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.

Predictors of nursing home placement at 2 years in Alzheimer's disease: A follow-up survey from the THERAD study.

OBJECTIVES: Nursing Home Placement (NHP) can prove to be the only solution to some dead-end situations in Alzheimer's disease (AD). The predictors of NHP are known and can be related to either the person with dementia or his/her caregiver. We aimed to identify predictors of NHP among people with AD over a 2-year follow-up period, with a particular interest in the modifiable predictors, notably those involving caregivers. METHODS: We studied data from the THERAD study, a French monocentric randomized controlled trial, involving 196 community-dwelling dyads, primarily assessing an educational intervention in AD. We performed a bivariate analysis followed by a multivariate Cox model, with a backward stepwise procedure. RESULTS: The mean age of the patients was 82 years old, 67.7% were women and 56.9% were living with a partner. The mean age of the caregivers was 65.8 years old, 64.6% were women and half were spouses of the patients with a moderate burden. During the follow-up, 23 patients died and 49 were institutionalized. The majority of NHPs occurred during the first year (35 NHP). The mean time to NHP was 27.77 months after the diagnosis. Five independent predictors of NHP were found: a higher patient education level (aHR 6.31; CI95% = 1.88-21.22), a high caregiver Burden (aHR 3.97; CI95% = 1.33-11.85), the caregiver being the offspring of the patient (aHR 2.92; CI95% = 1.43-5.95), loss of autonomy (aHR 2.75; CI95% = 1.13-6.65) and disinhibition as a behavioural and psychological symptoms of dementia (BPSD) (aHR 2.38; CI95% = 1.26-4.47). CONCLUSIONS: Our data are in accordance with the literature in identifying loss of autonomy, burden and BPSD (disinhibition) as risk factors of NHP. We also found high patient education level and status of offspring caregiver as additional factors. It is essential to take into account the caregiver status when designing psychoeducational trials aiming to delay NHP. Further studies need to take into account both the modifiable risk factors related to the patient (productive BPSD) and the needs of offspring caregivers (work-life balance, mental load).

Impact of an educational programme on Alzheimer's disease patients' quality of life: results of the randomized controlled trial THERAD.

BACKGROUND: Although educational interventions are recommended in Alzheimer's disease (AD), studies assessing the impact of interventions such as "therapeutic patient education" are scarce. Indeed, the intrinsic nature of the disease is considered a barrier to patients' involvement in such approaches. We aimed to evaluate an intervention by using a "dyadic" approach (patient and caregiver) in both intervention and assessment. METHODS: THERAD is a monocentric, randomized, controlled trial assessing the effects of a 2-month educational programme in mild to moderately severe AD patients among 98 dyads (caregiver/patient) on caregiver-reported patient quality of life (QOL) at 2 months. Community-dwelling patients and their caregivers were recruited in ambulatory units of the French Toulouse University Hospital. Self-reported patient QOL, autonomy, behavioural and psychological symptoms and caregiver QOL and burden were collected at 2, 6 and 12 months. Linear mixed models were used in modified intention-to-treat populations. We also performed sensitivity analysis. RESULTS: A total of 196 dyads were included, 98 in each group. The mean age of the patients was 82 years, 67.7% were women, diagnosed with AD (+/- cerebrovascular component) (mean MMSE =17.6), and 56.9% lived with a partner. The mean age of the caregivers was 65.7 years, and 64.6% were women (52.3% offspring/42.6% spouses), with a moderate burden (mean Zarit score = 30.9). The mean caregiver-reported patient QOL was lower than the self-reported QOL (28.61 vs. 33.96). We did not identify any significant difference in caregiver-reported patients' QOL (p = 0.297) at 2 months, but there was a significant difference in self-reported patients' QOL at 2 months (p = 0.0483) or 6 months (p = 0.0154). No significant difference was found for the secondary outcomes. The results were stable in the sensitivity analyses. CONCLUSIONS: This randomized controlled trial assessing an educational intervention in 196 dyads (Alzheimer's disease affected patient/caregiver) highlights the need to better consider the patient's point of view, since only the self-reported QOL was improved. Additional studies using this dyadic approach are necessary in targeted subpopulations of caregivers (spouse vs. child, gender) and of patients (severity of cognitive impairment or behavioural disturbances) TRIAL REGISTRATION: THERAD study NCT01796314 . Registered on February 19, 2013.

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.

Identifying specific needs in adult cystic fibrosis patients: a pilot study using a custom questionnaire.

BACKGROUND: Adult patients with cystic fibrosis (CF) experience daily physical symptoms and disabilities that can be challenging to address for health care teams. METHODS: We sought to identify the most frequent topics that CF adults need to discuss with health care teams using a custom questionnaire including 62 items. RESULTS: Fifty patients were included, 70% men, mean age 27.6 years, with a mean body mass index of 21.8 kg/m2. Mean FEV1% was 64% of predicted value. Forty-two percent of patients selected at least one topic. The most frequently selected topics were fatigue (20%), professional or scholar worries (18%), procreation (16%), physical activities (16%) and evolution of CF disease (16%). Women were more frequently concerned about fatigue, procreation and profession/school. CONCLUSIONS: Using a custom questionnaire, we identified that CF adults express various unmet needs that extend beyond usual respiratory and nutritional concerns or treatment adherence. The interest of this questionnaire by health care team for improving therapeutic management of CF patients remains to be validated. TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov (NCT02924818) on 5th October 2016.

Factors Associated with Potentially Inappropriate Transfer to the Emergency Department among Nursing Home Residents.

OBJECTIVES: To determine the factors associated with the potentially inappropriate transfer of nursing home (NH) residents to emergency departments (EDs) and to compare hospitalization costs before and after transfer of individuals addressed inappropriately vs those addressed appropriately. DESIGN: Multicenter, observational, case-control study. SETTING AND PARTICIPANTS: 17 hospitals in France, 1037 NH residents. MEASURES: All NH residents transferred to the 17 public hospitals' EDs in southern France were systematically included for 1 week per season. An expert panel composed of family physicians, emergency physicians, geriatricians, and pharmacists defined whether the transfer was potentially inappropriate or appropriate. Residents' and NHs' characteristics and contextual factors were entered into a mixed logistic regression to determine factors associated independently with potentially inappropriate transfers. Hospital costs were collected in the national health insurance claims database for the 6 months before and after the transfer. RESULTS: A total of 1037 NH residents (mean age 87.2 ± 7.1, 68% female) were transferred to the ED; 220 (21%) transfers were considered potentially inappropriate. After adjustment, anorexia [odds ratio (OR) 2.41, 95% confidence interval (CI) 1.57-3.71], high level of disability (OR 0.90, 95% CI 0.81-0.99), and inability to receive prompt medical advice (OR 1.67, 95% CI 1.20-2.32) were significantly associated with increased likelihood of potentially inappropriate transfers. The existence of an Alzheimer's disease special care unit in the NH (OR 0.66, 95% CI 0.48-0.92), NH staff trained on advance directives (OR 0.61, 95% CI 0.41-0.89), and calling the SAMU (mobile emergency medical unit) (OR 0.47, 95% CI 0.34-0.66) were significantly associated with a lower probability of potentially inappropriate transfer. Although the 6-month hospitalization costs prior to transfer were higher among potentially inappropriate transfers compared with appropriate transfers (€6694 and €4894, respectively), transfer appropriateness was not significantly associated with hospital costs. CONCLUSIONS AND IMPLICATIONS: Transfers from NHs to hospital EDs were frequently appropriate. Transfer appropriateness was conditioned by NH staff training, access to specialists' medical advice, and calling the SAMU before making transfer decisions. TRIAL REGISTRATION: clinicaltrials.gov, NCT02677272.

Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial.

Importance: Dementia is often underdiagnosed in nursing homes (NHs). This potentially results in inappropriate care, and high rates of emergency department (ED) transfers in particular. Objective: To assess whether systematic dementia screening of NH residents combined with multidisciplinary team meetings resulted in a lower rate of ED transfer at 12 months compared with usual care. Design, Setting, and Participants: Multicenter, cluster randomized trial with NHs as the unit of randomization. The IDEM (Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units) trial took place at 64 public and private NHs in France. Recruitment started on May 1, 2010, and was completed on March 31, 2012. Residents who were aged 60 years or older, had no diagnosed or documented dementia, were not bedridden, had lived in the NH for at least 1 month at inclusion, and had a life expectancy greater than 12 months were included. The residents were followed up for 18 months. The main study analyses were completed on October 14, 2016. Intervention: Two parallel groups were compared: an intervention group consisting of NHs that set up 2 multidisciplinary team meetings to identify residents with dementia and to discuss an appropriate care plan, and a control group consisting of NHs that continued their usual practice. During the inclusion period of 23 months, all residents of participating NHs who met eligibility criteria were included in the study. Main Outcomes and Measures: The primary end point (ED transfer) was analyzed at 12 months, but the residents included were followed up for 18 months. Results: A total of 64 NHs participated in the study and enrolled 1428 residents (mean [SD] age, 84.7 [8.1] years; 1019 [71.3%] female): 599 in the intervention group (32 NHs) and 829 in the control group (32 NHs). The final study visit was completed by 1042 residents (73.0%). The main reason for early discontinuation was death (318 residents [22.7%]). The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24). Conclusions and Relevance: This study failed to demonstrate that systematic screening for dementia in NHs resulted in fewer ED transfers. The findings do not support implementation of multidisciplinary team meetings for systematic dementia screening of all NH residents, beyond the national recommendations for dementia diagnosis, to reduce ED transfers. Trial Registration: ClinicalTrials.gov Identifier: NCT01569997.

Factors predisposing nursing home resident to inappropriate transfer to emergency department. The FINE study protocol.

BACKGROUND: Each year, around one out of two nursing home (NH) residents are hospitalized in France, and about half to the emergency department (ED). These transfers are frequently inappropriate. This paper describes the protocol of the FINE study. The first aim of this study is to identify the factors associated with inappropriate transfers to ED. METHODS/DESIGN: FINE is a case-control observational study. Sixteen hospitals participate. Inclusion period lasts 7 days per season in each center for a total period of inclusion of one year. All the NH residents admitted in ED during these periods are included. Data are collected in 4 times: before transfer in the NH, at the ED, in hospital wards in case of patient's hospitalization and at the patient's return to NH. The appropriateness of ED transfers (i.e. case versus control NH residents) is determined by a multidisciplinary team of experts. RESULTS: Our primary objective is to determine the factors predisposing NH residents to inappropriate transfer to ED. Our secondary objectives are to assess the cost of the transfers to ED; study the evolution of NH residents' functional status and the psychotropic and inappropriate drugs prescription between before and after the transfer; calculate the prevalence of potentially avoidable transfers to ED; and identify the factors predisposing NH residents to potentially avoidable transfer to ED. DISCUSSION: A better understanding of the determinant factors of inappropriate transfers to ED of NH residents may lead to proposals of recommendations of better practice in NH and would allow implementing quality improvement programs in the health organization.

Impact of a therapeutic educational program on quality of life in Alzheimer's disease: results of a pilot study.

BACKGROUND: Therapeutic patient education is expanding in the field of Alzheimer's disease (AD). OBJECTIVE: To evaluate the impact of a therapeutic educational program, on AD-affected patients and their caregivers, living in the community, on the patient's quality of life. METHODS: Non experimental before and after study. Patient/caregiver dyads were recruited in the geriatric department of the Toulouse University Hospital. The intervention consisted of an educational program, designed for both patients and caregivers. It included two individual sessions (at baseline (M0) and two months later (M2)) and four group sessions for caregivers only, one per week between M0 and M2. The primary outcome was the patient's quality of life at two months, hetero-evaluated by the caregiver. We compared the QoL-AD score between M0 and M2 with a paired Student's test. The secondary outcomes were patient's autonomy (activities of daily living) and caregiver's burden (Zarit Burden interview). RESULTS: 29 patient/caregiver dyads were recruited. The QoL-AD score was 24.6 ± 5.1 at M0 versus 27.2 ± 6.0 at M2 (p = 0.038). This difference is statistically significant. There was no difference in the secondary outcomes. CONCLUSION: This study revealed a significant positive impact of a therapeutic educational program on patients' quality of life. Our results led us to design a randomized controlled trial called the THERAD study (THERapeutic education in Alzheimer's disease). It started in January 2013, and the results will be available in 2015. If the efficacy of this approach is proven, it will be important to implement educational programs in the care plan of these patients.

Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer's disease patients' quality of life.

INTRODUCTION: Therapeutic education is expanding in the management of Alzheimer's disease (AD) patients. Several studies have revealed a positive impact of therapeutic educational programmes on the caregiver's burden and/or quality of life. However, to date, no study has evaluated its impact on the quality of life of the AD patient. METHODS: The THERAD study (THerapeutic Education in Alzheimer's Disease) is a 12-month randomised controlled trial that started in January 2013. This paper describes the study protocol. THERAD plans to enroll 170 dyads (AD patient and caregiver) on the basis of the following criteria: patient at a mild to moderately severe stage of AD, living at home, receiving support from a family caregiver. The main outcome is the patient's quality of life assessed by the Logsdon QoL-AD scale at 2 months, reported by the caregiver. The study is being led by geriatricians trained in therapeutic education at Toulouse University Hospital in France. To date, 107 caregiver/patient dyads have been recruited. CONCLUSION: This is the first trial designed to assess the specific impact of a therapeutic educational programme on the AD patient's quality of life. The final results will be available in 2015. TRIAL REGISTRATION: [ClinicalTrials.gov: NCT01796314] Registered 19 February 2013.

[A multiprofessional team for children living with sickle-cell anemia]. / Une équipe pluriprofessionnelle auprès d'enfants atteints de drépanocytose.

Sickle-cell anaemia is a rare hereditary disease characterised by abnormal blood cells. It causes highly painful vaso-occlusive crises. Multi-professional care is encouraged through the intervention of a network.

Factors associated with undertreatment of atrial fibrillation in geriatric outpatients with Alzheimer disease.

BACKGROUND: According to international recommendations [from the American College of Cardiology/American Heart Association/European Society of Cardiology] and those of the Haute Autorité de Santé (HAS) in France, treatment with a vitamin K antagonist is recommended in patients with atrial fibrillation (AF) in the presence of a high thromboembolic risk factor [history of stroke, transient ischemic attack, systemic embolism, or valvular heart disease, or presence of a mechanical heart valve prosthesis] or at least two moderate risk factors (age ≥75 years, hypertension, congestive heart failure, or diabetes). In patients with a major contraindication, the vitamin K antagonist can be replaced by an antiplatelet agent (APA). These recommendations are not systematically observed in patients with Alzheimer disease (AD). The aim of our study was to determine the factors associated with undertreatment of AF in geriatric outpatients with AD. METHODS: Use of oral anticoagulants or APAs was studied in 66 patients with AF who were included in the French Network on Alzheimer Disease (REAL.FR) cohort, consisting of 686 outpatients living at home, supported by an informal caregiver, and suffering from Alzheimer-type dementia, with a Mini Mental Status Examination (MMSE) score between 10 and 26. First, demographic characteristics (age, sex, body mass index [BMI], living arrangements, educational level), medical conditions (comorbidity, number of medications), disability (activities of daily living [ADL], instrumental activities of daily living [IADL]), risk of falls (one-leg balance test), cognitive status (according to MMSE, Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog], and Clinical Dementia Rating [CDR] scores), risk factors for stroke (hypertension, history of stroke, congestive heart failure, diabetes, or age ≥75 years) and potential contraindications to oral anticoagulants (OACs) or APAs (polypharmacy, risk of falls, renal failure, gastrointestinal diseases) of patients receiving OACs were compared with those of patients receiving APAs and those of patients receiving no treatment for AF. Then the same characteristics were compared between patients receiving no treatment for AF and those receiving OACs or APAs. RESULTS: Only 56 % (n = 37) of patients with AF were receiving OACs or APAs at the baseline visit, of whom 18 (49 %) were receiving OACs and 19 (51 %) were receiving APAs. Bivariate analysis showed that patients receiving OACs or APAs were significantly more likely to have a history of cardiovascular disease (p = 0.005)-in particular, hypertension (p = 0.037)-less likely to be living alone and unaided (p = 0.038), and less likely to be taking nonsteroidal anti-inflammatory drugs [NSAIDs] (p = 0.001). CONCLUSION: Despite the national and international recommendations, nearly half of AD patients with AF do not receive OACs or APAs. A history of cardiovascular disease-in particular, hypertension-improves access to treatment, but use of NSAIDs and living alone without home care seem to be the main factors associated with non-prescription of OACs or APAs.

Screening older people at risk of malnutrition or malnourished using the Simplified Nutritional Appetite Questionnaire (SNAQ): a comparison with the Mini-Nutritional Assessment (MNA) tool.

OBJECTIVES: The Mini-Nutritional Assessment (MNA) is recommended to assess malnutrition in older people. However, its implementation is challenging in large elderly population, nursing home, or community or large clinical research programs. The Simplified Nutritional Appetite Questionnaire (SNAQ), a self-assessment nutritional screening tool that predicts weight loss, could be used to screen older people at risk of malnutrition or malnourishment. Our objective was to assess whether the SNAQ is related to the MNA and can screen older people at risk of malnutrition or malnourishment. DESIGN/SETTING/PARTICIPANTS: Cross-sectional study conducted of 175 persons aged 65 or older who were community dwelling, hospitalized, and nursing home residents. MEASUREMENTS: The SNAQ and the MNA score were performed. Correlation between the scores was studied. The most discriminating SNAQ value, which separated the participant at risk of malnutrition or malnourishment from the participant with a normal nutrition status (defined by MNA), was calculated. RESULTS: The SNAQ and the MNA score were significantly correlated (Spearman test r = 0.48, P < .001). The distribution of the population using the SNAQ or the MNA was significantly different (MacNemar P < .01). The area under the receiver operator characteristic curve, which assesses the ability of the SNAQ score to predict an abnormal MNA score, was 0.767 (95% confidence interval, 0.69-0.85). An SNAQ score under 14 was the best clinical indicator of older people at risk of malnutrition or malnourishment (sensitivity = 71%, specificity = 74%). Using this cut-off, 26.8% of the population (n = 47) were misclassified. Most of them (n = 33; 18.8%) had an abnormal SNAQ with a normal MNA. CONCLUSION: The SNAQ is a poor screening tool to predict older people with an abnormal MNA score. However, an abnormal SNAQ might identify those who will lose weight earlier than will the MNA.