Considerations for the design of overdose education and naloxone distribution interventions: results of a multi-stakeholder workshop.

INTRODUCTION: Opioid overdose epidemic is a public health crisis that is impacting communities around the world. Overdose education and naloxone distribution programs equip and train lay people to respond in the event of an overdose. We aimed to understand factors to consider for the design of naloxone distribution programs in point-of-care settings from the point of view of community stakeholders. METHODS: We hosted a multi-stakeholder co-design workshop to elicit suggestions for a naloxone distribution program. We recruited people with lived experience of opioid overdose, community representatives, and other stakeholders from family practice, emergency medicine, addictions medicine, and public health to participate in a full-day facilitated co-design discussion wherein large and small group discussions were audio-recorded, transcribed and analysed using thematic approaches. RESULTS: A total of twenty-four participants participated in the multi-stakeholder workshop from five stakeholder groups including geographic and setting diversity. Collaborative dialogue and shared storytelling revealed seven considerations for the design of naloxone distribution programs specific to training needs and the provision of naloxone, these are: recognizing overdose, how much naloxone, impact of stigma, legal risk of responding, position as conventional first aid, friends and family as responders, support to call 911. CONCLUSION: To create an naloxone distribution program in emergency departments, family practice and substance use treatment services, stigma is a central design consideration for training and naloxone kits. Design choices that reference the iconography, type, and form of materials associated with first aid have the potential to satisfy the need to de-stigmatize overdose response.

Reducing use of coagulation tests in a family medicine practice setting: An implementation study.

Introduction: Clinicians often order the international normalized ratio (INR) and activated partial thromboplastin time (APTT) to evaluate for the possibility of inherited bleeding disorders despite sensitivities and specificities of 1%-2%. The most accurate tool to evaluate for bleeding disorders is a validated bleeding assessment tool (BAT). Our aim was to reduce coagulation testing by >50% in a large family practice in Ontario, Canada. Methods: We conducted an implementation study from May 2016 to February 2020. Iterative interventions included introduction of a validated BAT into the electronic medical record (EMR); removal of the APTT as a prepopulated selection from the laboratory requisition; and education targeting family medicine teams and laboratory personnel. The primary outcome was the rate of pre- and post-APTT testing. Creatinine testing was the control. Data were analyzed via an interrupted time series analysis using Stata 13. Results: Immediately following education of the laboratory personnel on coagulation testing, the APTT rate level dropped by 1.26 tests per 100 patient visits per month (p < 0.001) and was sustained until the end of the study. Meanwhile, the PT/INR and creatinine testing rate levels did not change (rate level = -0.02 per 100 visits per month, p = 0.79 and 0.49, p = 0.22 respectively). There was good uptake of the BAT following integration and 18/88 (20%) obtained a referral to hematology after BAT completion. Conclusions: Multidisciplinary, iterative interventions reduced APTT testing and enabled the use of BATs to guide hematology referrals in a large family practice.

Family physician practice patterns during COVID-19 and future intentions: Cross-sectional survey in Ontario, Canada.

OBJECTIVE: To determine the extent to which family physicians closed their doors altogether or for in-person visits during the pandemic, their future practice intentions, and related factors. DESIGN: Cross-sectional survey. SETTING: Six geographic areas in Toronto, Ont, aligned with Ontario Health Team regions. PARTICIPANTS: Family doctors practising office-based, comprehensive family medicine. MAIN OUTCOME MEASURES: Practice operations in January 2021, use of virtual care, and future plans. RESULTS: Of the 1016 (85.7%) individuals who responded to the survey, 99.7% (1001 of 1004) indicated their practices were open in January 2021, with 94.8% (928 of 979) seeing patients in person and 30.8% (264 of 856) providing in-person care to patients reporting COVID-19 symptoms. Respondents estimated spending 58.2% of clinical care time on telephone visits, 5.8% on video appointments, and 7.5% on e-mail or secure messaging. Among respondents, 17.5% (77 of 439) were planning to close their existing practices in the next 5 years. There were higher proportions of physicians who worked alone in clinics among those who did not see patients in person (27.6% no vs 12.4% yes, P<.05), among those who did not see symptomatic patients (15.6% no vs 6.5% yes, P<.001), and among those who planned to close their practices in the next 5 years (28.9% yes vs 13.9% no, P<.01). CONCLUSION: Most family physicians in Toronto were open to in-person care in January 2021, but almost one-fifth were considering closing their practices in the next 5 years. Policy makers need to prepare for a growing family physician shortage and better understand factors that support recruitment and retention.

Design details for overdose education and take-home naloxone kits: Codesign with family medicine, emergency department, addictions medicine and community.

INTRODUCTION: Overdose education and naloxone distribution (OEND) programmes equip and train people who are likely to witness an opioid overdose to respond with effective first aid interventions. Despite OEND expansion across North America, overdose rates are increasing, raising questions about how to improve OEND programmes. We conducted an iterative series of codesign stakeholder workshops to develop a prototype for take-home naloxone (THN)-kit (i.e., two doses of intranasal naloxone and training on how to administer it). METHODS: We recruited people who use opioids, frontline healthcare providers and public health representatives to participate in codesign workshops covering questions related to THN-kit prototypes, training on how to use it, and implementation, including refinement of design artefacts using personas and journey maps. Completed over 9 months, the workshops were audio-recorded and transcribed with visible results of the workshops (i.e., sticky notes, sketches) archived. We used thematic analyses of these materials to identify design requirements for THN-kits and training. RESULTS: We facilitated 13 codesign workshops to identify and address gaps in existing opioid overdose education training and THN-kits and emphasize timely response and stigma in future THN-kit design. Using an iterative process, we created 15 prototypes, 3 candidate prototypes and a final prototype THN-kit from the synthesis of the codesign workshops. CONCLUSION: The final prototype is available for a variety of implementation and evaluation processes. The THN-kit offers an integrated solution combining ultra-brief training animation and physical packaging of nasal naloxone to be distributed in family practice clinics, emergency departments, addiction medicine clinics and community settings. PATIENT OR PUBLIC CONTRIBUTION: The codesign process was deliberately structured to involve community members (the public), with multiple opportunities for public contribution. In addition, patient/public participation was a principle for the management and structuring of the research team.

Resuscitation simulation among people who are likely to witness opioid overdose: Experiences from the SOONER Trial.

The opioid crisis is a growing public health emergency and increasing resources are being directed towards overdose education. Simulation has emerged as a novel strategy for training overdose response, yet little is known about training non-clinicians in bystander resuscitation. Understanding the perspectives of individuals who are likely to experience or witness opioid overdose is critical to ensure that emergency response is effective. The Surviving Opioid Overdose with Naloxone Education and Resuscitation (SOONER) study evaluates the effectiveness of a novel naloxone education and distribution tool among people who are non-clinicians and likely to witness opioid overdose. Participants' resuscitation skills are evaluated using a realistic overdose simulation as the primary outcome of the trial. The purpose of our study is to describe the experience of participants with the simulation process in the SOONER study. We employed a semi-structured debriefing interview and a follow up qualitative interview to understand the experience of participants with simulation. A qualitative content analysis was performed using data from 21 participants who participated in the SOONER study. Our qualitative analysis identified 5 themes and 17 subthemes which described the experience of participants within the simulation process. These themes included realism, valuing practical experience, improving self-efficacy, gaining new perspective and bidirectional learning. Our analysis found that simulation was a positive and empowering experience for participants in the SOONER trial, most of whom are marginalized in society. Our study supports the notion that expanding simulation-based education to non-clinicians may offer an acceptable and effective way of supplementing current opioid overdose education strategies. Increasing the accessibility of simulation-based education may represent a paradigm shift whereby simulation is transformed from a primarily academic practice into a patient-based community resource.

Corrigendum to "Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial" [Resuscitation Plus 6 (2021) 100131].

[This corrects the article DOI: 10.1016/j.resplu.2021.100131.].

Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial.

AIM: We plan to conduct a randomised clinical trial among people likely to witness opioid overdose to compare the educational effectiveness of point-of-care naloxone distribution with best-available care, by observing participants' resuscitation skills in a simulated overdose. This mixed methods feasibility study aims to assess the effectiveness of recruitment and retention strategies and acceptability of study procedures. METHODS: We implemented candidate-driven recruitment strategies with verbal consent and destigmatizing study materials in a family practice, emergency department, and addictions service. People ≥16 years of age who are likely to witness overdose were randomized to point-of-care naloxone distribution or referral to an existing program. We evaluated participant skills as a responder to a simulated overdose 3-14 days post-recruitment. Retention strategies included flexible scheduling, reminders, cash compensation and refreshments. The primary outcome was recruitment and retention feasibility, defined as the ability to recruit 28 eligible participants in 28 days, with <50% attrition at the outcome simulation. Acceptability of study procedures and motivations for participation were assessed in a semi-structured interview. RESULTS: We enrolled 30 participants over 24 days, and retained 21 participants (70%, 95%CI 56.7-100). The most common motivation for participation was a desire to serve the community or loved ones in distress. Participants reported that study procedures were acceptable and that the outcome simulation provided a supportive and affirming environment. CONCLUSION: The planned trial is ready for implementation. Recruitment and retention is feasible and study processes are acceptable for people who are likely to witness overdose. (Registration: NCT03821649).

Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.

INTRODUCTION: The surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants' performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial. METHODS AND ANALYSIS: Strategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2 weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered. ETHICS AND DISSEMINATION: The study has been reviewed by ethics boards at St. Michael's Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT03821649).

Family medicine residents' perspectives on curricular messaging surrounding enhanced skills fellowship programs.

OBJECTIVE: To better understand the messages that family medicine residents receive about enhanced skills fellowship programs throughout their training. DESIGN: Phenomenologic approach using structured qualitative interviews. SETTING: Postgraduate family medicine program in Ontario. PARTICIPANTS: Eleven family medicine residents (5 first-year and 6 second-year residents) from 4 separate training sites. METHODS: Interviews were audiotaped and codes were developed by the study investigators. Themes arose from the data via the immersion and crystallization technique. MAIN FINDINGS: Themes emerged in 3 categories: perception of purpose, sources of messaging, and formal or informal versus hidden curricular messages. Fellowship programs were viewed by residents in terms of their personal and professional benefits. Residents learned about fellowship programs through word of mouth and from role models. The formal curriculum remained neutral about fellowship training. The hidden curriculum highlighted a number of messages: a) to maximize chances of acceptance into some fellowship programs, one should focus most of his or her elective time in that clinical area; b) many fellowships graduate subspecialists to the exclusion of family medicine; c) a fellowship is required to practise in a large urban centre but is not required to practise in rural communities; and d) those without fellowship training are less well regarded. CONCLUSION: Residents receive mixed messages regarding fellowship training. This might be a phenomenon isolated to a larger urban centre in Ontario. Decision making at the individual level in terms of career path seems to be affected and might have implications at the larger system level.

Organization of care for persons with HIV-infection: a systematic review.

The objective of this systematic review was to examine the effectiveness of the organization of care: case management, multidisciplinary care, multi-faceted treatment, hours of service, outreach programs and health information systems on medical, immunological, virological, psychosocial and economic outcomes for persons living with HIV/AIDS. We searched PubMed (MEDLINE) and 10 other electronic databases from 1 January 1980 to April, 2012 for both experimental and controlled observational studies. Thirty-three studies met the inclusion criteria. Eleven studies were randomized controlled trials (RCTs), three of which were conducted in low-middle income settings. Patient characteristics, study design, organization measures and outcomes data were abstracted independently by two reviewers from all studies. A risk of bias tool was applied to RCTs and a separate tool was used to assess the quality of observational studies. This review concludes that case management interventions were most consistently associated with improvements in immunological outcomes but case management demonstrates no clear association with other outcome measures. The same mixed results were also identified for multidisciplinary and multi-faceted care interventions. Eight studies with an outreach intervention were identified and demonstrated improvements or non-inferiority with respect to mortality, receipt of antiretroviral medications, immunological outcomes, improvements in healthcare utilization and lower reported healthcare costs when compared to usual care. Of the interventions examined in this review, sustained in-person case management and outreach interventions were most consistently associated with improved medical and economic outcomes, in particular antiretroviral prescribing, immunological outcomes and healthcare utilization. No firm conclusions can be reached about the impact of any one intervention on patient mortality.

The association of hospital, clinic and provider volume with HIV/AIDS care and mortality: systematic review and meta-analysis.

The objective of this systematic review and meta-analysis is to examine the association between hospital, clinic and provider patient volumes on HIV/AIDS patient outcomes including mortality, antiretroviral (ARV) use and proportion of patients on indicated opportunistic infection (OI) prophylaxis. We searched MEDLINE and nine other electronic databases from 1 January 1980 through 29 May 2009. Experimental and controlled observational studies of persons with HIV/AIDS were included. Studies examined the volume or concentration of patients with HIV/AIDS in hospitals, clinics or individual providers. Outcomes included mortality, ARV use and proportion of patients on indicated OI prophylaxis. We reviewed 22,692 titles and/or abstracts. Patient characteristics, study design, volume measures, medical outcomes and study confounders were abstracted. Data were extracted independently by two reviewers. Twenty-two studies were included in the final review. High volume hospital care was associated with lower in-hospital mortality (pooled odds ratio (OR) 0.71, 95% confidence interval [CI] 0.57-0.90 p = 0.004) and lower mortality 30 days from admission (pooled OR 0.62, 95% CI 0.47-0.81 p = 0.0004). Higher volume provider care was associated with significantly higher ARV use (pooled OR 4.41, 95% CI 2.70-7.18 p<0.00001). Differences in volume definitions and controlling for confounding variables did not appreciably alter the results. Higher volume hospitals, clinics and providers were associated with significantly decreased mortality for people living with HIV/AIDS and higher volume providers and clinics had higher ARV use. Heterogeneity of volume thresholds and absence of studies from resource-limited settings are major limitations.

Provider training and experience for people living with HIV/AIDS

BACKGROUND: The complexity of HIV/AIDS raises challenges for the effective delivery of care. It is important to ensure that the expertise and experience of care providers is of high quality. Training and experience of HIV/AIDS providers may impact not only individual patient outcomes but increasingly on health care costs as well. OBJECTIVE: The objective of this review is to assess the effects of provider training and experience on people living with HIV/AIDS on the following outcomes: immunological (ie. viral load, CD4 count), medical (ie. mortality, proportion on antiretrovirals), psychosocial (ie. quality of life measures) and economic outcomes (ie health care costs). CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW: We searched MEDLINE, EMBASE, Dissertation Abstracts International (DAI), CINAHL, HealthStar, PsycInfo, PsycLit, Social Sciences Abstracts, and Sociological Abstracts from January 1, 1980 through May 29, 2009. Electronic searches were performed for abstracts from major international AIDS conferences. Reference lists from pertinent articles, books and review articles were retrieved and reviewed. SELECTION CRITERIA: Randomized controlled trials (RCTs), controlled clinical trials, cohort, case control, cross-sectional studies and controlled before and after designs that examined the qualifications/training and patient volume of HIV/AIDS care of providers caring for persons known to be infected with HIV/AIDS were included. DATA COLLECTION AND ANALYSIS: At least two authors independently assessed trial quality and extracted data. Study authors were contacted for further information as required. Assessment of confounding factors was undertaken independently by two reviewers. MAIN RESULTS: A total of four studies (one randomized controlled trial, three non- randomized studies) involving 8488 people living with HIV/AIDS were included. The main findings of this review demonstrated a trend to improved outcomes when treated by a provider with more training/expertise in HIV/AIDS care in the outpatient (clinic) setting. Due to the heterogeneity of the included studies, we could not perform a meta-analysis. We present a descriptive review of the results. AUTHORS' CONCLUSIONS: The results demonstrate improved medical outcomes when treated by a provider with more training/expertise in HIV/AIDS care in the outpatient (clinic) setting. Since all of these studies were conducted in North America, this does not address any issues regarding the level of training/expertise required by providers working in countries with more limited resources. Practitioners who do not consider themselves "experts" in HIV/AIDS care and care for few of these patients need to seriously consider this review which demonstrates a trend towards worse patient outcomes when receiving care by those with low caseloads/training in HIV/AIDS care.

Provider training and experience for people living with HIV/AIDS.

BACKGROUND: The complexity of HIV/AIDS raises challenges for the effective delivery of care. It is important to ensure that the expertise and experience of care providers is of high quality. Training and experience of HIV/AIDS providers may impact not only individual patient outcomes but increasingly on health care costs as well. OBJECTIVES: The objective of this review is to assess the effects of provider training and experience on people living with HIV/AIDS on the following outcomes: immunological (ie. viral load, CD4 count), medical (ie. mortality, proportion on antiretrovirals), psychosocial (ie. quality of life measures) and economic outcomes (ie health care costs). SEARCH STRATEGY: We searched MEDLINE, EMBASE, Dissertation Abstracts International (DAI), CINAHL, HealthStar, PsycInfo, PsycLit, Social Sciences Abstracts, and Sociological Abstracts from January 1, 1980 through May 29, 2009.  Electronic searches were performed for abstracts from major international AIDS conferences. Reference lists from pertinent articles, books and review articles were retrieved and reviewed. SELECTION CRITERIA: Randomized controlled trials (RCTs), controlled clinical trials, cohort, case control, cross-sectional studies and controlled before and after designs that examined the qualifications/training and patient volume of HIV/AIDS care of providers caring for persons known to be infected with HIV/AIDS were included. DATA COLLECTION AND ANALYSIS: At least two authors independently assessed trial quality and extracted data. Study authors were contacted for further information as required. Assessment of confounding factors was undertaken independently by two reviewers. MAIN RESULTS: A total of four studies (one randomized controlled trial, three non- randomized studies) involving 8488 people living with HIV/AIDS were included. The main findings of this review demonstrated a trend to improved outcomes when treated by a provider with more training/expertise in HIV/AIDS care in the outpatient (clinic) setting. Due to the heterogeneity of the included studies, we could not perform a meta-analysis. We present a descriptive review of the results. AUTHORS' CONCLUSIONS: The results demonstrate improved medical outcomes when treated by a provider with more training/expertise in HIV/AIDS care in the outpatient (clinic) setting. Since all of these studies were conducted in North America, this does not address any issues regarding the level of training/expertise required by providers working in countries with more limited resources. Practitioners who do not consider themselves 'experts' in HIV/AIDS care and care for few of these patients need to seriously consider this review which demonstrates a trend towards worse patient outcomes when receiving care by those with low caseloads/training in HIV/AIDS care.