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Unnecessary Hospitalizations of Nursing Home ResidentsNCT02177058

Reducing Hospitalizations of Nursing Home Residents

A study testing INTERACT Quality improvement program and Quarterly surveys/data reporting in people with Unnecessary Hospitalizations of Nursing Home Residents, run by Florida Atlantic University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
What is being tested?
INTERACT Quality improvement program and Quarterly surveys/data reporting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
1 siteUnited States
Study dates
Jan 2012to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • > 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")
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  • < 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Florida Atlantic University, College of Medicine/College of Nursing

    Boca Raton, Florida, 33431

Other trials in United States

About this study

Official title: 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:

Read more

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.

Read the 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:

  1. Determine the effectiveness of implementing the INTERACT quality improvement program in reducing hospitalization rates.
  2. 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.
Being tested
INTERACT Quality improvement program, Quarterly surveys/data reporting
Keywords
Nursing homes, Hospitalizations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INTERACT Quality improvement programOther

    INTERACT training and implementation between APR 2013 and MAR 2014

  • Quarterly surveys/data reportingOther

    The nursing homes are asked to complete quarterly surveys between APR 2013 to MAR 2014

Study groups in NCT02177058
Study groupRoleWhat they receive
Immediate INTERACT implementationExperimentalINTERACT Quality improvement program training and implementation between APR 2013 and MAR 2014
Receives: Other: INTERACT Quality improvement program
Delayed intervention with reportingActive comparatorQuarterly surveys/data reporting between APR 2013 and MAR 2014. They receive INTERACT training starting on MAR 2014.
Receives: Other: Quarterly surveys/data reporting
Delayed intervention not reportingNo interventionNo data collected from these nursing homes for one year since baseline. They receive INTERACT training starting on MAR 2014.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reductions in hospitalization

    Measured: 1 year

Secondary outcomes (1)
  1. Reduction in hospitalization rates during high-risk periods and low-risk periods.

    High Risk Periods: within 30-day of NH admission. Low risk period: ≥31 days after NH admission.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2014 (estimated)
  2. Study startJan 2012
  3. Primary completionFeb 2017
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02177058
Sponsor's protocol ID
304897
Other IDs
5R01NR012936-02
Status last verified
Mar 2022
First submitted
26 Jun 2014
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 30108035
  • 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.

    PubMed 28672291
  • 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.

    PubMed 27349621

Questions about this trial

What is this clinical trial studying?

A study testing INTERACT Quality improvement program and Quarterly surveys/data reporting in people with Unnecessary Hospitalizations of Nursing Home Residents, run by Florida Atlantic University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reductions in hospitalization (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02177058, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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