Comparing paper Letters in addition to Emailed Audit and feedback in Refining Asthma treatment to Improve clinical and environmental Results in primary care through a cluster randomised controlled trial: the CLEAR AIR study.

BackgroundPhysical activity is well known to have beneficial effects on glycemic control and to reduce risk factors for cardiovascular disease in persons with type 2 diabetes. Yet, successful implementation of lifestyle interventions targeting physical activity in primary care has shown to be difficult. Smartphone apps may provide useful tools to support physical activity. The DiaCert app was specifically designed for integration into primary care and is an automated mobile health (mHealth) solution promoting daily walking.ObjectiveThis study aimed to investigate the effect of a 3-month-long intervention promoting physical activity through the use of the DiaCert app among persons with type 2 diabetes in Sweden. Our primary objective was to assess the effect on moderate to vigorous physical activity (MVPA) at 3 months of follow-up. Our secondary objective was to assess the effect on MVPA at 6 months of follow-up and on BMI, waist circumference, hemoglobin A1c, blood lipids, and blood pressure at 3 and 6 months of follow-up.MethodsWe recruited men and women with type 2 diabetes from 5 primary health care centers and 1 specialized center. Participants were randomized 1:1 to the intervention or control group. The intervention group was administered standard care and access to the DiaCert app at baseline and 3 months onward. The control group received standard care only. Outcomes of objectively measured physical activity using accelerometers, BMI, waist circumference, biomarkers, and blood pressure were assessed at baseline and follow-ups. Linear mixed models were used to assess differences in outcomes between the groups.ResultsA total of 181 study participants, 65.7% (119/181) men and 34.3% (62/181) women, were recruited into the study and randomized to the intervention (n=93) or control group (n=88). The participants’ mean age and BMI were 60.0 (SD 11.4) years and 30.4 (SD 5.3) kg/m2, respectively. We found no significant effect of the intervention (group by time interaction) on MVPA at either the 3-month (β=1.51, 95% CI –5.53 to 8.55) or the 6-month (β=–3.53, 95% CI –10.97 to 3.92) follow-up. We found no effect on any of the secondary outcomes at follow-ups, except for a significant effect on BMI at 6 months (β=0.52, 95% CI 0.20 to 0.84). However, mean BMI did not differ between the groups at the 6-month follow-up.ConclusionsWe found no evidence that persons with type 2 diabetes being randomized to use an app promoting daily walking increased their levels of MVPA at 3 or 6 months’ follow-up compared with controls receiving standard care. The effect of the app on BMI was unclear, and we found nothing to support an effect on secondary outcomes. Further research is needed to determine what type of mHealth intervention could be effective to increase physical activity among persons with type 2 diabetes.Trial RegistrationClinicalTrials.gov NCT03053336; https://clinicaltrials.gov/study/NCT03053336

An interactive booklet reduces antibiotic use for children with respiratory tract infections

Background:The impact of COVID has been felt by everyone. Yet, as the pandemic has dragged on, it has become more and more clear that there are those for whom the exacerbation of existing inequalities, or the increased upheaval and uncertainty of their lives means that although we have all been touched by pandemic, we are not ‘all in this together'.<br/><br/>Methods:This paper will introduce the experiences of 12 young people (aged 18–25) from a wider study of 52 adults in the Middlesbrough area of the UK during the pandemic, exploring issues including mental health, wellbeing and drug and alcohol taking behaviour (and the risk factors for such behaviours). Results:Showed increased pressure of disruption to socialisation during one's essential ‘formative years', the worries over wholesale changes to education—which have themselves widened pre-existing inequalities of access and achievement—the unknown impact of the pandemic on the future, and the added stigma of blame for spikes in infection have all contributed to a significant decrease in the health and wellbeing of young people. Interviewees spoke of changes to the way in which they socialised and connected with others, and how this in turn affected the way in which they used alcohol and drugs during this time. "Alcoholism and drug taking has skyrocketed during this lockdown, you see if people were allowed to go out and about and socialise with other people, then maybe they wouldn't be taking so many drugs, maybe they wouldn't be drinking the odd case [of beer]."<br/><br/>Conclusions:As we start to exit from the pandemic lockdown more work is needed to develop brief interventions for young people to tackle the multiple health and social needs they have encountered.

BackgroundMental health problems often lead to prolonged sick leave. In primary care, the usual approach towards these patients was the advice to take rest and not return to work before all complaints had disappeared. When complaints persist, these patients are often referred to psychologists from primary and specialized secondary care. As an alternative, ways have been sought to activate the Dutch occupational physician (OP) in primary care. Early 2000, the Dutch Association of Occupational Physicians (NVAB) published a guideline concerning the management by OPs of employees with mental health problems. The guideline received positive reactions from employees, employers and Dutch OPs. This manuscript describes the design of a study, which aims to assess the effects of the guideline, compared with usual care.Methods/DesignIn a randomized controlled trial (RCT), subjects in the intervention group were treated according to the guideline. The control group received usual care, with minimal involvement of the OP and easy access to a psychologist. Subjects were recruited from two Dutch police departments. The primary outcomes of the study are return to work and treatment satisfaction by the employee, employer, and OP. A secondary outcome is cost-effectiveness of the intervention, compared with usual care. Furthermore, prognostic measures are taken into account as potential confounders. A process evaluation will be done by means of performance indicators, based on the guideline.DiscussionIn this pragmatic trial, effectiveness instead of efficacy is studied. We will evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options in occupational health practice for employees on sick leave due to mental health problems. Additionally, they may contribute to new and better-suited guidelines and stepped care. Results will become available during 2007.Trial registrationCurrent Controlled Trials ISRCTN34887348

Potentially inappropriate medicines (PIMs) may cause 10% of unplanned admissions in elderly people. We performed an educational intervention in primary care to reduce acute health care consumption and PIMs through the promotion of medication reviews (MRs) in elderly patients. This cluster-randomized controlled trial was conducted in the context of an official campaign promoting rational drug use in elderly people. Sixty-nine primary health care practices with 119,910 patients aged older than or equal to 65 were randomized, with 1 dropout in the intervention group. The intervention consisted of educational outreach visits with feedback on prescribing and the development of a working procedure on MRs. Follow-up was 9months. Outcomes were assessed in an administrative health care database. The combined primary outcome was unplanned hospital admission and/or emergency department visit. Secondary outcomes were among other PIMs and rates of MRs. The risk differences in outcomes between intervention and control group were estimated by using regression models. During follow-up, 22.8% of patients in the intervention and 22.0% in the control group were admitted unplanned to hospital and/or experienced at least 1 emergency department (nonsignificant risk difference 0.8%, 95% CI -0.7% to 2.4%). There were no significant differences regarding secondary outcomes such as PIMs or MRs. No changes were seen in acute health care consumption, PIMs, and MRs in elderly patients after an educational intervention in primary care. The reasons for the lack of effect could be a suboptimal intervention, limitations in outcome measures, and the use of administrative data to monitor outcomes.

AimsChina’s primary care was required to improve the quality of atrial fibrillation (AF) management by government. The aim of the study was to investigate whether a clinical decision support system for non-valvular AF (GP-CDSS-2.0) affected appropriate anticoagulation of patients with AF in primary care.Methods and resultsThe study was a cluster randomized controlled study, carried out in 13 community health centers in Shanghai, China, as 1 community health center in the intervention group withdraw the study. Patients with AF who consented to take part in and finish the follow-up were enrolled. We allocated the 14 community health centers into the intervention and control groups using stratified randomization method at a ratio of 1 to 1. General practitioners in the intervention group treated patients using GP-CDSS-2.0, while those in the control group provided usual care. The proportion of appropriate anticoagulation was the primary outcome. The secondary outcomes and safety outcomes mainly included the transition rate of patients’ anticoagulation therapies and the incidences of bleeding and composite adverse outcomes. 405 patients were included in the analyses of primary outcome, with 182 in the intervention group and 223 in the control group. After 1 year’s follow-up, the proportion of appropriate anticoagulation in the intervention group was higher than that in the control group (55.2% in the intervention group and 35.9% in the control group; relative risk (RR) = 1.441, 95% CI, 1.429–1.453, p < 0.001). The proportion of appropriate anticoagulation in the intervention group and the control group increased by 20% and 0.9%, respectively, compared with those at baseline (35.2% in the intervention group and 35.0% in the control group). More subjects in the intervention group experienced a correct transition of their anticoagulation therapies during the study (RR = 2.528, 95% CI, 1.276–5.008, p = 0.008). The intervention group showed a tendency of less bleeding and composite adverse outcomes.ConclusionsThe utilization of GP-CDSS-2.0 in primary care had the potential to raise the proportion of appropriate anticoagulation among patients with AF. Additionally, it could assist them in transitioning to proper anticoagulation treatments.Trial registrationRegistration Number ChiCTR2100052307. Registration Date 22/11/2021.

In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators. We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve. In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement. The study is registered with the ISRCTN registry (ISRCTN91989345).

This paper describes an intervention study aimed at improving communication between hospital services and the primary health care team. A series of information cards were developed by breast specialist secondary care professionals for members of the primary health care team. Women with breast cancer were involved in the communication pathway and were asked to take the information cards to their own general practitioner (GP) practice. It was envisaged that women would be more likely to utilize the primary health care team for information if they were aware that the primary health care team was in receipt of information specific to the treatment they had received. Women newly diagnosed with breast cancer were allocated to either an intervention (n=38) or non-intervention (n=38) group. Patient interviews were carried out around the time of diagnosis and at 4 months from diagnosis. Interviews were also carried out with 31 GPs to ascertain their views on the provision of information for women with breast cancer, and on the information cards if relevant. The study findings were interesting although not significant in terms of the direction anticipated. The cards did not impact on the utilization of the primary health care team and women in the intervention group were no more likely to utilize primary care sources of information than women in the non-intervention group. Factors such as the long-standing relationship women had with their GP, the perceived lack of specialist knowledge on the part of GPs and district nurses, and the women's perception that information seeking was not a tangible reason for primary care contact had an impact on information-seeking behaviour.

Effectiveness of a home-based nursing support and cognitive restructuring intervention on the quality of life of family caregivers in primary care: A pragmatic cluster-randomized controlled trial

Costs and Health Outcomes Associated With Primary vs Secondary Care After an Asthma-Related Hospitalization

BackgroundOver the past decade, commissioning of primary care dentistry has seen contract currency evolving from payment for units of dental activity (UDAs) towards blended contracts that include key performance indicators such as access, quality and improved health outcome.ObjectivesThe aim of this study was to evaluate a blended/incentive-driven model of dental service provision. To (1) explore stakeholder perspectives of the new service delivery model; (2) assess the effectiveness of the new service delivery model in reducing the risk of and amount of dental disease and enhancing oral health-related quality of life (OHQoL) in patients; and (3) assess cost-effectiveness of the new service delivery model.MethodsUsing a mixed-methods approach, the study included three dental practices working under the blended/incentive-driven (incentive) contract and three working under the UDAs (traditional) contract. All were based in West Yorkshire. The qualitative study reports on the meaning of key aspects of the model for three stakeholder groups [lay people (patients and individuals without a dentist), commissioners and the primary care dental teams], with framework analysis of focus group and semistructured interview data. A non-randomised study compared clinical effectiveness and cost-effectiveness of treatment under the two contracts. The primary outcome was gingivitis, measured using bleeding on probing. Secondary outcomes included OHQoL and cost-effectiveness.ResultsParticipants in the qualitative study associated the incentive contract with more access, greater use of skill mix and improved health outcomes. In the quantitative analyses, of 550 participants recruited, 291 attended baseline and follow-up. Given missing data and following quality assurance, 188 were included in the bleeding on probing analysis, 187 in the caries assessment and 210 in the economic analysis. The results were mixed. The primary outcome favoured the incentive practices, whereas the assessment of caries favoured the traditional practices. Incentive practices attracted a higher cost for the service commissioner, but were financially attractive for the dental provider at the practice level. Differences in generic health-related quality of life were negligible. Positive changes over time in OHQoL in both groups were statistically significant.LimitationsThe results of the quantitative analysis should be treated with caution given small sample numbers, reservations about the validity of pooling, differential dropout results and data quality issues.ConclusionsA large proportion of people in this study who had access to a dentist did not follow up on oral care. These individuals are more likely to be younger males and have poorer oral health. Although access to dental services was increased, this did not appear to facilitate continued use of services.Future workFurther research is required to understand how best to promote and encourage appropriate dental service attendance, especially among those with a high level of need, to avoid increasing health inequalities, and to assess the financial impact of the contract. For dental practitioners, there are challenges around perceptions about preventative dentistry and use of the risk assessments and care pathways. Changes in skill mix pose further challenges.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

BackgroundIn primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators.Methods and findingsWe undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used ‘opt-out’ recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67–0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89–1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96–1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75–1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39–0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve.ConclusionsIn this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement.Trial registrationThe study is registered with the ISRCTN registry (ISRCTN91989345).

Digital inhalers can support medication adherence and asthma control in the short-term. Yet, long-term benefits are unknown. To investigate the clinical effects, usability, and cost-effectiveness of a digital inhaler. This was an open-label cluster randomized controlled trial of 12 months in Dutch primary care. Adults with suboptimal controlled asthma and nonadherence were eligible. General practices were randomly allocated to either intervention or control, stratified by practice size. Intervention and control patients received an electronic monitoring device attached to their budesonide/formoterol SYMBICORT Turbuhaler maintenance inhaler. Intervention patients used a smartphone application for data insights and reminders. Control patients' inhaler use was passively monitored. Primary outcome was 1-year medication adherence. Secondary outcomes included asthma control, quality of life, usability, and cost-effectiveness. Between June 27, 2019 and September 30, 2022, 136 clusters containing 164 participants were randomized (82 participants across 68 clusters in both groups). Estimated marginal means (EMM) for medication adherence were 71.4% (95% CI, 67.1-75.4) and 59.9% (95% CI, 55.0-64.7) in the intervention and control groups, respectively. Medication adherence was higher in the intervention group at week 2 (odds ratio [OR] = 2.19; 95% CI, 1.63-2.95). The difference in medication adherence between groups declined over time (P < .0001); no significant difference was found at study end (OR = 1.23; 95% CI, 0.91-1.66). Overall, Asthma Control Questionnaire-5 scores were significantly better (P = .0056) in the intervention group (EMM, 1.31; 95% CI, 1.18-1.44) compared with control (EMM, 1.56; 95% CI, 1.44-1.68). Quality of life (Mini Asthma Quality of Life Questionnaire scores) did not differ significantly between groups (P = .0530). However, the intervention group was almost three times more likely to reach the minimal clinically important difference for asthma-related quality of life (OR = 2.73; 95% CI, 1.02-7.54). Mean system usability score was 80.1 (SD, 13.8). Cost per 0.5-point Asthma Control Questionnaire-5 decrease was €278. Use of this digital inhaler led to significant improvements in medication adherence in the short term and to sustained improved asthma control over 12 months.

Global Initiative for Asthma (GINA) has recommended inhaled corticosteroid (ICS)-Formoterol as Track-1 treatment for patients. Using ICS and SABA (Short-Acting Beta-Agonist) as a reliever is an alternative Track-2 option. Both modalities are tied to type of inhaler use, dry powder inhalers (DPI) and propellent-containing metered-dose inhalers (pMDI). Compared to propellent-free DPI, pMDI have much higher carbon footprint (CF) detrimental to the environment. Leveraging on dispensed inhaler data from the electronic medical records of patients managed in primary care, the study aimed to quantify their CF using Budesonide-Formoterol (BUD-FOR) DPI alone, compared to those who were treated with BUD-FOR DPI + pMDI as a reliever. Electronic medical records from 8 public primary care clinics were analysed, covering adult asthma patients (aged ≥21) between 2018 and 2023. Data on inhaler dispensing, asthma control test (ACT) scores and rescue therapy (RT) needs were assessed. CF was computed based on inhaler canisters dispensed. Associations between treatment modality, asthma control, RT and CF were analysed using Generalized Estimating Equations. A total of 5634 patients using BUD-FOR DPI were included. Over the study period, Track-1 usage increased substantially from 466 to 2317 patients, while Track-2 rose modestly from 628 to 758. In 2023, 78.5% of patients achieved good asthma control compared to 68.7% in Track-2. The total CF per patient was substantially lower in Track-1 compared to Track-2 (3.3 vs 62.4 kgCO₂e). Patients in Track-1 had a significantly lower CF by 60 kgCO₂e (P < .001), had 1.5 times higher odds to achieve good asthma control based on ACT scores (P < .001) and had approximately 30% lower odds of receiving RT (P < .001). The average number of SABA-pMDI canisters dispensed per patient declined from 2.8 to 2.1 over the study period. BUD/FOR inhalers use per patient per year was consistently higher in Track 2 compared to Track 1, with an average difference of 1.2 canisters (5.3 vs 4.1). Patients managed under Track-1 treatment approach demonstrated significantly better asthma outcomes and lower CF. These findings highlight potential of Track-1 treatment as the preferred strategy, enabling better clinical outcomes and reduced environmental impact.

After the End of Free Fall: Geriatricizing Primary Care