6500 patients in the Registry in 2011. Seven more centers from the two French inter-regions of Rhône-Alpes-Auvergne and Grand-Ouest engaged in the PHARE-M LLC2: three pediatric centers (Angers, Grenoble, and Rennes), two adult centers (Nantes and Rennes), and two mixed centers (Clermont-Ferrand and Morbihan), to which the adult team at the Roscoff center was added, following up about 800 more patients.

Ninety-six trainees from the 14 CFCs participated in the two annual PHARE-M sessions. More than half of the participants (54%) belonged to the multidisciplinary “core” team and 15% were patients or parents of patients. Healthcare providers on the quality improvement teams represented a total of 75 people, patients/parents represented 15 people, and non-healthcare professionals represented six people. Psychologists and dieticians were particularly strongly enlisted to the quality improvement teams (9/75 (12%) and 7/75 (9.3%) respectively).

Among those 14 centers (out of 45 CF care centers in France), three elected a theme for improvement related to adult care, one chose a theme related to transition to transplantation, one chose a theme related to transition to adult care, and nine chose a theme related to either respiratory or nutritional pediatric care. Four of them worked closely with the Quality Department at their hospital. Companion articles in this supplement present the changes in processes and clinical outcomes achieved in some centers between 2012 and 2015 and the links developed between the program and the general quality process at the hospital [25–27]. They show that working in QI has allowed these teams to achieve their goals and even exceed them on various themes of improvement such as FEV1 for adolescents, BMI for children 2 to 12 y.o. or time on the lung transplant waiting list. The statistical analysis of the PHARE-M Performance research project, which will assess the effectiveness of the program to change patient outcomes at centers involved in LLC1 & 2, will be performed on the Registry data from 2011 to year 2015 and results will be available by the end of 2017.

The assessment of the teams’ satisfaction showed an increase between LLC1 and LLC2, as expressed at each training meeting and for the LLC overall, reflected in the median of all the participants’ scores on a scale from 0 to 10, where 10 represented maximum satisfaction (median score = 7.48) and the LLC2 (median score = 8.16).

At the teams’ request, two post-PHARE-M cycles were offered in 2014, one pediatric and the other adult, consisting of one meeting per year at a CFC, including a benchmarking visit, an account of the progress and outcomes of the teams’ actions, exchanges between the teams, and reminders fundamental aspects of the QIP.

Thirteen teams prepared their poster at the end of the PHARE-M session, and these posters were presented at the 1st CF Francophone Conference (2014). Three posters and their updates after 3 years were presented at the European CF conference (2012, 2014 and 2015) and the North American CF conference (2012). Videos featuring best practice recommendations concerning respiratory physiotherapy, physical and sports activities were prepared.

Improvement of the patient registry

The French Registry contains one value in a given year for patient health outcomes and long-term treatments, while patient data are recorded at each clinic visit in the electronic patient record within the hospital information system. The Registry Committee establishes rules to select the clinic visit in a given year from which the FEV1, height and weight values are taken to be transmitted to the Registry.

In 2011–2012, the histograms presenting the median values of the centers remained anonymous in the Patient Registry report by center. The transparency brought in the PHARE-M meetings opened up discussions between the teams, leading them either to focus on the themes of improvement when the centers presented unsatisfactory results compared to national median values, or to question the measurement processes at the center. An on-site quality audit of the data transmitted to the Registry was organized in 2014–2015 pointed to variability in the measurement processes and in the application of the selection rule [28]. Avenues for improvement have been identified to support quality improvement of the data transmitted to the Registry by the centers.

To respond to the requests were made to the Registry team, the body mass index (BMI) for children was presented in Z-score value for LLC2. The lag between the year to which the data refer and the time of publication of the report (approximately 2 years in 2011) led the teams to supplement the Registry data with more recent data pulled directly from their patient records. The 2015 Patient Registry report has been issued by the end of 2016 and then provide more actual data for the PHARE-M LLC5.

Sociological assessment of PHARE-M introduction

The assessment for the patient organization funding recommendations

He concluded that PHARE-M mainly impacted care quality by allowing centers to use existing resources and innovative actions to comply with CF care recommendations, and that such an impact on quality of care should improve other aims, including the partnership with families and patients, provided that the patient organization support is strengthened.

Clinic visit process redesign

During the on-site coaching visits, the clinic visit process was analyzed by the program coach coordinator according to patient shadowing and process mapping. Multidisciplinary team (MDT) staff meetings, at which patients’ situations and treatment plans were determined, were also analyzed. Observation of the multidisciplinary consultation process enabled identification of seven key steps of an “optimal” process (Fig. 1) and description of the tasks corresponding to each step (Table 2).

No.	Step	Who	What	Length (min)	Protocol
1	Installation of the patient	RN	- Setup in the dedicated room - Collection of new elements since the last visit - Verification of the results of examinations performed in the community or at the hospital - Needs for administrative documents (transport passes and certificates) - Reminder of the hygiene rules (wearing a mask) - Validation of the day’s clinic visit circuit	5–10	Hygiene — CR
2	Consultation w/nurse	RN	- Taking of measurements (weight and height) - Recording of the assessment in the patient’s electronic record - Taking stock of the treatments prescribed and taken - Care (implantable device, blood draw, etc.) - Events in the life of the patient to be prepared - Responses to the patient’s/parent’s questions	20–30	Measurement protocol (height and weight) according to the patient’s age
3	Respiratory assessment	PT	- Implementation of the hygiene protocol - Taking stock of the physiotherapy practiced in the community and review of instrumental aids - Taking stock of physical and sports activities - Physiotherapy session with sputum collection for sputum culture - Assessment of bronchial congestion - Recording of the assessment in the patient’s electronic record	40
4	PFT (pulmonary function test)		- Measurement of respiratory function - Recording in the patient’s electronic record	10	Recommendations of the American Thoracic Society
5	Other scheduled intervention		- Psychological assessment (psychologist), social assessment (social worker), or nutritional assessment (dietician) - Or individual therapeutic education session - Recording of the assessment in the patient’s electronic record	30–40
6	Medical consultation	Physician	- Additional examination - Clinical examination - Review of all treatment - Response to the patient’s/parent’s questions - Referral to the referent professional - Planning of the next visit and need for additional examinations to be performed at the hospital or in the community - Preparation of prescriptions - Recording in the patient’s electronic record - Signing of medical certificates	35–45	End of the course of consultation to benefit from assessments performed by the other professionals recorded in the patient’s electronic record
7	Departure of the patient	Admin. Sec. or RN	- Scheduling of the next appointment - Review of organization for departure (transport, nutritional need, and support) - Verification that the patient has all useful documents - Instructions for events by the next visit - Once the patient leaves the room, disinfection before accommodating the next patient.	30	Disinfection protocol

Implementation of the process first of all depends on the configuration of spaces. It also incorporates a therapeutic patient education session into the visit. It is linked to multidisciplinary staff meeting at which team members exchange information and hold discussions to ensure that the patient receives genuinely interdisciplinary care and that essential organizational aims are achieved: i) anticipating the consultations scheduled for the following week and having the professionals confirm their planning for these visits by specifying their aims for the patient; ii) drawing conclusions on the situation of the patients seen in the past week and establishing actions to be coordinated before the next visit by the professional in charge of monitoring them; and iii) preparing the visit report and scheduling the next visit.

Most coaching visits pointed out difficulties in sticking to this optimal process. At several centers, there was not enough time to review the situation of all patients seen the past week; as a solution to this problem patients having had an Annual Review or patients with specific needs were prioritized. It was sometimes difficult to get the entire MDT to meet at the same time. Patient records could not always be displayed during the staff meeting. Time was wasted on sharing data rather than making decisions. Effective meeting skills were developed and actions were taken according to a Professional Practice Evaluation process in order to improve the clinic visit process and the staff meeting.

PHARE-M standardization into a CPD program

Limitations of the program roll-out

Factors for success in replicating the US CF LLC program

Prospects for the roll-out of PHARE-M and a CQI process in CF care in France

As of early 2017, the PHARE-M has been implemented at 23 centers (out of 45) and LLC6 is ongoing with adult teams. The teams’ satisfaction is still increasing, with a median score of 9.1 for LLC5, which was a pediatric program. The outcomes of the centers will be made transparent among the professionals and the patient organization board only in the next few months. Public transparency will take more time.

The research program is aimed at assessing the impact of the PHARE-M on patient outcomes after 3 years, though it may be difficult to establish a causal link to the PHARE-M, given the evolving context in which centers operates and CF treatments are provided, and the bias inherent to recruiting centers that volunteer to participate. The realistic assessment will conduct an in-depth examination of “how and why” a stronger impact of the PHARE-M may have been observed at certain centers engaged in PHARE-M [33]. Presenting the results of the research program in 2017 and publishing on PHARE-M initiative will definitely increase the visibility of PHARE-M and raise awareness in France on this quality improvement approach.

Six years after the PHARE-M was launched in the CF network in France, half the centers have been trained, and the various stakeholders – professionals, patient organization representatives and hospital quality department members in some hospitals – perceive the strength of this LLC QI approach and wish to participate in it and contribute to rolling it out further. Interest in this approach is growing outside of CF care, for example among hospital quality professionals willing to test patient shadowing in other chronic care departments. Beyond these short-term contributions, the need for overall reflection to adapt the method to another model of care (translated in a disease specific Action Guide) requires a dedicated task force at an appropriate level of the health system. Experience with the QIP in CF may inspire its application to the care of other chronic diseases, and this article may contribute to its dissemination.