Assessing Digital Health Implementation for a Pediatric Chronic Pain Intervention: Comparing the RE-AIM and BIT Frameworks Against Real-World Trial Data and Recommendations for Future Studies (Preprint)

BACKGROUND Digital health interventions have demonstrated efficacy for several conditions including for pediatric chronic pain. However, the process of making interventions available to end users in an efficient and sustained way is challenging and remains a new area of research. To advance this field, comprehensive frameworks have been created. OBJECTIVE The aim of this study is to compare the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Behavior Interventions using Technology (BIT) frameworks with data collected from the web-based management of adolescent pain (WebMAP Mobile; WMM) randomized controlled trial (RCT). METHODS We conducted a hybrid effectiveness-implementation cluster RCT with a stepped wedge design in which the intervention was sequentially implemented in 8 clinics, following a usual care period. Participants were 143 youths (mean age 14.5 years, SD 1.9; 117/143, 81.8% female) with chronic pain, from which 73 were randomized to receive the active intervention. Implementation outcomes were assessed using the RE-AIM and BIT frameworks. RESULTS According to the RE-AIM framework, the WMM showed excellent reach, recruiting a sample 19% larger than the size originally planned and consenting 79.0% (143/181) of eligible referred adolescents. Effectiveness was limited, with only global impression of change showing significantly greater improvements in the treatment group; however, greater treatment engagement was associated with greater reductions in pain and disability. Adoption was excellent (all the invited clinics participated and referred patients). Implementation was acceptable, showing good user engagement and moderate adherence and positive attitudes of providers. Costs were similar to planned, with a 7% increase in funds needed to make the WMM publicly available. Maintenance was evidenced by 56 new patients downloading the app during the maintenance period and by all clinics agreeing to continue making referrals and all, but one, making new referrals. According to the BIT, 82% (60/73) of adolescents considered the treatment acceptable. In terms of adoption, 93% (68/73) downloaded the app, and all of them used it after their first log-in. In terms of appropriateness at the user level, 2 participants were unable to download the app. Perceptions of the appearance, navigation, and theme were positive. Providers perceived the WMM as a good fit for their clinic, beneficial, helpful, and resource efficient. In terms of feasibility, no technical issues were reported. In terms of fidelity, 40% (29/73) completed the treatment. Implementation costs were 7% above the budget. With regard to penetration, 56 new users accessed the app during the maintenance period. In terms of sustainability, 88% (7/8) of clinics continued recommending the WMM after the end of the study. CONCLUSIONS For the first time, a real-world digital health intervention was used as a proof of concept to test all the domains in the RE-AIM and BIT frameworks, allowing for comparisons. INTERNATIONAL REGISTERED REPORT RR2-10.1016/j.cct.2018.10.003

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Assessing Digital Health Implementation for a Pediatric Chronic Pain Intervention: Comparing the RE-AIM and BIT Frameworks Against Real-World Trial Data and Recommendations for Future Studies

Journal of Medical Internet Research ◽

10.2196/19898 ◽

2020 ◽

Vol 22 (9) ◽

pp. e19898 ◽

Cited By ~ 1

Author(s):

Rocio de la Vega ◽

Lee Ritterband ◽

Tonya M Palermo

Keyword(s):

Chronic Pain ◽

Real World ◽

Digital Health ◽

Controlled Trial ◽

User Engagement ◽

Maintenance Period ◽

Treatment Implementation ◽

Positive Attitudes ◽

Pediatric Chronic Pain ◽

Implementation Costs

Background Digital health interventions have demonstrated efficacy for several conditions including for pediatric chronic pain. However, the process of making interventions available to end users in an efficient and sustained way is challenging and remains a new area of research. To advance this field, comprehensive frameworks have been created. Objective The aim of this study is to compare the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Behavior Interventions using Technology (BIT) frameworks with data collected from the web-based management of adolescent pain (WebMAP Mobile; WMM) randomized controlled trial (RCT). Methods We conducted a hybrid effectiveness-implementation cluster RCT with a stepped wedge design in which the intervention was sequentially implemented in 8 clinics, following a usual care period. Participants were 143 youths (mean age 14.5 years, SD 1.9; 117/143, 81.8% female) with chronic pain, from which 73 were randomized to receive the active intervention. Implementation outcomes were assessed using the RE-AIM and BIT frameworks. Results According to the RE-AIM framework, the WMM showed excellent reach, recruiting a sample 19% larger than the size originally planned and consenting 79.0% (143/181) of eligible referred adolescents. Effectiveness was limited, with only global impression of change showing significantly greater improvements in the treatment group; however, greater treatment engagement was associated with greater reductions in pain and disability. Adoption was excellent (all the invited clinics participated and referred patients). Implementation was acceptable, showing good user engagement and moderate adherence and positive attitudes of providers. Costs were similar to planned, with a 7% increase in funds needed to make the WMM publicly available. Maintenance was evidenced by 56 new patients downloading the app during the maintenance period and by all clinics agreeing to continue making referrals and all, but one, making new referrals. According to the BIT, 82% (60/73) of adolescents considered the treatment acceptable. In terms of adoption, 93% (68/73) downloaded the app, and all of them used it after their first log-in. In terms of appropriateness at the user level, 2 participants were unable to download the app. Perceptions of the appearance, navigation, and theme were positive. Providers perceived the WMM as a good fit for their clinic, beneficial, helpful, and resource efficient. In terms of feasibility, no technical issues were reported. In terms of fidelity, 40% (29/73) completed the treatment. Implementation costs were 7% above the budget. With regard to penetration, 56 new users accessed the app during the maintenance period. In terms of sustainability, 88% (7/8) of clinics continued recommending the WMM after the end of the study. Conclusions For the first time, a real-world digital health intervention was used as a proof of concept to test all the domains in the RE-AIM and BIT frameworks, allowing for comparisons. International Registered Report Identifier (IRRID) RR2-10.1016/j.cct.2018.10.003

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Leveraging VR/AR to combat chronic pain in youth: Position paper from the Interdisciplinary Network on Virtual and Augmented (AR/VR) Technologies for Pain (INOVATE-Pain) Management (Preprint)

10.2196/preprints.25916 ◽

2020 ◽

Author(s):

Deirdre Elizabeth Logan ◽

Laura Edith Simons ◽

Thomas Caruso ◽

Jeffry I Gold ◽

Anya Griffin ◽

...

Keyword(s):

Chronic Pain ◽

Best Practices ◽

Digital Health ◽

Clinical Care ◽

Design Evaluation ◽

Pediatric Pain ◽

Research And Practice ◽

Pediatric Chronic Pain ◽

Chronic Pain Conditions ◽

Interdisciplinary Network

UNSTRUCTURED Background: Virtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions, but in this young field there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. Methods: The INOVATE-Pain consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. Results and Conclusions: Reviewing the state of the field, the consortium identified important directions for research-driven innovation in VR/AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR/AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions.

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Randomized controlled trial of a Web-based psychological treatment for pediatric chronic pain

Journal of Pain ◽

10.1016/j.jpain.2009.01.252 ◽

2009 ◽

Vol 10 (4) ◽

pp. S72

Author(s):

T. Palermo ◽

A. Long

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Psychological Treatment ◽

Controlled Trial ◽

Web Based ◽

Randomized Controlled ◽

Pediatric Chronic Pain

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Improved User Engagement and Assessment of Treatment Effectiveness in Patients Utilizing a Novel Digital Mobile Health Application During Spinal Cord Stimulation Screening Trials (Preprint)

10.2196/preprints.35134 ◽

2021 ◽

Author(s):

Jennifer M. Lee ◽

Rex Woon ◽

Mandy Ramsum ◽

Daniel Steven Halperin ◽

Roshini Jain

Keyword(s):

Spinal Cord ◽

Chronic Pain ◽

Success Rate ◽

Real Time ◽

Real World ◽

Spinal Cord Stimulation ◽

Activity Level ◽

User Engagement ◽

Health Related ◽

Screening Trial

BACKGROUND Patient outcomes and experience during a Spinal Cord Stimulation (SCS) screening trial can have a significant effect on whether or not to proceed with long-term, permanent implantation of an SCS device for treatment of chronic pain. Enhancing the ability to track and assess patients during this initial trial evaluation offers the potential for improved understanding regarding the suitability of permanent device implantation as well as identification of the particular SCS-based neurostimulative modalities and/or parameters that may provide substantial analgesia in a patient-specific manner. OBJECTIVE In this report, we describe a preliminary, real-world assessment of a new, real-time tracking, smart device-based digital application (app) used by patients with chronic pain undergoing trial screening for SCS therapy. METHODS This is a real-world, retrospective evaluation of 13,331 patients diagnosed with chronic pain who utilized the new “mySCS” mobile application (Boston Scientific, Valencia, CA) during an SCS screening trial. The app design is HIPAA-compliant and compatible with most commercially available smartphones (e.g., Apple ® iPhone ®, Android ®). The app enables tracking of user-inputted health-related responses (i.e., pain relief, activity level, and/or sleep quality) in addition to personal trial goals and a summary of overall experience during the SCS trial. A de-identified, aggregate analysis of user engagement, user-submitted responses, and overall trial success was conducted. RESULTS When provided the opportunity, the percentage of users who engaged with the tracking app for ≥50% of the time during their trial was found to be 64.5%. Among those who used the app, ~58% (n = 7795) entered a trial goal(s). Most patients underwent SCS screening with a trial duration of at least 7-days (n = 7739). Of those patients who undertook a 7-day SCS trial, 62.3% engaged the app for 4-days or more. In addition, among all who submitted descriptive responses using the app, health-related improvements were reported by 78% of patients who reached day 3 of the screening phase assessment and by 83% of those who reached trial completion. A trial success rate of 91% was determined for those who used the app (versus 85% success rate for non-users). CONCLUSIONS Data from this initial, real-world examination of a mobile, digital-health-based tracking application (“mySCS” app), as utilized during the SCS screening phase, demonstrates that substantial patient engagement can be achieved while also providing for the acquisition of more real-time and direct from patient outcome measures that may help facilitate improved SCS trial success.

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Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management

Journal of Medical Internet Research ◽

10.2196/25916 ◽

2021 ◽

Vol 23 (4) ◽

pp. e25916

Author(s):

Deirdre E Logan ◽

Laura E Simons ◽

Thomas J Caruso ◽

Jeffrey I Gold ◽

Walter Greenleaf ◽

...

Keyword(s):

Chronic Pain ◽

Virtual Reality ◽

Pain Management ◽

Augmented Reality ◽

Digital Health ◽

Clinical Care ◽

Pediatric Chronic Pain ◽

Widespread Access ◽

Chronic Pain Conditions ◽

Interdisciplinary Network

Background Virtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. Objective The INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. Methods An interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020. Results Reviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions. Conclusions To realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children.

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