Patient EngagementNCT04971278
Evaluating the Impact of a Supportive Care Program
An observational study of Patient Engagement and Morality, run by NYU Langone Health at 1 site in United States.
Trial summary
NYU's High Risk Program targets patients who may be more likely to have increased hospitalization due to health conditions that may cause death in the near future. Community Health Workers, a home visiting doctor service, a supportive care nurse, and behavioral health specialist engage the population to address a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Engagement, Morality
- What is being tested?
- Supportive care program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,201 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2019to 22 Sep 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: NYU Langone adult patients (>18 years old) at or above the 75th percentile on NYU's mortality model currently attributed to one of DSRIP's value based contracts.
Who may be able to join
- 18 years or older
- at or above the 75th percentile on the Mortality Model
- Attributed to a value based contract
Who cannot join
- Less than 18 years of age
- Below the 75th percentile on the Mortality Model
- Not attributed to a value based contract
Trial locations and contacts
1 site in 1 country.
About this study
NYU's High Risk Program targets patients who may be more likely to have increased hospitalization due to health conditions that may cause death in the near future. Community Health Workers, a home visiting doctor service, a supportive care nurse, and behavioral health specialist engage the population to address a range of biopsychosocial needs with end goal in increasing support in the community and engaging palliative and hospice care when appropriate to prevent hospital readmissions, shorten length of stay, reduce hospital utilization, and decrease overall patient cost with a focus on hospital spend.
- Conditions
- Patient Engagement, Morality
- Being tested
- Supportive care program
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive care programBehavioural
Community Health Workers, a home visiting doctor service, a supportive care nurse, and behavioral health specialist engage the population to address a range of biopsychosocial needs with end goal in increasing support in the community and engaging palliative and hospice care when appropriate to prevent hospital readmissions, shorten length of stay, reduce hospital utilization, and decrease overall patient cost with a focus on hospital spend.
| Study group | Role | What they receive |
|---|---|---|
| HealthFirst Intervention | Patients attributed to HealthFirst who will receive the intervention Receives: Behavioral: Supportive care program | |
| HealthFirst Control | Patients attributed to HealthFirst who will not receive the intervention | |
| Mortality Model Intervention | Patients who are identified as High Risk by the mortality predictive model and who receive the intervention. Receives: Behavioral: Supportive care program | |
| Mortality Model Control | Patients who are identified as High Risk by the mortality predictive model and who do not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Advance Care Planning note creation
How many and how often are ACP notes written for patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start7 Nov 2019
- Primary completion28 Feb 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies 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
- 1,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leora Horwitz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971278
- Sponsor's protocol ID
- QI-High Risk
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Supportive Care Program
- ClinicalTrials.gov ID
- NCT04971278
- Acronym / sponsor ID
- QI-High Risk
- Conditions
- Patient Engagement, Morality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,201 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 21 Jul 2021 (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.
NYU's High Risk Program targets patients who may be more likely to have increased hospitalization due to health conditions that may cause death in the near future. Community Health Workers, a home visiting doctor service, a supportive care nurse, and behavioral health specialist engage the population to address a range of biopsychosocial needs with end goal in increasing support in the community and engaging palliative and hospice care when appropriate to prevent hospital readmissions, shorten length of stay, reduce hospital utilization, and decrease overall patient cost with a focus on hospital spend.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HealthFirst Intervention | – | Behavioral: Supportive care programPatients attributed to HealthFirst who will receive the intervention |
| HealthFirst Control | – | –Patients attributed to HealthFirst who will not receive the intervention |
| Mortality Model Intervention | – | Behavioral: Supportive care programPatients who are identified as High Risk by the mortality predictive model and who receive the intervention. |
| Mortality Model Control | – | –Patients who are identified as High Risk by the mortality predictive model and who do not receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- NYU Langone adult patients (>18 years old) at or above the 75th percentile on NYU's mortality model currently attributed to one of DSRIP's value based contracts.
Key inclusion criteria (3 listed)
- 18 years or older
- at or above the 75th percentile on the Mortality Model
- Attributed to a value based contract
Key exclusion criteria (3 listed)
- Less than 18 years of age
- Below the 75th percentile on the Mortality Model
- Not attributed to a value based contract
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 |
|---|---|---|
| Supportive care programCommunity Health Workers, a home visiting doctor service, a supportive care nurse, and behavioral health specialist engage the population to address a range of biopsychosocial needs with end goal in increasing support in the community and engaging palliative and hospice care when appropriate to prevent hospital readmissions, shorten length of stay, reduce hospital utilization, and decrease overall patient cost with a focus on hospital spend. | Behavioural | HealthFirst Intervention, Mortality Model Intervention |
Primary outcome
Rate of Advance Care Planning note creation
Time frame: 2 years
How many and how often are ACP notes written for patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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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.
Leora Horwitz, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Engagement and Morality, run by NYU Langone Health at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Advance Care Planning note creation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2023.