An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research.
Mobile health (mHealth) apps can provide support to people living with a chronic disease by offering resources for communication, self-management, and social support. PositiveLinks (PL) is a clinic-deployed mHealth app designed to improve the health of people with HIV. In a pilot study, PL users experienced considerable improvements in care engagement and viral load suppression. To promote its expansion to other HIV clinics, we developed an implementation strategy consisting of training resources and on-demand program support.
The objective of our study was to conduct an interim analysis of the barriers and facilitators to PL implementation at early adopting sites to guide optimization of our implementation strategy.
Semistructured interviews with stakeholders at PL expansion sites were conducted. Analysis of interviews identified facilitators and barriers that were mapped to 22 constructs of the Consolidated Framework for Implementation Research (CFIR). The purpose of the analysis was to identify the facilitators and barriers to PL implementation in order to adapt the PL implementation strategy. Four Ryan White HIV clinics were included. Interviews were conducted with one health care provider, two clinic managers, and five individuals who coordinated site PL activities.
Ten common facilitators and eight common barriers were identified. Facilitators to PL implementation included PL's fit with patient and clinic needs, PL training resources, and sites' early engagement with their information technology personnel. Most barriers were specific to mHealth, including access to Wi-Fi networks, maintaining patient smartphone access, patient privacy concerns, and lack of clarity on how to obtain approvals for mHealth use.
The CFIR is a useful framework for evaluating mHealth interventions. Although PL training resources were viewed favorably, we identified important barriers to PL implementation in a sample of Ryan White clinics. This enabled our team to expand guidance on identifying information technology stakeholders and procuring and managing mobile resources. Ongoing evaluation results continue to inform improvements to the PL implementation strategy, facilitating PL access for future expansion sites.
Cohn WF
,Canan CE
,Knight S
,Waldman AL
,Dillingham R
,Ingersoll K
,Schexnayder J
,Flickinger TE
... -
《JMIR mHealth and uHealth》
Evaluation of the Implementation and Effectiveness of a Mobile Health Intervention to Improve Outcomes for People With HIV in the Washington, DC Cohort: Study Protocol for a Cluster Randomized Controlled Trial.
Gaps remain in achieving retention in care and durable HIV viral load suppression for people with HIV in Washington, DC (hereafter DC). Although people with HIV seeking care in DC have access to a range of supportive services, innovative strategies are needed to enhance patient engagement in this setting. Mobile health (mHealth) interventions have shown promise in reaching previously underengaged groups and improving HIV-related outcomes in various settings.
This study will evaluate the implementation and effectiveness of a clinic-deployed, multifeature mHealth intervention called PositiveLinks (PL) among people with HIV enrolled in the DC Cohort, a longitudinal cohort of people with HIV receiving care in DC. A cluster randomized controlled trial will be conducted using a hybrid effectiveness-implementation design and will compare HIV-related outcomes between clinics randomized to PL versus usual care.
The study aims are threefold: (1) We will perform a formative evaluation of PL in the context of DC Cohort clinics to test the feasibility, acceptability, and usability of PL and tailor the platform for use in this context. (2) We will conduct a cluster randomized controlled trial with 12 DC Cohort clinics randomized to PL or usual care (n=6 [50%] per arm) and measure the effectiveness of PL by the primary outcomes of patient visit constancy, retention in care, and HIV viral load suppression. We aim to enroll a total of 482 participants from DC Cohort clinic sites, specifically including people with HIV who show evidence of inconsistent retention in care or lack of viral suppression. (3) We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to measure implementation success and identify site, patient, provider, and system factors associated with successful implementation. Evaluation activities will occur pre-, mid-, and postimplementation.
Formative data collection was completed between April 2021 and January 2022. Preliminary mHealth platform modifications have been performed, and the first round of user testing has been completed. A preimplementation evaluation was performed to identify relevant implementation outcomes and design a suite of instruments to guide data collection for evaluation of PL implementation throughout the trial period. Instruments include those already developed to support DC Cohort Study activities and PL implementation in other cohorts, which required modification for use in the study, as well as novel instruments designed to complete data collection, as guided by the CFIR and RE-AIM frameworks.
Formative and preimplementation evaluations will be completed in spring 2022 when the trial is planned to launch. Specifically, comprehensive formative data analysis will be completed following data collection, coding, preliminary review, and synthesis. Corresponding platform modifications are ready for beta testing within the DC Cohort. Finalization of the platform for use in the trial will follow beta testing.
ClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019.
PRR1-10.2196/37748.
Hodges J
,Caldwell S
,Cohn W
,Flickinger T
,Waldman AL
,Dillingham R
,Castel A
,Ingersoll K
... -
《JMIR Research Protocols》
An mHealth Platform for People With HIV Receiving Care in Washington, District of Columbia: Qualitative Analysis of Stakeholder Feedback.
HIV viral suppression and retention in care continue to be challenging goals for people with HIV in Washington, District of Columbia (DC). The PositiveLinks mobile app is associated with increased retention in care and viral load suppression in nonurban settings. The app includes features such as daily medication reminders, mood and stress check-ins, an anonymized community board for peer-to-peer social support, secure messaging to care teams, and resources for general and clinic-specific information, among other features. PositiveLinks has not been tailored or tested for this distinct urban population of people with HIV.
This study aimed to inform the tailoring of a mobile health app to the needs of people with HIV and their providers in Washington, DC.
We conducted a 3-part formative study to guide the tailoring of PositiveLinks for patients in the DC Cohort, a longitudinal cohort of >12,000 people with HIV receiving care in Washington, DC. The study included in-depth interviews with providers (n=28) at study clinics, focus groups with people with HIV enrolled in the DC Cohort (n=32), and a focus group with members of the DC Regional Planning Commission on Health and HIV (COHAH; n=35). Qualitative analysis used a constant comparison iterative approach; thematic saturation and intercoder agreement were achieved. Emerging themes were identified and grouped to inform an adaptation of PositiveLinks tailored for patients and providers.
Emerging themes for patients, clinic providers, and COHAH providers included population needs and concerns, facilitators and barriers to engagement in care and viral suppression, technology use, anticipated benefits, questions and concerns, and suggestions. DC Cohort clinic and COHAH provider interviews generated an additional theme: clinic processes. For patients, the most commonly discussed potential benefits included improved health knowledge and literacy (mentioned n=10 times), self-monitoring (n=7 times), and connection to peers (n=6 times). For providers, the most common anticipated benefits were improved communication with the clinic team (n=21), connection to peers (n=14), and facilitation of self-monitoring (n=11). Following data review, site principal investigators selected core PositiveLinks features, including daily medication adherence, mood and stress check-ins, resources, frequently asked questions, and the community board. Principal investigators wanted English and Spanish versions depending on the site. Two additional app features (messaging and documents) were selected as optional for each clinic site. Overall, 3 features were not deployed as not all participating clinics supported them.
Patient and provider perspectives of PositiveLinks had some overlap, but some themes were unique to each group. Beta testing of the tailored app was conducted (August 2022). This formative work prepared the team for a cluster randomized controlled trial of PositiveLinks' efficacy. Randomization of clinics to PositiveLinks or usual care occurred in August 2022, and the randomized controlled trial launched in November 2022.
RR2-10.2196/37748.
Caldwell S
,Flickinger T
,Hodges J
,Waldman ALD
,Garofalini C
,Cohn W
,Dillingham R
,Castel A
,Ingersoll K
... -
《-》
A Digital Patient-Provider Communication Intervention (InvolveMe): Qualitative Study on the Implementation Preparation Based on Identified Facilitators and Barriers.
Chronic health conditions are affecting an increasing number of individuals, who experience various symptoms that decrease their quality of life. Digital communication interventions that enable patients to report their symptoms have been shown to positively impact chronic disease management by improving access to care, patient-provider communication, clinical outcomes, and health-related quality of life. These interventions have the potential to prepare patients and health care providers (HCPs) before visits and improve patient-provider communication. Despite the recent rapid development and increasing number of digital communication interventions that have shown positive research results, barriers to realizing the benefits offered through these types of interventions still exist.
The aim of this study is to prepare for the implementation of a digital patient-provider communication intervention in the daily workflow at 2 outpatient clinics by identifying potential determinants of implementation using the Consolidated Framework for Implementation Research (CFIR) to tailor the use of digital communication intervention to the intended context and identify key aspects for an implementation plan.
A combination of focus groups, workshops, and project steering committee meetings was conducted with HCPs (n=14) and patients (n=2) from 2 outpatient clinics at a university hospital. The CFIR was used to guide data collection and analysis. Transcripts, written minutes, and notes were analyzed and coded into 5 CFIR domains using thematic analysis.
Data were examined and analyzed into 18 CFIR constructs relevant to the study purpose. On the basis of the identified determinants, important intervention tailoring includes adjustments to the digital features and adjustments to fit the clinical workflow and a decision to conduct a future pilot study. Furthermore, it was decided to provide the intervention to patients as early as possible in their disease trajectory, with tailored information about its use. Key aspects for the implementation plan encompassed maintaining the identified engagement and positive attitude, involving key stakeholders in the implementation process, and providing the needed support and training.
This study offers insight into the involvement of stakeholders in the tailoring and implementation planning of a digital communication intervention in clinical practice. Stakeholder involvement in the identification of implementation facilitators and barriers can contribute to the tailoring of digital communication interventions and how they are used and can also inform systematic and targeted implementation planning.
Seljelid B
,Varsi C
,Solberg Nes L
,Øystese KA
,Børøsund E
... -
《JOURNAL OF MEDICAL INTERNET RESEARCH》