Experiences Among Patients With Cystic Fibrosis in the MucoExocet Study of Using Connected Devices for the Management of Pulmonary Exacerbations: Grounded Theory Qualitative Research.

BACKGROUND: Early detection of pulmonary exacerbations (PEx) in patients with cystic fibrosis is important to quickly trigger treatment and reduce respiratory damage. An intervention was designed in the frame of the MucoExocet research study providing patients with cystic fibrosis with connected devices and educating them to detect and react to their early signs of PEx. OBJECTIVE: This study aims to identify the contributions and conditions of home monitoring in relation to their care teams from the users' point of view to detect PEx early and treat it. This study focused on the patients' experiences as the first and main users of home monitoring. METHODS: A qualitative study was conducted to explore patients' and professionals' experiences with the intervention. We interviewed patients who completed the 2-year study using semistructured guides and conducted focus groups with the care teams. All the interviews were recorded and transcribed verbatim. Their educational material was collected. A grounded analysis was conducted by 2 researchers. RESULTS: A total of 20 patients completed the study. Three main categories emerged from the patients' verbatim transcripts and were also found in those of the professionals: (1) task technology fit, reflecting reliability, ease of use, accuracy of data, and support of the technology; (2) patient empowerment through technology, grouping patients' learnings, validation of their perception of exacerbation, assessment of treatment efficacy, awareness of healthy behaviors, and ability to react to PEx signs in relation to their care team; (3) use, reflecting a continuous or intermittent use, the perceived usefulness balanced with cumbersome measurements, routinization and personalization of the measurement process, and the way data are shared with the care team. Furthermore, 3 relationships were highlighted between the categories that reflect the necessary conditions for patient empowerment through the use of technology. CONCLUSIONS: We discuss a theorization of the process of patient empowerment through the use of connected devices and call for further research to verify or amend it in the context of other technologies, illnesses, and care organizations. TRIAL REGISTRATION: ClinicalTrials.gov NCT03304028; https://clinicaltrials.gov/ct2/show/results/NCT03304028.

How to integrate a patient partner into a care team? / Comment intégrer un patient partenaire dans une équipe de soins ?

Introduction: It is not rare anymore to find patients with knowledge and experience of a care pathway integrating a team of health professionals in order to improve the quality and relevance of their peers' care pathways. Purpose of research: The aim of this article is to propose practical methodological answers and structuring questions to institutions and any health actor interested in integrating a Patient Partner (PP) into a team of health professionals. Results: The results of an action-research (AR) carried out within a Cancer Treatment Centre (CTC) provide both a methodological framework and answers to the questions raised by this experimentation: How did the team and the PP organize themselves to implement the mission of peer support? What evaluations of the project should be put in place? How does everyone find their place in the project? And finally, what are the operational procedures, limits, and levers for integrating the PP into the team? Conclusions: In the discussion section, we propose a model of experimentation based on AR, highlighting the main drivers and the interventions that feed them. Finally, we share a series of structuring questions arising from the co-construction work carried out by the people involved, which allowed us to build our action plan for the integration of a PP in the care team at the Rennes CTC, and which seems to us sufficiently generalizable to be tested and used by other teams and in other contexts.

Introduction: Il n'est plus rare aujourd'hui de rencontrer des patients ayant la connaissance et l'expérience d'un parcours de soins, intégrer une équipe de professionnels de santé afin d'améliorer la qualité et la pertinence du parcours de soins de leurs pairs. But de l'étude: L'objectif de cet article est de proposer, aux institutions et à tout acteur de la santé qui envisagent d'intégrer un patient partenaire (PP) dans une équipe de professionnels de santé, des réponses méthodologiques pratiques et des questions structurantes pouvant soutenir leur expérimentation. Résultats: Les résultats issus d'une recherche-action (R-A) menée au sein d'un centre de lutte contre le cancer permettent à la fois de fournir un cadre méthodologique de coconstruction et d'apporter des réponses aux questions soulevées par les acteurs au cours de cette expérimentation : comment l'équipe et le PP se sont-ils organisés pour mettre en œuvre la mission de pair-accompagnant ? Quelles évaluations du projet mettre en place ? Comment chacun trouve-t-il sa place dans le projet ? Et finalement, quelles sont les modalités opérationnelles, les limites et leviers de l'intégration du patient partenaire dans l'équipe ? Nous proposons dans la partie discussion un modèle de l'expérimentation issu de la R-A mettant en exergue les drivers principaux ainsi que les interventions qui les nourrissent. Conclusions: Enfin, nous partageons une série de questions structurantes issues du travail de coconstruction des acteurs, qui nous a permis d'établir notre plan d'action pour l'intégration d'une PP dans l'équipe de soins au CLCC de Rennes (35), et qui nous semble suffisamment généralisable pour être testée et utilisée par d'autres équipes et dans d'autres contextes.

Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study.

BACKGROUND: Early detection of pulmonary exacerbations (PEx) in patients with cystic fibrosis (CF) is important to quickly trigger treatment and reduce respiratory damage. We hypothesized that using home-based and wearable connected devices (CDs) and educating patients to react in case of abnormal variations in a set of parameters would allow patients to detect and manage their PEx early with their care team. OBJECTIVE: This qualitative study aimed to assess the feasibility and appropriate conditions of a new PEx management process from the users' point of view by analyzing the experience of patients and of CF center teams regarding the education program, the use of CDs, and the relationship between the patient and the care team during PEx management. METHODS: We have been conducting a multicenter pilot study involving 36 patients with CF aged ≥12 years. The intervention was divided into 3 phases. In phase 1 (3 months), patients were equipped with CDs, and their parameters were collected on 3 nonconsecutive days each week. Phase 2 involved the development of a "React to PEx" educational program aimed at providing patients with a personalized action plan. A training session to the educational program was organized for the physicians. Physicians then determined the patients' personalized alert thresholds by reviewing the data collected during phase 1 and their patients' clinical history. In phase 3 (12 months), patients were educated by the physician during a clinic visit, and their action plan for reacting in timely fashion to their PEx signs was defined. Education and action plans were revised during clinic visits. At the end of the project, the patients' experience was collected during semistructured interviews with a researcher as part of the qualitative study. The experience of CF teams was collected during focus groups using a semistructured guide once all their patients had finished the study. The interviews and focus groups were recorded and transcribed verbatim to be analyzed. Data from educational sessions were collected throughout the educational program to be put into perspective with the learnings reported by patients. Analyses are being led by 2 researchers using NVivo (QSR International). RESULTS: The study received the favorable reception of the Committee for the Protection of Persons (CPP NORTH WEST III) on June 10, 2017 (#2017-A00723-50). Out of the 36 patients included in phase 1, 27 were educated and entered phase 3. We completed collection of all data from the patients and care providers. Qualitative analysis will provide a better understanding of users' experience on the conditions of data collection, how useful CDs are for detecting PEx, how useful the PEx action plan is for reacting quickly, what patients learned about PEx management, and the conditions for this PEx management to be sustainable in routine care. CONCLUSIONS: This study will open new perspectives for further research into the implementation of an optimal PEx care process in the organization of care teams in order to support patient self-management. TRIAL REGISTRATION: ClinicalTrials.gov NCT03304028; https://clinicaltrials.gov/ct2/show/results/NCT03304028. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14552.

Consensus Recommendations for the Use of Simulation in Therapeutic Patient Education.

INTRODUCTION: Simulation is rarely used to help individuals with chronic diseases develop skills. The aim of the study was to provide recommendations for the use of simulation in therapeutic patient education (S-TPE). METHODS: Expert consensus was achieved with the participation of the following 3 groups of experts: (a) expert patients and caregivers; (b) health professionals specialized in therapeutic patient education (TPE); and (c) simulation experts. Each expert received a list of questions by e-mail in 3 iterations. The synthesis of the 2 first questionnaires resulted in 34 first recommendations voted during the consensus conference meeting. Each recommendation was subject to an extensive literature review. The quality of the evidence and the strength of the recommendations were assessed through the evaluation, development, and evaluation criteria categories (GRADE criteria). The third questionnaire selected and illustrated recommendations more specific to the use of S-TPE. RESULTS: At the end of the process, the experts identified 26 recommendations specific to the use of S-TPE. They proposed examples of skills in different diseases and stressed the importance of adapting the conditions of use (location, equipment, time of the care) to the circumstances of the patient learner and skills to be developed. Experts should exercise great caution as this technique presents ethical considerations related to patient care. CONCLUSIONS: These recommendations underline the fact that simulation could bring added value to TPE. They provide a framework and examples for the experimental use of simulation in TPE. Research into feasibility and acceptability is needed.

A quality improvement program to improve nutritional status of children with Cystic Fibrosis aged 2-12 years old over a 3 year period at CF center Roscoff, Brittany.

BACKGROUND: The Cystic Fibrosis (CF) center in Roscoff (Brittany) has been involved in therapeutic education programs (TEP) since 2006 and took part in the pilot phase of the French quality improvement program (QIP) since 2011. The aim was to improve the nutritional status of children with cystic fibrosis aged 2-12 years old in order to optimize their health status as they enter adolescence. METHODS: A multidisciplinary quality team was created in order to select and address a specific health problem among our pediatric population. Following analysis of yearly indicators for our CF center, our team chose to improve quality of care concerning nutritional status of children aged 2-12 years old. Factors influencing efficacy were studied, tools were developed to implement a new nutritional program, results were analyzed on a real-time basis. RESULTS: Over the 3 year period, all patients from 2 years of age, were monitored with the new follow-up program (2012: N = 34; 2014: N = 44). Each patient was followed up at every clinic visit, their BMI z-score was calculated to decide their nutritional risk and personalize their follow-up program consequently. Between 1/1/2012 and 31/12/2014, the mean BMI z-score of the open cohort improved from -0.49 to -0.22. CONCLUSIONS: Since 2014, focus on nutrition using the newly-adapted program has become routine practice at each follow-up visit. Patients and parents expressed a high level of satisfaction (75% very satisfied). The follow-up program aimed at improving nutritional status for children aged 2-12 years old was successfully implemented and integrated into routine practice; it was therefore extended to all children with CF (1 month - 18 years) in our center. The relationship among professional and patients and parents was strengthened.

Lessons from patient and parent involvement (P&PI) in a quality improvement program in cystic fibrosis care in France.

BACKGROUND: Quality Improvement Programs (QIP) in cystic fibrosis (CF) care have emerged as strategies to reduce variability of care and of patient outcomes among centres facilitating the implementation of Best Practices in all centres. The US CF Foundation developed a Learning and Leadership Collaborative program which was transposed in France in 2011. Patient and parent involvement (P&PI) on the local quality teams (QTs) is one dimension of this complex intervention. The conditions and effects of this involvement needed to be evaluated. METHODS: In all settings, patients and parents were recruited by their centre care team. They were trained to QI method and tools and contributed their own expertise to improve the process of care. This involvement has been analyzed in the frame of the whole process evaluation. Observations and interviews conducted during the course of the first training year explored the motivations of the patients and parents to participate and the vision of the health care teams. A research study was carried out after three years with the patients/parents and the professionals to assess the French QIP's effectiveness using a questionnaire to report their opinions on various components of the program, including their experience of P&PI. Responses were analyzed in view of identifying consensus and dissensus between the two groups. RESULTS: At the introduction of the program, P&PI was an opportunity for healthcare providers to reflect on their conceptions of these individuals both as patients and as healthcare system users. Curiosity about the teams' functioning, the various center organizations and outcomes led patients to overcome their initial barriers to participation. Seventy-six people including 12 patients/parents from the 14 pilot centres responded to the questionnaire after 3 years. Consensus between professionals and patients/parents was high on most items characterizing the performance of the QIP, QT effectiveness and QT functioning. Patients, parents and professionals agreed on the main characteristics of care such as an optimized organization, multidisciplinary care and patient-centredness. Regarding the use of patient electronic records, the use of care guidelines or the organization of support in the patient community, responses were not consensual amongst patients/parents and a source of dissensus between the two groups. All agreed that the French QIP created good conditions for their involvement. In the end, both groups agreed that it was difficult to attribute the paternity of some changes specifically to any member in the team. DISCUSSION: Perspectives such as an educational framework to develop the skills and behaviors of professionals engaged in collaborative practice with patients and families and large patient experience surveys could be used to capture patients' experience of care in the improvement work. CONCLUSION: Success factors for patient/parent long-term involvement in QIPs have been identified. Answers to questions raised by the stakeholders about the feasibility, efficiency and usefulness of P&PI in this CF QIP could be given but new questions arose about the sustainability of continuous quality improvement over time.

Quality of care in cystic fibrosis: assessment protocol of the French QIP PHARE-M.

BACKGROUND: The PHARE-M care quality improvement program, modeled on the US Cystic Fibrosis Quality Improvement Program, was introduced at 14 cystic fibrosis centers (CFCs) in the French Cystic Fibrosis Network between 2011 and 2013. The pilot phase assessments attested the progressive adherence of the teams and improvements in care management. The PHARE-M Performance research project aims at assessing in 2015 the impact of the PHARE-M program on patient health indicators at trained versus untrained centers. It also sought to identify contextual factors that could account for variability in the performance of the PHARE-M among the trained centers. METHODS: A mixed methodology combining: a quantitative experimental study: a comparison, using a mixed model for repeated data (from 2011 to 2015), of the average changes over time in forced expiratory volume in 1 s (FEV1) and body mass index (BMI) between two groups of patients included in a closed cohort (non-transplant patients, continuous follow-up at one participating CFC, and a CF-causing mutation), one having benefitted from the PHARE-M program and the other not having done so, and a realistic study: a characterization of the impact on care management and an identification of mechanisms through which the PHARE-M intervention improved the team's effectiveness in different CFC contexts; this required modeling the intervention, context, and impact on care management with respect to the criteria of the chronic care model (CCM); this was done using a self-administered questionnaire given to professionals and patients/parents supplemented with focus groups. CONCLUSION: Although the study population was controlled, it may be difficult to establish a causal relationship between the differences in the changes over time in patient health indicators in the two groups of patients and the PHARE-M intervention as it is often the case in complex interventions rolled out in adaptive environments. The analysis of factors associated with variations in the impact of the PHARE-M at the different trained CFCs required the adoption of instruments validated in other contexts; these could be useful for assessing the performance of other interventions in healthcare practices at CFCs in France.

A quality improvement program for adolescents with cystic fibrosis: focus on psychosocial skills.

BACKGROUND: The two pediatric cystic fibrosis centers (CFCs) in Paris (Robert Debré) and Nantes, France, have been developing therapeutic patient education (TPE) programs since 2006 and have been engaged in the pilot phase of the quality improvement program (QIP) named the Hospital Program to Improve Outcomes and Expertise in Cystic Fibrosis (PHARE-M) since 2011. The objective was to improve the FEV1 of the cohort of adolescents to prepare them for their optimal transition to an adult CFC. METHODS: The two CFCs formed a multidisciplinary quality team and used the analysis of causes of insufficient respiratory function taking into account the adolescents' psychosocial factors. At the Nantes CFC, the approach was centered on adolescents' body image and their motivation to take care of themselves by assigning specific aspects of patient follow-up to each professional in the team. At R. Debré, an individual cause-and-effect diagram identified for each patient the medical and psychosocial factors that could account for insufficient respiratory function. Personalized actions were offered to each patient. RESULTS: In 2014, the median FEV1 (Forced Expiratory Volume in 1 Second) of the adolescent cohort exceeds 90% at the 2 CFCs (Nantes and R. Debré). Between 2011 and 2014 both centers improved their ranking for FEV1% in adolescents in the Registry histograms. At R. Debré, the personalized process allowed to reinforce equality of care, offering to all the opportunity to benefit from TPE sessions and coaching with an adapted physical activity teacher. The psychologist developed a specific tool to support the patient-centered process. CONCLUSION: The link between TPE and QIP was strong at our two centers enhancing patient centered care and targeting an optimal transition to an adult program.

Lessons from the on-site quality audit of data transmitted to the French cystic fibrosis registry.

BACKGROUND: The French Cystic Fibrosis Registry takes a census of the population of patients and records their annual data transmitted by Cystic Fibrosis Centers (CFCs). Quality of patient data has been a focus in the past years, with the implementation of automated controls before data integration. The objective was to assess, at the 14 CFCs trained in the quality improvement named Hospital Program to Improve Outcomes and Expertise in Cystic Fibrosis (PHARE-M), the quality of the 2012 and 2013 data transmitted to the French Registry with respect to the rules established to obtain forced expiratory volume in 1 second (FEV1%) and anthropometric data. METHODS: The clinical researcher selected 20 patients at each CFC from age ranges corresponding to different visit frequencies and measurement procedures in order to reach saturation of error causes. The control consisted in comparing source data, pulmonary function tests (PFTs), patient records, and data in the Registry. RESULTS: The audit focused on 242 patients, 2455 consultations and 1855 PFTs. Less than 5% of data concerning weight, height, or FEV1 (L) in the patient records files had discrepancies with source data. Discrepancies on patient height between patient records and PFT files were found in 11% of cases. For one hundred and ten patients (45%), anomalies were found between the patient record and the Registry for the FEV1% and the associated anthropometric measurements mainly related to the interpretation of the selection rule of the venue corresponding to the "best spirometry in the year" and the reference standard used (local standards versus Knudson reference equations). For the 33 children in the age range of 6-17 years old (27% out of 120 children records controlled), the FEV1% value in the Registry presented an average deviation of +4.25% (min. = -9.3%; max. = +16.9%; median = 4%) with the value from the Patient record. CONCLUSIONS: This first on-site quality audit of the data transmitted to the Registry pointed out variability in the measurement process at the CFCs. The rule for selecting the data for the Registry was applied differently at some CFCs, and various local References for the FEV1% calculation were used. Avenues for improvement have been identified.

Introduction of a collaborative quality improvement program in the French cystic fibrosis network: the PHARE-M initiative.

BACKGROUND: An agreement, signed in 2007 by the 49 French Cystic Fibrosis Centers, included a commitment to participate, within the next 5 years, in a care quality assessment and improvement program (QIP). The objective was to roll out in the French Cystic Fibrosis (CF) care network a QIP adapted from the US program for Accelerating Improvement in Cystic Fibrosis Care developed by The Dartmouth Institute Microsystem Academy (TDIMA) and customized by the US CF Foundation between 2002 and 2013. METHODS: The French national team at the Nantes-Roscoff CF Center of Expertise was trained at TDIMA and visited US CF centers involved in US Learning and Leadership Collaboratives (LLCs). It introduced the PHARE-M QIP in France by transposing the Action Guide and material. A PHARE-M LLC1 including seven centers, underwent two external assessments. Adjustments were made, then a PHARE-M LLC2 was rolled out at seven more centers in two regions. On-site coaching was strengthened. The teams' satisfaction was assessed and further adjustments were made. In 2014, the program sought recognition as a continuing education program for healthcare professionals. RESULTS: Ninety-six trainees including 14 patients/parents from the 14 CFCs volunteered to participate, test and adapt the program during LLC1 and LLC2 sessions. Comparison of patient outcomes collected in the Registry report by CF center, reflection on potential best practices, selection by each team of an improvement theme, implementation of improvement actions, and exchanges between teams fostered the adhesion of the teams. The program strengthened quality of care, interdisciplinary functioning and collaboration with patients/parents at the centers. The satisfaction expressed by the teams increased over time. A post-PHARE-M cycle maintains the focus on continuous quality improvement (CQI). In 2015, PHARE-M was recognized as a continuing professional development program in healthcare. CONCLUSIONS: The PHARE-M is a complex intervention in multidisciplinary teams working in a variety of hospital settings. A confluence of factors motivated teams to engage in the program. Involving Patient/Parent in quality improvement (QI) work and developing patient therapeutic education for self-management appeared to be complementary approaches to improve care. Incorporating the program into hospital continuing education insures its sustainability. Transparency of Patient Registry indicators per center published in a brief lapse of time is required to effectively support CQI. The impact of the PHARE-M on patient outcomes after 3 years is the subject of a research program funded by the French Ministry of Health whose results will be available in 2017.

[Towards the active participation of users in quality approaches]. / Vers une participation active des usagers dans les démarches qualité.

Since the 1990s, the quality approach has been developing in hospitals in accordance with an assessment strategy, based on reference guidelines, or with a continuous quality improvement strategy, more favourable to the participation of players. The increase in chronic diseases encourages the participation of patients, with their own particular expertise on the disease and the associated care. Patients can also be involved in a collective mission, favourable to the improvement of the care provision.