Applying the Multiphase Optimization Strategy for the Development of Optimized Interventions in Palliative Care.
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SUBMITTER: Wells RD
PROVIDER: S-EPMC8274323 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature
Publications
Applying the Multiphase Optimization Strategy for the Development of Optimized Interventions in Palliative Care.
Wells Rachel D RD Guastaferro Kate K Azuero Andres A Rini Christine C Hendricks Bailey A BA Dosse Chinara C Taylor Richard R Williams Grant R GR Engler Sally S Smith Charis C Sudore Rebecca R Rosenberg Abby R AR Bakitas Marie A MA Dionne-Odom J Nicholas JN
Journal of pain and symptom management 20201128 1
Recent systematic reviews and meta-analyses have reported positive benefit of multicomponent "bundled" palliative care interventions for patients and family caregivers while highlighting limitations in determining key elements and mechanisms of improvement. Traditional research approaches, such as the randomized controlled trial (RCT), typically treat interventions as "bundled" treatment packages, making it difficult to assess definitively which aspects of an intervention can be reduced or repla ...[more]
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Project description:ObjectiveOptimizing multicomponent behavioral and biobehavioral interventions presents a complex decision problem. To arrive at an intervention that is both effective and readily implementable, it may be necessary to weigh effectiveness against implementability when deciding which components to select for inclusion. Different components may have differential effectiveness on an array of outcome variables. Moreover, different decision-makers will approach this problem with different objectives and preferences. Recent advances in decision-making methodology in the multiphase optimization strategy (MOST) have opened new possibilities for intervention scientists to optimize interventions based on a wide variety of decision-maker preferences, including those that involve multiple outcome variables. In this study, we introduce decision analysis for intervention value efficiency (DAIVE), a decision-making framework for use in MOST that incorporates these new decision-making methods. We apply DAIVE to select optimized interventions based on empirical data from a factorial optimization trial.MethodWe define various sets of hypothetical decision-maker preferences, and we apply DAIVE to identify optimized interventions appropriate to each case.ResultsWe demonstrate how DAIVE can be used to make decisions about the composition of optimized interventions and how the choice of optimized intervention can differ according to decision-maker preferences and objectives.ConclusionsWe offer recommendations for intervention scientists who want to apply DAIVE to select optimized interventions based on data from their own factorial optimization trials. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
| S-EPMC10837328 | biostudies-literature
Project description:BackgroundNewly arrived Chinese Americans face difficulties engaging in advance care planning (ACP) discussions with their family caregivers. Avoiding such discussions and failing to complete advance directives can delay palliative and hospice care. Yet, timely palliative care is essential to maintaining the quality of life at the end of life. Currently, there is a lack of interventions to help Chinese Americans diagnosed with cancer or heart disease overcome the barriers to engaging in ACP discussions via effective use of resilience.ObjectiveThis study aims to develop a culturally tailored, resilience-building intervention for Chinese Americans with cancer or heart disease.MethodsThe development of this intervention will be guided by the 3-phase multiphase optimization strategy. In the first phase of preparation, we will examine the prespecified components of the intervention through pilot studies to understand the necessity of each component. First, a qualitative study will be conducted to understand the experiences of 10 religious or spiritual leaders who have provided pastoral or spiritual care to Chinese Americans in Chicago, United States. The interview findings will be categorized as facilitators and barriers and integrated into the development of the intervention's resilience-building guide. Second, a cross-sectional study will be conducted to assess the readiness of Chinese Americans to engage in ACP discussions with their family using surveys. Third, think-aloud interviews will be conducted to understand the experiences of 18 pairs of Chinese Americans and their family caregivers regarding the prototype of the culturally tailored, resilience-building intervention. Finally, we will examine the feasibility and acceptability of the intervention prototype along with issues related to the study's implementation process.ResultsRecruitment for the qualitative study began in November 2023. As of October 2024, a total of 7 participants have been recruited, enabling a preliminary qualitative analysis to evaluate the analytical framework developed from the literature. Recruitment for the cross-sectional study began in April 2024, and as of October 2024, a total of 63 Chinese Americans have participated. The potential participant recruitment lists for the think-aloud interviews have been received, enabling recruitment to begin after the preliminary qualitative analysis is completed.ConclusionsThe proposed culturally tailored, resilience-building intervention is an innovative way to facilitate ACP discussions among Chinese Americans, particularly those diagnosed with serious chronic diseases. The findings from all 3 study methods will inform the development of the proposed intervention and identify effective recruitment strategies for this underserved and hard-to-reach population to be used in future research.International registered report identifier (irrid)DERR1-10.2196/59343.
| S-EPMC11632283 | biostudies-literature
Project description:BackgroundPoor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults' focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) suggests that interventions leveraging emerging adults' innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities.ObjectiveThis research project will use the multiphase optimization strategy to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A1c (HbA1c), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA1c≥9.0%).MethodsA question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA1c. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults' gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome.ResultsA total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023.ConclusionsAt the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D.Trial registrationClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959.International registered report identifier (irrid)DERR1-10.2196/20191.
| S-EPMC7609201 | biostudies-literature
Project description:With thousands of mobile health (mHealth) solutions on the market, patients and health care providers struggle to identify which solution to use and prescribe. The lack of evidence-based mHealth solutions may be because of limited research on intervention development and the continued use of traditional research methods for mHealth evaluation. The Multiphase Optimization Strategy (MOST) is a framework that aids in developing interventions that produce the best-expected outcomes (ie, effectiveness), given constraints imposed on affordability, scalability, and efficiency (also known as achieving intervention EASE). The preparation phase of the MOST highlights the importance of formative intervention development-a stage often overlooked and rarely published. The aim of the preparation phase of the MOST is to identify candidate intervention components, create a conceptual model, and define the optimization objective. Although the MOST sets these 3 targets, no guidance is provided on how to conduct quality research within the preparation phase and what specific steps can be taken to identify potential intervention components, develop the conceptual model, and achieve intervention EASE with the implementation context in mind. To advance the applicability of the MOST within the field of implementation science, this study provides an account of the methods used to develop an mHealth intervention using the MOST. Specifically, we provide an example of how to achieve the goals of the preparation phase by outlining the formative development of an mHealth-prompting intervention within a diabetes prevention program. In addition, recommendations are proposed for future researchers to consider when conducting formative research on mHealth interventions with implementation in mind. Given its considerable reach, mHealth has the potential to positively affect public health by decreasing implementation costs and improving accessibility. The MOST is well-suited for the efficient development and optimization of mHealth interventions. By using an implementation-focused lens and outlining the steps in developing an mHealth intervention using the preparation phase of the MOST, this study may guide future intervention developers toward maximizing the impact of mHealth outside academia.
| S-EPMC9092234 | biostudies-literature
Project description:BackgroundMore than half of persons living with HIV (PLWH) in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST), will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear), social- (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study.Methods/designStudy aims are: 1) using a highly efficient fractional factorial experimental design, identify which of five intervention components contribute meaningfully to improvement in HIV viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of intervention component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American/Black and Hispanic PLWH (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N = 512).DiscussionThis is the first study to apply the MOST framework in the field of HIV prevention and treatment. This innovative study will produce a culturally based HIV care continuum intervention for the nation's most vulnerable PLWH, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability.Trial registrationClinicalTrials.gov, NCT02801747 , Registered June 8, 2016.
| S-EPMC5418718 | biostudies-literature
Project description:BackgroundReports of children's engagement in active transportation outline low participation rates in many countries despite many associated mental, physical, and social health benefits. One of the main contributors to this phenomenon is a cited lack of education and knowledge among children regarding active travel (AT), specifically road safety. To address this issue, the aim of this study was to evaluate the feasibility and effectiveness of an online road safety education intervention to promote AT among children and their parents.MethodsApplying the Multiphase Optimization Strategy (MOST) for intervention development, implementation, and evaluation, we designed and assessed a four-module online road safety education intervention with a sample of 57 parent-child dyads using a 23 factorial design featuring both qualitative and quantitative analyses.ResultsMain intervention feasibility findings include positive and critical feedback on the program's content and design, and moderate participant engagement as reflected by program retention and completion rates. With respect to the preliminary intervention effectiveness on children, a significant improvement in road safety knowledge scores was observed for groups that feature the "wheeling safety and skills" module. Slight improvements in AT knowledge scores across all the intervention groups were observed, but were not of significance. Preliminary intervention effectiveness on select parental AT practices and perceptions saw significant improvements in some groups. Groups that featured the 'wheeling safety and skills' module exhibited significantly higher guided choice scores upon completion of the program than those who did not receive this component.ConclusionThe MOST framework allowed us to design and evaluate the feasibility and preliminary effectiveness of an online road safety education intervention. The developed intervention has demonstrated that it has the potential to improve children's road safety knowledge and some areas of parental AT practices and perceptions, to which improvements may be attributed to the inclusion of the "wheeling safety and skills" module, suggesting that the targeted focus on cycling skills is a prioritized area. AT programming and practice implications are discussed. Future research is encouraged to refine modules to better reflect the priorities of children and parents and to test these refined components among larger samples.Word count9,391 (excludes abstract, tables, figures, abbreviations, and references).
| S-EPMC11223427 | biostudies-literature
Project description:Obesity-attributable medical expenditures remain high, and interventions that are both effective and cost-effective have not been adequately developed. The Opt-IN study is a theory-guided trial using the Multiphase Optimization Strategy (MOST) to develop an optimized, scalable version of a technology-supported weight loss intervention.Opt-IN aims to identify which of 5 treatment components or component levels contribute most meaningfully and cost-efficiently to the improvement of weight loss over a 6 month period.Five hundred and sixty obese adults (BMI 30-40 kg/m(2)) between 18 and 60 years old will be randomized to one of 16 conditions in a fractional factorial design involving five intervention components: treatment intensity (12 vs. 24 coaching calls), reports sent to primary care physician (No vs. Yes), text messaging (No vs. Yes), meal replacement recommendations (No vs. Yes), and training of a participant's self-selected support buddy (No vs. Yes). During the 6-month intervention, participants will monitor weight, diet, and physical activity on the Opt-IN smartphone application downloaded to their personal phone. Weight will be assessed at baseline, 3, and 6 months.The Opt-IN trial is the first study to use the MOST framework to develop a weight loss treatment that will be optimized to yield the best weight loss outcome attainable for $500 or less.
| S-EPMC4104542 | biostudies-other
Project description: Not available
| S-EPMC8478014 | biostudies-literature
Project description:Study objectiveTobacco dependence treatment initiated in the hospital emergency department (ED) is effective. However, trials typically use multicomponent interventions, making it difficult to distinguish specific components that are effective. In addition, interactions between components cannot be assessed. The Multiphase Optimization Strategy allows investigators to identify these effects.MethodsWe conducted a full-factorial, 24 or 16-condition optimization trial in a busy hospital ED to examine the performance of 4 tobacco dependence interventions: a brief negotiation interview; 6 weeks of nicotine replacement therapy with the first dose delivered in the ED; active referral to a telephone quitline; and enrollment in SmokefreeTXT, a free short-messaging service program. Study data were analyzed with a novel mixed methods approach to assess clinical efficacy, cost-effectiveness, and qualitative participant feedback. The primary endpoint was tobacco abstinence at 3 months, verified by exhaled carbon monoxide using a Bedfont Micro+ Smokerlyzer.ResultsBetween February 2017 and May 2019, we enrolled 1,056 adult smokers visiting the ED. Odd ratios (95% confidence intervals) from the primary analysis of biochemically confirmed abstinence rates at 3 months for each intervention, versus control, were: brief negotiation interview, 1.8 (1.1, 2.8); nicotine replacement therapy, 2.1 (1.3, 3.2); quitline, 1.4 (0.9, 2.2); SmokefreeTXT, 1.1 (0.7, 1.7). There were no statistically significant interactions among components. Economic and qualitative analyses are in progress.ConclusionThe brief negotiation interview and nicotine replacement therapy were efficacious. This study is the first to identify components of ED-initiated tobacco dependence treatment that are individually effective. Future work will address the scalability of the brief negotiation interview and nicotine replacement therapy by offering provider-delivered brief negotiation interviews and nicotine replacement therapy prescriptions.
| S-EPMC9868063 | biostudies-literature
Project description:Background/aimsPreventing the development of childhood obesity requires multilevel, multicomponent, comprehensive approaches. Study designs often do not allow for systematic evaluation of the efficacy of individual intervention components before the intervention is fully tested. As such, childhood obesity prevention programs may contain a mix of effective and ineffective components. This article describes the design and rationale of a childhood obesity preventive intervention developed using the multiphase optimization strategy, an engineering-inspired framework for optimizing behavioral interventions. Using a series of randomized experiments, the objective of the study was to systematically test, select, and refine candidate components to build an optimized childhood obesity preventive intervention to be evaluated in a subsequent randomized controlled trial.MethodsA 24 full factorial design was used to test the individual and combined effects of four candidate intervention components intended to reduce the risk for childhood obesity. These components were designed with a focus on (a) improving children's healthy eating behaviors and nutrition knowledge, (b) increasing physical activity and reducing sedentary activity in the childcare setting, (c) improving children's behavioral self-regulation, and (d) providing parental web-based education to address child target outcomes. The components were tested with approximately 1400 preschool children, ages 3-5 years in center-based childcare programs in Pennsylvania, the majority of which served predominantly Head-Start eligible households. Primary child outcomes included healthy eating knowledge, physical and sedentary activity, and behavioral self-regulation. Secondary outcomes included children's body mass index and appetitive traits related to appetite regulation.ResultsFour intervention components were developed, including three classroom curricula designed to increase preschool children's nutrition knowledge, physical activity, and behavioral, emotional, and eating regulation. A web-based parent education component included 18 lessons designed to improve parenting practices and home environments that would bolster the effects of the classroom curricula. A plan for analyzing the specific contribution of each component to a larger intervention was developed and is described. The efficacy of the four components can be evaluated to determine the extent to which they, individually and in combination, produce detectable changes in childhood obesity risk factors. The resulting optimized intervention should later be evaluated in a randomized controlled trial, which may provide new information on promising targets for obesity prevention in young children.ConclusionThis research project highlights the ways in which an innovative approach to the design and initial evaluation of preventive interventions may increase the likelihood of long-term success. The lessons from this research project have implications for childhood obesity research as well as other preventive interventions that include multiple components, each targeting unique contributors to a multifaceted problem.
| S-EPMC10338696 | biostudies-literature