Improving Patient Prioritization During Hospital-homecare Transition (PREVENT)
Primary Purpose
Diabetes Mellitus, Type 2, Congestive Heart Failure, Obstructive Pulmonary Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PREVENT clinical decision support
Sponsored by
About this trial
This is an interventional screening trial for Diabetes Mellitus, Type 2 focused on measuring home health, clinical decisions support, care transitions, patient prioritization, health informatics, home care
Eligibility Criteria
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.
Sites / Locations
- Columbia University School of Nursing
- Visiting Nurse Service of New York
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental phase
Arm Description
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.
Outcomes
Primary Outcome Measures
To learn if using PREVENT tool results in decreased incidence of rehospitalization [defined as recurrent hospital admission within 60 days from hospital discharge]
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.
To learn if using PREVENT tool results in high nurses' system usability perception measured by the System Usability Scale (SUS).
Nurses' usability perception of the clinical decision support tool (PREVENT) will be assessed by using he System Usability Scale (SUS).
Secondary Outcome Measures
Full Information
NCT ID
NCT04136951
First Posted
October 18, 2019
Last Updated
July 18, 2022
Sponsor
Columbia University
Collaborators
Visiting Nurse Service of New York, National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT04136951
Brief Title
Improving Patient Prioritization During Hospital-homecare Transition
Acronym
PREVENT
Official Title
Improving Patient Prioritization During Hospital-homecare Transition: A Mixed Methods Study of a Clinical Decision Support Tool
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Visiting Nurse Service of New York, National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Congestive Heart Failure, Obstructive Pulmonary Disease, Dyspnea, Renal Failure
Keywords
home health, clinical decisions support, care transitions, patient prioritization, health informatics, home care
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
2094 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PREVENT clinical decision support
Intervention Description
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.
Primary Outcome Measure Information:
Title
To learn if using PREVENT tool results in decreased incidence of rehospitalization [defined as recurrent hospital admission within 60 days from hospital discharge]
Description
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.
Time Frame
within 60 days after hospital discharge
Title
To learn if using PREVENT tool results in high nurses' system usability perception measured by the System Usability Scale (SUS).
Description
Nurses' usability perception of the clinical decision support tool (PREVENT) will be assessed by using he System Usability Scale (SUS).
Time Frame
30-60 days after clinical decision support tool (PREVENT) implementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxim Topaz, PhD
Phone
16462760460
Email
mt3315@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxim Topaz, PhD
Organizational Affiliation
Associate Professor of Nursing at CUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University School of Nursing
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxim Topaz
Phone
646-276-0460
Email
mt3315@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Maxim Topaz, PhD
First Name & Middle Initial & Last Name & Degree
Kenrick Cato, PhD
Facility Name
Visiting Nurse Service of New York
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxim Topaz
Phone
646-276-0460
Email
mt3315@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Margaret McDonald, PhD
First Name & Middle Initial & Last Name & Degree
Yolanda Barron-Vaya, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No sharing planned
Citations:
PubMed Identifier
30203417
Citation
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.
Results Reference
background
PubMed Identifier
27437047
Citation
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.
Results Reference
background
PubMed Identifier
19717799
Citation
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.
Results Reference
background
PubMed Identifier
24551412
Citation
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.
Results Reference
background
PubMed Identifier
28479081
Citation
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.
Results Reference
background
PubMed Identifier
33480855
Citation
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.
Results Reference
derived
Learn more about this trial
Improving Patient Prioritization During Hospital-homecare Transition
We'll reach out to this number within 24 hrs