Demographic patterns of exposure and transmission for a rural Canadian community outbreak of COVID-19, 2020.

Background: A coronavirus disease 2019 (COVID-19) community outbreak was declared October 5-December 3, 2020, in the Restigouche region of New Brunswick, Canada. This article describes the epidemiological characteristics of the outbreak and assesses factors associated with its transmission in rural communities, informing public health measures and programming. Methods: A provincial line list was developed from case and contact interviews. Descriptive epidemiological methods were used to characterize the outbreak. Incidence rates among contacts, and by gender for the regional population were estimated. Results: There were 83 laboratory-confirmed cases of COVID-19 identified during the observation period. The case ages ranged from 10-89 years of age (median age group was 40-59 years of age) and 51.2% of the cases were male. Symptom onset dates ranged from September 27-October 27, 2020, with 83% of cases being symptomatic. A cluster of early cases at a social event led to multiple workplace outbreaks, though the majority of cases were linked to household transmission. Complex and overlapping social networks resulted in multiple exposure events and that obscured transmission pathways. The incidence rate among men was higher than women, men were significantly more likely to have transmission exposure at their workplace than women, and men were the most common index cases within a household. No transmission in school settings among children was documented despite multiple exposures. Conclusion: This investigation highlighted the gendered nature and complexity of a COVID-19 outbreak in a rural Canadian community. Targeted action at workplaces and strategic messaging towards men are likely required to increase awareness and adherence to public health measures to reduce transmission in these settings.

Predicting death in home care users: derivation and validation of the Risk Evaluation for Support: Predictions for Elder-Life in the Community Tool (RESPECT).

BACKGROUND: Prognostication tools that report personalized mortality risk and survival could improve discussions about end-of-life and advance care planning. We sought to develop and validate a mortality risk model for older adults with diverse care needs in home care using self-reportable information - the Risk Evaluation for Support: Predictions for Elder-Life in the Community Tool (RESPECT). METHODS: Using a derivation cohort that comprised adults living in Ontario, Canada, aged 50 years and older with at least 1 Resident Assessment Instrument for Home Care (RAI-HC) record between Jan. 1, 2007, and Dec. 31, 2012, we developed a mortality risk model. The primary outcome was mortality 6 months after a RAI-HC assessment. We used proportional hazards regression with robust standard errors to account for clustering by the individual. We validated this algorithm for a second cohort of users of home care who were assessed between Jan. 1 and Dec. 31, 2013. We used Kaplan-Meier survival curves to estimate the observed risk of death at 6 months for assessment of calibration and median survival. We constructed 61 risk groups based on incremental increases in the estimated median survival of about 3 weeks among adults at high risk and 3 months among adults at lower risk. RESULTS: The derivation and validation cohorts included 435 009 and 139 388 adults, respectively. We identified a total of 122 823 deaths within 6 months of a RAI-HC assessment in the derivation cohort. The mean predicted 6-month mortality risk was 10.8% (95% confidence interval [CI] 10.7%-10.8%) and ranged from 1.54% (95% CI 1.53%-1.54%) in the lowest to 98.1% (95% CI 98.1%-98.2%) in the highest risk group. Estimated median survival spanned from 28 days (11 to 84 d at the 25th and 75th percentiles) in the highest risk group to over 8 years (1925 to 3420 d) in the lowest risk group. The algorithm had a c-statistic of 0.753 (95% CI 0.750-0.756) in our validation cohort. INTERPRETATION: The RESPECT mortality risk prediction tool that makes use of readily available information can improve the identification of palliative and end-of-life care needs in a diverse older adult population receiving home care.

Do-Not-Resuscitate and Do-Not-Hospitalize Orders in Nursing Homes: Who Gets Them and Do They Make a Difference?

OBJECTIVES: To describe the rate of do-not-resuscitate (DNR) and do-not-hospitalize (DNH) orders among residents newly admitted into long-term care homes. We also assessed the association between DNR and DNH orders with hospital admissions, deaths in hospital, and survival. DESIGN: A retrospective cohort study. SETTING AND PARTICIPANTS: Admissions in all 640 publicly funded long-term care homes in Ontario, Canada, between January 1, 2010 and March 1, 2012 (n = 49,390). MEASURES: We examined if a DNR and/or DNH was recorded on resident's admission assessment. All residents were followed until death, discharge, or end of study to ascertain rates of several outcomes, including death and hospitalization, controlling for resident characteristics. RESULTS: Upon admission, 60.7% of residents were recorded to have a DNR and 14.8% a DNH order. Those who were older, female, widowed, lived in rural facilities, lived in higher income neighborhoods prior to entry, had higher health instability or cognitive impairment, and spoke English or French were more likely to receive a DNR or DNH. Survival time was only slightly shorter for those with a DNR and DNH with a mean of 145 and 133 days, respectively, vs 160 and 153 days for those without a DNR and DNH. After controlling for age, sex, rurality, neighborhood income, marital status, health instability, cognitive performance score, and multimorbidity, DNR and DNH were associated with an odds ratio of 0.57 [95% confidence interval (CI) 0.53-0.62] and 0.41 (95% CI 0.37-0.46) for dying in hospital, respectively. Those with a DNR and DNH, after adjustment, had an incidence rate ratio of 0.87 (95% CI 0.83-0.90) and 0.70 (95% CI 0.67-0.73), respectively, days spent in hospital. CONCLUSIONS AND IMPLICATIONS: This study outlines identifiable factors influencing whether residents have a DNR and/or DNH order upon admission. Both orders led to lower rates, but not absolute avoidance, of hospitalizations near and at death.

Health Care Utilization and Costs for Patients With End-Stage Liver Disease Are Significantly Higher at the End of Life Compared to Those of Other Decedents.

BACKGROUND & AIMS: Patients with end-stage liver disease (ESLD) have progressively complex medical needs. However, little is known about their end-of-life health care utilization or associated costs. We performed a population-based study to evaluate the end-of-life direct utilization and costs for patients with ESLD among health care sectors in the province of Ontario. METHODS: We used linked Ontario health administrative databases to conduct a population-based retrospective cohort study of all decedents from April 1, 2010, through March 31, 2013. Patients with ESLD were compared with patients without ESLD with regard to total health care utilization and costs in the last year and last 90 days of life. RESULTS: The median age at death was significantly lower for ESLD decedents (65 y; interquartile range, 56-75 y) than for individuals without ESLD (80 y; interquartile range, 68-88 y). The median cost in the last year of life was significantly greater for patients with ESLD ($51,235 vs $44,456 without ESLD) (P < .001). Median ESLD end-of-life care costs also significantly exceeded those associated with 4 of the 5 most resource-intensive chronic conditions ($69,040 for ESLD vs $59,088 for non-ESLD) (P < .001). Cost differences were most pronounced in the final 90 days of life. During this period, patients with ESLD spent 4.7 more days in the hospital (95% CI, 4.3-5.1 d) than patients without ESLD (P < .0001), had significantly higher odds of dying in an institutional setting (odds ratio, 1.8; 95% CI, 1.7-1.9) (P < .0001), and incurred an additional $4201 in costs (95% CI, $3384-$5019; P < .0001). CONCLUSIONS: In a population-based study in Canada, we found that patients with ESLD incur significantly higher end-of-life care costs than decedents without ESLD, predominantly owing to increased time in the hospital during the final 90 days of life.

Does End-of-Life Care Differ for Anglophones and Francophones? A Retrospective Cohort Study of Decedents in Ontario, Canada.

BACKGROUND: Approximately half of decedents in Ontario, Canada, receive some palliative care, but little is known about the influence of language on the nature of these services. OBJECTIVE: To examine differences between English- and French-speaking residents of Ontario in end-of-life care and outcomes (e.g., health care costs and location of death). DESIGN: A retrospective cohort study using multiple linked databases. SETTING/SUBJECTS: A population-based cohort of decedents in Ontario (2010-2013) who were living in long-term care institutions (i.e., nursing homes) or receiving home care before death (N = 25,759). Data from two regions with higher representations of Francophones were examined, with the final distribution by primary language being 75% Anglophone, 18% Francophone, and 7% other languages. RESULTS: Compared with Anglophones, Francophones were more frequent users of long-term care (47.6% vs. 37.1%) and less frequent users of home care (71.3% vs. 76.3%). In adjusted models, the number of days spent in hospital in the last 90 days of life was similar between Anglophones and Francophones, although the odds of dying in hospital were significantly higher among the latter. The mean total health care cost in the last year of life was slightly lower among French ($62,085) compared with English ($63,814) speakers. CONCLUSIONS: There are statistically significant differences in end-of-life outcomes between linguistic groups in Ontario, namely more institutionalization in long-term care, less home care use and more deaths in-hospital among Francophones (adjusted). Future research is needed to examine the cause of these differences. Strategies to ensure equitable access to quality end-of-life care are required.

Associations between physician home visits for the dying and place of death: A population-based retrospective cohort study.

BACKGROUND: While most individuals wish to die at home, the reality is that most will die in hospital. AIM: To determine whether receiving a physician home visit near the end-of-life is associated with lower odds of death in a hospital. DESIGN: Observational retrospective cohort study, examining location of death and health care in the last year of life. SETTING/PARTICIPANTS: Population-level study of Ontarians, a Canadian province with over 13 million residents. All decedents from April 1, 2010 to March 31, 2013 (n = 264,754). RESULTS: More than half of 264,754 decedents died in hospital: 45.7% died in an acute care hospital and 7.7% in complex continuing care. After adjustment for multiple factors-including patient illness, home care services, and days of being at home-receiving at least one physician home visit from a non-palliative care physician was associated with a 47% decreased odds (odds-ratio, 0.53; 95%CI: 0.51-0.55) of dying in a hospital. When a palliative care physician specialist was involved, the overall odds declined by 59% (odds ratio, 0.41; 95%CI: 0.39-0.43). The same model, adjusting for physician home visits, showed that receiving palliative home care was associated with a similar reduction (odds ratio, 0.49; 95%CI: 0.47-0.51). CONCLUSION: Location of death is strongly associated with end-of-life health care in the home. Less than one-third of the population, however, received end-of-life home care or a physician visit in their last year of life, revealing large room for improvement.

Critical care at the end of life: a population-level cohort study of cost and outcomes.

BACKGROUND: Despite the high cost associated with ICU use at the end of life, very little is known at a population level about the characteristics of users and their end of life experience. In this study, our goal was to characterize decedents who received intensive care near the end of life and examine their overall health care use prior to death. METHODS: This was a retrospective cohort study that examined all deaths in a 3-year period from April 2010 to March 2013 in Ontario, Canada. Using population-based health administrative databases, we examined healthcare use and cost in the last year of life. RESULTS: There were 264,754 individuals included in the study, of whom 18% used the ICU in the last 90 days of life; 34.5% of these ICU users were older than 80 years of age and 53.0% had more than five chronic conditions. The average cost of stay for these decedents was CA$15,511 to CA$25,526 greater than for those who were not admitted to the ICU. These individuals also died more frequently in hospital (88.7% vs 36.2%), and spent more time in acute-care settings (18.7 days vs. 10.5 days). CONCLUSIONS: We showed at a population level that a significant proportion of those with ICU use close to death are older, multi-morbid individuals who incur significantly greater costs and die largely in hospital, with higher rates of readmission, longer lengths of stay and higher rates of aggressive care.

High end of life health care costs and hospitalization burden in inflammatory bowel disease patients: A population-based study.

BACKGROUND: End of life (EOL) care is associated with greater costs, particularly for acute care services. In patients with inflammatory bowel disease (IBD), EOL costs may be accentuated due to reliance on hospital-based services and expensive diagnostic tests and treatments. We aimed to compare EOL health care use and costs between IBD and non-IBD decedents. METHODS: We conducted a retrospective cohort study of all decedents of Ontario, Canada between 2010 and 2013 using linked health administrative data. IBD (N = 2,214) and non-IBD (N = 262,540) decedents were compared on total direct health care costs in the last year of life and hospitalization time during the last 90 days of life. RESULTS: During the last 90 days of life, IBD patients spent an average of 16 days in hospital, equal to 2.1 greater adjusted hospital days (95% confidence interval [CI] 1.5-2.8 days) than non-IBD patients. IBD diagnosis was associated with $7,210 CAD (95% CI $5,005 - $9,464) higher adjusted per-patient cost in the last year of life, of which 76% was due to excess hospitalization costs. EOL cost of IBD care was higher than 15 of 16 studied chronic conditions. Health care costs rose sharply in the last 90 days of life, primarily due to escalating hospitalization costs. CONCLUSIONS: IBD patients spend more time in hospital and incur substantially greater health care costs than other decedents as they approach the EOL. These excess costs could be curtailed through avoidance of unnecessary hospitalizations and expensive treatments in the setting of irreversible deterioration.

Level of Need, Divertibility, and Outcomes of Newly Admitted Nursing Home Residents.

OBJECTIVES: To describe the level of need and divertibility of newly admitted nursing home residents, describe the factors that drive need, and describe the outcomes of residents across different levels of need. DESIGN: Retrospective cohort study. SETTING: A total of 640 publicly funded nursing homes (also known as long-term care facilities) in Ontario, Canada. PARTICIPANTS: All newly admitted residents between January 1, 2010 and March 1, 2012. MEASUREMENTS: We categorized residents into 36 groups based on different levels of (1) cognitive impairment, (2) difficulty in activities of daily living (ADL), (3) difficulty in instrumental ADLs, and (4) whether or not they had a caregiver at home. Residents were then categorized as having low, intermediate, or high needs; applying results from previous "Balance of Care" studies, we also captured the proportion who could have been cost-effectively diverted into the community. We then contrasted the characteristics of residents across the needs and divertible groupings, and compared 4 outcomes among these groups: hospital admissions, emergency department visits, mortality, and return to home. RESULTS: A population-level cohort of 64,105 incident admissions was captured. About two-thirds had great difficulty performing ADLs (65%) and had mild to severe cognitive impairment (66%); over 90% had great difficulty with instrumental ADLs. Just less than 50% of the new admissions were considered to be residents with high care needs (cognitively impaired with great ADL difficulty), while only 4.5% (2880 residents) had low care needs (cognition and ADL intact). Those with dementia (71.0%) and previous stroke (21.5%) were over-represented in the high needs group. Those that cannot be divertible to anywhere else but an institution with 24 hour nursing care comprised 41.3% (n = 26,502) of residents. Only 5.4% (n = 3483), based on community resources available, could potentially be cost-effectively diverted to the community. Those at higher needs experienced higher rates of mortality, higher total cost across all health sectors, and lower rates of return to home. CONCLUSIONS: The majority of those admitted into nursing homes have high levels of need (driven largely by dementia and stroke) and could not have their needs met cost-effectively elsewhere, suggesting that the system is at capacity. Caring for the long-term care needs of the aging population should consider the balance of investments in institution and community settings.

Children's End-of-Life Health Care Use and Cost.

BACKGROUND AND OBJECTIVES: Heath care use and cost for children at the end of life is not well documented across the multiple sectors where children receive care. The study objective was to examine demographics, location, cause of death, and health care use and costs over the last year of life for children aged 1 month to 19 years who died in Ontario, Canada. METHODS: We conducted a population-based retrospective cohort study using administrative databases to determine the characteristics of and health care costs by age group and cause of death over a 3-year period from 2010 to 2013. RESULTS: In our cohort of 1620 children, 41.6% died of a chronic disease with wide variation across age groups. The mean health care cost over the last year of life was $78 332 (Canadian) with a median of $18 450, reflecting the impact of high-cost decedents. The mean costs for children with chronic or perinatal/congenital illnesses nearly tripled over the last 4 months of life. The majority of costs (67.0%) were incurred in acute care settings, with 88.0% of children with a perinatal/congenital illness and 79.7% with a chronic illness dying in acute care. Only 33.4% of children received home care in the last year of life. CONCLUSIONS: Children in Ontario receive the majority of their end-of-life care in acute care settings at a high cost to the health care system. Initiatives to optimize care should focus on early discussion of the goals of care and assessment of whether the care provided fits with these goals.

Reporting and design elements of audit and feedback interventions: a secondary review.

BACKGROUND: Audit and feedback (A&F) is a frequently used intervention aiming to support implementation of research evidence into clinical practice with positive, yet variable, effects. Our understanding of effective A&F has been limited by poor reporting and intervention heterogeneity. Our objective was to describe the extent of these issues. METHODS: Using a secondary review of A&F interventions and a consensus-based process to identify modifiable A&F elements, we examined intervention descriptions in 140 trials of A&F to quantify reporting limitations and describe the interventions. RESULTS: We identified 17 modifiable A&F intervention elements; 14 were examined to quantify reporting limitations and all 17 were used to describe the interventions. Clear reporting of the elements ranged from 56% to 97% with a median of 89%. There was considerable variation in A&F interventions with 51% for individual providers only, 92% targeting behaviour change and 79% targeting processes of care, 64% performed by the provider group and 81% reporting aggregate patient data. CONCLUSIONS: Our process identified 17 A&F design elements, demonstrated gaps in reporting and helped understand the degree of variation in A&F interventions.

A Population-Based Study of Care at the End of Life Among People With HIV in Ontario From 2010 to 2013.

BACKGROUND: Aging and increasing comorbidity is changing the end-of-life experience of people living with HIV (PLHIV) in the developed world. We quantified, at a population level, the receipt of health care services and associated costs across a comprehensive set of sectors among decedents with and without HIV. METHODS: We conducted a retrospective population-level observational study of all decedents in Ontario and their receipt of health care services, captured through linked health administrative databases, between April 1, 2010 and March 31, 2013. We identified PLHIV using a validated algorithm. We described the characteristics of PLHIV and their receipt of health care services and associated costs by health care sector in the last year of life. RESULTS: We observed 264,754 eligible deaths, 570 of whom had HIV. PLHIV were significantly younger than those without HIV (mean age of death 56.1 years vs. 76.6 years, [P < 0.01]). PLHIV spent a mean of 20.0 days in an acute care hospital in the last 90 days of life compared with 12.1 days for decedents without HIV (P < 0.01); after adjustment, HIV was associated with 4.5 more acute care days (P < 0.01). Mean cost of care in the last year was significantly higher among PLHIV ($80,885.62 vs. $53,869.77), mostly attributable to acute care costs. INTERPRETATION: PLHIV in Ontario are dying younger, spending more time and dying more often in hospital, and incur significantly increased costs before death. Greater involvement of community-based palliative care may improve the dying experience for this complex population.

Does Primary Care Model Effect Healthcare at the End of Life? A Population-Based Retrospective Cohort Study.

BACKGROUND: Comprehensive primary care may enhance patient experience at end of life. OBJECTIVE: To examine whether belonging to different models of primary care is associated with end-of-life healthcare use and outcomes. DESIGN: Retrospective population cohort study, using health administrative databases to describe health services and costs in the last six months of life across three primary care models: enrolled to a physician remunerated mainly by capitation, with incentives for comprehensive care and access in some to allied health practitioners (Capitation); remunerated mainly from fee-for-service (FFS) with smaller incentives for comprehensive care (Enhanced FFS); and not enrolled, seeing physicians remunerated solely through FFS (Traditional FFS). SETTING: People who died from April 1, 2010 to March 31, 2013 in Ontario, Canada. MEASURES: Health service utilization, costs, and place of death. RESULTS: Approximately two-thirds (62.7%) of decedents had more contact with a specialist than family physician. Those in Capitation models were more likely to have the majority of physician services provided by a family physician (44.9% vs. 38.6% in Enhanced FFS and 34.3% in Traditional FFS) and received more home care service days (mean 27.2 vs. 24.2 in Enhanced FFS and 21.7 in Traditional FFS). And 22.5% had a home visit by a family physician. Controlling for potential confounders, decedents spent significantly more days in an institution in Enhanced FFS (1.1, 95% confidence interval [CI]: 0.9-1.5) and Traditional FFS (2.2, 95% CI: 1.8-2.6) than in Capitation. CONCLUSION: Decedents in comprehensive primary care models received more care in the community and spent less time in institutions.

Algorithm for predicting death among older adults in the home care setting: study protocol for the Risk Evaluation for Support: Predictions for Elder-life in the Community Tool (RESPECT).

INTRODUCTION: Older adults living in the community often have multiple, chronic conditions and functional impairments. A challenge for healthcare providers working in the community is the lack of a predictive tool that can be applied to the broad spectrum of mortality risks observed and may be used to inform care planning. OBJECTIVE: To predict survival time for older adults in the home care setting. The final mortality risk algorithm will be implemented as a web-based calculator that can be used by older adults needing care and by their caregivers. DESIGN: Open cohort study using the Resident Assessment Instrument for Home Care (RAI-HC) data in Ontario, Canada, from 1 January 2007 to 31 December 2013. PARTICIPANTS: The derivation cohort will consist of ∼437 000 older adults who had an RAI-HC assessment between 1 January 2007 and 31 December 2012. A split sample validation cohort will include ∼122 000 older adults with an RAI-HC assessment between 1 January and 31 December 2013. MAIN OUTCOME MEASURES: Predicted survival from the time of an RAI-HC assessment. All deaths (n≈245 000) will be ascertained through linkage to a population-based registry that is maintained by the Ministry of Health in Ontario. STATISTICAL ANALYSIS: Proportional hazards regression will be estimated after assessment of assumptions. Predictors will include sociodemographic factors, social support, health conditions, functional status, cognition, symptoms of decline and prior healthcare use. Model performance will be evaluated for 6-month and 12-month predicted risks, including measures of calibration (eg, calibration plots) and discrimination (eg, c-statistics). The final algorithm will use combined development and validation data. ETHICS AND DISSEMINATION: Research ethics approval has been granted by the Sunnybrook Health Sciences Centre Review Board. Findings will be disseminated through presentations at conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02779309, Pre-results.

Hospitalization and Mortality Rates in Long-Term Care Facilities: Does For-Profit Status Matter?

OBJECTIVES: To establish if proprietary status (ie, for-profit or not-for-profit) is associated with mortality and hospitalizations among publicly funded long-term care (nursing) homes. METHODS: We conducted a retrospective cohort study of new admissions in 640 publicly funded long-term care facilities in Ontario, Canada (384 for-profit, 256 not-for-profit). A population-based cohort of 53,739 incident admissions into long-term care facilities between January 1, 2010, and March 1, 2012, was observed. We measured adjusted rates of hospital admissions and mortality, per 1000 person-years (PY) of follow-up, among for-profit and not-for-profit facilities at 3, 6, and 12 months postadmission. Rates were measured postadmission and until discharge or death, whichever came first. RESULTS: One year after admission and before discharge, 11.7% of residents died and 25.7% had at least one hospitalization. After 12 months of follow-up, residents in for-profit facilities had a hospitalization rate of 462 per 1000 PY versus 358 per 1000 PY in not-for-profit facilities. During this period, the crude mortality rate in for-profit facilities was 208 per 1000 PY versus 185 per 1000 PY in not-for-profit facilities. At 3, 6, and 1 year after admission, for-profit facilities had an adjusted hazard ratio of 1.36 (95% confidence interval [CI] 1.28-1.43), 1.33 (95% CI 1.27-1.39), and 1.25 (95% CI 1.21-1.30) for hospitalizations and hazards of 1.20 (95% CI 1.11-1.29), 1.16 (95% CI 1.09-1.24), and 1.10 (95% CI 1.05-1.16) for mortality, respectively. CONCLUSIONS: Publicly funded for-profit facilities have significantly higher rates of both mortality and hospital admissions.

A systematic review of the use of theory in randomized controlled trials of audit and feedback.

BACKGROUND: Audit and feedback is one of the most widely used and promising interventions in implementation research, yet also one of the most variably effective. Understanding this variability has been limited in part by lack of attention to the theoretical and conceptual basis underlying audit and feedback. Examining the extent of theory use in studies of audit and feedback will yield better understanding of the causal pathways of audit and feedback effectiveness and inform efforts to optimize this important intervention. METHODS: A total of 140 studies in the 2012 Cochrane update on audit and feedback interventions were independently reviewed by two investigators. Variables were extracted related to theory use in the study design, measurement, implementation or interpretation. Theory name, associated reference, and the location of theory use as reported in the study were extracted. Theories were organized by type (e.g., education, diffusion, organization, psychology), and theory utilization was classified into seven categories (justification, intervention design, pilot testing, evaluation, predictions, post hoc, other). RESULTS: A total of 20 studies (14%) reported use of theory in any aspect of the study design, measurement, implementation or interpretation. In only 13 studies (9%) was a theory reportedly used to inform development of the intervention. A total of 18 different theories across educational, psychological, organizational and diffusion of innovation perspectives were identified. Rogers' Diffusion of Innovations and Bandura's Social Cognitive Theory were the most widely used (3.6% and 3%, respectively). CONCLUSIONS: The explicit use of theory in studies of audit and feedback was rare. A range of theories was found, but not consistency of theory use. Advancing our understanding of audit and feedback will require more attention to theoretically informed studies and intervention design.