The Barriers and Facilitators to Decentralised Nurse-Led Mental Health Service Delivery in Sierra Leone.

In 2009, 98.0% of people with mental illness in Sierra Leone were not receiving treatment, partly due to the absence of public psychiatric facilities outside the capital. In response to this situation, the Ministry of Health and Sanitation rolled out nurse-led mental health units (MHUs) to every district. This study evaluates the barriers and facilitators to mental health service delivery in decentralised MHUs in Sierra Leone using key informant interviews and focus group discussions with 13 purposefully sampled clinical staff and senior management personnel. The interviews were audio-recorded, translated from Krio if necessary, transcribed, and analysed using manifest content analysis. The findings suggest that factors affecting nurse-led mental health service delivery include small workforce and high workload, culture and beliefs, risks, lack of safety measures and required resources, outdated policies, poor salaries, lack of funds for medication, distance, power, influence, and stigma. Factors that could facilitate nurse-led mental health services include: increasing motivation, increasing the workforce, knowledge sharing, mentorship, availability of medication, passion and modern psychiatry. The findings contribute towards understanding the challenges and opportunities faced by the recently established nurse-led decentralised mental health services across Sierra Leone, in order to address the large mental health treatment gap. We hope the findings will inform further policy and planning to improve the quality of decentralised mental healthcare.

A mixed-methods feasibility study of a new digital health support package for people after stroke: the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) intervention.

BACKGROUND: Evidence for digital health programmes to support people living with stroke is growing. We assessed the feasibility of a protocol and procedures for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial. METHODS: We conducted a mixed-method feasibility study. Participants with acute stroke were recruited from three hospitals (Melbourne, Australia). Eligibility: Adults with stroke discharged from hospital to home within 10 days, modified Rankin Score 0-4 and prior use of Short Message System (SMS)/email. While in hospital, recruited participants contributed to structured person-centred goal setting and completed baseline surveys including self-management skills and health-related quality of life. Participants were randomised 7-14 days after discharge via REDCap® (1:1 allocation). Following randomisation, the intervention group received a 12-week programme of personalised electronic support messages (average 66 messages sent by SMS or email) aligned with their goals. The control group received six electronic administrative messages. Feasibility outcomes included the following: number of patients screened and recruited, study retainment, completion of outcome measures and acceptability of the ReCAPS intervention and trial procedures (e.g. participant satisfaction survey, clinician interviews). Protocol fidelity outcomes included number of goals developed (and quality), electronic messages delivered, stop messages received and engagement with messages. We undertook inductive thematic analysis of interview/open-text survey data and descriptive analysis of closed survey questions. RESULTS: Between November 2018 and October 2019, 312 patients were screened; 37/105 (35%) eligible patients provided consent (mean age 61 years; 32% female); 33 were randomised (17 to intervention). Overall, 29 (88%) participants completed the12-week outcome assessments with 12 (41%) completed assessments in the allocated timeframe and 16 also completing the satisfaction survey (intervention=10). Overall, trial participants felt that the study was worthwhile and most would recommend it to others. Six clinicians participated in one of three focus group interviews; while they reported that the trial and the process of goal setting were acceptable, they raised concerns regarding the additional time required to personalise goals. CONCLUSION: The study protocol and procedures were feasible with acceptable retention of participants. Consent and goal personalisation procedures should be centralised for the phase III trial to reduce the burden on hospital clinicians. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618001468213 (date 31/08/2018); Universal Trial Number: U1111-1206-7237.

Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).

RATIONALE: To address unmet needs, electronic messages to support person-centered goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited. HYPOTHESIS: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomization. METHODS AND DESIGN: Multicenter, double-blind, randomized controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalized, goal-centered, and administrative electronic messages, while the control group only receive administrative messages. The trial includes a process evaluation, assessment of treatment fidelity, and an economic evaluation. Participants: Confirmed stroke (modified Rankin Score: 0-4), aged ≥18 years with internet/mobile phone access, discharged directly home from hospital. Randomization: 1:1 computer-generated, stratified by age and baseline disability. Outcomes assessments: Collected at 90 days and 12 months following randomization. OUTCOMES: Primary outcomes include hospital emergency presentations/admissions within 90 days of randomization. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months. Sample size: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of α = 0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n = 668 are obtained, with maximum sample capped at 1100. DISCUSSION: We will provide new evidence on the potential effectiveness, implementation, and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.

The burden of mental disorder in Sierra Leone: a retrospective observational evaluation of programmatic data from the roll out of decentralised nurse-led mental health units.

BACKGROUND: In sub-Saharan Africa the treatment gap for mental disorders is high. In 2009, 98.0% of people with mental illness in Sierra Leone were not receiving treatment, partly due to the absence of public psychiatric facilities outside the capital. In response, the Ministry of Health and Sanitation rolled out nurse-led mental health units (MHU) to every district. This study aims to retrospectively evaluate the uptake of these services by examining the pathways to care, diagnosis, management, and treatment gap, to provide insight into the functioning of these units and the potential burden of mental health disorders in Sierra Leone. METHODS: We evaluated the roll out of MHU using summary data from all units between 1 st January 2015 and 1 st January 2017, to establish the burden of diagnoses among service users, pathways to care, treatments provided, and treatment gaps. Negative binomial regressions examine bivariate relationships between diagnoses, treatments, and medication inaccessibility with demographics (age and sex), location (Freetown vs the rest and Ebola endemic regions vs the rest) and year. RESULTS: We collected data from 15 MHU covering 13 districts in 24 months. There were 2401 referrals. The largest age category was 25-34 (23.4%). The prominent diagnoses were epilepsy (43.5%, associated with children) and psychosis (17.5%, associated with males). Reported depression (8.6%) and suicide attempts (33 patients) were low. Ebola endemic regions reported higher rates of grief, trauma, and medically unexplained symptoms. In 24.7% of cases where medication was required, it was not accessible. CONCLUSIONS: Nurse-led MHU can have a modest effect on the treatment gap in resource constrained environments such as Sierra Leone, particularly in epilepsy and psychosis.

Mental health in Sierra Leone.

Sierra Leone is a West African country with a population of just over 7 million. Many Sierra Leoneans lived through the psychologically distressing events of the civil war (1991-2002), the 2014 Ebola outbreak and frequent floods. Traditionally, mental health services have been delivered at the oldest mental health hospital in sub-Saharan Africa, with no services available anywhere else in the country. Mental illness remains highly stigmatised. Recent advances include revision of the Mental Health Policy and Strategic Plan and the strengthening of mental health governance and district services. Many challenges lie ahead, with the crucial next steps including securing a national budget line for mental health, reviewing mental health legislation, systematising training of mental health specialists and prioritising the procurement of psychotropic medications. National and international commitment must be made to reduce the treatment gap and provide quality care for people with mental illness in Sierra Leone.

Scale-out of a community-based behavioral intervention for childhood obesity: pilot implementation evaluation.

BACKGROUND: Expanding the use of evidence-based behavioral interventions in community settings has met with limited success in various health outcomes as fidelity and dose of clinical interventions are often diluted when translated to communities. We conducted a pilot implementation study to examine adoption of the rigorously evaluated Healthier Families Program by Parks and Recreation centers in 3 cities across the country (MI, GA, NV) with diverse socio-cultural environments. METHODS: Using the RE-AIM framework, we evaluated the program both quantitatively (pre/post surveys of health behavior change; attendance & fidelity) and qualitatively (interviews with Parks and Recreation staff and participants following the program). RESULTS: The 3 partner sites recruited a total of 26 parent-child pairs. REACH: Among the 24 participants who completed pre/post surveys, 62.5% were 25-34 years old, and average child age was 3.6 (SD 0.7) years. The distribution of self-reported race/ethnicity was 54% non-Hispanic White, 38% non-Hispanic Black, and 8% Latino. EFFECTIVENESS: Qualitative interviews with participants demonstrated increased use of the built environment for physical activity and continued use of key strategies for health behavior change. ADOPTION: Three of five (60%) collaborating sites proceeded with implementation of the program. IMPLEMENTATION: The average attendance for the 12-week program was 7.6 (SD 3.9) sessions, with 71% attending > 50% of sessions. Average fidelity for the 12 weekly sessions was 25.2 (SD 1.2; possible range 9-27). MAINTENANCE: All 3 partner sites continued offering the program after grant funding was complete. CONCLUSIONS: This pilot is among the first attempts to scale-out an evidence-based childhood obesity intervention in community Parks and Recreation centers. While this pilot was not intended to confirm the efficacy of the original trial on Body Mass Index (BMI) reduction, the effective and sustained behavior change among a geographically and ethnically diverse population with high attendance and fidelity demonstrates an effective approach on which to base future large-scale implementation efforts to reduce childhood obesity in community settings.

Preclinical to Human Translational Pharmacology of the Novel M1 Positive Allosteric Modulator MK-7622.

The current standard of care for treating Alzheimer's disease is acetylcholinesterase inhibitors, which nonselectively increase cholinergic signaling by indirectly enhancing activity of nicotinic and muscarinic receptors. These drugs improve cognitive function in patients, but also produce unwanted side effects that limit their efficacy. In an effort to selectively improve cognition and avoid the cholinergic side effects associated with the standard of care, various efforts have been aimed at developing selective M1 muscarinic receptor activators. In this work, we describe the preclinical and clinical pharmacodynamic effects of the M1 muscarinic receptor-positive allosteric modulator, MK-7622. MK-7622 attenuated the cognitive-impairing effects of the muscarinic receptor antagonist scopolamine and altered quantitative electroencephalography (qEEG) in both rhesus macaque and human. For both scopolamine reversal and qEEG, the effective exposures were similar between species. However, across species the minimum effective exposures to attenuate the scopolamine impairment were lower than for qEEG. Additionally, there were differences in the spectral power changes produced by MK-7622 in rhesus versus human. In sum, these results are the first to demonstrate translation of preclinical cognition and target modulation to clinical effects in humans for a selective M1 muscarinic receptor-positive allosteric modulator.

Community readiness assessment for obesity research: pilot implementation of the Healthier Families programme.

BACKGROUND: This article reports on the development of a systematic approach to assess for community readiness prior to implementation of a behavioural intervention for childhood obesity. Using the Consolidated Framework for Implementation Research (CFIR), we developed research tools to evaluate local community centres' organisational readiness and their capacity to implement the intervention. METHODS: Four community Parks and Recreation centres from different states expressed interest in piloting an approach for dissemination and implementation of an evidence-based obesity prevention program for families with young children (Healthier Families). We conducted a mixed methods pre-implementation evaluation using the CFIR to evaluate the alignment of organisational priorities with the Healthier Families programme. Written surveys assessed organisational readiness for change amongst organisational leaders, recreation programmers, and staff (N = 25). Key informant interviews were conducted among staff to assess organisational readiness and with community members to assess community readiness (N = 64). Surveys were analysed with univariate statistics. Interviews were transcribed, coded and analysed using inductive and deductive methods of analysis. RESULTS: Mixed-methods analysis led to the identification of three key domains on which to assess the organisational readiness to adopt a childhood obesity intervention, namely the physical infrastructure, the knowledge infrastructure, and the social infrastructure. The most critical measure of compatibility was the social infrastructure, since obstacles in the knowledge and physical infrastructures could be overcome by the strength of social resources, including the staff's ingenuity and commitment to a healthier community. This approach guided an assessment of organisational readiness prior to community organisations adopting and preparing to disseminate an obesity prevention community-based program in a wide-range of social and environmental contexts. CONCLUSIONS: Using a comprehensive pre-implementation assessment of the knowledge, physical and social infrastructures in a community is an essential step in effective dissemination for community-based behavioural interventions. Our research found that, when evaluating readiness and alignment, a responsive social infrastructure could provide the capacity to overcome potential barriers to implementation in either the knowledge or physical infrastructures.

cGMP production of the radiopharmaceutical [18 F]MK-6240 for PET imaging of human neurofibrillary tangles.

Fluorine-18-labelled 6-(fluoro)-3-(1H-pyrrolo[2,3-c]pyridin-1-yl)isoquinolin-5-amine ([18 F]MK-6240) is a novel potent and selective positron emission tomography (PET) radiopharmaceutical for detecting human neurofibrillary tangles, which are made up of aggregated tau protein. Herein, we report the fully automated 2-step radiosynthesis of [18 F]MK-6240 using a commercially available radiosynthesis module, GE Healthcare TRACERlab FXFN . Nucleophilic fluorination of the 5-diBoc-6-nitro precursor with potassium cryptand [18 F]fluoride (K[18 F]/K222 ) was performed by conventional heating, followed by acid deprotection and semipreparative high-performance liquid chromatography under isocratic conditions. The isolated product was diluted with formulation solution and sterile filtered under Current Good Manufacturing Practices, and quality control procedures were established to validate this radiopharmaceutical for human use. At the end of synthesis, 6.3 to 9.3 GBq (170-250 mCi) of [18 F]MK-6240 was formulated and ready for injection, in an uncorrected radiochemical yield of 7.5% ± 1.9% (relative to starting [18 F]fluoride) with a specific activity of 222 ± 67 GBq/µmol (6.0 ± 1.8 Ci/µmol) at the end of synthesis (90 minutes; n = 3). [18 F]MK-6240 was successfully validated for human PET studies meeting all Food and Drug Administration and United States Pharmacopeia requirements for a PET radiopharmaceutical. The present method can be easily adopted for use with other radiofluorination modules for widespread clinical research use.