Adapt and Incorporate dDPP Into Clinical Workflows

October 13, 2021 updated by: NYU Langone Health

An Observational Study to Adapt a Digital Diabetes Prevention Program (dDPP) and Incorporate it Into the Clinical Workflows.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Digital Diabetes Prevention Program (dDPP)
dDPP tool suite to integrate with the EHR and clinical workflows

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability will be assessed using a 5-point Likert scale
Time Frame: 12 Months
5 point likert scale is measured on a 5 point scale, 1 being "very unsatisfied" and 5 being "very satisfied." Higher scores mean more usability
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

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

Investigators

  • Principal Investigator: Devin Mann, MD, NYU Langone

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2026

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19-00758

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).Upon reasonable request.Requests should be directed to devin.mann@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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