This QIP, designed according to the systematic approach described by Nelson, Batalden, and Godfrey [13], is focused on the clinical microsystem, which includes the multidisciplinary care team, patients and their family. The LLC QI format has been adopted by the CF Foundation in 2002 to support the CF centers’ work to reduce the variation in patient outcomes across the US network. This adoption included adaptations to the specificities of the care center network, such as local culture, patient population and multidisciplinary staff and the healthcare system in which it existed, as described by Godfrey and Oliver [6]. The French program is derived from the 2006 US LLC program and benefitted from the experience with and customization of the program in the US CF care network.
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
Training materials were provided free of charge by the US CFF and access to TDIMA’s electronic resources was authorized. Resources were developed before the program started in France (September 2011). They included:
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the translation of training materials, including the Action Guide for Accelerating Improvement in Cystic Fibrosis Care [14] under a Dartmouth Director supervision;
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the drafting of a French national report entitled “Registry, a Tool for Quality Improvement” (RTQI), to inform patients and parents and present the usefulness of the French CF Registry to assess improvement on patient outcomes; “The 10 Goals of the PHARE-M” (see below) and an itemization of each goal with the respective roles in a for care improvement partnership to be played by the patients, their family and the healthcare providers;
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the creation of a website dedicated to the PHARE-M (http://pharem.centre-reference-muco-nantes.fr/) containing tools, training materials and updates and serving as a messaging tool dedicated to the teams engaged in the PHARE-M; and
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the selection of a web conference tool for remote training meetings.
The 10 Goals of the PHARE-M are:
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1.
Parents and patients are full partners of the healthcare team. Each patient/family has a right to clear and understandable information.
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2.
Each patient, regardless of his or her geographical, social, and cultural circumstances, enjoys effective multidisciplinary care.
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3.
Each patient/family has a right to therapeutic education to aid in acquiring or strengthening the skills required to best manage life with cystic fibrosis.
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4.
Patients grow normally and have a normal nutritional status.
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5.
Respiratory infections and exacerbations thereof are detected as early as possible, and appropriate treatments are started without delay.
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6.
Physical and sports activities are encouraged from an early age and adapted to each patient throughout his or her life.
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7.
Suitable measures are put in place and hygiene advice is given to prevent cross-contamination.
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8.
Complications, including diabetes, are diagnosed and treated early.
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9.
All patients who progress to a state of severe respiratory failure are informed of their therapeutic alternatives, then either supported in their decision to undergo transplantation or accompanied at the end of life.
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10.
Post-transplant care aims at sustainable improvement in quality of life and in physical, psychological, and social health.
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.
Close collaboration with the TDIMA and the CFF was sustained over the course of LLC1 through:
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the participation of members of the national team, as well as physicians at several pilot centers, in the adult LLC session at the North American conference in Anaheim (October 2011);
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the participation of the Director of TDIMA Clinical Microsystem Group in the third face-to-face meeting to supervise the poster session meeting (PHARE-M LLC1, Marseille, March 2012);
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the trainings for the physiotherapist and the parent on the national team in the TDIMA’s “eCoach the Coaches” course at the same time as the PHARE-M LLC1.
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.
The main adaptations in the PHARE-M LLC2 were:
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Drafting of a second version of the Action Guide illustrated with examples from the French teams in LLC1 instead of examples borrowed from the American teams;
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Reduction of certain theoretical presentations in the training materials in favor of more exercises during face-to-face meetings;
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Updated and revised version of the RTQI with was more systematically offered to patients/parents and professionals, either in its entirety or as separate chapters focusing on the goal chosen by the team at the center;
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Formalization of the “PHARE-M referent” role on each quality improvement team, for a non-physician professional subsidized by the patient organization;
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Incentive to enlist a quality engineer from the hospital quality department on the quality improvement team at the center, this professional sometimes becoming the PHARE-M referent;
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One on-site coaching of the team at each center, offered during a visit by the program coordinator and focusing on mapping the clinic process with the “Shadowing a Patient” method [19]; and
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Simplification of the PHARE-M website by withdrawing the PHARE-M specific messaging tool for the teams engaged in the PHARE-M as they did not use it in addition to their existing messaging tool.
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’ satisfaction and suggestions were recorded at every face-to-face meeting and web conference during LLC2. They led to two more adjustments to the training material:
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rearrangement of the content of the third and fourth face-to-face sessions by moving up the benchmarking visit and delaying the poster at the end of the LLC session; and
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strengthening of the link with TPE, underlying the importance of programming time for educational sessions during the clinic visit, focusing on the improvement goal and particular needs of the patient.
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 [22,23,24], 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.