- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04136951
Improving Patient Prioritization During Hospital-homecare Transition (PREVENT)
Improving Patient Prioritization During Hospital-homecare Transition: A Mixed Methods Study of a Clinical Decision Support Tool
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maxim Topaz, PhD
- Phone Number: 16462760460
- Email: mt3315@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University School of Nursing
-
Contact:
- Maxim Topaz
- Phone Number: 646-276-0460
- Email: mt3315@cumc.columbia.edu
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Principal Investigator:
- Maxim Topaz, PhD
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Sub-Investigator:
- Kenrick Cato, PhD
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New York, New York, United States, 10033
- Visiting Nurse Service of New York
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Contact:
- Maxim Topaz
- Phone Number: 646-276-0460
- Email: mt3315@cumc.columbia.edu
-
Principal Investigator:
- Margaret McDonald, PhD
-
Sub-Investigator:
- Yolanda Barron-Vaya, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Aim 1:
Inclusion criteria:
- 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
- 18 years old or older.
Exclusion criteria:
All other patients are going to be excluded.
Aim 2 :
Inclusion criteria:
- working as an admission staff for VNSNY
- 18 years old or older.
Exclusion criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To learn if using PREVENT tool results in decreased incidence of rehospitalization [defined as recurrent hospital admission within 60 days from hospital discharge]
Time Frame: within 60 days after hospital discharge
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Patient outcomes include rehospitalization measure within 60 days after hospital discharge.
The hypothesis is that using the PREVENT tool will result in decreased incidence of rehospitalization.
Rehospitalization information will be extracted from the New York Regional Health Information Exchange (RHIO) database.
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within 60 days after hospital discharge
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To learn if using PREVENT tool results in high nurses' system usability perception measured by the System Usability Scale (SUS).
Time Frame: 30-60 days after clinical decision support tool (PREVENT) implementation
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Nurses' usability perception of the clinical decision support tool (PREVENT) will be assessed by using he System Usability Scale (SUS).
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30-60 days after clinical decision support tool (PREVENT) implementation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maxim Topaz, PhD, Associate Professor of Nursing at CUMC
Publications and helpful links
General Publications
- 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.
- Bowles KH, Ratcliffe S, Potashnik S, Topaz M, Holmes J, Shih NW, Naylor MD. Using Electronic Case Summaries to Elicit Multi-Disciplinary Expert Knowledge about Referrals to Post-Acute Care. Appl Clin Inform. 2016 May 18;7(2):368-79. doi: 10.4338/ACI-2015-11-RA-0161. eCollection 2016.
- Bakken S, Ruland CM. Translating clinical informatics interventions into routine clinical care: how can the RE-AIM framework help? J Am Med Inform Assoc. 2009 Nov-Dec;16(6):889-97. doi: 10.1197/jamia.M3085. Epub 2009 Aug 28.
- Topaz M, Shalom E, Masterson-Creber R, Rhadakrishnan K, Monsen KA, Bowles KH. Developing nursing computer interpretable guidelines: a feasibility study of heart failure guidelines in homecare. AMIA Annu Symp Proc. 2013 Nov 16;2013:1353-61. eCollection 2013.
- O'Connor M, Hanlon A, Mauer E, Meghani S, Masterson-Creber R, Marcantonio S, Coburn K, Van Cleave J, Davitt J, Riegel B, Bowles KH, Keim S, Greenberg SA, Sefcik JS, Topaz M, Kong D, Naylor M. Identifying distinct risk profiles to predict adverse events among community-dwelling older adults. Geriatr Nurs. 2017 Nov-Dec;38(6):510-519. doi: 10.1016/j.gerinurse.2017.03.013. Epub 2017 May 4.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Signs and Symptoms, Respiratory
- Heart Failure
- Diabetes Mellitus, Type 2
- Lung Diseases, Obstructive
- Dyspnea
Other Study ID Numbers
- AAAS7265
- 1R01NR018831-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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