Dataset Information

A Behavioral Economics-Electronic Health Record Module to Promote Appropriate Diabetes Management in Older Adults: Protocol for a Pragmatic Cluster Randomized Controlled Trial.

ABSTRACT:

Background

The integration of behavioral economics (BE) principles and electronic health records (EHRs) using clinical decision support (CDS) tools is a novel approach to improving health outcomes. Meanwhile, the American Geriatrics Society has created the Choosing Wisely (CW) initiative to promote less aggressive glycemic targets and reduction in pharmacologic therapy in older adults with type 2 diabetes mellitus. To date, few studies have shown the effectiveness of combined BE and EHR approaches for managing chronic conditions, and none have addressed guideline-driven deprescribing specifically in type 2 diabetes. We previously conducted a pilot study aimed at promoting appropriate CW guideline adherence using BE nudges and EHRs embedded within CDS tools at 5 clinics within the New York University Langone Health (NYULH) system. The BE-EHR module intervention was tested for usability, adoption, and early effectiveness. Preliminary results suggested a modest improvement of 5.1% in CW compliance.

Objective

This paper presents the protocol for a study that will investigate the effectiveness of a BE-EHR module intervention that leverages BE nudges with EHR technology and CDS tools to reduce overtreatment of type 2 diabetes in adults aged 76 years and older, per the CW guideline.

Methods

A pragmatic, investigator-blind, cluster randomized controlled trial was designed to evaluate the BE-EHR module. A total of 66 NYULH clinics will be randomized 1:1 to receive for 18 months either (1) a 6-component BE-EHR module intervention + standard care within the NYULH EHR, or (2) standard care only. The intervention will be administered to clinicians during any patient encounter (eg, in person, telemedicine, medication refill, etc). The primary outcome will be patient-level CW compliance. Secondary outcomes will measure the frequency of intervention component firings within the NYULH EHR, and provider utilization and interaction with the BE-EHR module components.

Results

Study recruitment commenced on December 7, 2020, with the activation of all 6 BE-EHR components in the NYULH EHR.

Conclusions

This study will test the effectiveness of a previously developed, iteratively refined, user-tested, and pilot-tested BE-EHR module aimed at providing appropriate diabetes care to elderly adults, compared to usual care via a cluster randomized controlled trial. This innovative research will be the first pragmatic randomized controlled trial to use BE principles embedded within the EHR and delivered using CDS tools to specifically promote CW guideline adherence in type 2 diabetes. The study will also collect valuable information on clinician workflow and interaction with the BE-EHR module, guiding future research in optimizing the timely delivery of BE nudges within CDS tools. This work will address the effectiveness of BE-inspired interventions in diabetes and chronic disease management.

Trial registration

ClinicalTrials.gov NCT04181307; https://clinicaltrials.gov/ct2/show/NCT04181307.

International registered report identifier (irrid)

DERR1-10.2196/28723.

SUBMITTER: Belli HM

PROVIDER: S-EPMC8581753 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundIntensive glycemic control is of unclear benefit and carries increased risk for older adults with diabetes. The American Geriatrics Society's (AGS) Choosing Wisely (CW) guideline promotes less aggressive glycemic targets and reduction in pharmacologic therapy for older adults with type II diabetes. Meanwhile, behavioral economic (BE) approaches offer promise in influencing hard-to-change behavior, and previous studies have shown the benefits of using electronic health record (EHR) technology to encourage guideline adherence.ObjectiveThis study aimed to develop and pilot test an intervention that leverages BE with EHR technology to promote appropriate diabetes management in older adults.DesignA pilot study within the New York University Langone Health (NYULH) EHR and Epic system to deliver BE-inspired nudges at five NYULH clinics at varying time points from July 12, 2018, through October 31, 2019.ParticipantsClinicians across five practices in the NYULH system whose patients were older adults (age 76 and older) with type II diabetes.InterventionsA BE-EHR module comprising six nudges was developed through a series of design workshops, interviews, user-testing sessions, and clinic visits. BE principles utilized in the nudges include framing, social norming, accountable justification, defaults, affirmation, and gamification.Main measuresPatient-level CW compliance.Key resultsCW compliance increased 5.1% from a 16-week interval at baseline to a 16-week interval post intervention. From February 14 to June 5, 2018 (prior to the first nudge launch in Vanguard clinics), CW compliance for 1278 patients was mean (95% CI)-16.1% (14.1%, 18.1%). From July 3 to October 22, 2019 (after BE-EHR module launch at all five clinics), CW compliance for 680 patients was 21.2% (18.1%, 24.3%).ConclusionsThe BE-EHR module shows promise for promoting the AGS CW guideline and improving diabetes management in older adults. A randomized controlled trial will commence to test the effectiveness of the intervention across 66 NYULH clinics.Nih trial registry numberNCT03409523.

Project description:ImportanceEmergency nurses experience high levels of workplace violence during patient interactions. Little is known about the efficacy of behavioral flags, which are notifications embedded within electronic health records (EHRs) as a tool to promote clinician safety.ObjectiveTo explore the perspectives of emergency nurses on EHR behavioral flags, workplace safety, and patient care.Design, setting, and participantsIn this qualitative study, semistructured interviews were conducted with emergency nurses at an academic, urban emergency department (ED) between February 8 and March 25, 2022. Interviews were audio recorded, transcribed, and analyzed using thematic analysis. Data analysis was performed from April 2 to 13, 2022.Main outcomes and measuresThemes and subthemes of nursing perspectives on EHR behavioral flags were identified.ResultsThis study included 25 registered emergency nurses at a large academic health system, with a mean (SD) tenure of 5 (6) years in the ED. Their mean (SD) age was 33 (7) years; 19 were women (76%) and 6 were men (24%). Participants self-reported their race as Asian (3 [12%]), Black (3 [12%]), White (15 [60%]), or multiple races (2 [8%]); 3 participants (12%) self-reported their ethnicity as Hispanic or Latinx. Five themes (with subthemes) were identified: (1) benefits of flags (useful advisory; prevents violence; engenders compassion), (2) issues with flags (administrative and process issues; unhelpful; unenforceable; bias; outdated), (3) patient transparency (patient accountability; damages patient-clinician relationship), (4) system improvements (process; built environment; human resources; zero-tolerance policies), and (5) difficulties of working in the ED (harassment and abuse; unmet mental health needs of patients; COVID-19-related strain and burnout).Conclusions and relevanceIn this qualitative study, nursing perspectives on the utility and importance of EHR behavioral flags varied. For many, flags served as an important forewarning to approach patient interactions with more caution or use safety skills. However, nurses were skeptical of the ability of flags to prevent violence from occurring and noted concern for the unintended consequences of introducing bias into patient care. These findings suggest that changes to the deployment and utilization of flags, in concert with other safety interventions, are needed to create a safer work environment and mitigate bias.

Project description:BackgroundCurrent guidelines recommend less aggressive target hemoglobin A1c (HbA1c) levels based on older age and lower life expectancy for older adults with diabetes. The effectiveness of electronic health record (EHR) clinical decision support (CDS) in promoting guideline adherence is undermined by alert fatigue and poor workflow integration. Integrating behavioral economics (BE) and CDS tools is a novel approach to improving adherence to guidelines while minimizing clinician burden.MethodsWe will apply a systematic, user-centered design approach to incorporate BE "nudges" into a CDS module and will perform user testing in two "vanguard" sites. To accomplish this, we will conduct (1) semi-structured interviews with key informants (n = 8), (2) a 2-h, design-thinking workshop to derive and refine initial module ideas, and (3) semi-structured group interviews at each site with clinic leaders and clinicians to elicit feedback on three proposed nudge module components (navigator section, inbasket refill protocol, medication preference list). Detailed field notes will be summarized by module idea and usability theme for rapid iteration. Frequency of firing and user action taken will be assessed in the first month of implementation via EHR reporting to confirm that module components and related reporting are working as expected as well as assess utilization. To assess the utilization and feasibility of the new tools and generate estimates of clinician compliance with the Choosing Wisely guideline for diabetes management in older adults, a 6-month, single-arm pilot study of the BE-EHR module will be conducted in six outpatient primary care clinics.DiscussionWe hypothesize that a low burden, user-centered approach to design will yield a BE-driven, CDS module with relatively high utilization by clinicians. The resulting module will establish a platform for exploring the ability of BE concepts embedded within the EHR to affect guideline adherence for other use cases.

Project description:BackgroundCigarette smoking is disproportionately high among people experiencing homelessness (PEH). Contingency management (CM) is a strategy that has shown considerable efficacy for smoking cessation and has been used in short-term studies of smoking abstinence in PEH. We describe a pilot, pragmatic randomized controlled trial protocol, which leverages an electronic health record (EHR) infrastructure to assess the feasibility and acceptability of an extended CM intervention to improve long-term abstinence in PEH.MethodsWe will conduct the study at three safety-net clinics in San Francisco among 90 adults experiencing homelessness who smoke cigarettes currently and have a desire to quit. We will encourage all participants to receive smoking cessation services that include behavioral counseling and pharmacotherapy through their clinics. We will randomly assign participants to an extended CM intervention group with escalating incentives contingent on abstinence or to a control group with fixed incentives for attending study visits. We will use the EHR to recruit participants, track receipt of counseling and pharmacotherapy during clinical care, and communicate with providers on participants' progress. CM participants will get escalating incentives for demonstration of carbon monoxide-verified abstinence over 6 months, with a total possible earnings of $475. Control participants will receive a fixed incentive of $5 for attending study visits, totaling $125. We will conduct the carbon-monoxide verified abstinence assessments-which will determine CM incentive amounts-daily during week 1, bi-weekly through week 4, weekly through week 13, and monthly through week 24. Measures of feasibility and acceptability, both quantitative and qualitative, will include assessments of screening and recruitment, adherence to study visits, engagement in smoking cessation clinical care, retention, and participant satisfaction. One of the primary clinical outcomes will be biochemically verified 7-day point prevalence abstinence at 6 months. We will measure secondary outcomes, which will include 7-day point prevalence abstinence at 2 weeks, 3 and 12 months.DiscussionThis trial will allow us to assess the feasibility and acceptability of a CM cessation intervention among PEH. The protocol's clinical setting and use of EHRs gives it significant potential for scalability. If found to be feasible, acceptable, and subsequently efficacious in a larger trial, the intervention could reduce tobacco-related health disparities by increasing long-term smoking abstinence among this vulnerable population.Trial registrationClinicalTrials.gov NCT04982952. Registered on July 29, 2021.

Project description:BackgroundMany patients with or at risk for chronic kidney disease (CKD) in the primary care setting are not receiving recommended care.ObjectiveThe objective of this study is to determine whether a multifaceted, low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting.DesignA pragmatic cluster-randomized trial, with an embedded qualitative process evaluation, will be conducted.SettingThe study population comes from the Electronic Medical Record Administrative data Linked Database®, which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario, Canada. The 34 primary care clinics will be randomized to the intervention or control group.InterventionThe intervention group will receive resources from the "CKD toolkit" to help improve care including practice audit and feedback, printed educational materials for physicians and patients, electronic decision support and reminders, and implementation support.MeasurementsPatients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records. Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records. The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin. Secondary outcomes include process of care measures such as screening tests, CKD recognition, monitoring tests, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions, blood pressure targets met, and nephrologist referral. Hierarchical analytic modeling will be performed to account for clustering. Semistructured interviews will be conducted with a random purposeful sample of physicians in the intervention group to understand why the intervention achieved the observed effects.ConclusionsIf our intervention improves care, then the CKD toolkit can be adapted and scaled for use in other primary care clinics which use electronic medical records.Trial registrationClinicalTrials.gov Identifier: NCT02274298.