Correction: Addressing Implementation Challenges to Digital Care Delivery for Adults With Multiple Chronic Conditions: Stakeholder Feedback in a Randomized Controlled Trial (Preprint)

BACKGROUND Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on the use of telemonitoring in this population, particularly those with multiple chronic conditions (MCCs). OBJECTIVE This randomized controlled trial (RCT) and embedded qualitative study aimed to evaluate the impact and experiences of patients and healthcare providers (HCPs) using a telemonitoring system with decision support to manage complex patients, including those with MCCs, compared to the standard of care. METHODS A pragmatic 6-month RCT sought to recruit 146 patients with a diagnosis of heart failure (HF), uncontrolled hypertension (HT), and/or insulin requiring diabetes (DM) from outpatient specialty settings in Toronto, Canada. Participants were randomized into the control and telemonitoring groups with the latter being instructed to take readings relevant to their condition(s). The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status as measured by the SF-36. Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported healthcare utilization. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group were interviewed about their experiences RESULTS A total of 96 patients were recruited and randomized. Recruitment was terminated early due to implementation challenges and the onset of COVID-19. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of HF patients found improvements in self-care maintenance (P=.036) and physical quality of life (P= .046). Opinions expressed by the 5 HCPs and 13 patients interviewed differed based on the condition(s) monitored. Although HF patients reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care, and the design of the decision support whereby it was indicated that fluctuations in HT and DM patient status typically required less urgent intervention compared to HF. CONCLUSIONS Consistent with previous studies, we recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary, but not sufficient components of such programs for complex patients with lower acuity. We conclude that a multidisciplinary model of care that includes care coordination must accompany telemonitoring systems which may best be operationalized through novel models of care, such as nurse-led models. CLINICALTRIAL ClinicalTrials.gov NCT03127852, ISRCTN (41238563) INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.8367

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Research and Implementation Lessons Learned From a Youth-Targeted Digital Health Randomized Controlled Trial (the ARMADILLO Study)

JMIR mhealth and uhealth ◽

10.2196/13005 ◽

2019 ◽

Vol 7 (8) ◽

pp. e13005

Author(s):

Lianne Gonsalves ◽

Winnie Wangari Njeri ◽

Megan Schroeder ◽

Jefferson Mwaisaka ◽

Peter Gichangi

Keyword(s):

Randomized Controlled Trial ◽

Digital Health ◽

Controlled Trial ◽

Text Message ◽

Health Interventions ◽

World Health ◽

Intervention Period ◽

Implementation Challenges ◽

Randomized Controlled ◽

Client Side

Background Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya. Objective This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers. Methods This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey. Results Two study team decisions had significant implications for the success of the trial’s enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were “stuck” at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period. Conclusions The ARMADILLO study’s implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting. Clinical Trial International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148

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Addressing Implementation Challenges to Digital Care Delivery for Adults With Multiple Chronic Conditions: Stakeholder Feedback in a Randomized Controlled Trial (Preprint)

10.2196/preprints.23498 ◽

2020 ◽

Author(s):

Kelly Williams ◽

Sarah Markwardt ◽

Shannon M Kearney ◽

Jordan F Karp ◽

Kevin L Kraemer ◽

...

Keyword(s):

Chronic Conditions ◽

Care Delivery ◽

Text Message ◽

Chronically Ill ◽

High Tech ◽

Multiple Chronic Conditions ◽

Broadband Internet ◽

Implementation Challenges ◽

Before And After ◽

The Impact

BACKGROUND Digital tools accessed via smartphones can promote chronic condition management, reduce disparities in health care and hospital readmissions, and improve quality of life. However, whether digital care strategies can be implemented successfully on a large scale with traditionally underserved populations remains uncertain. OBJECTIVE As part of a randomized trial comparing care delivery strategies for Medicaid and Medicare-Medicaid beneficiaries with multiple chronic conditions, our stakeholders identified implementation challenges, and we developed stakeholder-driven adaptions to improve a digitally delivered care management strategy (high-tech care). METHODS We used 4 mechanisms (study support log, Patient Partners Work Group log, case interview log, and implementation meeting minutes) to capture stakeholder feedback about technology-related challenges and solutions from 9 patient partners, 129 participants, and 32 care managers and used these data to develop and implement solutions. To assess the impact, we analyzed high-tech care exit surveys and intervention engagement outcomes (video visits and condition-specific text message check-ins sent at varying intervals) before and after each solution was implemented. RESULTS Challenges centered around 2 themes: difficulty using both smartphones and high-tech care components and difficulty using high-tech care components due to connectivity issues. To respond to the first theme’s challenges, we devised 3 solutions: tech visits (eg, in-person technology support visits), tech packet (eg, participant-facing technology user guide), and tailored condition-specific text message check-ins. During the first 20 months of implementation, 73 participants received at least one tech visit. We observed a 15% increase in video call completion for participants with data before and after the tech visit (n=25) and a 7% increase in check-in completion for participants with data before and after the tech visit (n=59). Of the 379 participants given a tech packet, 179 completed care during this timeframe and were eligible for an exit survey. Of the survey respondents, 76% (73/96) found the tech packet helpful and 64% (62/96) actively used it during care. To support condition-specific text message check-in completion, we allowed for adaption of day and/or time of the text message with 31 participants changing the time they received check-ins and change in standard biometric settings with 13 physicians requesting personalized settings for participants. To respond to the second theme’s challenges, tech visits or phone calls were made to demonstrate how to use a smartphone to connect or disconnect from the internet, to schedule video calls, or for condition-specific text message check-ins in a location with broadband/internet. CONCLUSIONS Having structured stakeholder feedback mechanisms is key to identify challenges and solutions to digital care engagement. Creating flexible and scalable solutions to technology-related challenges will increase equity in accessing digital care and support more effective engagement of chronically ill populations in the use of these digital care tools. CLINICALTRIAL ClinicalTrials.gov NCT03451630; https://clinicaltrials.gov/ct2/show/NCT03451630.

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Optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy: study protocol for a cluster randomized controlled trial

Trials ◽

10.1186/s13063-020-04899-7 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Laura Packel ◽

Prosper Njau ◽

Carolyn Fahey ◽

Angela Ramadhani ◽

William H. Dow ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Viral Suppression ◽

Controlled Trial ◽

Cash Transfers ◽

Cash Transfer ◽

Hiv Care ◽

Effective Strategy ◽

Implementation Challenges ◽

Randomized Controlled ◽

Cluster Randomized

Abstract Background Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone region, Tanzania. Methods We will conduct a type I hybrid implementation–effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with a mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic). Discussion This trial will provide evidence not only about the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond. Trial registration ClinicalTrials.gov NCT04201353. Registered on December 17, 2019

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