AgedNCT02211274
VA Community Living Centers to Home
A study testing Everyday Competence Assessment and Planning for Community Transitions in people with Aged and Frail Elderly, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Older adults prefer to live as in the community as long as possible. Creating a standardized treatment planning process that includes assessments of everyday competence and goal-setting techniques to help Veterans move from VA nursing homes back to the community can improve functional health, well-being, and quality… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged, Frail Elderly
- What is being tested?
- Everyday Competence Assessment and Planning for Community Transitions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2016to 28 Feb 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CLC residents will be included if they are able to demonstrate understanding of the informed consent process through teach-back and to communicate verbally.
Who cannot join
- CLC residents will be excluded if they are too cognitively impaired or have serious mental illness too severe to meaningfully participate in interviews (i.e., they are not "transition-capable").
- No participants will be excluded based on gender, race, social class, or ethnicity.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
Official title: Improving Veteran Transitions From VA Community Living Centers to the Community
Older adults prefer to live as in the community as long as possible. Creating a standardized treatment planning process that includes assessments of everyday competence and goal-setting techniques to help Veterans move from VA nursing homes back to the community can improve functional health, well-being, and quality of life for older Veterans. Research has shown that 29% of nursing home residents might be able to live safely in the community instead. Currently, VA provides nursing home care to more than 13,000 Veterans across the country, which costs about $3.3 billion a year. It is expensive for VA to provide nursing home care to these inappropriate residents and they are using limited resources that could be given to another Veteran with more urgent needs. The Everyday Competence Assessment and Planning for Community Transitions (ECAP-CT) toolkit will help these Veterans to move back into the community with the services and supports they need based on their individual level of everyday competence.
Read the detailed description
Up to 29% of Community Living Center (CLC; VA nursing homes) residents may not require nursing home levels of care and could successfully reside in the community with appropriate rehabilitative services. Many older adults prefer to remain in their homes, though living independently in the community is not always possible or safe. According to the model of person-environment fit (P-E fit), older adults are at risk for poor outcomes when the demands and resources available in the living environment are not in balance with the individual's everyday competence (the ability to solve problems associated with everyday life). Community-dwelling older adults with low levels of everyday competence and little support are at risk for nursing home transition. Conversely, older adults with higher levels of everyday competence who live in more restrictive environments (e.g., nursing home) may experience declines in functioning resulting from a lack of stimulation. Often, transitions into nursing homes occur during a time of crisis (e.g., after acute hospital stay), leaving little opportunity for appropriate consideration of the individual's current and future level of everyday competence.
In VA, a major focus is to minimize the time spent in the CLCs by providing rehabilitation services and transitioning Veterans back into the community. The mission for the CLC program is to return the Veteran to his or her highest level of well-being, thus maximizing P-E fit. Despite this, CLC staff and Veterans face many barriers to facilitating transitions to the community (e.g., caregiving needs, housing, etc.). Currently no standardized process exists to assure that treatment planning includes processes to maximize P-E fit (e.g., assessing everyday competence, setting resident-directed goals around rehabilitation needs, and developing care plans to transition the Veteran to the community whenever possible).
The investigators' team has developed an instrument to allow providers to assess everyday competence for safe and independent living in the community. However, to ensure successful transitions, assessing everyday competence without intervention is not sufficient. Once CLC interdisciplinary team members have an understanding of the resident's everyday competence and barriers to transition, goal-setting must occur, focused on rehabilitation goals and care planning around transitioning to the community.
The objective of the proposed research is to develop an effective and feasible toolkit the CLC interdisciplinary team can use to 1) assess the Veteran's everyday competence for safe and independent living; 2) develop personally meaningful rehabilitation goals that facilitate successful transition out of the CLC based on everyday competence; and 3) conduct structured care planning to support resident goals around transitioning back into the community. With the innovative consideration of everyday competence and goal-setting in this context, Veterans will have optimal P-E fit upon returning to the community, thus ensuring a successful transition outcome (i.e., not readmitted to the CLC within 90 days).
- Conditions
- Aged, Frail Elderly
- Being tested
- Everyday Competence Assessment and Planning for Community Transitions
- Keywords
- Quality of Life, Nursing Homes, Housing for the Elderly, Homes for the Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everyday Competence Assessment and Planning for Community TransitionsOther
Also called ECAP - CT
The Everyday Competence Assessment and Planning for Community Transitions (ECAP-CT) toolkit will allow CLC interdisciplinary team members to 1) assess the Veteran's everyday competence for safe and independent living; 2) develop personally meaningful rehabilitation goals that facilitate successful transition out of the CLC based on everyday competence; and 3) conduct structured treatment planning to support resident goals around transitioning back into the community. By considering everyday competence and goal-setting in this context, Veterans will have optimal P-E fit upon returning to the community, ensuring a successful transition.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Individuals who want to leave the CLC will be allowed to participate in the study, there will be no assignment to groups. Individuals who want to leave the CLC will undergo transition care planning using the investigators' standardized toolkit. The investigators will compare outcomes to administrative data from other similar VA nursing homes. Receives: Other: Everyday Competence Assessment and Planning for Community Transitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition Outcome
The primary outcome of interest for this pilot study will be transition outcome. Transitions will be "successful" if the resident leaves the CLC with a "community" destination and is not readmitted to the CLC within 90 days. For the purposes of this study, transitions to the "community" include any non-institutional environment that is more independent than the CLCs (e.g., single-family home, senior apartment, assisted living, medical foster home, etc.). For individuals who are unable to transition or who transition and are readmitted to the CLC within 90 days, these transitions will be "unsuccessful".
Measured: 90 days post-discharge
Secondary outcomes (9)
Goal Attainment Scaling
An important outcome for participants at the intervention sites will be Goal Attainment Scaling64, which will allow us to identify if the resident was able to achieve the transition goals within the planned timeframe.
Measured: Baseline
Multilevel Assessment Instrument - Environment Scale [MAI-ES]
Measures person-environment fit
Measured: Baseline and 90 days
Multilevel Assessment Instrument - Environment Scale [MAI-ES]
Measures person-environment fit. Will be assessed at baseline and 90 days.
Measured: 90 days
Multilevel Assessment Instrument - Environment Scale
Measures person-environment fit.
Measured: Baseline and 90 days post discharge
Money Follows the Person - Quality of Life Scale
Measures quality of life for individuals moving from a nursing home to the community.
Measured: Baseline and 90 days post discharge
Care Transitions Measure - 3
Measures individual's preparation for transitioning out of a health care facility.
Measured: Baseline and 90 days post discharge
Geriatric Depression Scale - Residential
Measure of depression for older adults residing in residential care facilities.
Measured: Baseline and 90 days post discharge
Length of Stay in CLC
Length of stay in the clc
Measured: 30 days and 90 days post discharge
Health Services Utilization
Identify health services (e.g., hospital admission, ER visit, etc.) utilization following transition from CLC.
Measured: 30 days and 90 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study start1 Jul 2016
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Why it stopped: Due to issues with the study, we did not proceed with enrolling participants in the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Whitney L. Mills, PhD, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211274
- Sponsor's protocol ID
- D1241-W
- Status last verified
- Apr 2020
- First submitted
- 31 Jul 2014
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Veteran Transitions From VA Community Living Centers to the Community
- ClinicalTrials.gov ID
- NCT02211274
- Acronym / sponsor ID
- D1241-W
- Conditions
- Aged, Frail Elderly
- Keywords
- Quality of Life, Nursing Homes, Housing for the Elderly, Homes for the Aged
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to issues with the study, we did not proceed with enrolling participants in the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 7 Aug 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.
Older adults prefer to live as in the community as long as possible. Creating a standardized treatment planning process that includes assessments of everyday competence and goal-setting techniques to help Veterans move from VA nursing homes back to the community can improve functional health, well-being, and quality of life for older Veterans. Research has shown that 29% of nursing home residents might be able to live safely in the community instead. Currently, VA provides nursing home care to more than 13,000 Veterans across the country, which costs about $3.3 billion a year. It is expensive for VA to provide nursing home care to these inappropriate residents and they are using limited resources that could be given to another Veteran with more urgent needs. The Everyday Competence Assessment and Planning for Community Transitions (ECAP-CT) toolkit will help these Veterans to move back into the community with the services and supports they need based on their individual level of everyday competence.
Detailed description
Up to 29% of Community Living Center (CLC; VA nursing homes) residents may not require nursing home levels of care and could successfully reside in the community with appropriate rehabilitative services. Many older adults prefer to remain in their homes, though living independently in the community is not always possible or safe. According to the model of person-environment fit (P-E fit), older adults are at risk for poor outcomes when the demands and resources available in the living environment are not in balance with the individual's everyday competence (the ability to solve problems associated with everyday life). Community-dwelling older adults with low levels of everyday competence and little support are at risk for nursing home transition. Conversely, older adults with higher levels of everyday competence who live in more restrictive environments (e.g., nursing home) may experience declines in functioning resulting from a lack of stimulation. Often, transitions into nursing homes occur during a time of crisis (e.g., after acute hospital stay), leaving little opportunity for appropriate consideration of the individual's current and future level of everyday competence.
In VA, a major focus is to minimize the time spent in the CLCs by providing rehabilitation services and transitioning Veterans back into the community. The mission for the CLC program is to return the Veteran to his or her highest level of well-being, thus maximizing P-E fit. Despite this, CLC staff and Veterans face many barriers to facilitating transitions to the community (e.g., caregiving needs, housing, etc.). Currently no standardized process exists to assure that treatment planning includes processes to maximize P-E fit (e.g., assessing everyday competence, setting resident-directed goals around rehabilitation needs, and developing care plans to transition the Veteran to the community whenever possible).
The investigators' team has developed an instrument to allow providers to assess everyday competence for safe and independent living in the community. However, to ensure successful transitions, assessing everyday competence without intervention is not sufficient. Once CLC interdisciplinary team members have an understanding of the resident's everyday competence and barriers to transition, goal-setting must occur, focused on rehabilitation goals and care planning around transitioning to the community.
The objective of the proposed research is to develop an effective and feasible toolkit the CLC interdisciplinary team can use to 1) assess the Veteran's everyday competence for safe and independent living; 2) develop personally meaningful rehabilitation goals that facilitate successful transition out of the CLC based on everyday competence; and 3) conduct structured care planning to support resident goals around transitioning back into the community. With the innovative consideration of everyday competence and goal-setting in this context, Veterans will have optimal P-E fit upon returning to the community, thus ensuring a successful transition outcome (i.e., not readmitted to the CLC within 90 days).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Everyday Competence Assessment and Planning for Community TransitionsIndividuals who want to leave the CLC will be allowed to participate in the study, there will be no assignment to groups. Individuals who want to leave the CLC will undergo transition care planning using the investigators' standardized toolkit. The investigators will compare outcomes to administrative data from other similar VA nursing homes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CLC residents will be included if they are able to demonstrate understanding of the informed consent process through teach-back and to communicate verbally.
Key exclusion criteria (2 listed)
- CLC residents will be excluded if they are too cognitively impaired or have serious mental illness too severe to meaningfully participate in interviews (i.e., they are not "transition-capable").
- No participants will be excluded based on gender, race, social class, or ethnicity.
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 |
|---|---|---|
| Everyday Competence Assessment and Planning for Community TransitionsAlso: ECAP - CTThe Everyday Competence Assessment and Planning for Community Transitions (ECAP-CT) toolkit will allow CLC interdisciplinary team members to 1) assess the Veteran's everyday competence for safe and independent living; 2) develop personally meaningful rehabilitation goals that facilitate successful transition out of the CLC based on everyday competence; and 3) conduct structured treatment planning to support resident goals around transitioning back into the community. By considering everyday competence and goal-setting in this context, Veterans will have optimal P-E fit upon returning to the community, ensuring a successful transition. | Other | Study Group |
Primary outcome
Transition Outcome
Time frame: 90 days post-discharge
The primary outcome of interest for this pilot study will be transition outcome. Transitions will be "successful" if the resident leaves the CLC with a "community" destination and is not readmitted to the CLC within 90 days. For the purposes of this study, transitions to the "community" include any non-institutional environment that is more independent than the CLCs (e.g., single-family home, senior apartment, assisted living, medical foster home, etc.). For individuals who are unable to transition or who transition and are readmitted to the CLC within 90 days, these transitions will be "unsuccessful".
9 secondary outcomes
Goal Attainment Scaling
Time frame: Baseline
Multilevel Assessment Instrument - Environment Scale [MAI-ES]
Time frame: Baseline and 90 days
Multilevel Assessment Instrument - Environment Scale [MAI-ES]
Time frame: 90 days
Multilevel Assessment Instrument - Environment Scale
Time frame: Baseline and 90 days post discharge
Money Follows the Person - Quality of Life Scale
Time frame: Baseline and 90 days post discharge
Care Transitions Measure - 3
Time frame: Baseline and 90 days post discharge
Geriatric Depression Scale - Residential
Time frame: Baseline and 90 days post discharge
Length of Stay in CLC
Time frame: 30 days and 90 days post discharge
Health Services Utilization
Time frame: 30 days and 90 days post discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- 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.
Whitney L. Mills, PhD principal investigator
Providence VA Medical Center, Providence, RI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everyday Competence Assessment and Planning for Community Transitions in people with Aged and Frail Elderly, run by VA Office of Research and Development at 2 sites 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 2 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: withdrawn, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Transition Outcome (time frame: 90 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2020.