Quality ImprovementINTERACTNCT04195880
Reducing Veterans Hospitalizations From Community Living Centers
A study testing Interventions to Reduce Acute Care Transfers in people with Quality Improvement, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of the project was to implement and evaluate the intervention, Interventions to Reduce Acute Care Transfers (INTERACT) in VHA CLCs, which is designed to improve the care of Veterans using CLCs who experience acute changes in their condition and at the same time reduce their rate of hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality Improvement
- What is being tested?
- Interventions to Reduce Acute Care Transfers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,543 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans in experimental and control CLCs during 18 months during which the INTERAC intervention was implemented.
Who cannot join
- Veterans not in participating CLCs
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
About this study
Official title: Implementing and Evaluating INTERACT in VA CLCs
The goal of the project was to implement and evaluate the intervention, Interventions to Reduce Acute Care Transfers (INTERACT) in VHA CLCs, which is designed to improve the care of Veterans using CLCs who experience acute changes in their condition and at the same time reduce their rate of hospitalization.
Read the detailed description
The project was designed to show that engagement by frontline CLC staff, in using the INTERACT (VA version of INTERACT) program will identify Veterans' clinical problems earlier, help evaluate and safely initiate management of acute changes in conditions in the CLC, communicate more effectively with physicians about Veterans' conditions, thereby avoiding unnecessary hospitalizations, and provide more emergent hospitalizations when necessary.
The project planned to implement the INTERACT quality improvement program as the intervention in up to 15 randomly selected, pair matched CLCs for a 6 month intensive training period and an additional 12-18 month ongoing follow-up monitoring period.
Additionally, a quantitative and qualitative evaluation of the implementation of the INTERACT intervention was done to characterize the fidelity with which CLCs in the intervention pairs participated in training, engaged in regular conference calls, undertook root cause analyses identifying why hospitalizations occurred and used the tools in which they were trained.
The program's effect is based on three core strategies: 1) enabling front-line NH staff to identify acute conditions early in their course, thereby helping to prevent them from becoming severe enough to require acute hospitalization; 2) providing communication and decision support tools that assist with the safe and effective management of certain conditions in the Community Living Center (CLC) without transfer to the acute hospital; and 3) educating CLC staff in advance care planning and discussions about end-of-life and comfort care plans, and thus increasing the use of advance directives, comfort care measures, and palliative and hospice care as an alternative to hospitalization when appropriate.
- Conditions
- Quality Improvement
- Being tested
- Interventions to Reduce Acute Care Transfers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions to Reduce Acute Care TransfersOther
Also called INTERACT
Experimental CLCs were trained in INTERACT QI Intervention, containing tools, strategies and educational resources designed to catch and manage acute changes in conditions early that a Veteran may be experiencing, leading to a potential reduction in preventable hospital transfers from CLCs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental VA Community Living Centers | Experimental | Eight VA CLCs selected to receive the INTERACT intervention Receives: Other: Interventions to Reduce Acute Care Transfers |
| Control VA Community Living Centers | No intervention | Eight CLCs, matched to experiment CLCs, based on size, location to VAMC, and hospitalization rates, did not receive the intervention and continued care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Admissions Per Person Year Alive Measured at the Facility Month Level
hospital admissions from nursing home per person year at risk of being hospitalized calculated for each of the 16 facilities per month of observation during the 18 months of the active study and 18 months preceding introduction of the intervention in the experimental facilities. This measure is constructed from EMR data and not from a scale.
Measured: 36 months
Secondary outcomes (1)
Potentially Avoidable Hospitalizations
Potentially avoidable hospitalization per person year alive aggregated to the facility level. These hospitalizations are a sub-set of all hospitalizations based upon an AHRQ algorithm frequently referenced in the literature.
Measured: 18 months followup during observation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Jan 2016
- Primary completion1 Dec 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality ImprovementStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Model description
- Pair matched cluster randomized trial; randomization at the provider level.
- Masking
- None (open label)
- Enrolment
- 6,543 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Providence VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Vincent Mor, PhD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195880
- Sponsor's protocol ID
- CRE 12-025
- Other IDs
- CIRB 13-10
- Acronym
- INTERACT
- Status last verified
- Jul 2023
- First submitted
- 10 Dec 2019
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mochel AL, Henry ND, Saliba D, Phibbs CS, Ouslander JG, Mor V. INTERACT in VA Community Living Centers (CLCs): Training and Implementation Strategies. Geriatr Nurs. 2018 Mar-Apr;39(2):212-218. doi: 10.1016/j.gerinurse.2017.09.002. Epub 2017 Oct 5.
PubMed 28988835Mochel AL, Holle CL, Rudolph JL, Ouslander JG, Saliba D, Mor V, Mittman BS. Influencing Factors Associated with Implementation of INTERACT (Interventions to Reduce Acute Care Transfers) in VA Community Living Centers (CLCs) Using the Consolidated Framework. J Aging Soc Policy. 2022 Sep 3;34(5):673-689. doi: 10.1080/08959420.2021.1926862. Epub 2021 Jun 4.
PubMed 34085597
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating INTERACT in VA CLCs
- ClinicalTrials.gov ID
- NCT04195880
- Acronym / sponsor ID
- INTERACT / CRE 12-025
- Conditions
- Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,543 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Providence VA Medical Center
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Posted 11 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the project was to implement and evaluate the intervention, Interventions to Reduce Acute Care Transfers (INTERACT) in VHA CLCs, which is designed to improve the care of Veterans using CLCs who experience acute changes in their condition and at the same time reduce their rate of hospitalization.
Detailed description
The project was designed to show that engagement by frontline CLC staff, in using the INTERACT (VA version of INTERACT) program will identify Veterans' clinical problems earlier, help evaluate and safely initiate management of acute changes in conditions in the CLC, communicate more effectively with physicians about Veterans' conditions, thereby avoiding unnecessary hospitalizations, and provide more emergent hospitalizations when necessary.
The project planned to implement the INTERACT quality improvement program as the intervention in up to 15 randomly selected, pair matched CLCs for a 6 month intensive training period and an additional 12-18 month ongoing follow-up monitoring period.
Additionally, a quantitative and qualitative evaluation of the implementation of the INTERACT intervention was done to characterize the fidelity with which CLCs in the intervention pairs participated in training, engaged in regular conference calls, undertook root cause analyses identifying why hospitalizations occurred and used the tools in which they were trained.
The program's effect is based on three core strategies: 1) enabling front-line NH staff to identify acute conditions early in their course, thereby helping to prevent them from becoming severe enough to require acute hospitalization; 2) providing communication and decision support tools that assist with the safe and effective management of certain conditions in the Community Living Center (CLC) without transfer to the acute hospital; and 3) educating CLC staff in advance care planning and discussions about end-of-life and comfort care plans, and thus increasing the use of advance directives, comfort care measures, and palliative and hospice care as an alternative to hospitalization when appropriate.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pair matched cluster randomized trial; randomization at the provider level.
| Arm | Type | Receives |
|---|---|---|
| Experimental VA Community Living Centers | Experimental | Other: Interventions to Reduce Acute Care TransfersEight VA CLCs selected to receive the INTERACT intervention |
| Control VA Community Living Centers | No intervention | –Eight CLCs, matched to experiment CLCs, based on size, location to VAMC, and hospitalization rates, did not receive the intervention and continued care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans in experimental and control CLCs during 18 months during which the INTERAC intervention was implemented.
Key exclusion criteria (1 listed)
- Veterans not in participating CLCs
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 |
|---|---|---|
| Interventions to Reduce Acute Care TransfersAlso: INTERACTExperimental CLCs were trained in INTERACT QI Intervention, containing tools, strategies and educational resources designed to catch and manage acute changes in conditions early that a Veteran may be experiencing, leading to a potential reduction in preventable hospital transfers from CLCs. | Other | Experimental VA Community Living Centers |
Primary outcome
Hospital Admissions Per Person Year Alive Measured at the Facility Month Level
Time frame: 36 months
hospital admissions from nursing home per person year at risk of being hospitalized calculated for each of the 16 facilities per month of observation during the 18 months of the active study and 18 months preceding introduction of the intervention in the experimental facilities. This measure is constructed from EMR data and not from a scale.
1 secondary outcome
Potentially Avoidable Hospitalizations
Time frame: 18 months followup during observation period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28988835Mochel AL, Henry ND, Saliba D, Phibbs CS, Ouslander JG, Mor V. INTERACT in VA Community Living Centers (CLCs): Training and Implementation Strategies. Geriatr Nurs. 2018 Mar-Apr;39(2):212-218. doi: 10.1016/j.gerinurse.2017.09.002. Epub 2017 Oct 5.
- Results publication: PubMed 34085597Mochel AL, Holle CL, Rudolph JL, Ouslander JG, Saliba D, Mor V, Mittman BS. Influencing Factors Associated with Implementation of INTERACT (Interventions to Reduce Acute Care Transfers) in VA Community Living Centers (CLCs) Using the Consolidated Framework. J Aging Soc Policy. 2022 Sep 3;34(5):673-689. doi: 10.1080/08959420.2021.1926862. Epub 2021 Jun 4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vincent Mor, PhD principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions to Reduce Acute Care Transfers in people with Quality Improvement, run by VA Office of Research and Development 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 1 inclusion and 1 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 27 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 11 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Admissions Per Person Year Alive Measured at the Facility Month Level (time frame: 36 months). 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 NCT04195880, which also lists 2 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 27 Jul 2023.