MedDataX Logo

Adapt and Incorporate dDPP Into Clinical Workflows

NCT ID: NCT04049500

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This observational study will seek to adapt a digital diabetes prevention program (dDPP) tool suite into clinical workflows. This tool pushes key dDPP data elements (e.g. weight and daily step count) directly into EHR workflows of primary care to enhance patient engagement. It seeks to determine the impact of combining adapted visualizations and summaries of key dDPP data elements directly into the EHR with automated notifications and messaging designed to enhance patient engagement in the dDPP. The study will involve provider workflow analysis based on observation and facilitated group tool adaptation sessions.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary objective: to examine the impact of the dDPP tool suite on the EHR and clinical workflows, and identify optimization opportunities.

Secondary objective: to assess the "usability" of the proposed dDPP tool suite in clinical practice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physician-Patient Relations Nurse-Patient Relations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clinicians

Five practices will be selected from NYULH ambulatory practice sites to represent the spectrum of provider settings within the system. These sites will be the clinical partners for the adaptation of the dDPP tool suite

Digital Diabetes Prevention Program (dDPP)

Intervention Type OTHER

dDPP tool suite to integrate with the EHR and clinical workflows

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Diabetes Prevention Program (dDPP)

dDPP tool suite to integrate with the EHR and clinical workflows

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Physicians
* Nurses
* Practice assistants
* Health coaches
* Population health managers
* Patient navigators

Exclusion Criteria

* Practices will be ineligible for participation if they treat fewer than 100 adults with prediabetes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Devin Mann, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

References

Explore related publications, articles, or registry entries linked to this study.

Rodriguez DV, Lawrence K, Gonzalez J, Brandfield-Harvey B, Xu L, Tasneem S, Levine DL, Mann D. Leveraging Generative AI Tools to Support the Development of Digital Solutions in Health Care Research: Case Study. JMIR Hum Factors. 2024 Mar 6;11:e52885. doi: 10.2196/52885.

Reference Type DERIVED
PMID: 38446539 (View on PubMed)

Lawrence K, Rodriguez DV, Feldthouse DM, Shelley D, Yu JL, Belli HM, Gonzalez J, Tasneem S, Fontaine J, Groom LL, Luu S, Wu Y, McTigue KM, Rockette-Wagner B, Mann DM. Effectiveness of an Integrated Engagement Support System to Facilitate Patient Use of Digital Diabetes Prevention Programs: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 9;10(2):e26750. doi: 10.2196/26750.

Reference Type DERIVED
PMID: 33560240 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19-00758

Identifier Type: -

Identifier Source: org_study_id