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Objective To evaluate whether follow-up of patients with obstructive sleep apnoea (OSA) undergoing CPAP treatment could be performed in primary care (PC) settings. Design Non-inferiority, randomised, prospective controlled study. Settings Sleep unit (SU) at the University Hospital and in 8 PC units in Lleida, Spain. Participants Patients with OSA were randomised to be followed up at the SU or PC units over a 6-month period. Main outcomes measured The primary outcome was CPAP compliance at 6 months. The secondary outcomes were Epworth Sleep Scale (ESS) score, EuroQoL, patient satisfaction, body mass index (BMI), blood pressure and cost-effectiveness. Results We included 101 patients in PC ((mean±SD) apnoea–hypopnoea index (AHI) 50.8±22.9/h, age 56.2±11 years, 74% male) and 109 in the SU (AHI 51.4±24.4/h, age 55.8±11 years, 77% male)). The CPAP compliance was (mean (95% CI) 4.94 (4.47 to 5.5) vs 5.23 (4.79 to 5.66) h, p=0.18) in PC and SU groups, respectively. In the SU group, there were greater improvements in ESS scores (mean change 1.79, 95% CI +0.05 to +3.53, p=0.04) and patient satisfaction (−1.49, 95% CI −2.22 to −0.76); there was a significant mean difference in BMI between the groups (0.57, 95% CI +0.01 to +1.13, p=0.04). In the PC setting, there was a cost saving of 60%, with similar effectiveness, as well as a decrease in systolic blood pressure (−5.32; 95% CI −10.91 to +0.28, p=0.06). Conclusions For patients with OSA, treatment provided in a PC setting did not result in worse CPAP compliance compared with a specialist model and was shown to be a cost-effective alternative. Trial registration number Clinical Trials NCT01918449.

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Background To investigate organisational factors influencing the implementation challenges of redesigning services for people with long term conditions in three locations in England, using remote care (telehealth and telecare). Methods Case-studies of three sites forming the UK Department of Health’s Whole Systems Demonstrator (WSD) Programme. Qualitative research techniques were used to obtain data from various sources, including semi-structured interviews, observation of meetings over the course programme and prior to its launch, and document review. Participants were managers and practitioners involved in the implementation of remote care services. Results The implementation of remote care was nested within a large pragmatic cluster randomised controlled trial (RCT), which formed a core element of the WSD programme. To produce robust benefits evidence, many aspect of the trial design could not be easily adapted to local circumstances. While remote care was successfully rolled-out, wider implementation lessons and levels of organisational learning across the sites were hindered by the requirements of the RCT. Conclusions The implementation of a complex innovation such as remote care requires it to organically evolve, be responsive and adaptable to the local health and social care system, driven by support from front-line staff and management. This need for evolution was not always aligned with the imperative to gather robust benefits evidence. This tension needs to be resolved if government ambitions for the evidence-based scaling-up of remote care are to be realised.

Collaborative chronic care models (CCMs) have extensive randomized clinical trial evidence for effectiveness in serious mental illnesses, but little evidence exists regarding their feasibility or effect in typical practice conditions. To determine the effectiveness of implementation facilitation in establishing the CCM in mental health teams and the impact on health outcomes of team-treated individuals. This quasi-experimental, randomized stepped-wedge implementation trial was conducted from February 2016 through February 2018, in partnership with the US Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention. Nine facilities were enrolled from all VA facilities in the United States to receive CCM implementation support. All veterans (n = 5596) treated by designated outpatient general mental health teams were included for hospitalization analyses, and a randomly selected sample (n = 1050) was identified for health status interviews. Individuals with dementia were excluded. Clinicians (n = 62) at the facilities were surveyed, and site process summaries were rated for concordance with the CCM process. The CCM implementation start time was randomly assigned across 3 waves. Data analysis of this evaluable population was performed from June to September 2018. Internal-external facilitation, combining a study-funded external facilitator and a facility-funded internal facilitator working with a designated team for 1 year. Facilitation was hypothesized to be associated with improvements in both implementation and intervention outcomes (hybrid type II trial). Implementation outcomes included the clinician Team Development Measure (TDM) and proportion of CCM-concordant team care processes. The study was powered for the primary health outcome, mental component score (MCS). Hospitalization rate was derived from administrative data. The veteran population (n = 5596) included 881 women (15.7%), and the mean (SD) age was 52.2 (14.5) years. The interviewed sample (n = 1050) was similar but was oversampled for women (n = 210 [20.0%]). Facilitation was associated with improvements in TDM subscales for role clarity (53.4%-68.6%; δ = 15.3; 95% CI, 4.4-26.2; P = .01) and team primacy (50.0%-68.6%; δ = 18.6; 95% CI, 8.3-28.9; P = .001). The percentage of CCM-concordant processes achieved varied, ranging from 44% to 89%. No improvement was seen in veteran self-ratings, including the primary outcome. In post hoc analyses, MCS improved in veterans with 3 or more treated mental health diagnoses compared with others (β = 5.03; 95% CI, 2.24-7.82; P < .001). Mental health hospitalizations demonstrated a robust decrease during facilitation (β = -0.12; 95% CI, -0.16 to -0.07; P < .001); this finding withstood 4 internal validity tests. Implementation facilitation that engages clinicians under typical practice conditions can enhance evidence-based team processes; its effect on self-reported overall population health status was negligible, although health status improved for individuals with complex conditions and hospitalization rate declined. ClinicalTrials.gov Identifier: NCT02543840.

Objectives To compare patient outcomes of three regimes of follow-up care for rheumatoid arthritis (RA) outpatients with low disease activity. Methods RA outpatients (n=287) with Disease Activity Score (DAS28-CRP)<3.2 and Health Assessment Questionnaire<2.5 from two Danish rheumatology clinics were randomised to 2-year follow-up by either: (1) planned rheumatologist consultations, (2) shared care without planned consultations or (3) planned nursing consultations. The primary outcome was change in disease activity. DAS28-CRP, Health Assessment Questionnaire, visual analogue scale (VAS)-pain, fatigue, global health, confidence and satisfaction, quality-of-life by the Short Form 12 and self-efficacy measured by the RA Self-Efficacy questionnaire and the Arthritis Self-Efficacy Scale, were recorded annually and safety measures were recorded. x-Rays of hands and feet were taken at baseline and at 2-year follow-up. Mixed effect models were used to explore differences between the three groups over time. Results At 2-year follow-up, the group allocated to nursing consultations had lower disease activity than the group that underwent rheumatologist consultations (DAS28-CRP −0.3, p=0.049). The nursing group increased their self-efficacy (Arthritis Self-Efficacy Scale 18.8, p=0.001), confidence (10.7, p=0.001) and satisfaction (10.8, p<0.001) compared with the rheumatologist group. The shared care group reported a transient lower satisfaction compared with the rheumatologist group after 1 year (−8.8, p=0.004). No statistically significant differences were seen in other outcome variables. Conclusions It is safe to implement shared care and nursing consultations as alternatives to rheumatologist consultations for RA outpatients with low disease activity without deterioration in disease control. Nursing consultations can enhance patients’ self-efficacy, confidence and satisfaction.

Background Better management of long-term conditions remains a policy priority, with a focus on improving outcomes and reducing use of expensive hospital services. A number of interventions have been tested, but many have failed to show benefit in rigorous comparative research. In 2016, the NHS Test Beds scheme was launched to implement and test interventions combining digital technologies and pathway redesign in routine health care settings, with each intervention comprising multiple innovations to better realise benefit from their ‘combinatorial’ effect. We present the evaluation of one of the NHS Test Beds, which combined risk stratification algorithms, practice-based quality improvement and health monitoring and coaching to improve management of long-term conditions in a single health economy in the north-west of England. Methods The NHS Test Bed was implemented in one clinical commissioning group in the north-west of England (patient population 235,800 served by 36 general practices). Routine administrative data on hospital use (the primary outcome) and a selection of secondary outcomes (data from both hospital and primary care) were collected in the intervention site, and from a comparator area in the same region. We used difference-in-differences analysis to compare outcomes in the NHS Test Bed area and the comparator after initiation of the combinatorial intervention. Results Tests confirmed the existence of parallel trends in the intervention and comparator sites for hospital outcomes for the period April 2016 to March 2017, and for some of the planned primary care outcomes. Based on 10 months of post-intervention secondary care data and 13 months post-intervention primary care data, we found no significant impact on primary outcomes between the intervention and comparator site, and a significant impact on only one secondary outcome. Conclusion A combinatorial digital and organisational intervention to improve the management of long-term conditions was implemented across a whole health economy, but we found no evidence of a positive impact on health care utilisation outcomes in hospital and primary care.

Summary Following initiation of oral bisphosphonate therapy through a secondary fracture prevention program, 2-year treatment compliance and persistence remained high and were similar in patients randomised to follow-up by either the program or primary care physician. Thus, community-based and specialist management are equally effective in supporting compliance and persistence with anti-osteoporotic treatments. Introduction The purpose of this study was to determine whether management by a secondary fracture prevention (SFP) program (aka “fracture liaison service”) results in better compliance and persistence to oral bisphosphonate therapy than follow-up by the primary care physician, after initiation within an SFP program. Methods This prospective RCT included 102 patients with incident osteoporotic fractures referred to a SFP program in Sydney, Australia. Following oral bisphosphonate therapy initiation, patients were randomised to either 6-monthly follow-up with the SFP program (group A) or referral to their primary care physician with a single SFP program visit at 24 months (group B). Compliance and persistence to treatment were measured using pharmaceutical claims data. Predictors of compliance and persistence and associations between compliance and persistence, and changes in bone mineral density (BMD) or bone resorption marker, urinary deoxypyridinoline over 24 months were analysed. Results The median medication possession ratio at 24 months was 0.78 (IQR, 0.50–0.93) in group A and 0.79 (IQR, 0.48–0.96) in group B ( p  = 0.68). Persistence at 24 months was also similar in both groups (64 vs. 61 %, respectively; p  = 0.75). After adjusting for confounders, patients in group A were not more likely to be compliant (OR, 1.06; 95 % CI, 0.46–2.47) or persistent (HR, 0.83; 95 % CI, 0.27–1.67) than those randomised to group B. Time-based changes in BMD or bone turnover were not associated with compliance or persistence. Conclusion Compliance and persistence to oral bisphosphonate therapy remain high amongst patients initiated within an SFP program, with community-based and SFP program management being equally effective in maintaining therapeutic compliance and persistence over 2 years. These results indicate that one of the main functions of an SFP program may be the initiation of therapy rather than continuous patient monitoring.

Background Implementation fidelity, the degree to which a care program is implemented as intended, can influence program impact. Since results of trials that aim to implement comprehensive care programs for frail, older people have been conflicting, assessing implementation fidelity alongside these trials is essential to differentiate between flaws inherent to the program and implementation issues. This study demonstrates how a theory-based assessment of fidelity can increase insight in the implementation process of a complex intervention in primary elderly care. Methods The Geriatric Care Model was implemented among 35 primary care practices in the Netherlands. During home visits, practice nurses conducted a comprehensive geriatric assessment and wrote a tailored care plan. Multidisciplinary team consultations were organized with the aim to enhance the coordination between professionals caring for a single patient with complex needs. To assess fidelity, we identified 5 key intervention components and formulated corresponding research questions using Carroll’s framework for fidelity. Adherence (coverage, frequency, duration, content) was assessed per intervention component during and at the end of the intervention period. Two moderating factors (participant responsiveness and facilitation strategies) were assessed at the end of the intervention. Results Adherence to the geriatric assessments and care plans was high, but decreased over time. Adherence to multidisciplinary consultations was initially poor, but increased over time. We found that individual differences in adherence between practice nurses and primary care physicians were moderate, while differences in participant responsiveness (satisfaction, involvement) were more distinct. Nurses deviated from protocol due to contextual factors and personal work routines. Conclusions Adherence to the Geriatric Care Model was high for most of the essential intervention components. Study limitations include the limited number of assessed moderating factors. We argue that a longitudinal investigation of adherence per intervention component is essential for a complete understanding of the implementation process, but that such investigations may be complicated by practical and methodological challenges. Trial registration The Netherlands National Trial Register (NTR). Trial number: 2160 .

ObjectiveTo evaluate the effectiveness of a nurse-supported self-management programme to improve social participation of dual sensory impaired older adults in long-term care homes.DesignCluster randomised controlled trial.SettingThirty long-term care homes across the Netherlands.ParticipantsLong-term care homes were randomised into intervention clusters (n=17) and control clusters (n=13), involving 89 dual sensory impaired older adults and 56 licensed practical nurses.InterventionNurse-supported self-management programme.MeasurementsEffectiveness was evaluated by the primary outcome social participation using a participation scale adapted for visually impaired older adults distinguishing four domains: instrumental activities of daily living, social-cultural activities, high-physical-demand and low-physical-demand leisure activities. A questionnaire assessing hearing-related participation problems was added as supportive outcome. Secondary outcomes were autonomy, control, mood and quality of life and nurses’ job satisfaction. For effectiveness analyses, linear mixed models were used. Sampling and intervention quality were analysed using descriptive statistics.ResultsSelf-management did not affect all four domains of social participation; however. the domain ‘instrumental activities of daily living’ had a significant effect in favour of the intervention group (P=0.04; 95% CI 0.12 to 8.5). Sampling and intervention quality was adequate.ConclusionsA nurse-supported self-management programme was effective in empowering the dual sensory impaired older adults to address the domain ‘instrumental activities of daily living’, but no differences were found in addressing the other three participation domains. Self-management showed to be beneficial for managing practical problems, but not for those problems requiring behavioural adaptations of other persons.Trial registration number NCT01217502; Results.