An interventional study of PREVENT clinical decision support in Diabetes Mellitus, Type 2, Congestive Heart Failure and Obstructive Pulmonary Disease, sponsored by Columbia University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Columbia University · Not applicable, Interventional, and Screening
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 1,915 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Aim 1:
Inclusion criteria:
Exclusion criteria:
All other patients are going to be excluded.
Aim 2 :
Inclusion criteria:
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.
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
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.
Number of Rehospitalizations Within 60 Days After Hospital Discharge
To learn if using PREVENT tool results in decreased incidence of rehospitalization \[defined as recurrent hospital admission within 60 days from hospital discharge\]
Time frame: Up to 60 days after hospital discharge
System Usability Scale (SUS) Score
Nurses' usability perception of the clinical decision support tool (PREVENT) will be assessed by using the System Usability Scale (SUS). The SUS is a 10 item questionnaire, each with a five-point Likert scale, allowing users to rate their agreement or disagreement. The SUS score is calculated by converting the raw scores from the Likert scale and then multiplying the sum by 2.5, resulting in a score between 0 and 100, where a higher score indicates greater perceived usability.
Time frame: 30-60 days after clinical decision support tool (PREVENT) implementation
| Milestone | PREVENT |
|---|---|
| Started | 1915 |
| Completed | 1915 |
| Not completed | 0 |
| Milestone | PREVENT |
|---|---|
| Started | 1915 |
| Completed | 1915 |
| Not completed | 0 |
To learn if using PREVENT tool results in decreased incidence of rehospitalization \[defined as recurrent hospital admission within 60 days from hospital discharge\]
| rehospitalizations | PREVENT |
|---|---|
| Number of Rehospitalizations Within 60 Days After Hospital Discharge | 807 |
Nurses' usability perception of the clinical decision support tool (PREVENT) will be assessed by using the System Usability Scale (SUS). The SUS is a 10 item questionnaire, each with a five-point Likert scale, allowing users to rate their agreement or disagreement. The SUS score is calculated by converting the raw scores from the Likert scale and then multiplying the sum by 2.5, resulting in a score between 0 and 100, where a higher score indicates greater perceived usability.
No measurements were reported for this outcome.
Collected over 60 days following each home healthcare admission. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PREVENT | 0/1,915 (0%) | 0/1,915 (0%) | 0/1,915 (0%) |
| Age, Categorical(Participants) | PREVENT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 1915 |
| Sex: Female, Male(Participants) | PREVENT |
|---|---|
| Female | 1113 |
| Male | 802 |
| Race/Ethnicity, Customized(Participants) | PREVENT |
|---|---|
| Black | 375 |
| Hispanic | 923 |
| White | 492 |
| Other | 125 |
| Unknown/Not reported | 0 |
| Region of Enrollment(Participants) | PREVENT |
|---|---|
| United States | 1915 |
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