Patient safety in marginalised groups: a narrative scoping review.

BACKGROUND: Marginalised groups ('populations outside of mainstream society') experience severe health inequities, as well as increased risk of experiencing patient safety incidents. To date however no review exists to identify, map and analyse the literature in this area in order to understand 1) which marginalised groups have been studied in terms of patient safety research, 2) what the particular patient safety issues are for such groups and 3) what contributes to or is associated with these safety issues arising. METHODS: Scoping review. Systematic searches were performed across six electronic databases in September 2019. The time frame for searches of the respective databases was from the year 2000 until present day. RESULTS: The searches yielded 3346 articles, and 67 articles were included. Patient safety issues were identified for fourteen different marginalised patient groups across all studies, with 69% (n = 46) of the studies focused on four patient groups: ethnic minority groups, frail elderly populations, care home residents and low socio-economic status. Twelve separate patient safety issues were classified. Just over half of the studies focused on three issues represented in the patient safety literature, and in order of frequency were: medication safety, adverse outcomes and near misses. In total, 157 individual contributing or associated factors were identified and mapped to one of seven different factor types from the Framework of Contributory Factors Influencing Clinical Practice within the London Protocol. Patient safety issues were mostly multifactorial in origin including patient factors, health provider factors and health care system factors. CONCLUSIONS: This review highlights that marginalised patient groups are vulnerable to experiencing a variety patient safety issues and points to a number of gaps. The findings indicate the need for further research to understand the intersectional nature of marginalisation and the multi-dimensional nature of patient safety issues, for groups that have been under-researched, including those with mental health problems, communication and cognitive impairments. Such understanding provides a basis for working collaboratively to co-design training, services and/or interventions designed to remove or at the very least minimise these increased risks. TRIAL REGISTRATION: Not applicable for a scoping review.

Overcoming challenges in delivering integrated motivational interviewing and cognitive behavioural therapy for bipolar disorder with co-morbid alcohol use: therapist perspectives.

BACKGROUND: Alcohol misuse is common in bipolar disorder and is associated with worse outcomes. A recent study evaluated integrated motivational interviewing and cognitive behavioural therapy for bipolar disorder and alcohol misuse with promising results in terms of the feasibility of delivering the therapy and the acceptability to participants. AIMS: Here we present the experiences of the therapists and supervisors from the trial to identify the key challenges in working with this client group and how these might be overcome. METHOD: Four therapists and two supervisors participated in a focus group. Topic guides for the group were informed by a summary of challenges and obstacles that each therapist had completed at the end of therapy for each individual client. The audio recording of the focus group was transcribed and data were analysed using thematic analysis. RESULTS: We identified five themes: addressing alcohol use versus other problems; impact of bipolar disorder on therapy; importance of avoidance and overcoming it; fine balance in relation to shame and normalising use; and 'talking the talk' versus 'walking the walk'. CONCLUSIONS: Findings suggest that clients may be willing to explore motivations for using alcohol even if they are not ready to change their drinking, and they may want help with a range of mental health problems. Emotional and behavioural avoidance may be a key factor in maintaining alcohol use in this client group and therapists should be aware of a possible discrepancy between clients' intentions to reduce misuse and their actual behaviour.

Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis.

BACKGROUND: Naltrexone is an opioid antagonist used in many different conditions, both licensed and unlicensed. It is used at widely varying doses from 3 to 250 mg. The aim of this review was to extensively evaluate the safety of oral naltrexone by examining the risk of serious adverse events and adverse events in randomised controlled trials of naltrexone compared to placebo. METHODS: A systematic search of the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, other databases and clinical trials registries was undertaken up to May 2018. Parallel placebo-controlled randomised controlled trials longer than 4 weeks published after 1 January 2001 of oral naltrexone at any dose were selected. Any condition or age group was included, excluding only studies in opioid or ex-opioid users owing to possible opioid/opioid antagonist interactions. The systematic review used the guidance of the Cochrane Handbook and Preferred Reporting Items for Systematic Reviews and Meta-analyses harms checklist throughout. Numerical data were independently extracted by two people and cross-checked. Risk of bias was assessed with the Cochrane risk-of-bias tool. Meta-analyses were performed in R using random effects models throughout. RESULTS: Eighty-nine randomised controlled trials with 11,194 participants were found, studying alcohol use disorders (n = 38), various psychiatric disorders (n = 13), impulse control disorders (n = 9), other addictions including smoking (n = 18), obesity or eating disorders (n = 6), Crohn's disease (n = 2), fibromyalgia (n = 1) and cancers (n = 2). Twenty-six studies (4,960 participants) recorded serious adverse events occurring by arm of study. There was no evidence of increased risk of serious adverse events for naltrexone compared to placebo (risk ratio 0.84, 95% confidence interval 0.66-1.06). Sensitivity analyses pooling risk differences supported this conclusion (risk difference -0.01, 95% confidence interval -0.02-0.00) and subgroup analyses showed that results were consistent across different doses and disease groups. Secondary analysis revealed only six marginally significant adverse events for naltrexone compared to placebo, which were of mild severity. CONCLUSIONS: Naltrexone does not appear to increase the risk of serious adverse events over placebo. These findings confirm the safety of oral naltrexone when used in licensed indications and encourage investments to undertake efficacy studies in unlicensed indications. TRIAL REGISTRATION: PROSPERO 2017 CRD42017054421 .

Is telephone health coaching a useful population health strategy for supporting older people with multimorbidity? An evaluation of reach, effectiveness and cost-effectiveness using a 'trial within a cohort'.

BACKGROUND: Innovative ways of delivering care are needed to improve outcomes for older people with multimorbidity. Health coaching involves 'a regular series of phone calls between patient and health professional to provide support and encouragement to promote healthy behaviours'. This intervention is promising, but evidence is insufficient to support a wider role in multimorbidity care. We evaluated health coaching in older people with multimorbidity. METHODS: We used the innovative 'Trials within Cohorts' design. A cohort was recruited, and a trial was conducted using a 'patient-centred' consent model. A randomly selected group within the cohort were offered the intervention and were analysed as the intervention group whether they accepted the offer or not. The intervention sought to improve the skills of patients with multimorbidity to deal with a range of long-term conditions, through health coaching, social prescribing and low-intensity support for low mood. RESULTS: We recruited 4377 older people, and 1306 met the eligibility criteria (two or more long-term conditions and moderate 'patient activation'). We selected 504 for health coaching, and 41% consented. More than 80% of consenters received the defined 'dose' of 4+ sessions. In an intention-to-treat analysis, those selected for health coaching did not improve on any outcome (patient activation, quality of life, depression or self-care) compared to usual care. We examined health care utilisation using hospital administrative and self-report data. Patients selected for health coaching demonstrated lower levels of emergency care use, but an increase in the use of planned services and higher overall costs, as well as a quality-adjusted life year (QALY) gain. The incremental cost per QALY was £8049, with a 70-79% probability of being cost-effective at conventional levels of willingness to pay. CONCLUSIONS: Health coaching did not lead to significant benefits on the primary measures of patient-reported outcome. This is likely related to relatively low levels of uptake amongst those selected for the intervention. Demonstrating effectiveness in this design is challenging, as it estimates the effect of being selected for treatment, regardless of whether treatment is adopted. We argue that the treatment effect estimated is appropriate for health coaching, a proactive model relevant to many patients in the community, not just those seeking care. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ( ISRCTN12286422 ).

The feasibility and acceptability of a novel anxiety in bipolar disorder intervention compared to treatment as usual: A randomized controlled trial.

BACKGROUND: Comorbid anxiety is common in bipolar disorder (BD) and associated with worse clinical outcomes including increased suicidality. Despite effective psychological treatments for anxiety, research into treating anxiety in BD is underdeveloped. This paper describes a novel psychological intervention to address anxiety in context of bipolar disorder (AIBD). METHODS: Adults with BD and clinically significant anxiety symptoms were randomized to AIBD plus treatment as usual (TAU) or TAU alone. AIBD offered 10 sessions of psychological therapy using a formulation-based approach. Feasibility and acceptability were evaluated through recruitment, retention, therapy attendance, alliance, fidelity, and qualitative feedback. Clinical outcomes were assessed at baseline, 16, 48, and 80 weeks: interim assessments of relapse at 32 and 64 weeks. RESULTS: Seventy-two participants were recruited with 88% retention to 16 weeks and 74% to 80 weeks (similar between arms). Therapy participants attended x ¯ 7.7 (SD 2.8) sessions. Therapeutic alliance and therapy fidelity were acceptable. Qualitative interviews indicated that participants valued integrated support for anxiety with BD and coping strategies. Some suggested a longer intervention period. Clinical outcomes were not significantly different between arms up to 80 weeks follow-up. CONCLUSIONS: AIBD is feasible and acceptable but lack of impact on clinical outcomes indicates that adaptations are required. These are discussed in relation to qualitative feedback and recent literature published since the trial completed.

Enacting person-centredness in integrated care: A qualitative study of practice and perspectives within multidisciplinary groups in the care of older people.

BACKGROUND: Person-centredness is important in delivering care for long-term conditions. New models of care aim to co-ordinate care through integration of health and social care which require new ways of working, often remotely from the patient. OBJECTIVE: To describe how person-centred care is enacted within multidisciplinary groups (MDGs) created as part of a new service, integrating health and social care for older people. METHODS: We followed the implementation of eight neighbourhood MDGs, observing and interviewing staff from three MDGs at different phases of programme implementation using semi-structured topic guides. RESULTS: Thirty-four MDG meetings were observed and 32 staff interviewed. Three core themes were identified which impacted on enactment of person-centred care: the structural context of MDGs enabling person-centred care; interaction of staff and knowledge sharing during the MDG meetings; and direct staff involvement of the person outside the MDG discussion. CONCLUSIONS: This study provides new insights into attempts to enact person-centred care within a new model of service delivery. Teams did what they could to enact person-centred care in the absence of the "real" patient within MDG meetings. They were successful in delivering and co-ordinating some aspects of care (eg prompting medication reviews, referring to social worker, health improvement and arranging further multidisciplinary team meetings for complex cases). This "absence of patients" and time pressures within the MDGs led to reliance on the "virtual" record, enhanced by additional "soft" knowledge provided by staff, rather than ensuring the patient's voice was included.

Implementing resources to support the diagnosis and management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in primary care: A qualitative study.

BACKGROUND: Previous research has highlighted that many GPs lack the confidence and knowledge to diagnose and manage people with CFS/ME. Following the development of an online training module for GPs, and an information pack and DVD for patients, this study explored the extent to which these resources can be implemented in routine primary care. METHODS: Semi structured qualitative interviews were completed with patients and GPs across North West England. All interviews were transcribed and analysed using open exploratory thematic coding. Following this thematic analysis, the authors conducted a further theory-driven analysis of the data guided by Normalisation Process Theory. RESULTS: When used in line with advice from the research team, the information resource and training were perceived as beneficial to both patients and GPs in the diagnosis and management of CFS/ME. However, 47 % of patients in this study did not receive the information pack from their GP. When the information pack was used, it was often incomplete, sent in the post, and GPs did not work with patients to discuss the materials. Only13 out of 21 practices completed the training module due to time pressures and the low priority placed on low prevalence, contentious, hard to manage conditions. When the module was completed, many GPs stated that it was not feasible to retain the key messages as they saw so few patients with the condition. Due to the complexity of the condition, GPs also believed that the diagnosis and management of CFS/ME should take place in a specialist care setting. CONCLUSION: While barriers to the implementation of training and resources for CFS/ME remain, there is a need to support CFS/ME patients to access reliable, evidence based information outside primary care. Our findings suggest that future research should develop an online resource for patients to support self-management.

Overcoming the barriers to the diagnosis and management of chronic fatigue syndrome/ME in primary care: a meta synthesis of qualitative studies.

BACKGROUND: The NICE guideline for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) emphasises the need for an early diagnosis in primary care with management tailored to patient needs. However, GPs can be reluctant to make a diagnosis and are unsure how to manage people with the condition. METHODS: A meta synthesis of published qualitative studies was conducted, producing a multi-perspective description of barriers to the diagnosis and management of CFS/ME, and the ways that some health professionals have been able to overcome them. Analysis provided second-order interpretation of the original findings and developed third-order constructs to provide recommendations for the medical curriculum. RESULTS: Twenty one qualitative studies were identified. The literature shows that for over 20 years health professionals have reported a limited understanding of CFS/ME. Working within the framework of the biomedical model has also led some GPs to be sceptical about the existence of the condition. GPs who provide a diagnosis tend to have a broader, multifactorial, model of the condition and more positive attitudes towards CFS/ME. These GPs collaborate with patients to reach agreement on symptom management, and use their therapeutic skills to promote self care. CONCLUSIONS: In order to address barriers to the diagnosis and management of CFS/ME in primary care, the limitations of the biomedical model needs to be recognised. A more flexible bio-psychosocial approach is recommended where medical school training aims to equip practitioners with the skills needed to understand, support and manage patients and provide a pathway to refer for specialist input.

A randomised controlled trial of time limited CBT informed psychological therapy for anxiety in bipolar disorder.

BACKGROUND: Anxiety comorbidity is common in bipolar disorder and is associated with worse treatment outcomes, greater risk of self harm, suicide and substance misuse. To date however there have been no psychological interventions specifically designed to address this problem. The primary objective of this trial is to establish the acceptability and feasibility of a new integrated intervention for anxiety in bipolar disorder designed in collaboration with individuals with personal experience of both problems. METHODS AND DESIGN: Single blind randomised controlled trials to assess the feasibility and acceptability of a time limited CBT informed psychological intervention for anxiety in bipolar disorder (AIBD) compared with treatment as usual. Participants will be recruited from across the North West of England from specialist mental health services and through primary care and self referral. The primary outcome of the study is the feasibility and acceptability of AIBD assessed by recruitment to target and retention to follow-up, as well as absence of untoward incidents associated with AIBD. We will also estimate the effect size of the impact of the intervention on anxiety and mood outcomes, as well as calculate preliminary estimates of cost-effectiveness and investigate potential mechanisms for this (stigma, self appraisal and stability of social rhythms). DISCUSSION: This is the first trial of an integrated intervention for anxiety in bipolar disorder. It is of interest to researchers involved in the development of new therapies for bipolar disorder as well as indicating the wider potential for evaluating approaches to the treatment of comorbidity in severe mental illness.

Cost-effectiveness of supported self-management for CFS/ME patients in primary care.

BACKGROUND: Nurse led self-help treatments for people with chronic fatigue syndrome/myalgic encephalitis (CFS/ME) have been shown to be effective in reducing fatigue but their cost-effectiveness is unknown. METHODS: Cost-effectiveness analysis conducted alongside a single blind randomised controlled trial comparing pragmatic rehabilitation (PR) and supportive listening (SL) delivered by primary care nurses, and treatment as usual (TAU) delivered by the general practitioner (GP) in North West England. A within trial analysis was conducted comparing the costs and quality adjusted life years (QALYs) measured within the time frame of the trial. 296 patients aged 18 and over with CFS/ME diagnosed using the Oxford criteria were included in the cost-effectiveness analysis. RESULTS: Treatment as usual is less expensive and leads to better patient outcomes compared with Supportive Listening. Treatment as usual is also less expensive than Pragmatic Rehabilitation. PR was effective at reducing fatigue in the short term, but the impact of the intervention on QALYs was uncertain. However, based on the results of this trial, PR is unlikely to be cost-effective in this patient population. CONCLUSIONS: This analysis does not support the introduction of SL. Any benefits generated by PR are unlikely to be of sufficient magnitude to warrant recommending PR for this patient group on cost-effectiveness grounds alone. However, dissatisfaction with current treatment options means simply continuing with 'treatment as usual' in primary care is unlikely to be acceptable to patients and practitioners. TRIAL REGISTRATION: The trial registration number is IRCTN74156610.

Developing resources to support the diagnosis and management of Chronic Fatigue Syndrome/Myalgic Encephalitis (CFS/ME) in primary care: a qualitative study.

BACKGROUND: NICE guidelines emphasise the need for a confident, early diagnosis of Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) in Primary Care with management tailored to the needs of the patient. Research suggests that GPs are reluctant to make the diagnosis and resources for management are currently inadequate. This study aimed to develop resources for practitioners and patients to support the diagnosis and management of CFS/ME in primary care. METHODS: Semi structured interviews were conducted with patients, carers, GPs, practice nurses and CFS/ME specialists in North West England. All interviews were audio recorded, transcribed and analysed qualitatively using open explorative thematic coding. Two patient involvement groups were consulted at each stage of the development of resources to ensure that the resources reflect everyday issues faced by people living with CFS/ME. RESULTS: Patients and carers stressed the importance of recognising CFS/ME as a legitimate condition, and the need to be believed by health care professionals. GPs and practice nurses stated that they do not always have the knowledge or skills to diagnose and manage the condition. They expressed a preference for an online training package. For patients, information on getting the most out of a consultation and the role of carers was thought to be important. Patients did not want to be overloaded with information at diagnosis, and suggested information should be given in steps. A DVD was suggested, to enable information sharing with carers and family, and also for those whose symptoms act as a barrier to reading. CONCLUSION: Rather than use a top-down approach to the development of training for health care practitioners and information for patients and carers, we have used data from key stakeholders to develop a patient DVD, patient leaflets to guide symptom management and a modular e-learning resource which should equip GPs to diagnose and manage CFS/ME effectively, meet NICE guidelines and give patients acceptable, evidence-based information.

Reducing fatigue-related symptoms in Long COVID-19: a preliminary report of a lymphatic drainage intervention.

In the early days of the first global wave of the COVID-19 pandemic, the potential for a postviral syndrome to manifest following COVID-19 infection was first recognized. Here, we present an analysis of a case series of the first 20 patients' data collected in clinical practice to evaluate the potential of a possible alternative treatment for Long COVID. Methods: Face-to-face treatment sessions with Perrin technique practitioners occurred weekly involving effleurage/other manual articulatory techniques. The individuals being treated also undertook daily self-massage along with gentle mobility exercises. Patients recorded symptom severity using the self-report 54-item profile of fatigue-related states (PFRS) before and after treatment. Results: The mean age of male patients was 41.8 years (range, 29-53 years), and for female patients, 39.3 years (range, 28-50 years). None of the participants had a prior diagnosis of chronic fatigue syndrome, and all were new attendees to the clinics at the time of initial assessment. The average number of treatment sessions was 9.7 in men and 9.4 in women. The reduction in PFRS scores was 45% in men and 52% in women. The highest subscale scores on average were for fatigue, with the lowest for somatic symptoms. All subscale scores showed, on average, a similar reduction of approximately 50% postintervention, with the reduction in score relating to a decrease in the severity of symptoms. Conclusion: Our findings suggest that a specific manual lymphatic drainage intervention may help to reduce fatigue symptoms related to Long COVID. Perhaps preventing acute symptoms through early intervention.

Advancing Mental heaLth Provision In PHarmacY (AMPLIPHY): A feasibility study.

BACKGROUND: Specifically-designed community pharmacy-based services represent opportunities to support people with their mental health. As few such services exist worldwide, the Advancing Mental HeaLth Provision In PharmacY (AMPLIPHY) was designed with stakeholders. The purpose was to support people with their mental health when initiated on new prescription or change in drug, dose or quantity of antidepressant, through a series of consultations (up to 3 months). OBJECTIVE(S): The aim was to evaluate the feasibility of the AMPLIPHY service. The objectives were to: i) pilot the service; ii) examine anonymous consultation data to understand patients' characteristics, priorities and consultation focus and iii) Evaluate pharmacists' experiences. METHODS: This service evaluation involved a concurrent mixed methods design. Patient characteristics were extracted from consultation notes and descriptive statistics applied. Content analysis was used to summarise consultation foci and comparisons between patients' priorities with consultation content were made. Pharmacists were interviewed at the start (n = 10) and end (n = 4) of the pilot with themes identified using thematic analysis. RESULTS: Seventy-six patients participated (63% of recruitment target). The median age was 39 (IQR 28-47) and 62% were female. Seventy percent of patients had one consultation, 26% had two and 4% had three. Prescription for new antidepressant was the most common reason for entry (74%) and sertraline was most prescribed (46%). Consultations commonly focussed on life experience (n = 51), medication (n = 47), health (n = 42), support (n = 36) and patients' expression of their feelings (n = 31). The pharmacists' experiences were summarised in three themes: i) Motivation, ii) Practicalities and iii) Experience and Outcomes. CONCLUSIONS: Pharmacists were motivated to deliver this novel service and some patients were willing to join the service. Analysis of patient demographics, consultation notes and interviews provide insight into the strengths and challenges of the service and provides a blueprint for future service developments.

Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder.

BACKGROUND: Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years), and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. METHODS/DESIGN: Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. DISCUSSION: The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement.

Trading off accuracy and explainability in AI decision-making: findings from 2 citizens' juries.

OBJECTIVE: To investigate how the general public trades off explainability versus accuracy of artificial intelligence (AI) systems and whether this differs between healthcare and non-healthcare scenarios. MATERIALS AND METHODS: Citizens' juries are a form of deliberative democracy eliciting informed judgment from a representative sample of the general public around policy questions. We organized two 5-day citizens' juries in the UK with 18 jurors each. Jurors considered 3 AI systems with different levels of accuracy and explainability in 2 healthcare and 2 non-healthcare scenarios. Per scenario, jurors voted for their preferred system; votes were analyzed descriptively. Qualitative data on considerations behind their preferences included transcribed audio-recordings of plenary sessions, observational field notes, outputs from small group work and free-text comments accompanying jurors' votes; qualitative data were analyzed thematically by scenario, per and across AI systems. RESULTS: In healthcare scenarios, jurors favored accuracy over explainability, whereas in non-healthcare contexts they either valued explainability equally to, or more than, accuracy. Jurors' considerations in favor of accuracy regarded the impact of decisions on individuals and society, and the potential to increase efficiency of services. Reasons for emphasizing explainability included increased opportunities for individuals and society to learn and improve future prospects and enhanced ability for humans to identify and resolve system biases. CONCLUSION: Citizens may value explainability of AI systems in healthcare less than in non-healthcare domains and less than often assumed by professionals, especially when weighed against system accuracy. The public should therefore be actively consulted when developing policy on AI explainability.

Visual impairment and medication safety: a protocol for a scoping review.

BACKGROUND: The number of individuals with a visual impairment in the UK was estimated a few years ago to be around 1.8 million. People can be visually impaired from birth, childhood, early adulthood or later in life. Those with visual impairment are subject to health inequities and increased risk for patient safety incidents in comparison to the general population. They are also known to be at an increased risk of experiencing medication errors compared to those without visual impairment. In view of this, this review aims to understand the issues of medication safety for VI people. METHODS/DESIGN: Four electronic bibliographic databases will be searched: MEDLINE, Embase, PsycInfo and CINAHL. Our search strategy will include search combinations of two key blocks of terms. Studies will not be excluded based on design. Included studies will be empirical studies. They will include studies that relate to both medication safety and visual impairment. Two reviewers (SG and LR) will screen all the titles and abstracts. SG, LR, RM, SCS and PL will perform study selection and data extraction using standard forms. Disagreements will be resolved through discussion or third party adjudication. Data to be collected will include study characteristics (year, objective, research method, setting, country), participant characteristics (number, age, gender, diagnoses), medication safety incident type and characteristics. DISCUSSION: The review will summarise the literature relating to medication safety and visual impairment.

Feasibility and acceptability of integrated psychological therapy versus treatment as usual for people with bipolar disorder and co-morbid alcohol use: A single blind randomised controlled trial.

BACKGROUND: Alcohol use is a common problem in bipolar disorder (BD) and evidence indicates more promising outcomes for alcohol use than other substances. No trials have evaluated individual integrated motivational interviewing and cognitive behaviour therapy (MI-CBT) for problematic alcohol use in BD. We therefore assessed the feasibility and acceptability of a novel MI-CBT intervention for alcohol use in BD. METHODS: A single blind RCT was conducted to compare MI-CBT plus treatment as usual (TAU) with TAU only. MI-CBT was delivered over 20 sessions with participants followed up at 3, 6, 9 and 12 months post-randomisation. Primary outcomes were the feasibility and acceptability of MI-CBT (recruitment to target, retention to follow-up and therapy, acceptability of therapy and absence of adverse events). We also conducted preliminary analyses of alcohol and mood outcomes (frequency and severity of alcohol use and time to mood relapse). RESULTS: 44 participants were recruited with 75% retention to 6 and 12 months follow-up. Therapy participants attended a mean of 17.6 (SD 4.5) sessions. Therapy alliance and treatment fidelity were acceptable. Qualitative interviews indicated the intervention was experienced as collaborative, and helpful, in addressing mood and alcohol issues, although risk of overconfidence following therapy was also identified. Clinical outcomes did not differ between arms at 12 months follow-up. LIMITATIONS: As a feasibility and acceptability trial any secondary results should be treated with caution. CONCLUSIONS: Integrated MI-CBT is feasible and acceptable, but lack of clinical impact, albeit in a feasibility study, suggests need for further development. Potential adaptations are discussed.

Targeting the 'right' patients for integrated care: stakeholder perspectives from a qualitative study.

Objective To explore the perceptions of relevant stakeholders in terms of targeting the 'right' patients for integrated care. Methods Secondary analysis of qualitative interviews with relevant stakeholders (including programme managers, programme initiators, a representative of the payers, medical and social care professionals and allied health services staff) from two integrated care sites in England. A thematic analysis was conducted of cross-cutting themes. Results Both sites focused on individualized management of 'high-risk' patients through multidisciplinary team case management. The data-driven approach to targeting patients, recommended in the policy literature, did not align with stakeholders' experience of selecting patients in practice. The 'right' patients were at lower risk than those recommended by policy, and their complexities were identified as comprising mostly social rather than medical issues. Conclusions These findings raise timely questions about the individualized management approach. They potentially explain why management of high-risk patients has not been found to be effective using quantitative measures, undermining the assumption that this approach will lead to cost savings. There is a need to expand beyond an individually targeted approach to incorporate prevention and to address social issues.

Integrated psychological therapy for people with bipolar disorder and co-morbid alcohol use: A feasibility and acceptability randomised controlled trial.

BACKGROUND: Co-morbid substance misuse, particularly alcohol, is common in bipolar disorder (BD) and associated with worse treatment outcomes. Research into psychological interventions for substance misuse in BD is at an early stage and no studies have specifically targeted problematic alcohol use. This paper describes the context and protocol for a feasibility and acceptability randomised controlled trial (RCT) evaluating a novel intervention combining motivational interviewing and cognitive behavioural therapy (MI-CBT) for participants with BD and problematic alcohol use, developed in collaboration with people with lived experience of both issues. METHODS AND DESIGN: An RCT will assess the feasibility and acceptability of MI-CBT in addition to treatment as usual (TAU) compared with TAU alone. Participants will be recruited from across the North West of England through NHS services and self-referral. The primary outcomes will be the feasibility and acceptability of the intervention assessed by recruitment to target, adherence to intervention, retention rate at follow-up, absence of adverse events and qualitative analysis of participants' reported experiences of intervention. The effect size of the impact of the intervention on alcohol use and mood outcomes will also be estimated. In addition, we will explore a number of potential process variables in therapy. DISCUSSION: This is the first RCT evaluating MI-CBT for BD and problematic alcohol use. Given the prevalence and impact of alcohol problems in BD this novel integrated intervention may have potential to offer important improvements in clinical and functional outcomes.

Clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder (PARADES): a pragmatic, multicentre, observer-blind, randomised controlled superiority trial.

BACKGROUND: Group psychoeducation is a low-cost National Institute for Health and Care Excellence-recommended treatment for bipolar disorder. However, the clinical effectiveness and acceptability of this intervention are unclear compared with unstructured peer support matched for delivery and aim of treatment, and for previous bipolar history. We aimed to assess the clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder. METHODS: We did this pragmatic, multicentre, parallel-group, observer-blind, randomised controlled superiority trial at eight community sites in two regions in England. Participants aged 18 years or older with bipolar disorder and no episode in the preceding 4 weeks were recruited via self-referral or secondary care referral. Participants were individually randomly assigned (1:1), via a computer-generated stochastic allocation sequence, to attend 21 2-h weekly sessions of either structured group psychoeducation or optimised unstructured peer support. Randomisation was minimised by number of previous episodes (one to seven, eight to 19, or ≥20) and stratified by clinical site. Outcome assessors were masked to group allocation. The primary outcome was time from randomisation to next bipolar episode, with planned moderator analysis of number of previous bipolar episodes and qualitative interview of participant experience. We did analysis by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN62761948. FINDINGS: Between Sept 28, 2009, and Jan 9, 2012, we randomly assigned 304 participants to receive psychoeducation (n=153) or peer support (n=151); all (100%) participants had complete primary outcome data. Attendance at psychoeducation groups was higher than at peer-support groups (median 14 sessions [IQR three to 18] vs nine sessions [two to 17]; p=0·026). At 96 weeks, 89 (58%) participants in the psychoeducation group had experienced a next bipolar episode compared with 98 (65%) participants in the peer-support group; time to next bipolar episode did not differ between groups (hazard ratio [HR] 0·83, 95% CI 0·62-1·11; p=0·217). Planned moderator analysis showed that psychoeducation was most beneficial in participants with few (one to seven) previous bipolar episodes (χ2; HR 0·28, 95% CI 0·12-0·68; p=0·034). Four (1%) participants (one in the psychoeducation group and three in the peer-support group) died during follow-up; these deaths were deemed unrelated to the study interventions or procedures. INTERPRETATION: Structured group psychoeducation was no more clinically effective than similarly intensive unstructured peer support, but was more acceptable and improved outcome in participants with fewer previous bipolar episodes. Optimum provision of structured psychological interventions, such as group psychoeducation, early in the course of bipolar disorder might have important benefits on the course of illness, and merits further research. FUNDING: National Institute for Health Research.