Physician-Patient RelationsNCT04049500
Adapt and Incorporate dDPP Into Clinical Workflows
An observational study of Physician-Patient Relations and Nurse-Patient Relations, run by NYU Langone Health.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Physician-Patient Relations, Nurse-Patient Relations
- What is being tested?
- Digital Diabetes Prevention Program (dDPP)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Physicians
- Nurses
- Practice assistants
- Health coaches
- Population health managers
- Patient navigators
Who cannot join
- Practices will be ineligible for participation if they treat fewer than 100 adults with prediabetes.
About this study
Official title: 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.
Read the 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.
- Being tested
- Digital Diabetes Prevention Program (dDPP)
- Keywords
- Physicians, Nurses, Practice assistants, Health coaches, Population health managers, Patient navigators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Diabetes Prevention Program (dDPP)Other
dDPP tool suite to integrate with the EHR and clinical workflows
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Digital Diabetes Prevention Program (dDPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability will be assessed using a 5-point Likert scale
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study startSep 2021 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: study was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physician-Patient RelationsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devin Mann, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049500
- Sponsor's protocol ID
- 19-00758
- Status last verified
- Oct 2021
- First submitted
- 1 Aug 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38446539Lawrence 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.
PubMed 33560240
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Adapt a Digital Diabetes Prevention Program (dDPP) and Incorporate it Into the Clinical Workflows.
- ClinicalTrials.gov ID
- NCT04049500
- Acronym / sponsor ID
- 19-00758
- Keywords
- Physicians, Nurses, Practice assistants, Health coaches, Population health managers, Patient navigators
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinicians | – | Other: Digital Diabetes Prevention Program (dDPP)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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Physicians
- Nurses
- Practice assistants
- Health coaches
- Population health managers
Key exclusion criteria (1 listed)
- Practices will be ineligible for participation if they treat fewer than 100 adults with prediabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Diabetes Prevention Program (dDPP)dDPP tool suite to integrate with the EHR and clinical workflows | Other | Clinicians |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 38446539Rodriguez 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.
- Derived from this study: PubMed 33560240Lawrence 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Physician-Patient Relations
Active, not recruitingPhase 3
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
RecruitingObservational study
The Parasite and Infestation Study
Parasite and Infestation Physician-Patient Diagnostic Incongruency
Recruiting
Ambient AI Scribe (Voa Health) in Outpatient Clinics: Draft Notes, Documentation Burden, and Well-Being
Burnout, Professionals, Medical Records Systems, Computerized
RecruitingObservational study
A "Physician & Patient-powered" Cohort Registry (MY MYELOMA)
Multiple Myeloma
Recruiting
One-Page Truth-Telling Aid for Cancer Disclosure
Neoplams, Physician-Patient Relations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devin Mann, MD principal investigator
NYU Langone
Questions about this trial
What is this clinical trial studying?
An observational study of Physician-Patient Relations and Nurse-Patient Relations, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability will be assessed using a 5-point Likert scale (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049500, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.