- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02177058
Reducing Hospitalizations of Nursing Home Residents
Implementing Interventions to Reduce Hospitalizations of Nursing Home Residents
This project directly addresses the national imperative for innovative strategies to improve care for Medicare beneficiaries and reduce health care costs. The overall objective of the proposed project is to improve the care of older individuals who reside in nursing homes (NHs), and at the same time reduce unnecessary Medicare expenditures. This goal will be accomplished by testing a quality improvement program designed to reduce the number of avoidable hospitalizations of NH residents in a randomized controlled trial.
The primary hypotheses to be tested are:
Hypothesis1: Interventions to Reduce Acute Care Transfers (INTERACT) implementation NHs will have a greater reduction in hospitalization rate than the control and monitoring only NHs during the 12-month implementation compared to a 12-month baseline period.
Hypothesis 2: Reductions in Medicare expenditures for hospitalizations in the INTERACT implementation NHs will be greater than the estimated costs of implementing the intervention.
Hypothesis 3: The effects of INTERACT on hospitalization rates will be greater among patients on the Medicare skilled benefit for post-acute care, than for long-stay patients.
Hypothesis 4: The effects of INTERACT on hospitalization rates will be greatest among those NHs with higher vs. lower intensity (fidelity) of implementing the program.
Hypothesis 5: There will be a greater reduction in measures of hospitalizations for conditions defined as "potentially preventable" than for other transfers and hospitalizations.
Hypothesis 6: Implementation of INTERACT will not be associated with worsening of relevant quality measures in the participating NHs.
Study Overview
Status
Intervention / Treatment
Detailed Description
Hospitalizations of Nursing Home (NH) residents are frequent and associated with numerous complications and increased health care costs. Previous research suggests that as many as two-thirds of such hospitalizations may be avoidable. Anticipated changes in Medicare reimbursement will reduce financial incentives that favor hospitalization, but could result in reduced care quality if NH staff does not have the training and clinical tools to manage residents in the NH when acute changes occur. INTERACT (Interventions to Reduce Acute Care Transfers) is a quality improvement program that utilizes tools based on established clinical guidelines. The tools target three key strategies to reduce potentially avoidable hospitalizations: 1) preventing conditions from becoming severe enough to require acute hospital care; 2) managing selected acute conditions in the NH; and 3) improving advance care planning for residents among whom a palliative or comfort care plan, rather than acute hospitalization, may be appropriate. Preliminary research involving 30 NHs demonstrated a 17% reduction in hospitalizations compared to the same six-month period in the previous year. The cost of the intervention was $7,700; projected savings to Medicare of reduced hospital admissions from a 100-bed NH were $125,000/year. While these results are promising, the effectiveness of INTERACT in reducing hospitalizations remains to be tested in a controlled trial. The proposed project will therefore involve an interdisciplinary team of experienced NH researchers in conducting a randomized controlled trial to test the implementation of the INTERACT program. NHs randomized to the INTERACT intervention will participate in 3-months of training, and receive support during the 12-month implementation period by an experienced nurse practitioner through regular multi-NH conference calls, monthly individual calls, and as-needed telephonic or email communication. The effects of implementing the INTERACT intervention on hospitalization rates will be compared to a randomly assigned group of usual care control NHs and a group that will self-monitor hospitalization rates only. The hypotheses to be tested are:
1) INTERACT implementation NHs will have a greater reduction in hospitalization rates than the control and monitoring only NHs during the 12-month implementation compared to a 12-month baseline period; and 2) reductions in Medicare expenditures for hospitalizations in the INTERACT intervention NHs will exceed the estimated costs of implementing the intervention.
The specific aims of this project are to:
- Determine the effectiveness of implementing the INTERACT quality improvement program in reducing hospitalization rates.
- Calculate the differences in Medicare expenditures for hospitalizations between NHs implementing INTERACT, the usual care control group, and NHs in the monitoring hospitalization rates only group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Boca Raton, Florida, United States, 33431
- Florida Atlantic University, College of Medicine/College of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- > 40 Beds
- MD, NP or PA available on-site at least 1/week
- Capable of Starting intravenous fluids
- Capable of Providing respiratory treatments
- Capable of Assessing oxygenation status by pulse oximetry
- < 4 hrs turnaround time for STAT medications ("stat" is an abbreviation of the Latin word statim, meaning "immediately, without delay")
- < 8 hrs. turnaround time for STAT laboratory tests
- < 8 hrs. turnaround time for STAT X-rays
- Computers available for online staff training
- Strong support for participation from the facility administrator, director of nursing, and medical director, as well as corporate leadership (for NHs that are part of a corporate chain), as evidenced by a signed agreement before enrollment
- > 10% 30-day readmission rates
Exclusion Criteria:
- Hospital based
- Having only private pay residents (no Medicare/Medicaid, no Medicare provider number).
- Participation in a project designed specifically to reduce acute care transfers or hospitalization rates (including federal demonstrations)
- Conducting more than one other major quality improvement or research project during the project period which would threaten their ability to fully participate in the trial.
- Specialize in Pediatrics (> 30 % of patients in NHs are pediatric)
- Specialize in HIV (> 30 % of patients in NHs are HIV)
- Specialize in Respiratory care with ventilator care (>30% of patients in NH are in this category)
- Robust INTERACT implementation and/or very low hospitalization rate
- Located in a country outside USA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate INTERACT implementation
INTERACT Quality improvement program training and implementation between APR 2013 and MAR 2014
|
INTERACT training and implementation between APR 2013 and MAR 2014
|
|
Active Comparator: Delayed intervention with reporting
Quarterly surveys/data reporting between APR 2013 and MAR 2014.
They receive INTERACT training starting on MAR 2014.
|
The nursing homes are asked to complete quarterly surveys between APR 2013 to MAR 2014
|
|
No Intervention: Delayed intervention not reporting
No data collected from these nursing homes for one year since baseline.
They receive INTERACT training starting on MAR 2014.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reductions in hospitalization
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in hospitalization rates during high-risk periods and low-risk periods.
Time Frame: 30 days
|
High Risk Periods: within 30-day of NH admission.
Low risk period: ≥31 days after NH admission.
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph G Ouslander, MD, Florida Atlantic University
- Principal Investigator: Ruth M Tappen, EdD RN FAAN, Florida Atlantic University
Publications and helpful links
General Publications
- Tappen RM, Newman D, Huckfeldt P, Yang Z, Engstrom G, Wolf DG, Shutes J, Rojido C, Ouslander JG. Evaluation of Nursing Facility Resident Safety During Implementation of the INTERACT Quality Improvement Program. J Am Med Dir Assoc. 2018 Oct;19(10):907-913.e1. doi: 10.1016/j.jamda.2018.06.017. Epub 2018 Aug 11.
- Kane RL, Huckfeldt P, Tappen R, Engstrom G, Rojido C, Newman D, Yang Z, Ouslander JG. Effects of an Intervention to Reduce Hospitalizations From Nursing Homes: A Randomized Implementation Trial of the INTERACT Program. JAMA Intern Med. 2017 Sep 1;177(9):1257-1264. doi: 10.1001/jamainternmed.2017.2657.
- Ouslander JG, Naharci I, Engstrom G, Shutes J, Wolf DG, Rojido M, Tappen R, Newman D. Hospital Transfers of Skilled Nursing Facility (SNF) Patients Within 48 Hours and 30 Days After SNF Admission. J Am Med Dir Assoc. 2016 Sep 1;17(9):839-45. doi: 10.1016/j.jamda.2016.05.021. Epub 2016 Jun 24.
Helpful Links
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 304897
- 5R01NR012936-02 (U.S. NIH Grant/Contract)
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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