Barriers encountered during enrollment in an internet-mediated randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Online technology is a promising resource for conducting clinical research. While the internet may improve a study's reach, as well as the efficiency of data collection, it may also introduce a number of challenges for participants and investigators. The objective of this research was to determine the challenges that potential participants faced during the enrollment phase of a randomized controlled intervention trial of Stepping Up to Health, an internet-mediated walking program that utilized a multi-step online enrollment process.</p> <p>Methods</p> <p>We conducted a quantitative content analysis of 623 help tickets logged in a participant management database during the enrollment phase of a clinical trial investigating the effect of an automated internet-mediated walking intervention. Qualitative coding was performed by two trained coders, and 10% of the sample was coded by both coders to determine inter-coder reliability. Quantitative analyses included standard descriptive statistics on ticket characteristics and theme frequency, and a Poisson regression analysis identified characteristics of potential participants who reported more frequent problems during enrollment.</p> <p>Results</p> <p>In total, 880 potential participants visited the study website and 80% completed the enrollment screening. Of the potential participants who visited the study website, 38% had help tickets logged in the participant management database. The total number of help tickets associated with individual potential participants ranged from 0 to 7 (M = .71). Overall, 46% of help tickets were initiated by email and 54% were initiated by phone. The most common help ticket theme was issues related to the study process (48%). The next most prominent theme was discussion related to obtaining medical clearance (34%), followed by issues related to pedometers and uploading (31%). Older individuals, women, and those with lower self-rated internet ability were more likely to report problems during the enrollment process.</p> <p>Conclusion</p> <p>Prospective participants in an online clinical trial encountered a number of barriers to enrollment that led them to request help from study staff. Questions about the complex enrollment process itself were common. In a complex multi-step enrollment process, providing personalized feedback to potential participants indicating their status within the enrollment process may be beneficial.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NCT00729040</p

Evaluating Active U: an Internet-mediated physical activity program.

Background: Engaging in regular physical activity can be challenging, particularly during the winter months. To promote physical activity at the University of Michigan during the winter months, an eight-week Internet-mediated program (Active U) was developed providing participants with an online physical activity log, goal setting, motivational emails, and optional team participation and competition. Methods: This study is a program evaluation of Active U. Approximately 47,000 faculty, staff, and graduate students were invited to participate in the online Active U intervention in the winter of 2007. Participants were assigned a physical activity goal and were asked to record each physical activity episode into the activity log for eight weeks. Statistics for program reach, effectiveness, adoption, and implementation were calculated using the Re-Aim framework. Multilevel regression analyses were used to assess the decline in rates of data entry and goal attainment during the program, to assess the likelihood of joining a team by demographic characteristics, to test the association between various predictors and the number of weeks an individual met his or her goal, and to analyze server load. Results: Overall, 7,483 individuals registered with the Active U website (≈16% of eligible), and 79% participated in the program by logging valid data at least once. Staff members, older participants, and those with a BMI < 25 were more likely to meet their weekly physical activity goals, and average rate of meeting goals was higher among participants who joined a competitive team compared to those who participated individually (IRR = 1.28, P < .001). Conclusion: Internet-mediated physical activity interventions that focus on physical activity logging and goal setting while incorporating team competition may help a significant percentage of the target population maintain their physical activity during the winter months

Integrating an internet-mediated walking program into family medicine clinical practice: a pilot feasibility study

<p>Abstract</p> <p>Background</p> <p>Regular participation in physical activity can prevent many chronic health conditions. Computerized self-management programs are effective clinical tools to support patient participation in physical activity. This pilot study sought to develop and evaluate an online interface for primary care providers to refer patients to an Internet-mediated walking program called Stepping Up to Health (SUH) and to monitor participant progress in the program.</p> <p>Methods</p> <p>In Phase I of the study, we recruited six pairs of physicians and medical assistants from two family practice clinics to assist with the design of a clinical interface. During Phase II, providers used the developed interface to refer patients to a six-week pilot intervention. Provider perspectives were assessed regarding the feasibility of integrating the program into routine care. Assessment tools included quantitative and qualitative data gathered from semi-structured interviews, surveys, and online usage logs.</p> <p>Results</p> <p>In Phase I, 13 providers used SUH and participated in two interviews. Providers emphasized the need for alerts flagging patients who were not doing well and the ability to review participant progress. Additionally, providers asked for summary views of data across all enrolled clinic patients as well as advertising materials for intervention recruitment. In response to this input, an interface was developed containing three pages: 1) a recruitment page, 2) a summary page, and 3) a detailed patient page. In Phase II, providers used the interface to refer 139 patients to SUH and 37 (27%) enrolled in the intervention. Providers rarely used the interface to monitor enrolled patients. Barriers to regular use of the intervention included lack of integration with the medical record system, competing priorities, patient disinterest, and physician unease with exercise referrals. Intention-to-treat analyses showed that patients increased walking by an average of 1493 steps/day from pre- to post-intervention (<it>t </it>= (36) = 4.13, <it>p </it>< 0.01).</p> <p>Conclusions</p> <p>Providers successfully referred patients using the SUH provider interface, but were less willing to monitor patient compliance in the program. Patients who completed the program significantly increased their step counts. Future research is needed to test the effectiveness of integrating SUH with clinical information systems over a longer evaluation period.</p

Barriers and Considerations in the Design and Implementation of Digital Behavioral Interventions: Qualitative Analysis

BackgroundDigital behavioral interventions have become increasingly popular for their ability to support patient diagnosis and treatment, chronic disease self-management, behavior change, and adherence to recommended care. However, digital intervention development is impeded by challenges such as limited technical skills, limited access to developers, and cost. The purpose of this study is to elicit in-depth qualitative feedback from intervention developers who have interest in digital behavioral interventions but lack programming skills regarding the barriers they experience and key considerations in the design and implementation of digital interventions. ObjectiveThis study aims to understand barriers in the design and implementation of digital behavioral interventions, as well as to identify key considerations for researchers who are developing these interventions. MethodsWe conducted semistructured qualitative interviews with 18 researchers who had experience either designing (but not coding) digital behavioral interventions or running research studies with them. Participants were a convenience sample of users of the Computerized Intervention Authoring System platform, an existing no-code development platform for building digital intervention content, and were recruited through either direct email solicitation or snowball sampling. All interviews were conducted and recorded over videoconference between February and April 2020. Recordings from interviews were transcribed and thematically analyzed by multiple coders. ResultsInterviews were completed with 18 participants and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project/study staff. Three key barriers in the development of digital behavior interventions were identified during interviews: lack of cross-disciplinary understanding; variability in recipients’ technology access, infrastructure, and literacy; and the idea that evidence-based in-person interactions do not translate directly to digital interactions. Interviewees identified several key considerations that interventionists learned to prioritize, which have the potential to overcome these barriers and lead to successful interventions. ConclusionsBarriers in the development of digital behavioral interventions are often created by a lack of cross-disciplinary understanding, which can lead to difficulties conceptualizing interventions, unrealistic expectations in terms of cost, and confusion about the development process. Moreover, concerns about research study participant characteristics and access to technology, as well as the translation of in-person interventions to digital, are apparent. Appropriate training in how to work with software development teams may help future digital behavior intervention creators overcome these barriers and may lead to new, exciting innovations in this space

The Perceived Benefits of Digital Interventions for Behavioral Health: Qualitative Interview Study

BackgroundDigital interventions have gained momentum in terms of behavioral health. However, owing to lacking standard approaches or tools for creating digital behavioral interventions, clinical researchers follow widely varying conceptions of how best to go about digital intervention development. Researchers also face significant cost-, time-, and expertise-related challenges in digital intervention development. Improving the availability of tools and guidance for researchers will require a thorough understanding of the motivations and needs of researchers seeking to create digital interventions. ObjectiveThis study aims to understand the perceptions of behavioral researchers toward digital interventions, and inform the use of these interventions, by documenting the reasons why researchers are increasingly focusing their efforts on digital interventions and their perspectives on the perceived benefits that digital approaches can provide for researchers and intervention recipients. MethodsWe conducted semistructured qualitative interviews with 18 researchers who had experience designing digital behavioral interventions or running studies with them. A convenience sample of interviewees was recruited from among users of the Computerized Intervention Authoring System platform, a web-based tool that facilitates the process of creating and deploying digital interventions in behavioral research. Interviews were conducted over teleconference between February and April 2020. Recordings from the interviews were transcribed and thematically analyzed by multiple coders. ResultsInterviews were completed with 18 individuals and lasted between 24 and 65 (mean 46.9, SD 11.3) minutes. Interviewees were predominantly female (17/18, 94%) and represented different job roles, ranging from researcher to project or study staff. Four major themes came out of the interviews concerning the benefits of digital interventions for behavioral health: convenience and flexibility for interventionists and recipients, support for implementing evidence-based interventions with fidelity, scaling and improving access to interventions, and getting a foot in the door despite stigma and disenfranchisement. ConclusionsInterviewees described a number of important potential benefits of digital interventions, particularly with respect to scientific rigor, scalability, and overcoming barriers to reaching more people. There are complex considerations with regard to translating behavior change strategies into digital forms of delivery, and interventionists make individual, sometimes unexpected, choices with minimal evidence of their relative effectiveness. Future research should investigate how behavioral researchers can be supported in making these choices toward usability, ease of access, and approachability of digital interventions. Our study underscores the need for authoring platforms that can facilitate the process of creating and deploying digital interventions to reach their full potential for interventionists and recipients alike

Facilitators and barriers to blood pressure telemonitoring: A mixed-methods study

Background Telemonitoring of blood pressure (BP) may improve BP control. However, many patients are not using BP telemonitoring due to personal, technological, and health system barriers. Individuals are required to have electronic health literacy (e-HL), defined as knowledge and skills to use technology services effectively, such as BP telemonitoring. Objective The objective was to determine the facilitators and barriers experienced by patients with hypertension in telemonitoring of BP using the e-HL framework (e-HLF). Methods This study was a prospective mixed-methods study using a convergent design. We recruited a convenience sample of 21 patients with hypertension. The qualitative section was online or phone individual in-depth interviews based on the e-HLF, which has seven domains. The quantitative section was an online survey consisting of demographics, an e-HL questionnaire, and patient–provider communication preferences. A joint display was used in the mixed-methods analysis. Results Five themes including knowledge, motivation, skills, systems, and behaviors along with 28 subthemes comprising facilitators or barriers of BP telemonitoring were identified. The mixed-methods results showed concordance between the participants’ e-HL status and their experiences in the ability to actively engage with BP monitoring and managing digital services (domain 3) of the e-HLF. Other e-HL domains showed discordance. Conclusion Patients may engage with BP telemonitoring when they feel the usefulness of concurrent access to telemonitoring services that suit their needs

Adding an Online Community to an Internet-Mediated Walking Program. Part 2: Strategies for Encouraging Community Participation

Starting a new online community with a limited number of members who have not self-selected for participation in the community is challenging. The space must appear active to lure visitors to return; when the pool of participants is small, a large fraction must be converted from lurkers to contributors, and contributors must receive responses quickly to encourage continued participation. We report on strategies for overcoming these challenges and our experience implementing them within an online community add-on to an existing Internet-mediated walking program

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial

Abstract Background Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations. Methods Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months. Discussion The Reach Out study is designed to determine which behavioral intervention components or ‘dose’ of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities. Trial registration This study was registered at clinicaltrials.gov, identifier NCT03422718 . The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.http://deepblue.lib.umich.edu/bitstream/2027.42/173818/1/13063_2020_Article_4340.pd