A Smartphone-Smartcard Platform for Implementing Contingency Management in Buprenorphine Maintenance Patients With Concurrent Stimulant Use Disorder

Background and Objectives: Opioid agonist pharmacotherapies are effective in the treatment of opioid use disorder (OUD) but concurrent stimulant use is common and can lead to relapse and treatment drop out. Contingency management in combination with opioid agonist pharmacotherapy has broad beneficial effects in polysubstance users, including promoting drug abstinence and treatment retention, but clinic-based implementation can be burdensome. The present study was conducted to evaluate a contingency management intervention delivered via a smartphone-smartcard platform in OUD patients who had concurrent stimulant use disorder.Methods: Retrospective comparison of (n = 124) patients; half received the contingency management intervention and half were matched controls. Drug use and clinic attendance outcomes over four consecutive 30-day periods were analyzed with regression.Results: The intervention group showed consistently higher rates of drug abstinence and clinic attendance which were significant at the latter two timepoints.Discussion: Smartphone-smartcard platforms can facilitate dissemination of contingency management by surmounting or obviating key barriers to adoption. They appear to be convenient for all stakeholders, are easy to use, and facilitate high-fidelity implementation. Delivering contingency management via a smartphone-smartcard platform produces effects consistent with those observed when the intervention is delivered with substantially costlier and more burdensome in-person procedures.

Sickle Cell Screening in Children in a Resource Constrained Environment: Diagnosis and Follow up

Introduction: Sickle cell disease (SCD) is the most common hemoglobinopathy in the world and it disproportionately affects population in tropical, resource-constrained regions where there is a high prevalence of malaria. Efforts to screen for SCD have been highly prioritized in these areas despite limited resources. However, follow up after diagnosis remains a challenge. Counterintuitively, many of those diagnosed with SCD are lost to follow up after screening while others lack access to treatment that would otherwise prevent them from developing adverse health effects of SCD which is the primary reason for screening for the disease. Objectives: To determine the rate of enrollment of children with sickle cell disease into comprehensive sickle cell clinic and initiation of sickle cell treatment after screening positive for SCD. Methodology: This is a cross sectional study. Families of children aged 5 years and below who screened positive for SCD as part of a validation of point of care test between 2017 and 2018 in Homabay County Referral Hospital in Kenya were contacted by phone and an inquiry was made on their health status, clinic visits and treatment for SCD. Five attempts were made at reaching the families within a period of one week. Data were analyzed using frequency tables. Results: Seven hundred children under 5 years were screened for SCD between 2017 and 2018 at Homabay County Referral Hospital and 34 were found to have sickle cell disease by screening and confirmatory testing. The mean age at the time of testing was 24 months (range 4 to 59 months). Mean follow up time was 33 months after diagnosis(range 32-35 months). Twenty-seven participants were reachable on phone and 8 could not be traced. Out of those contacted three had died from possible infectious diseases and one had stopped attending sickle cell clinic for unclear reasons. Twenty-three children were consistent with clinic attendance and were taking folic acid, and proguanil for malaria prophylaxis. Eight had not been started on hydroxyurea because they were asymptomatic for sickle cell. Fifteen patients who had been started on hydroxyurea had already experienced at least 3 or more painful crises, hospitalizations, febrile illness, or more than 1 blood transfusions within a year. These criteria are used to initiate hydroxyurea because of limited supply. In a setting where typically more than 50% of children screened for SCD are lost to follow up, 77% of the children were traceable and of those alive 96% were enrolled to comprehensive sickle cell clinic. Preliminary results from screening with point of care test permitted intensive education of families with a child highly likely to have SCD. This likely contributed to the high proportion of children attending SCD clinic. Relocation of families and unreliable phone contacts may have contributed to cases of lost to follow up. Conclusion: While screening for SCD is crucial for timely diagnosis and prevention of life-threatening complication of SCD, establishing consistent follow-up of patients is challenging. Timely screening results and education based on these results is an effective strategy to increase SCD clinic attendance, treatment adherence, and improve outcomes in children with SCD. Disclosures Strouse: Takeda: Consultancy.

Safety Evaluation of an Expedited Omalizumab Home Self-Administration Pathway (Preprint)

BACKGROUND The Northern Ireland Regional Immunology Service (NIRIS) has developed an expedited omalizumab home self-administration pathway to reduce face-to-face clinic attendance during the COVID19 pandemic. This audit evaluates the safety of this pathway with a particular focus on anaphylaxis. OBJECTIVE To retrospectively audit the records of 39 patient undertaking expedited home self-administration at NIRIS for complications, particularly Emergency Department attendance for anaphylaxis. The target was for 100% of patients to complete a six-month course without experiencing anaphylaxis related to omalizumab administration. METHODS 39 records of patients who underwent expedited omalizumab self-administration were audited by a single reviewer. They were prospectively collected between March 2020 and August 2021. Clinical data was collected from the Northern Ireland Electronic Care Record (NIECR). RESULTS 100% of patients were in the process of completing or had completed a six-dose course without anaphylaxis. 7.6% of patients attended the Emergency Department during their course of omalizumab. 0% experienced anaphylaxis triggered by omalizumab. The target of 100% patients completing the expedited pathway without omalizumab-related anaphylaxis was met. CONCLUSIONS The expedited omalizumab home self-administration pathway is safe and may become the standard of care post-pandemic.

The Development of Theory-Informed Participant-Centred Interventions to Maximise Participant Retention in Randomised Controlled Trials

BackgroundA failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention. MethodsThis study used a multi-phase sequential mixed methods approach informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions based on participant accounts were described and developed in a co-design workshop with trial participants. We then assessed acceptability and feasibility of two of the prioritised retention interventions during a focus group, which also included a questionnaire, involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). ResultsEight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed based on suggestions provided by trial participants: 1. Incentives and rewards for follow-up clinic attendance; 2. Goal setting for improving questionnaire return; 3. Self-monitoring to improve questionnaire return and/or clinic attendance; and 4. Motivational information to improve questionnaire return and clinic attendance. Seventeen trial stakeholders (participants, trialists, ethics committee members) contributed to the evaluation of acceptability and feasibility of the retention interventions, which were generally positive with some areas for consideration highlighted. ConclusionsThis is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess their effectiveness and assess resource implications.

The Impact of COVID-19 Pandemic on Cleft Care Services at a Tertiary Health Facility in Nigeria

Background: This study assessed the impact of COVID-19 Pandemic on cleft care services at a Nigerian tertiary health facility and the adaptations made during and after the population quarantine period. Methodology: A prospective and retrospective survey of all patients with orofacial cleft who had cleft surgeries, orthodontic interventions, and speech therapy in isolation or any of the combination was carried out. The survey period was divided into pre-COVID-19 lockdown period, the COVID-19 lockdown period, and the post-COVID-19 lockdown period with each of the periods spanning 4 months. The data which include: number of cleft clinic attendance, number of cleft surgical procedures, orthodontic interventions, and speech therapy session were retrieved from patients’ case records in the cleft and orthodontic clinics. The data was also reported for each period and represented as numbers and percentages. The trend of cleft services was plotted as line graphs and the impact of the COVID-19 pandemic on cleft care services is said to be significant when P value is <.005. Result: During the COVID-19 Lockdown period, there was a 66% drop in level of cleft clinic attendance, 78% drop in cleft surgeries, 78% drop in Orthodontic interventions, and a 58% drop in the number of Speech Therapy sessions. After the Lockdown period, the clinic attendance increased by a 190%, cleft surgeries rose by more than 10-fold, and the orthodontic interventions increased 10-fold. The speech therapy sessions dwindled further by 6% during the post-COVID-19 Lockdown period. The drop in cleft care service during the study period was significant ( P = .001). The post Lockdown surge in cleft care services was also statistically significant ( P = .001). Conclusion: The COVID-19 pandemic significantly altered the volume of cleft care services but also with a significant rebound post-lockdown period.

Direct and indirect effects of COVID 19 on thalassemia care in an adult thalassaemia care unit in Sri Lanka

Patients with thalassemia syndromes(TS) affected with COVID 19 attending a thalassemia center in Sri Lanka situated in the region most affected with COVID 19 were studied over a 16- month period. To assess the collateral effects on overall thalassemia care in the center, data on transfusion, chelation, clinic attendance was analyzed. Morbidity events and deaths recorded during the COVID 19 period and a similar period before the beginning of COVID 19 infection in Sri Lanka too were reordered in all clinic registrants. Seven patients (of 502) with TS had developed COVID 19 during the 16-month period and all were minimally symptomatic and had recovered without complications. Number of monthly clinic visits reduced from 338 in pre-COVID19 to 268 during COVID-19 (P = 0.004). Iron chelators usage too reduced during pandemic period (P < 0.001). Though admissions related to morbidity reduced during the pandemic (58 vs 16, P <0.001) there were more non COVID19 deaths (8 vs 4). Numbers affected with COVID 19 and the severity of infection seemed milder in this cohort of patients with TS but the collateral effects on the management of the unit and its effects on mortality in this vulnerable population appears to have been substantial.

1254 Virtual Fracture Clinic Management of Little (5th) Metacarpal Neck Fractures; a Safe and Feasible Option?

Aim To determine the safety and efficacy of a Virtual Fracture Clinic (VFC) in managing little metacarpal neck fractures. Method Retrospective review of consecutive little MC neck fractures presenting to the ED June-December 2020 and subsequently referred on to VFC. Patient demographics and clinic outcomes were reviewed using electronic patient records and radiographs. Results Fifty patients were identified (Male:Female 37:13; mean age 26 years, range 3-89 years). Of these, 41/50 were discharged directly following VFC advice, with no adverse event. The remaining 9/50 had a face-to-face Fracture Clinic review due to safeguarding concerns (2), concurrent neck of fourth MC fracture (2), concerns regarding fracture pattern (4), and an unclear indication (1). These 9/50 were discharged after single review, with no adverse events to date. Conclusions Our data suggest that VFC review of patients with little MC neck fractures is a safe and feasible means of patient care which has the potential to reduce the requirement of face-to-face patient contact during the Covid-19 pandemic and reduce fracture clinic attendance. We suggest the routine incorporation of a Virtual Fracture Clinic for these hand injuries. Further work is needed to formally investigate associated patient satisfaction and the application of this approach to other trauma presentations.

Indirect effects of COVID-19 on maternal, neonatal, child, sexual and reproductive health services in Kampala, Uganda

BackgroundCOVID-19 impacted global maternal, neonatal and child health outcomes. We hypothesised that the early, strict lockdown that restricted individuals’ movements in Uganda limited access to services.MethodsAn observational study, using routinely collected data from Electronic Medical Records, was carried out, in Kawempe district, Kampala. An interrupted time series analysis assessed the impact on maternal, neonatal, child, sexual and reproductive health services from July 2019 to December 2020. Descriptive statistics summarised the main outcomes before (July 2019–March 2020), during (April 2020–June 2020) and after the national lockdown (July 2020–December 2020).ResultsBetween 1 July 2019 and 31 December 2020, there were 14 401 antenatal clinic, 33 499 deliveries, 111 658 childhood service and 57 174 sexual health attendances. All antenatal and vaccination services ceased in lockdown for 4 weeks.During the 3-month lockdown, the number of antenatal attendances significantly decreased and remain below pre-COVID levels (370 fewer/month). Attendances for prevention of mother-to-child transmission of HIV dropped then stabilised. Increases during lockdown and immediately postlockdown included the number of women treated for high blood pressure, eclampsia and pre-eclampsia (218 more/month), adverse pregnancy outcomes (stillbirths, low-birth-weight and premature infant births), the rate of neonatal unit admissions, neonatal deaths and abortions. Maternal mortality remained stable. Immunisation clinic attendance declined while neonatal death rate rose (from 39 to 49/1000 livebirths). The number of children treated for pneumonia, diarrhoea and malaria decreased during lockdown.ConclusionThe Ugandan response to COVID-19 negatively impacted maternal, child and neonatal health, with an increase seen in pregnancy complications and fetal and infant outcomes, likely due to delayed care-seeking behaviour. Decreased vaccination clinic attendance leaves a cohort of infants unprotected, affecting all vaccine-preventable diseases. Future pandemic responses must consider impacts of movement restrictions and access to preventative services to protect maternal and child health.

Budget Impact Analysis of prolonged-release buprenorphine depot-formulation for the management of patients affected by opioid use disorder

Background: Opioid use disorder (OUD) is a disorder associated with significant rate of morbidity and mortality. Frequent clinic attendance for supervised consumption of sublingual buprenorphine is common. Prolonged-release buprenorphine (PRB) allows a management based on weekly or monthly subcutaneous injections, thus limiting the burdens of clinic attendance and the risks associated with sublingual formulations. Objective: To determine the price level of PRB that allows to obtain a neutral impact from the point of view of the economic resources absorbed, in comparison with the alternatives currently available in the Italian context for the management of patients suffering from OUD. Methods: The analysis assumes a daily PRB cost of €8.526 (neutral cost). The analysis aims to determine the economic impact associated with the introduction of PRB in the Italian context for the management of OUD patients. Results are expressed in terms of differential resourced absorbed in the alternative scenarios. A one-way sensitivity analysis was also carried out to test the robustness of the results. Results: The introduction of PRB implies an increase in the drug acquisition costs over the 5-year time horizon of €19.563.019,13: such costs are fully compensated by the other cost driver considered in the analysis (drug tests provided, health professionals’ time destined to the provision of the treatment, indirect costs, for savings equal to €6.167.026,94, €9.106.824,67 and €4.289.167,53 respectively) demonstrating its effectiveness in particular by an organizational point of view. Lower price levels for PRB would imply significant savings for the SSN. Conclusions: PRB resulted to be associated to a lower level of resources’ absorption in the Italian sector as compared with the available alternatives thus allowing to re-allocate health founds to other fields of the care sector ensuring greater safety for patients and a decreased misuse and diversion rate.