INTERACT: Reducing Veterans Hospitalizations From Community Living Centers

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT04195880
• Collaborator: Providence VA Medical Center (U.S. Fed)
• Enrollment: 6,543
• Location: 1
• Arms: 2
• Actual Duration (Months): 29
• Patients Per Site Per Month: 225.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Quality Improvement	Other: Interventions to Reduce Acute Care Transfers	N/A

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

• Study Type: Interventional
• Actual Enrollment: 6543 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pair matched cluster randomized trial; randomization at the provider level.Pair matched cluster randomized trial; randomization at the provider level.
• Masking: None (Open Label)
• Masking Description: Intervention implemented in providers assigned to experimental condition, so all knew they were in a study. Control facilities did not know there was a study underway.
• Primary Purpose: Health Services Research
• Official Title: Implementing and Evaluating INTERACT in VA CLCs
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental VA Community Living Centers Eight VA CLCs selected to receive the INTERACT intervention	Other: Interventions to Reduce Acute Care Transfers; 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.; Other Names: INTERACT
No Intervention: Control VA Community Living Centers 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

Outcome Measures

Primary Outcome Measures

1. Hospital Admissions Per Person Year Alive Measured at the Facility Month Level [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.

Secondary Outcome Measures

1. Potentially Avoidable Hospitalizations [18 months followup during observation period.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Veterans in experimental and control CLCs during 18 months during which the INTERAC intervention was implemented.

Exclusion Criteria:

• Veterans not in participating CLCs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence VA Medical Center, Providence, RI	Providence	Rhode Island	United States	02908

Sponsors and Collaborators

• VA Office of Research and Development
• Providence VA Medical Center

Investigators

• Principal Investigator: Vincent Mor, PhD, Providence VA Medical Center, Providence, RI

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 28, 2017

More Information

Additional Information:

• Click here for more information about this study: Implementing and Evaluating INTERACT in VA CLCs

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04195880
• Other Study ID Numbers: CRE 12-025; CIRB 13-10
• First Posted: Dec 12, 2019
• Last Update Posted: May 21, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Recruitment Details	All Veterans admitted to any of the eight experimental and eight control facilities (VA Community Living Centers) during the study timeframe, January 2016 - December 2017.

Arm/Group Title	Experimental VA Community Living Centers	Control VA Community Living Centers
Arm/Group Description	Eight VA CLCs selected to receive the INTERACT intervention Interventions to Reduce Acute Care Transfers: 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.	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
Period Title: Overall Study
STARTED	3205	3338
COMPLETED	3205	3338
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Experimental VA Community Living Centers	Control VA Community Living Centers	Total
Arm/Group Description	Eight VA CLCs selected to receive the INTERACT intervention Interventions to Reduce Acute Care Transfers: 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.	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	Total of all reporting groups
Overall Participants	3205	3338	6543
Age, Customized (Count of Participants)
<55	121 3.8%	141 4.2%	262 4%
55-64	542 16.9%	583 17.5%	1125 17.2%
65-74	1187 37%	1150 34.5%	2337 35.7%
75-84	673 21%	656 19.7%	1329 20.3%
85+	682 21.3%	808 24.2%	1490 22.8%
Sex: Female, Male (Count of Participants)
Female	110 3.4%	84 2.5%	194 3%
Male	3095 96.6%	3254 97.5%	6349 97%
Race/Ethnicity, Customized (Count of Participants)
White, non-Hispanic	2308 72%	2374 71.1%	4682 71.6%
Black	788 24.6%	816 24.4%	1604 24.5%
Hispanic	47 1.5%	79 2.4%	126 1.9%
Other	28 0.9%	39 1.2%	67 1%
Unknown	34 1.1%	30 0.9%	64 1%
Region of Enrollment (Count of Participants)
United States	3205 100%	3338 100%	6543 100%

Outcome Measures

1. Primary Outcome

Title	Hospital Admissions Per Person Year Alive Measured at the Facility Month Level
Description	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.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental VA Community Living Centers	Control VA Community Living Centers
Arm/Group Description	Eight VA CLCs selected to receive the INTERACT intervention Interventions to Reduce Acute Care Transfers: 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.	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
Measure Participants	3205	3338
Mean (Standard Error) [hospitalizations per person year alive]	5.5 (2.5)	5.8 (2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental VA Community Living Centers, Control VA Community Living Centers
	Comments	We assumed the average monthly pre-intervention hospitalization rates of intervention and control CLCs were equal, so only average monthly post-intervention hospitalization rates might diverge. Each CLC had its own start month and contributed 18 months pre-intervention and 18 months post-intervention. Hospitalizations rates were modeled using a multilevel negative-binomial regression because it allows for over-dispersion, which is commonly observed with medical events such as a count.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	negative-binomial regression coefficient
	Comments

2. Secondary Outcome

Title	Potentially Avoidable Hospitalizations
Description	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.
Time Frame	18 months followup during observation period.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental VA Community Living Centers	Control VA Community Living Centers
Arm/Group Description	Eight VA CLCs selected to receive the INTERACT intervention Interventions to Reduce Acute Care Transfers: 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.	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
Measure Participants	3205	3338
Number (95% Confidence Interval) [hospitalizations per person year alive]	.3	.2

Adverse Events

Time Frame	Adverse event data were collected during the study timeframe (18 Months, introduction of intervention, implementation and monitoring) for the eight experimental CLC Veterans and eight controls
Adverse Event Reporting Description	To ensure the safety of Veterans in the CLC and confirm the intervention is not reducing hospitalizations to the detriment of Veterans', we had a safety monitoring plan in place which was reviewed and signed off by the Data Safety Monitoring Board (DSMB) and we generated mortality data for all CLC residents in both INTERACT (experimental) and control facilities, charting changes in mortality rates relative to the historical and contemporary mortality rates of paired facilities.
Arm/Group Title	Experimental VA Community Living Centers		Control VA Community Living Centers
Arm/Group Description	Eight VA CLCs selected to receive the INTERACT intervention Interventions to Reduce Acute Care Transfers: 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.		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
All Cause Mortality
	Experimental VA Community Living Centers		Control VA Community Living Centers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3205 (0%)		0/3338 (0%)
Serious Adverse Events
	Experimental VA Community Living Centers		Control VA Community Living Centers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3205 (0%)		0/3338 (0%)
Other (Not Including Serious) Adverse Events
	Experimental VA Community Living Centers		Control VA Community Living Centers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3205 (0%)		0/3338 (0%)

Limitations/Caveats

Our intervention and control CLCs were not perfectly matched. Due to incomplete implementation of INTERACT in all intervention sites, we acknowledge that this was an incomplete test of the efficacy of the program when properly implemented

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.