Internet and Telephone Support for Discontinuing Long-Term Antidepressants: The REDUCE Cluster Randomized Trial.

Importance: There is significant concern regarding increasing long-term antidepressant treatment for depression beyond an evidence-based duration. Objective: To determine whether adding internet and telephone support to a family practitioner review to consider discontinuing long-term antidepressant treatment is safe and more effective than a practitioner review alone. Design, Setting, and Participants: In this cluster randomized clinical trial, 131 UK family practices were randomized between December 1, 2018, and March 31, 2022, with remote computerized allocation and 12 months of follow-up. Participants and researchers were aware of allocation, but analysis was blind. Participants were adults who were receiving antidepressants for more than 1 year for a first episode of depression or more than 2 years for recurrent depression who were currently well enough to consider discontinuation and wished to do so and who were at low risk of relapse. Of 6725 patients mailed invitations, 330 (4.9%) were eligible and consented. Interventions: Internet and telephone self-management support, codesigned and coproduced with patients and practitioners. Main Outcomes and Measures: The primary (safety) outcome was depression at 6 months (prespecified complete-case analysis), testing for noninferiority of the intervention to under 2 points on the 9-item Patient Health Questionnaire (PHQ-9). Secondary outcomes (testing for superiority) were antidepressant discontinuation, anxiety, quality of life, antidepressant withdrawal symptoms, mental well-being, enablement, satisfaction, use of health care services, and adverse events. Analyses for the main outcomes were performed on a complete-case basis, and multiple imputation sensitivity analysis was performed on an intention-to-treat basis. Results: Of 330 participants recruited (325 eligible for inclusion; 178 in intervention practices and 147 in control practices; mean [SD] age at baseline, 54.0 [14.9] years; 223 women [68.6%]), 276 (83.6%) were followed up at 6 months, and 240 (72.7%) at 12 months. The intervention proved noninferior; mean (SD) PHQ-9 scores at 6 months were slightly lower in the intervention arm than in the control arm in the complete-case analysis (4.0 [4.3] vs 5.0 [4.7]; adjusted difference, -1.1; 95% CI, -2.1 to -0.1; P = .03) but not significantly different in an intention-to-treat multiple imputation sensitivity analysis (adjusted difference, -0.9 (95% CI, -1.9 to 0.1; P = .08). By 6 months, antidepressants had been discontinued by 66 of 145 intervention arm participants (45.5%) who provided discontinuation data and 54 of 129 control arm participants (41.9%) (adjusted odds ratio, 1.02; 95% CI, 0.52-1.99; P = .96). In the intervention arm, antidepressant withdrawal symptoms were less severe, and mental well-being was better compared with the control arm; differences were small but significant. There were no significant differences in the other outcomes; 28 of 179 intervention arm participants (15.6%) and 22 of 151 control arm participants (14.6%) experienced adverse events. Conclusions and Relevance: In this cluster randomized clinical trial of adding internet and telephone support to a practitioner review for possible antidepressant discontinuation, depression was slightly better with support, but the rate of discontinuation of antidepressants did not significantly increase. Improvements in antidepressant withdrawal symptoms and mental well-being were also small. There were no significant harms. Family practitioner review for possible discontinuation of antidepressants appeared safe and effective for more than 40% of patients willing and well enough to discontinue. Trial Registration: ISRCTN registry Identifiers: ISRCTN15036829 (internal pilot trial) and ISRCTN12417565 (main trial).

Uptake and adoption of the NHS App in England: an observational study.

BACKGROUND: Technological advances have led to the use of patient portals that give people digital access to their personal health information. The NHS App was launched in January 2019 as a 'front door' to digitally enabled health services. AIM: To evaluate patterns of uptake of the NHS App, subgroup differences in registration, and the impact of COVID-19. DESIGN AND SETTING: An observational study using monthly NHS App user data at general-practice level in England was conducted. METHOD: Descriptive statistics and time-series analysis explored monthly NHS App use from January 2019-May 2021. Interrupted time-series models were used to identify changes in the level and trend of use of different functionalities, before and after the first COVID-19 lockdown. Negative binomial regression assessed differences in app registration by markers of general-practice level sociodemographic variables. RESULT: Between January 2019 and May 2021, there were 8 524 882 NHS App downloads and 4 449 869 registrations, with a 4-fold increase in App downloads when the COVID Pass feature was introduced. Analyses by sociodemographic data found 25% lower registrations in the most deprived practices (P<0.001), and 44% more registrations in the largest sized practices (P<0.001). Registration rates were 36% higher in practices with the highest proportion of registered White patients (P<0.001), 23% higher in practices with the largest proportion of 15-34-year-olds (P<0.001) and 2% lower in practices with highest proportion of people with long-term care needs (P<0.001). CONCLUSION: The uptake of the NHS App substantially increased post-lockdown, most significantly after the NHS COVID Pass feature was introduced. An unequal pattern of app registration was identified, and the use of different functions varied. Further research is needed to understand these patterns of inequalities and their impact on patient experience.

Perspectives of people with Parkinson's disease and family carers about disease management in community settings: A cross-country qualitative study.

AIM: To explore perceptions of people with Parkinson's disease and family carers about the use and impact of health and social care services, community and voluntary sector resources for the management of Parkinson's disease. BACKGROUND: Resources from outside the formal health care system and collaborations between different levels and sectors could address the unmet needs of people with Parkinson's disease and their family carers and improve the management of Parkinson's disease in the community setting. DESIGN: A qualitative exploratory study was carried out in Denmark, Norway, Spain and the United Kingdom and was reported using the COREQ. METHODS: Individual semi-structured interviews were conducted with people with Parkinson's disease and family carers between May and August 2020. Interviews were digitally recorded, transcribed verbatim and analysed using thematic analysis. A meta-ethnographic approach was used to analyse and synthesise cross-national findings. RESULTS: Forty-seven people with Parkinson's disease and 39 family carers participated in the four countries. Four themes and eight sub-themes emerged: (1) Personalised care for needs throughout the Parkinson's disease journey; (2) Accessibility of different types of support systems (including initiatives to support emotional well-being, physical rehabilitation, information on the healthcare services, voluntary associations and community groups); (3) Multiagency collaborations, a more comprehensive approach; (4) Acknowledgment of people with Parkinson's and family carers own role in Parkinson's disease management. CONCLUSIONS: An integrated and person-and-community-centred approach, which includes the participation of the health, social, voluntary and community sectors, is desired by people with Parkinson's disease and their family carers to improve the management of Parkinson's in the community setting. These findings could contribute to the creation of more sustainable care systems at the European level that would better respond to individual and changing needs in people with Parkinson's disease and their family carers, and in other long-term conditions. PATIENT OR PUBLIC CONTRIBUTION: The Patient and Public Involvement groups contributed to the design of the study, the interview guides and validation of findings. RELEVANCE TO CLINICAL PRACTICE: This study will inform the management of Parkinson's disease at the community level and the use of resources not only directly linked to the health system. Taking into account all the actors that provide care and support to people with Parkinson' disease and family carers facilitates the creation of strategies that better respond to individual needs. Nurses and other health and social care professionals in the community and specialist levels of care should collaborate to develop multisectoral strategies that promote personalised and integrated care throughout the Parkinson's journey.

Managing Parkinson's during the COVID-19 pandemic: Perspectives from people living with Parkinson's and health professionals.

OBJECTIVES: The aim of this study was to understand how people living with Parkinson's and healthcare professionals perceived their care management and interactions with health services were affected during the COVID-19 pandemic. BACKGROUND: During the COVID-19 pandemic, many governments introduced restrictions and services that support Parkinson's care management had to cease or be delivered remotely. These changes may have had an impact on the well-being of people living with Parkinson's. METHODS: A qualitative exploratory UK study was carried out. Semi-structured individual interviews with people living with Parkinson's and health professionals were recorded, transcribed verbatim and analysed using Braun´s and Clarke´s thematic analysis. Eleven patients and 10 health professionals were recruited between April and September 2020. The study was reported using the COREQ. RESULTS: Two main themes were identified. In the first theme, many patients and professionals reported that the COVID-19 pandemic made some people living with Parkinson's feel isolated and vulnerable due to disruptions to their social networks and usual activities related to Parkinson's disease care. However, other patients remained connected with their networks. In the second theme, patients and most professionals mentioned that some clinical practices were cancelled, delayed or transformed to remote consultation. CONCLUSION: The COVID-19 restrictions had an impact on how people living with Parkinson's managed their care and in their interactions with healthcare services. Health professionals should assess the risk of vulnerability, social isolation, physical inactivity and confidence with remote consultations in people living with Parkinson's. This might inform a rethinking of existing clinical interactions with people living with Parkinson's towards a flexible, sustainable, person-centred care model. RELEVANCE TO CLINICAL PRACTICE: This study has shown that Parkinson's care management and interactions with healthcare services should provide personalised and flexible support. To meet this challenge, the design of the organisation of health services should include greater involvement of patients and person-centred care models.

Patient-initiated cardiovascular monitoring with commercially available devices: How useful is it in a cardiology outpatient setting? Mixed methods, observational study.

BACKGROUND: The availability, affordability and utilisation of commercially available self-monitoring devices is increasing, but their impact on routine clinical decision-making remains little explored. We sought to examine how patient-generated cardiovascular data influenced clinical evaluation in UK cardiology outpatient clinics and to understand clinical attitudes and experiences with using data from commercially available self-monitoring devices. METHODS: Mixed methods study combining: a) quantitative and qualitative content analysis of 1373 community cardiology clinic letters, recording consultations between January-September 2020 including periods with different Covid-19 related restrictions, and b) semi-structured qualitative interviews and group discussions with 20 cardiology-affiliated clinicians at the same NHS Trust. RESULTS: Patient-generated cardiovascular data were described in 185/1373 (13.5%) clinic letters overall, with the proportion doubling following onset of the first Covid-19 lockdown in England, from 8.3% to 16.6% (p < 0.001). In 127/185 (69%) cases self-monitored data were found to: provide or facilitate cardiac diagnoses (34/127); assist management of previously diagnosed cardiac conditions (55/127); be deployed for cardiovascular prevention (16/127); or be recommended for heart rhythm evaluation (10/127). In 58/185 (31%) cases clinicians did not put the self-monitored data to any evident use and in 12/185 (6.5%) cases patient-generated data prompted an unnecessary referral. In interviews and discussions, clinicians expressed mixed views on patient-generated data but foresaw a need to embrace and plan for this information flow, and proactively address challenges with integration into traditional care pathways. CONCLUSIONS: This study suggests patient-generated data are being used for clinical decision-making in ad hoc and opportunistic ways. Given shifts towards remote monitoring in clinical care, accelerated by the pandemic, there is a need to consider how best to incorporate patient-generated data in clinical processes, introduce relevant training, pathways and governance frameworks, and manage associated risks.

Correction: A Facilitated Web-Based Self-Management Tool for People With Type 1 Diabetes Using an Insulin Pump: Intervention Development Using the Behavior Change Wheel and Theoretical Domains Framework.

[This corrects the article DOI: 10.2196/13980.].

A Facilitated Web-Based Self-Management Tool for People With Type 1 Diabetes Using an Insulin Pump: Intervention Development Using the Behavior Change Wheel and Theoretical Domains Framework.

BACKGROUND: Type 1 diabetes (T1D) requires intensive self-management (SM). An insulin pump is designed to better support personal T1D management, but at the same time, it exacerbates the complexity and requirements of SM. Research shows that people with diabetes are likely to benefit from navigating and connecting to local means of social support and resources through web-based interventions that offer flexible, innovative, and accessible SM. However, questions remain as to which behavior change mechanisms within such resources benefit patients most and how to foster engagement with and endorsement of SM interventions. OBJECTIVE: The aim of this study was to evaluate the perspectives and experiences of people with T1D using an insulin pump and specialist health care professionals (HCPs) and determine what behavior change characteristics and strategies are required to inform the optimization of an existing web-based social network (SN) intervention to support SM. METHODS: Focus groups with insulin pump users (n=19) and specialist HCPs (n=20) in 6 National Health Service (NHS) trusts across the south of England examined the barriers and enablers to incorporating and self-managing an insulin pump. An analysis was undertaken using the Behavior Change Wheel and Theoretical Domains Framework, followed by a taxonomy of behavior change techniques (BCTs) to identify the contents of and strategies for the implementation of a complex health intervention. RESULTS: A total of 4 themes represent the SM perspectives and experiences of stakeholders: (1) a desire for access to tailored and appropriate resources and information-the support and information required for successful SM are situational and contextual, and these vary according to time and life circumstances, and therefore, these need to be tailored and appropriate; (2) specific social support preferences-taking away isolation as well as providing shared learnings and practical tips, but limitations included the fear of judgment from others and self-pity from peers; (3) the environmental context, that is, capacity and knowledge of pump clinic HCPs-HCPs acknowledge the patient's need for holistic support but lack confidence in providing it; and (4) professional responsibility and associated risks and dangers, whereas HCPs are fearful of the consequences of promoting non-NHSSM support, and they question whether SM support fits into their role. BCTs were identified to address these issues. CONCLUSIONS: The use of behavioral theory and a validated implementation framework provided a comprehensive approach for systematically identifying barriers and enablers of self-managing T1D with an insulin pump. A web-based SN intervention appears to offer additional forms of SM support while complementing NHS services. However, for intervention implementation, HCPs' apprehensions about responsibility when signposting to non-NHS SM support would need to be addressed, and opportunistic features would need to be added, through which pump users could actively engage with other people living with T1D.

Partner involvement in treatment-related decision making in triadic clinical consultations - A systematic review of qualitative and quantitative studies.

OBJECTIVE: Explore how partners are involved in treatment-related decision-making within triadic clinical encounters. METHODS: Studies were identified via database searches and reference lists. One author assessed eligibility of studies, which were verified by an additional co-author. Data were extracted by one author and cross-checked for accuracy by a second. Quality of articles was assessed using Qualsyst. Retrieved studies were categorised by one author, and agreed through discussion. RESULTS: From 2442 records, 14 studies were included and categorised as: (1) Descriptions of partner role and behaviour; (2) Role intentions of partners; (3) Relationship between partner and patient behaviour; (4) HCP-Partner interactions. CONCLUSION: Partners are often involved in triadic clinical consultations that have implications for treatment-related decision making. Most studies offered general descriptions but lacked detailed investigation of communicative processes in triads and how these may operate with partners vs. other companions. PRACTICE IMPLICATIONS: Existing studies lack detailed investigation through direct observation of the processes of partner involvement. Research in other areas of clinical communication suggests that future interventions could be informed by attention to the following areas: partner behaviour vs. other companion types in triads; relationships between partner involvement and decision-making processes; partner involvement in triads vs. other groups (e.g. quadratic).

Liraglutide and the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis: protocol for a pilot trial.

BACKGROUND: People with severe mental illness (SMI) are two to three times more likely to be overweight and obese than the general population and this is associated with significant morbidity and premature mortality. Although lifestyle interventions can support people with SMI to lose weight, some are unable to make the necessary lifestyle changes or, despite making the changes, continue to gain weight. OBJECTIVE: To assess the feasibility and acceptability of delivering a full-scale trial evaluating whether liraglutide 3.0 mg, a once-daily injectable therapy, may be an effective treatment of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis. METHODS: Design: a single-centre, double-blind, randomised, placebo-controlled trial. SETTING: mental health facilities within Southern Health NHS Trust. PARTICIPANTS: 60 adults with schizophrenia, schizoaffective or first-episode psychosis prescribed antipsychotic medication will be recruited. Participants will be overweight or obese, defined by their baseline BMI which will be: • BMI ≥ 30 kg/m2 or • BMI ≥ 27 kg/m2 to < 30 kg/m2 in the presence of at least one weight-related consequence. This is in concordance with the current EU licence for liraglutide (maximum dosage 3.0 mg). INTERVENTION: participants will be allocated in a 1:1 ratio using a computer-based randomisation programme to either once-daily subcutaneously administered liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. All participants will receive standardised written information about healthy eating and exercise at their randomisation visit. OUTCOMES: the main aim of the study is to gather data on recruitment, consent, retention and adherence. Qualitative interviews with a purposive sub-sample of participants and healthcare workers will provide data on intervention feasibility and acceptability. Secondary clinical outcome measurements will be assessed at 3 and 6 months and will include: weight, fasting plasma glucose, lipid profile, HbA1c level; and the Brief Psychiatric Rating Scale. DISCUSSION: This study should provide evidence of the potential benefits of liraglutide (maximum dosage 3.0 mg daily) on body weight and metabolic variables in people with schizophrenia, schizoaffective disorder and first-episode psychosis. It will also address the feasibility and acceptability of the use of liraglutide in mental health settings. This will inform the design of a longer outcome study that will be needed to determine whether any weight loss can be maintained in the long term. TRIAL REGISTRATION: Universal Trial Number (UTN), ID: U1111-1203-0068. Registered on on 2/10/2017. European Clinical Trials Database (EudraCT), ID: 2017-004064-35. Registered on 3/10/2017.

Supporting Good Intentions With Good Evidence: How to Increase the Benefits of Diabetes Social Media.

Social media provides a platform for easily accessible, relevant health information and emotional and practical support at the touch of a button for millions of people with diabetes. Therein however lies a challenge. The accuracy and reliability of such information is often unknown and unverified, not all interactions are deemed supportive; practically or emotionally, and not all members of society have equitable access. Cyber bullying, requests for personal information and uninvited sharing are among the risks associated with social media, yet the use of online social media is increasing exponentially. Such reliance on web-based health information has given rise to concerns about patients' ability to accurately assess the credibility of online sources as well as the potential detrimental effect on personal well-being and patient-provider relations. In addition, there are rising digital disparities for particular subpopulations. Further, these concerns apply to where and how health care professionals should engage or refer patients to in terms of platforms of online support. There is little doubt regarding the popularity of social media, both within and outside of the health arena but there are also concerns. This article outlines five key areas associated with social media use in people living with diabetes and presents potential considerations moving forward. We focus on (1) social media as a platform for information and support; (2) social media interactions that are not supportive; (3) lessons from the DOC; (4) concerns about accuracy, reliability, and accessibility of information; and (5) differing priorities of health care professionals and patients.

The process of incorporating insulin pumps into the everyday lives of people with Type 1 diabetes: A critical interpretive synthesis.

BACKGROUND: Insulin pump therapy (IPT) is a technological advancement that has been developed to help people manage Type 1 diabetes (T1D). However, ways of managing diabetes requiring the implementation of health technologies bring new complexities and a need to understand the factors which enable people with T1D to incorporate a novel device. This new comprehension could provide an exemplar for people with long-term conditions to incorporate new technologies more generally. OBJECTIVE: To determine what influences the incorporation, adaptation and use of IPT into the everyday lives of people living with diabetes. DESIGN: Critical interpretive synthesis (CIS) using systematic searches undertaken in 7 electronic databases of literature, published 2008 onwards. RESULTS: A total of 4998 titles were identified, 274 abstracts reviewed, 39 full articles retrieved and 22 papers selected for analysis. Three themes emerged which were of relevance to the introduction and use of IPT; Tensions between expectations and experiences in adoption and early adaptation; Negotiation of responsibility and accessing support; Reflexivity, active experimentation and feedback. CONCLUSIONS: This CIS builds on earlier reviews on lived experiences of IPT. Novel insights are offered through examination of the experiences of pump users from children through to adults, their families and health-care professionals. Expectations of what the device can do to improve self-management impacts on the early stages of adoption as the reality of the technology requires substantial thought and action. Areas for intervention to improve IPT incorporation include establishing who is responsible for management tasks of the device and enabling navigation to further means of support and resources.

Commissioning of self-management support for people with long-term conditions: an exploration of commissioning aspirations and processes.

OBJECTIVES: To explore how self-management support (SMS) is considered and conceptualised by Clinical Commissioning Groups (CCGs) and whether this is reflected in strategic planning and commissioning. SMS is an essential element of long-term condition (LTC) management and CCGs are responsible for commissioning services that are coordinated, integrated and link into patient's everyday lives. This focus provides a good test and exemplar for how commissioners communicate with their local population to find out what they need. DESIGN: A multisite, quasi-ethnographic exploration of 9 CCGs. SETTING: National Health Service (NHS) CCGs in southern England, representing varied socioeconomic status, practice sizes and rural and urban areas. DATA COLLECTION/ANALYSIS: Content analysis of CCG forward plans for mention of SMS. Semistructured interviews with commissioners (n=10) explored understanding of SMS and analysed thematically. The practice of commissioning explored through the observations of Service User Researchers (n=5) attending Governing Body meetings (n=10, 30 hours). RESULTS: Observations illuminate the relative absence of SMS and gateways to active engagement with patient and public voices. Content analysis of plans point to tensions between local aspirations and those identified by NHS England for empowering patients by enhancing SMS services ('person-centred', whole systems). Interview data highlight disparities in the process of translating the forward plans into practice. Commissioners reference SMS as a priority yet details of local initiatives are notably absent with austerity (cost-containment) and nationally measured biomedical outcomes taking precedence. CONCLUSIONS: Commissioners conceptualise locally sensitive SMS as a means to improve health and reduce service use, but structural and financial constraints result in prioritisation of nationally driven outcome measures and payments relating to biomedical targets. Ultimately, there is little evidence of local needs driving SMS in CCGs. CCGs need to focus more on early strategic planning of lay involvement to provide an avenue for genuine engagement, so that support can be provided for communities and individuals in a way people will engage with.