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.
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
- Conditions the study is for
- Unnecessary Hospitalizations of Nursing Home Residents
- 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
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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Immediate INTERACT implementation | Experimental | INTERACT Quality improvement program training and implementation between APR 2013 and MAR 2014 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in hospitalization
Measured: 1 year
Secondary outcomes (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.
- First posted27 Jun 2014 (estimated)
- Study startJan 2012
- Primary completionFeb 2017
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unnecessary Hospitalizations of Nursing Home ResidentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Joseph G Ouslander, MD, Principal investigator, Florida Atlantic UniversityRuth M Tappen, EdD RN FAAN, Principal investigator, Florida Atlantic University
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 30108035Kane 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 28672291Ouslander 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Interventions to Reduce Hospitalizations of Nursing Home Residents
- ClinicalTrials.gov ID
- NCT02177058
- Acronym / sponsor ID
- 304897
- Keywords
- Nursing homes, Hospitalizations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Minnesota
- Study start
- Jan 2012 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate INTERACT implementation | Experimental | Other: INTERACT Quality improvement programINTERACT Quality improvement program training and implementation between APR 2013 and MAR 2014 |
| Delayed intervention with reporting | Active comparator | Other: Quarterly surveys/data reportingQuarterly surveys/data reporting between APR 2013 and MAR 2014. They receive INTERACT training starting on MAR 2014. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- > 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTERACT Quality improvement programINTERACT training and implementation between APR 2013 and MAR 2014 | Other | Immediate INTERACT implementation |
| Quarterly surveys/data reportingThe nursing homes are asked to complete quarterly surveys between APR 2013 to MAR 2014 | Other | Delayed intervention with reporting |
Primary outcome
Reductions in hospitalization
Time frame: 1 year
1 secondary outcome
Reduction in hospitalization rates during high-risk periods and low-risk periods.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Derived from this study: PubMed 30108035Tappen 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.
- Derived from this study: PubMed 28672291Kane 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.
- Derived from this study: PubMed 27349621Ouslander 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph G Ouslander, MD principal investigator
Florida Atlantic University
Ruth M Tappen, EdD RN FAAN principal investigator
Florida Atlantic University
1 site in 1 country: see every site and its status.
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.