Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial.

INTRODUCTION: Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management. METHODS AND ANALYSIS: This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness). ETHICS AND DISSEMINATION: Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications. TRIAL REGISTRATION NUMBER: clinicaltrials.gov; NCT05666323.

Socio-economic status moderates within-person associations of risk factors and smoking lapse in daily life.

BACKGROUND AND AIMS: Individuals of lower socio-economic status (SES) display a higher prevalence of smoking and have more diffxiculty quitting than higher SES groups. The current study investigates whether the within-person associations of key risk (e.g. stress) and protective (self-efficacy) factors with smoking lapse varies by facets of SES. DESIGN AND SETTING: Observational study using ecological momentary assessment to collect data for a 28-day period following a smoking quit attempt. Multi-level mixed models (i.e. generalized linear mixed models) examined cross-level interactions between lapse risk and protective factors and indicators of SES on smoking lapse. PARTICIPANTS: A diverse sample of 330 adult US smokers who completed a larger study examining the effects of race/ethnicity and social/environmental influences on smoking cessation. MEASUREMENTS: Risk factors included momentary urge, negative affect, stress; protective factors included positive affect, motivation, abstinence self-efficacy; SES measures: baseline measures of income and financial strain; the primary outcome was self-reported lapse. FINDINGS: Participants provided 43 297 post-quit observations. Mixed models suggested that income and financial strain moderated the effect of some risk factors on smoking lapse. The within-person association of negative [odds ratio (OR) = 0.967, 95% CI= 0.945, 0.990, P < 0.01] and positive affect (OR = 1.023, 95% CI = 1.003, 1.044, P < 0.05) and abstinence self-efficacy (OR = 1.020, 95% CI = 1.003, 1.038, P < 0.05) on lapse varied with financial strain. The within-person association of negative affect (OR = 1.005, 95% CI = 1.002, 1.008, P < 0.01), motivation (OR = 0.995, 95% CI = 0.991, 0.999, P < 0.05) and abstinence self-efficacy (OR = 0.996, 95% CI = 0.993, 0.999, P < 0.01) on lapse varied by income. The positive association of negative affect with lapse was stronger among individuals with higher income and lower financial strain. The negative association between positive affect and abstinence self-efficacy with lapse was stronger among individuals with lower financial strain, and the negative association between motivation and abstinence self-efficacy with lapse was stronger among those with higher income. The data were insensitive to detect statistically significant moderating effects of income and financial strain on the association of urge or stress with lapse. CONCLUSION: Some risk factors (e.g. momentary negative affect) exert a weaker influence on smoking lapse among lower compared to higher socio-economic status groups.

An ecological momentary assessment study of outcome expectancies and smoking lapse in daily life.

OBJECTIVE: Outcome expectancies have been identified as key components of behavior change. Expectancies related to affect control are hypothesized to play an important role in smoking cessation, such that smokers may be more likely to lapse if they believe they can control their affect by smoking and less likely if they believe they can control their affect by means other than smoking. However, little is known about whether real-time, real-world changes in affect control expectancies influence smoking lapse during a quit attempt. METHODS: A diverse sample (N = 369) of adult smokers completed ecological momentary assessment of smoking expectancies and lapse for 28 days following a quit attempt. Multilevel logistic regression was used to examine whether the difference score of positive smoking outcome expectancies (the belief that smoking would improve mood) minus positive coping outcome expectancies (the belief that something other than smoking would improve mood) was related to smoking lapse in daily life. RESULTS: There was a significant within-person association between the expectancies difference score and lapse likelihood. When the difference score was 1 unit above a person's typical level, odds of lapse increased by 18.65 % (ß = 0.174, SE = 0.024, p < .0001, OR = 1.189, 95 % CI [1.135, 1.247]). CONCLUSION: Smokers undergoing a quit attempt were more likely to lapse in moments when the difference in the belief that smoking would improve their mood minus the belief that something other than smoking would improve their mood was larger. This work has relevance for tailoring interventions to both cultivate positive coping outcome expectancies and reduce smoking outcome expectancies, and informs theoretical models about the dynamic nature of outcome expectancies.

Evaluation in Life Cycle of Information Technology (ELICIT) framework: Supporting the innovation life cycle from business case assessment to summative evaluation.

OBJECTIVE: Our objective was to develop an evaluation framework for electronic health record (EHR)-integrated innovations to support evaluation activities at each of four information technology (IT) life cycle phases: planning, development, implementation, and operation. METHODS: The evaluation framework was developed based on a review of existing evaluation frameworks from health informatics and other domains (human factors engineering, software engineering, and social sciences); expert consensus; and real-world testing in multiple EHR-integrated innovation studies. RESULTS: The resulting Evaluation in Life Cycle of IT (ELICIT) framework covers four IT life cycle phases and three measure levels (society, user, and IT). The ELICIT framework recommends 12 evaluation steps: (1) business case assessment; (2) stakeholder requirements gathering; (3) technical requirements gathering; (4) technical acceptability assessment; (5) user acceptability assessment; (6) social acceptability assessment; (7) social implementation assessment; (8) initial user satisfaction assessment; (9) technical implementation assessment; (10) technical portability assessment; (11) long-term user satisfaction assessment; and (12) social outcomes assessment. DISCUSSION: Effective evaluation requires a shared understanding and collaboration across disciplines throughout the entire IT life cycle. In contrast with previous evaluation frameworks, the ELICIT framework focuses on all phases of the IT life cycle across the society, user, and IT levels. Institutions seeking to establish evaluation programs for EHR-integrated innovations could use our framework to create such shared understanding and justify the need to invest in evaluation. CONCLUSION: As health care undergoes a digital transformation, it will be critical for EHR-integrated innovations to be systematically evaluated. The ELICIT framework can facilitate these evaluations.

Increasing treatment enrollment among smokers who are not motivated to quit: a randomized clinical trial.

There is a significant research-to-practice gap with respect to reaching underserved populations with evidence-based tobacco cessation treatments. Increasing enrollment in evidence-based treatments is necessary to reduce tobacco use and tobacco-related health inequities. The purpose of the current study was to evaluate whether Motivation And Problem Solving (MAPS), a flexible, holistic counseling/navigation approach delivered via phone, and proactive provision of Nicotine Replacement Therapy (NRT) would improve Quitline enrollment among a sample of low SES smokers who were not motivated to quit. In a 3×2 factorial design, cigarette smokers (N = 603) were randomized to one of six treatment conditions (Standard Treatment, MAPS-6, or MAPS-12 by NRT or no NRT). Results indicated that both MAPS-6 and MAPS-12 increased Quitline enrollment compared to Standard Treatment (ps < .03). There were no differences between MAPS conditions. NRT did not increase Quitline enrollment. MAPS is an effective intervention with the potential to be disseminated and implemented in healthcare and community settings to increase the reach of evidence-based interventions for tobacco cessation.

Implementing lung cancer screening in primary care: needs assessment and implementation strategy design.

Lung cancer screening with low-dose computed tomography (CT) could help avert thousands of deaths each year. Since the implementation of screening is complex and underspecified, there is a need for systematic and theory-based strategies. Explore the implementation of lung cancer screening in primary care, in the context of integrating a decision aid into the electronic health record. Design implementation strategies that target hypothesized mechanisms of change and context-specific barriers. The study had two phases. The Qualitative Analysis phase included semi-structured interviews with primary care physicians to elicit key task behaviors (e.g., ordering a low-dose CT) and understand the underlying behavioral determinants (e.g., social influence). The Implementation Strategy Design phase consisted of defining implementation strategies and hypothesizing causal pathways to improve screening with a decision aid. Three key task behaviors and four behavioral determinants emerged from 14 interviews. Implementation strategies were designed to target multiple levels of influence. Strategies included increasing provider self-efficacy toward performing shared decision making and using the decision aid, improving provider performance expectancy toward ordering a low-dose CT, increasing social influence toward performing shared decision making and using the decision aid, and addressing key facilitators to using the decision aid. This study contributes knowledge about theoretical determinants of key task behaviors associated with lung cancer screening. We designed implementation strategies according to causal pathways that can be replicated and tested at other institutions. Future research is needed to evaluate the effectiveness of these strategies and to determine the contexts in which they can be effectively applied.

Application of community - engaged dissemination and implementation science to improve health equity.

Community engagement is critical to accelerate and improve implementation of evidence-based interventions to reduce health inequities. Community-engaged dissemination and implementation research (CEDI) emphasizes engaging stakeholders (e.g., community members, practitioners, community organizations, etc.) with diverse perspectives, experience, and expertise to provide tacit community knowledge regarding the local context, priorities, needs, and assets. Importantly, CEDI can help improve health inequities through incorporating unique perspectives from communities experiencing health inequities that have historically been left out of the research process. The community-engagement process that exists in practice can be highly variable, and characteristics of the process are often underreported, making it difficult to discern how engagement of community partners was used to improve implementation. This paper describes the community-engagement process for a multilevel, pragmatic randomized trial to increase the reach and impact of evidence-based tobacco cessation treatment among Community Health Center patients; describes how engagement activities and the resulting partnership informed the development of implementation strategies and improved the research process; and presents lessons learned to inform future CEDI research.

QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers.

BACKGROUND: Tobacco use remains the leading cause of death and disability in the USA and is disproportionately concentrated among low socioeconomic status (SES) populations. Community Health Centers (CHCs) are a key venue for reaching low SES populations with evidence-based tobacco cessation treatment such as Quitlines. Electronic health record (EHR)-based interventions at the point-of-care, text messaging (TM), and phone counseling have the potential to increase Quitline reach and are feasible to implement within CHCs. However, there is a lack of data to inform how, when, and in what combination these strategies should be implemented. The aims of this cluster-randomized trial are to evaluate multi-level implementation strategies to increase the Reach (i.e., proportion of tobacco-using patients who enroll in the Quitline) and Impact (i.e., Reach × Efficacy [efficacy is defined as the proportion of tobacco-using patients who enroll in Quitline treatment that successfully quit]) and to evaluate characteristics of healthcare system, providers, and patients that may influence tobacco-use outcomes. METHODS: This study is a multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART), conducted in CHCs (N = 33 clinics; N = 6000 patients). In the first phase, clinics will be randomized to two different EHR conditions. The second and third phases are patient-level randomizations based on prior treatment response. Patients who enroll in the Quitline receive no further interventions. In phase two, patients who are non-responders (i.e., patients who do not enroll in Quitline) will be randomized to receive either TM or continued-EHR. In phase three, patients in the TM condition who are non-responders will be randomized to receive either continued-TM or TM + phone coaching. DISCUSSION: This project will evaluate scalable, multi-level interventions to directly address strategic national priorities for reducing tobacco use and related disparities by increasing the Reach and Impact of evidence-based tobacco cessation interventions in low SES populations. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (NCT03900767) on April 4th, 2019.