Improving Patient Prioritization During Hospital-homecare Transition

NCT ID: NCT04136951

Last Updated: 2025-10-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1915 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-05-01

Brief Summary

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

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.

Detailed Description

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

Each year, more than 5 million patients are admitted to the approximately 12,000 homecare agencies across the United States. About 20% of homecare patients are rehospitalized during the homecare episode, with as many as 68% of these rehospitalizations occurring within the first two weeks of services. A significant portion of these rehospitalizations may be prevented by timely and appropriately targeted allocation of homecare services. The first homecare nursing visit is one of the most critical steps of the homecare episode. This visit includes an examination of the home environment, a discussion regarding whether a caregiver is present, an assessment of the patient's capacity for self-care, and medication reconciliation. A unique care plan is created based on this evaluation of the patient's needs. Hence, appropriate timing of the first visit is crucial, especially for patients with urgent healthcare needs. However, nurses often have very limited and inaccurate information about incoming patients and patient priority decisions vary significantly between nurses.

The investigators developed an innovative decision support tool called "Priority for the First Nursing Visit Tool" (PREVENT) to assist nurses in prioritizing patients in need of immediate first homecare nursing visits. In a recent efficacy pilot study of PREVENT, high-risk patients received their first homecare nursing visit a half day sooner as compared to the control group, and 60-day rehospitalizations decreased by almost half as compared to the control group. The proposed study assembles a strong interdisciplinary team of experts in health informatics, nursing, homecare, and sociotechnical disciplines to evaluate PREVENT in a pre-post intervention effectiveness study. Specifically, the study aims are: Aim 1) Evaluate the effectiveness of the PREVENT tool on process and patient outcomes. Using survival analysis and logistic regression with propensity score matching the researchers will test the following hypotheses: Compared to not using the tool in the pre-intervention phase, when homecare clinicians use the PREVENT tool, high risk patients in the intervention phase will: a) receive more timely first homecare visits and b) have decreased incidence of rehospitalization and have decreased emergency department (ED) use within 60 days. Aim 2) Explore PREVENT's reach and adoption by the homecare admission staff and describe the tool's implementation during homecare admission. Aim 2 will be assessed using mixed methods including homecare admission staff interviews, think-aloud simulations, and analysis of staffing and other relevant data.

This innovative study addresses several National Institute of Nursing Research strategic priorities, such as promoting innovation and using technology to improve health. Mixed methods will enable us to gain in-depth understanding of the complex socio-technological aspects of hospital-homecare transition.

Conditions

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

Diabetes Mellitus, Type 2 Congestive Heart Failure Obstructive Pulmonary Disease Dyspnea Renal Failure

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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

Experimental phase

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.

Group Type EXPERIMENTAL

PREVENT clinical decision support

Intervention Type OTHER

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.

Interventions

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

PREVENT clinical decision support

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.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

1. being a patient of either NewYork-Presbyterian (NYP)/Columbia University Irving Medical Center or NewYork-Presbyterian Allen Hospital;
2. being referred to Visiting Nurse Services of New York (VNSNY) homecare services
3. 18 years old or older.


1. working as an admission staff for VNSNY
2. 18 years old or older.

Exclusion Criteria

All other patients are going to be excluded.

Aim 2 :


All other staff members are going to be excluded.

For both study aims, there will be no exclusion based on sex, race, or ethnic group.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Visiting Nurse Service of New York

OTHER

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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

Maxim Topaz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Maxim Topaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Nursing at CUMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbia University School of Nursing

New York, New York, United States

Site Status

Visiting Nurse Service of New York

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

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

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.

Reference Type RESULT
PMID: 30203417 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33480855 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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

1R01NR018831-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS7265

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Connect-Home Clinical Trial
NCT03810534 COMPLETED NA