NCT02177058

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

August 4, 2022

Status Verified

March 1, 2022

Enrollment Period

5.1 years

First QC Date

June 26, 2014

Last Update Submit

August 2, 2022

Conditions

Unnecessary Hospitalizations of Nursing Home Residents

Keywords

Nursing homesHospitalizations

Outcome Measures

Primary Outcomes (1)

  • Reductions in hospitalization

    1 year

Secondary Outcomes (1)

  • Reduction in hospitalization rates during high-risk periods and low-risk periods.

    30 days

Study Arms (3)

Immediate INTERACT implementation

EXPERIMENTAL

INTERACT Quality improvement program training and implementation between APR 2013 and MAR 2014

Other: INTERACT Quality improvement program

Delayed intervention with reporting

ACTIVE COMPARATOR

Quarterly surveys/data reporting between APR 2013 and MAR 2014. They receive INTERACT training starting on MAR 2014.

Other: Quarterly surveys/data reporting

Delayed intervention not reporting

NO INTERVENTION

No data collected from these nursing homes for one year since baseline. They receive INTERACT training starting on MAR 2014.

Interventions

INTERACT Quality improvement programOTHER

INTERACT training and implementation between APR 2013 and MAR 2014

Immediate INTERACT implementation
Quarterly surveys/data reportingOTHER

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

Delayed intervention with reporting

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University, College of Medicine/College of Nursing

Boca Raton, Florida, 33431, United States

Location

Related Publications (3)

  • 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.

    PMID: 30108035DERIVED

  • 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.

    PMID: 28672291DERIVED

  • 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.

    PMID: 27349621DERIVED

Related Links

Study Officials

  • Joseph G Ouslander, MD

    Florida Atlantic University

    PRINCIPAL INVESTIGATOR

  • Ruth M Tappen, EdD RN FAAN

    Florida Atlantic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 27, 2014

Study Start

January 1, 2012

Primary Completion

February 1, 2017

Study Completion

February 28, 2021

Last Updated

August 4, 2022

Record last verified: 2022-03

Locations

US(1)