Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study.

BACKGROUND: The COVID-19 pandemic disrupted the delivery of diabetes care and worsened mental health among many patients with type 2 diabetes (T2D). This disruption puts patients with T2D at risk for poor diabetes outcomes, especially those who experience social disadvantage due to socioeconomic class, rurality, or ethnicity. The appropriate use of communication technology could reduce these gaps in diabetes care created by the pandemic and also provide support for psychological distress. OBJECTIVE: The purpose of this study is to test the feasibility of an innovative co-designed Technology-Enabled Collaborative Care (TECC) model for diabetes management and mental health support among adults with T2D. METHODS: We will recruit 30 adults with T2D residing in Ontario, Canada, to participate in our sequential explanatory mixed methods study. They will participate in 8 weekly web-based health coaching sessions with a registered nurse, who is a certified diabetes educator, who will be supported by a digital care team (ie, a peer mentor, an addictions specialist, a dietitian, a psychiatrist, and a psychotherapist). Assessments will be completed at baseline, 4 weeks, and 8 weeks, with a 12-week follow-up. Our primary outcome is the feasibility and acceptability of the intervention, as evident by the participant recruitment and retention rates. Key secondary outcomes include assessment completion and delivery of the intervention. Exploratory outcomes consist of changes in mental health, substance use, and physical health behaviors. Stakeholder experience and satisfaction will be explored through a qualitative descriptive study using one-on-one interviews. RESULTS: This paper describes the protocol of the study. The recruitment commenced in June 2021. This study was registered on October 29, 2020, on ClinicalTrials.gov (Registry ID: NCT04607915). As of June 2022, all participants have been recruited. It is anticipated that data analysis will be complete by the end of 2022, with study findings available by the end of 2023. CONCLUSIONS: The development of an innovative, technology-enabled model will provide necessary support for individuals living with T2D and mental health challenges. This TECC program will determine the feasibility of TECC for patients with T2D and mental health issues. TRIAL REGISTRATION: ClinicalTrials.gov NCT04607915; https://clinicaltrials.gov/ct2/show/NCT04607915. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39724.

The Impact of a Clinical Decision Support System for Addressing Physical Activity and Healthy Eating During Smoking Cessation Treatment: Hybrid Type I Randomized Controlled Trial.

BACKGROUND: People who smoke have other risk factors for chronic diseases, such as low levels of physical activity and poor diet. Clinical decision support systems (CDSSs) might help health care practitioners integrate interventions for diet and physical activity into their smoking cessation programming but could worsen quit rates. OBJECTIVE: The aims of this study are to assess the effects of the addition of a CDSS for physical activity and diet on smoking cessation outcomes and to assess the implementation of the study. METHODS: We conducted a pragmatic hybrid type I effectiveness-implementation trial with 232 team-based primary care practices in Ontario, Canada, from November 2019 to May 2021. We used a 2-arm randomized controlled trial comparing a CDSS addressing physical activity and diet to treatment as usual and used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to measure implementation outcomes. The primary outcome was self-reported 7-day tobacco abstinence at 6 months. RESULTS: We enrolled 5331 participants in the study. Of these, 2732 (51.2%) were randomized to the intervention group and 2599 (48.8%) to the control group. At the 6-month follow-up, 29.7% (634/2137) of respondents in the intervention arm and 27.3% (552/2020) in the control arm reported abstinence from tobacco. After multiple imputation, the absolute group difference was 2.1% (95% CI -0.5 to 4.6; F1,1000.42=2.43; P=.12). Mean exercise minutes changed from 32 (SD 44.7) to 110 (SD 196.1) in the intervention arm and from 32 (SD 45.1) to 113 (SD 195.1) in the control arm (group effect: B=-3.7 minutes; 95% CI -17.8 to 10.4; P=.61). Servings of fruit and vegetables changed from 2.64 servings to 2.42 servings in the intervention group and from 2.52 servings to 2.45 servings in the control group (incidence rate ratio for intervention group=0.98; 95% CI 0.93-1.02; P=.35). CONCLUSIONS: A CDSS for physical activity and diet may be added to a smoking cessation program without affecting the outcomes. Further research is needed to improve the impact of integrated health promotion interventions in primary care smoking cessation programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04223336 https://www.clinicaltrials.gov/ct2/show/NCT04223336. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19157.

Effects of COVID-19-Related Disruptions on Service Use in a Large Smoking Cessation Program.

INTRODUCTION: The COVID-19 pandemic caused a rapid shift to virtual care, with largely unknown consequences for accessibility. The purpose of this study is to examine pandemic-related changes in use of care for smoking cessation. AIMS AND METHODS: We conducted a secondary analysis 65 565 enrollments in a large smoking cessation program in Ontario, Canada. We used piecewise mixed-effects regression to examine how weeks nicotine replacement therapy (NRT) received, as well as counseling provided and visits attended, varied with date of enrollment over three time periods: more than 6 months before the pandemic began; the 6 months before the pandemic; and the pandemic period itself. We then examined changes in the associations between use of care and participant characteristics by fitting a model including a set of interactions between time and other variables. Based on an omnibus test of these interactions, we then tested individual terms, using the Holm method to control the family-wise error rate. RESULTS: From the start of the pandemic in March 2020, the total weeks of NRT provided rose significantly and then declined, while the amount of counseling fell. Associations between NRT use and participant characteristics changed significantly after the pandemic onset. Individual models showed that people with lower income, living in areas of higher marginalization, unable to work, and reporting higher levels of depressive symptoms all received NRT for a longer time during the pandemic period. CONCLUSIONS: The pandemic led to small but significant changes in the amount of services used per enrollment. The transition to remote care appears to have reduced the effects of socioeconomic and health barriers. IMPLICATIONS: The amount of care used by participants in tobacco cessation treatment is known to be associated with health and sociodemographic characteristics. Most of these associations did not change markedly following the pandemic-related switch to virtual care in 2020; however, the effects of some economic and health barriers seem to have lessened, perhaps because of a likely reduction in transport and time requirements of treatment.

Changes in the reach of a smoking cessation program in Ontario, Canada, during the COVID-19 pandemic: a cross-sectional study.

BACKGROUND: Given the harms associated with tobacco use, continuing the provision of smoking cessation treatment during the COVID-19 pandemic is critical. The aim of this study was to examine pandemic-related changes in enrolment, total treatment use and participant characteristics in a large, publicly funded smoking cessation program in Ontario, Canada. METHODS: We conducted a secondary data analysis of patients who enrolled in the program between Jan. 1, 2018, and Dec. 7, 2020. We used descriptive statistics to examine changes in treatment use. To test for differences in sociodemographic and health variables, we used segmented mixed-effects regression with a break point on Mar. 17, 2020, when Ontario declared a state of emergency. We tested 25 variables, using Holm's correction for multiplicity. RESULTS: We analyzed 60 373 enrolments. In the month after the break point, enrolments fell 69% and total visits fell 42% relative to previous years. After Mar. 17, 2020, those who enrolled were less likely to report employment in the previous week (absolute expected difference -12.4%, 95% confidence interval [CI] -15.0% to -9.8%); were more likely to be occasional (1.3%, 95% CI 0.6% to 1.9%) or noncurrent smokers (1.7%, 95% CI 0.8% to 2.6%); were less likely to have set a target quit date (-4.8%, 95% CI -7.0% to -2.6%); and were more likely to have a physical health (6.6%, 95% CI 4.0% to 9.2%), mental health (4.6%, 95% CI 1.9% to 7.2%) or substance use diagnosis (3.5%, 95% CI 1.3% to 5.6%). INTERPRETATION: Sharp decreases in new enrolments and subsequent visits to smoking cessation programs were seen when pandemic restrictions were implemented in Ontario, but the characteristics of the people who accessed the programs did not change markedly. Incorporating an equity perspective is essential when new models of care for smoking cessation are developed.

Effect of COVID-19 on smoking cessation outcomes in a large primary care treatment programme: an observational study.

OBJECTIVES: The COVID-19 pandemic has changed patterns of smoking, other substance use and other health-related behaviours, leading to a virtualisation of non-urgent medical care. In this study, we examine associated changes in outcomes of smoking-cessation treatment. DESIGN: Observational study. SETTING: Data are drawn from 221 physician-led primary care practices participating in a smoking cessation program in Ontario, Canada. PARTICIPANTS: 43 509 patients (53% female), comprising 35 385 historical controls, 6109 people enrolled before the pandemic and followed up during it, and 1815 people enrolled after the pandemic began. INTERVENTION: Nicotine-replacement therapy with counselling. PRIMARY OUTCOME MEASURE: 7-day self-reported abstinence from cigarettes at a follow-up survey 6 months after entry. RESULTS: For people followed up in the 6 months (6M) after the pandemic began, quit probability declined with date of enrolment. Predicted probabilities were 31.2% (95% CI 30.0% to 32.5%) for people enrolled in smoking cessation treatment 6 months prior to the emergency declaration and followed up immediately after the state of emergency was declared, and 24.1% (95% CI 22.1% to 26.2%) for those enrolled in treatment immediately before the emergency declaration and followed up 6M later (difference=-6.5%, 95% CI -9.0% to -3.9%). Seasonality and total treatment use did not explain this decline. CONCLUSION: The probability of successful smoking cessation following treatment fell during the pandemic, with the decline consistent with an effect of 'exposure' to the pandemic-era environment. As many changes happened simultaneously, specific causes cannot be identified; however, the possibility that virtual care has been less effective than in-person treatment should be explored.