NCT04136951

Brief Summary

This research work is focused on building and evaluating one of the first evidence-based clinical decision support tools for homecare in the United States. The results of this study have the potential to standardize and individualize nursing decision making using cutting-edge technology and to improve patient outcomes in the homecare setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,915

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
3.8 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 8, 2025

Completed
Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

October 18, 2019

Results QC Date

August 15, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

home healthclinical decisions supportcare transitionspatient prioritizationhealth informaticshome care

Outcome Measures

Primary Outcomes (1)

  • Number of Rehospitalizations Within 60 Days After Hospital Discharge

    To learn if using PREVENT tool results in decreased incidence of rehospitalization \[defined as recurrent hospital admission within 60 days from hospital discharge\]

    Up to 60 days after hospital discharge

Other Outcomes (1)

  • System Usability Scale (SUS) Score

    30-60 days after clinical decision support tool (PREVENT) implementation

Study Arms (1)

Experimental phase

EXPERIMENTAL

The PREVENT recommendation about patient homecare priority will be shared in homecare referral communication with the homecare intake coordinators. Homecare intake coordinators will be instructed to prioritize high risk patients for care.

Other: PREVENT clinical decision support

Interventions

PREVENT clinical decision support tool consideres five patient risk factors as significant predictors of patient's priority for the first homecare nursing visit: (a) Presence of wounds (either surgical or pressure ulcers); (b) a documented comorbid condition of depression; (c) need for assistive equipment, assistive person, or both for toileting; (d) number of medications; and (e) number of comorbid conditions. Each risk factor was assigned a specific score based on the logistic regression weights. For instance, for a wound (e.g., pressure ulcer, vascular ulcer), the patient received a score of 15 points. For each additional co-morbid condition, one point was added to the final score. Summing the scores for the factors generated a cumulative score. The optimal cut-off point was established based on the regression model performance statistics, indicating that patients with a score greater than 26 points are a high priority for the first nursing visit.

Experimental phase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being a patient of either NewYork-Presbyterian (NYP)/Columbia University Irving Medical Center or NewYork-Presbyterian Allen Hospital;
  • being referred to Visiting Nurse Services of New York (VNSNY) homecare services
  • years old or older.

You may not qualify if:

  • All other patients are going to be excluded.
  • Aim 2 :
  • working as an admission staff for VNSNY
  • years old or older.
  • All other staff members are going to be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University School of Nursing

New York, New York, 10032, United States

Location

Visiting Nurse Service of New York

New York, New York, 10033, United States

Location

Related Publications (2)

  • Topaz M, Trifilio M, Maloney D, Bar-Bachar O, Bowles KH. Improving patient prioritization during hospital-homecare transition: A pilot study of a clinical decision support tool. Res Nurs Health. 2018 Oct;41(5):440-447. doi: 10.1002/nur.21907. Epub 2018 Sep 11.

  • Zolnoori M, McDonald MV, Barron Y, Cato K, Sockolow P, Sridharan S, Onorato N, Bowles K, Topaz M. Improving Patient Prioritization During Hospital-Homecare Transition: Protocol for a Mixed Methods Study of a Clinical Decision Support Tool Implementation. JMIR Res Protoc. 2021 Jan 22;10(1):e20184. doi: 10.2196/20184.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart FailureLung Diseases, ObstructiveDyspneaRenal Insufficiency

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Maxim Topaz, PhD, Elizabeth Standish Gill Associate Professor of Nursing
Organization
Columbia University

Study Officials

  • Maxim Topaz, PhD

    Associate Professor of Nursing at CUMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: To examine the study aims, the researchers are using an embedded mixed methods study design. The researchers will conduct pre- and post intervention trial of clinical decision support tool PREVENT's integration into clinical practice using homecare admissions from two New York City urban hospitals serving diverse racial and ethnic population. Quantitative methods, including logistic regression and survival analysis with propensity score matching, will be used to evaluate the effects of the tool on process and patient outcomes. Qualitative methods will be used to match the quantitative questions and provide an in depth insight into homecare admission processes using think-aloud simulations and interviews with homecare admission staff.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 23, 2019

Study Start

August 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

October 8, 2025

Results First Posted

October 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

No sharing planned

Locations