Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol

Almeida, Fabio A.; Michaud, Tzeyu L.; Wilson, Kathryn E.; Goessl, Cody; Porter, Gwenndolyn; Evans, Greg; Dressler, Emily V.; Boggs, Ashley; Katula, Jeffrey A.; Sweet, Cynthia Castro; Estabrooks, Paul A.

doi:10.1016/j.cct.2019.105877

Cited by 21 publications

(26 citation statements)

References 36 publications

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“…A computer programmer applied pre-speci ed inclusion and exclusion criteria to identify potential eligible participants via EHR query [5]. Once a list of potential participants was generated, a physician champion engaged PCPs at each of the participating clinics for patient list review and clearance, or potential participant referral.…”

Section: Participant Identi Cationmentioning

confidence: 99%

“…The PREDICTS trial recruited 599 overweight or obese adults with prediabetes, determined by the HbA1c range of 5.7%-6.4%. The study protocol and details about participant recruitment and intervention reach are presented in detail elsewhere [5,30]. In brief, eight clinics within the Nebraska Medicine healthcare system in the Greater Omaha area participated in the trial, from which 22,642 patients aged 19 and older who were at risk of T2D and had a Body Mass Index ≥ 25 kg/m 2 were identi ed via an electronic health record (EHR) system query.…”

Section: Setting and Overview Of The Predicts Trialmentioning

confidence: 99%

“…The Centers for Disease Control and Prevention (CDC) Diabetes Prevention Recognition Program developed standards to track and ensure the quality of lifestyle intervention programs, and currently recognizes both in-person and virtual/online/digital programs to support relevant behavior changes [4]. To date, most of these programs have been delivered in person [5,6], limiting program scalability and accessibility for at risk individuals dealing with time and/or transportation barriers. In a recent review study of identifying factors leading to successful implementation of DPP in real word settings [7], Aziz and colleagues emphasized that even modest weight loss can have signi cant population-level impact if a high proportion of at-risk individuals participate in the programs.…”

Section: Introductionmentioning

confidence: 99%

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Costing a population health management approach for participant recruitment to a diabetes prevention study

Michaud

Wilson

Silva

et al. 2020

Preprint

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Background Limited research has reported the economic feasibility—from both a research and practice perspective—of efforts to recruit and enroll an intended audience in evidence-based approaches for disease prevention. This study aims to retrospectively assess and estimate the costs of a population health management (PHM) approach to identify, engage, and enroll patients in a Type 1 Hybrid Effectiveness-Implementation (HEI), diabetes-prevention trial. Methods We used descriptive analyses and activity-based costing to estimate the recruitment costs of a PHM approach integrated within a HEI trial. Measures included total costs and costs per participant screened and enrolled to ensure trial accrual rates were achieved. We took the perspective of a healthcare system which may adopt, and possibly sustain, the strategy in the typical practice. We also estimated replication costs based on how the strategy could be applied in healthcare systems interested in referring patients to a local diabetes prevention program from a payer perspective. In this case, we examined differences in cost based on requirements for and types of, glucose testing, and by labor activities and non-labor resources associated with recruitment using sensitivity analyses. Results The total recruitment and enrollment costs were $389,949 to accrue 599 participants over approximately 15 months. The average cost per screened and enrolled participant was $276 and $651, respectively. Primary costs included hemoglobin A1c testing ($83,106), recruitment screening calls ($48,791), and personnel time ($96,187). Translating to the typical settings, total recruitment costs for replication was estimated as $192,625 (range: $42,523-$208,876). Sensitivity analysis results indicated replication costs would be approximately $229 - $430 per patient enrolled if glucose testing was necessary, based on the Medicare covered services. For a private payer perspective, and without glucose testing, per-participant screening and enrollment costs were estimated at $30. Conclusions A PHM approach can be used to accrue a large number of participants in a short period of time for an HEI trial, at a comparable cost per participant. However, when trial requirements are removed and PHM approaches are used as a method for healthcare systems to identify and enroll patients in a local program—the costs are relatively low.

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Section: Participant Identi Cationmentioning

confidence: 99%

Section: Setting and Overview Of The Predicts Trialmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Costing a population health management approach for participant recruitment to a diabetes prevention study

Michaud

Wilson

Silva

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…The Centers for Disease Control and Prevention (CDC) Diabetes Prevention Recognition Program developed standards to track and ensure the quality of lifestyle intervention programs, and currently recognizes both in-person and virtual/online/digital programs to support relevant behavior changes [ 7 ]. To date, most of these programs have been delivered in person [ 8 , 9 ], limiting program scalability and accessibility for at-risk individuals dealing with time and/or transportation barriers. In a recent review study of identifying factors leading to the successful implementation of DPP in real-world settings [ 10 ], Aziz et al emphasized that even modest weight loss can have a significant population-level impact if a high proportion of at-risk individuals participate in the programs.…”

Section: Introductionmentioning

confidence: 99%

Costing a population health management approach for participant recruitment to a diabetes prevention study

Michaud

Wilson

Silva

et al. 2021

Translational Behavioral Medicine

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Limited research has reported the economic feasibility—from both a research and practice perspective—of efforts to recruit and enroll an intended audience in evidence-based approaches for disease prevention. We aimed to retrospectively assess and estimate the costs of a population health management (PHM) approach to identify, engage, and enroll patients in a Type 1 Hybrid Effectiveness-Implementation (HEI), diabetes-prevention trial. We used activity-based costing to estimate the recruitment costs of a PHM approach integrated within an HEI trial. We took the perspective of a healthcare system that may adopt, and possibly sustain, the strategy in the typical practice. We also estimated replication costs based on how the strategy could be applied in healthcare systems interested in referring patients to a local diabetes prevention program from a payer perspective. The total recruitment and enrollment costs were $360,424 to accrue 599 participants over approximately 15 months. The average cost per screened and enrolled participant was $263 and $620, respectively. Translating to the typical settings, total recruitment costs for replication were estimated as $193,971 (range: $43,827–$210,721). Sensitivity and scenario analysis results indicated replication costs would be approximately $283–$444 per patient enrolled if glucose testing was necessary, based on the Medicare-covered services. From a private payer perspective, and without glucose testing, per-participant assessed costs were estimated at $31. A PHM approach can be used to accrue a large number of participants in a short period of time for an HEI trial, at a comparable cost per participant.

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“…Conceptualization of the RE-AIM framework has evolved over the past 20 years ( 6 ) to include a focus on qualitative research ( 1 ), cost across dimensions ( 9 ), and use in hybrid effectiveness-implementation research ( 10 , 11 ). RE-AIM also provides composite metrics that address different aspects of intervention impact ( Table 1 ) ( 12 ).…”

Section: Introductionmentioning

confidence: 99%

Comparing, Contrasting, and Integrating Dissemination and Implementation Outcomes Included in the RE-AIM and Implementation Outcomes Frameworks

Reilly

Kennedy

Porter

et al. 2020

Front. Public Health

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As the field of dissemination and implementation science matures, there are a myriad of outcomes, identified in numerous frameworks, that can be considered across individual, organizational, and population levels. This can lead to difficulty in summarizing literature, comparing across studies, and advancing translational science. This manuscript sought to (1) compare, contrast, and integrate the outcomes included in the RE-AIM and Implementation Outcomes Frameworks (IOF) and (2) expand RE-AIM indicators to include relevant IOF dissemination and implementation outcomes. Cross tabular comparisons were made between the constitutive definitions of each construct, across frameworks, to reconcile apparent discrepancies between approaches and to distinguish between implementation outcomes and implementation antecedents. A great deal of consistency was identified across approaches, including adoption (the intention, initial decision, or action to employ an evidence-based intervention), fidelity/implementation (the degree to which an intervention was delivered as intended), organizational maintenance/sustainability (extent to which a newly implemented treatment is maintained or institutionalized), and cost. The IOF construct of penetration was defined as a higher-order construct that may encompass the reach, adoption, and organizational maintenance outcomes within RE-AIM. Within the IOF approach acceptability, appropriateness, and feasibility did not match constitutive definitions of dissemination or implementation but rather reflected theoretical antecedents of implementation outcomes. Integration of the IOF approach across RE-AIM indicators was successfully achieved by expanding the operational definitions of RE-AIM to include antecedents to reach, adoption, implementation, and organizational maintenance. Additional combined metrics were also introduced including penetration, individual level utility, service provider utility, organizational utility, and systemic utility. The expanded RE-AIM indicators move beyond the current approaches described within both the RE-AIM framework and IOF and provides additional planning and evaluation targets that can contribute to the scientific field and increase the translation of evidence into practice.

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Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol

Cited by 21 publications

References 36 publications

Costing a population health management approach for participant recruitment to a diabetes prevention study

Costing a population health management approach for participant recruitment to a diabetes prevention study

Costing a population health management approach for participant recruitment to a diabetes prevention study

Comparing, Contrasting, and Integrating Dissemination and Implementation Outcomes Included in the RE-AIM and Implementation Outcomes Frameworks

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