Nursing HomeCNHDashboardNCT02674698
Disseminating a Dashboard for VA Purchased Community Nursing Homes
A study testing Access to the CNH Dashboard Step 1, Access to the CNH Dashboard Step 2 and Access to the CNH Dashboard Step 3 in people with Nursing Home and Veterans, run by Providence VA Medical Center.
Trial summary
Objectives: The purpose of this proposal is to evaluate the impact of the CNH Dashboard implementation on the quality of VA Purchased CNH care relative to other CNH facilities, and to evaluate the quality of Veteran-specific care in purchased CNH facilities by transition and safety outcome measures derived from… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nursing Home, Veterans, Functional Impairment
- What is being tested?
- Access to the CNH Dashboard Step 1, Access to the CNH Dashboard Step 2 and Access to the CNH Dashboard Step 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2018
- 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
- No individual patients will be randomized
Who cannot join
None listed.
About this study
Objectives: The purpose of this proposal is to evaluate the impact of the CNH Dashboard implementation on the quality of VA Purchased CNH care relative to other CNH facilities, and to evaluate the quality of Veteran-specific care in purchased CNH facilities by transition and safety outcome measures derived from Veteran-specific CMS data.
Methods: The investigators will evaluate the effect of the CNH Dashboard release in a randomized, stepped-wedge dissemination. This dissemination design allows us to determine the impact of the CNH Dashboard on the quality of purchased CNH facility more systematically than a single phase roll-out. In each of the 4 steps, The investigators will release the CNH Dashboard to a randomly selected set of VISNs. Dashboard release will be accompanied by education.
Read more
Findings: The CNH Dashboard has actionable information to leaders in GEC at the local, regional, and national levels.
Impact: When completed, this program will improve the quality of care Veterans receive in VA purchased CNH programs as demonstrated by improved selection of CNH facilities and Veteran-specific measures.
Read the detailed description
Objective: To evaluate the impact of the CNH Dashboard implementation on the quality of contracted CNHs relative to non-contracted CNH in a VAMC Market.
Stepped wedge Dashboard Implementation The investigators propose a stepped wedge implementation of the CNH Dashboard, randomized at the VISN level (n=3-4 per period). The stepped wedge allows for maximization of GEC resources with a systematic roll out to provide sufficient education to every randomized VISN (see education program below). Every 3 months, we will bring a new randomized group of VISNs 'online' with the CNH Dashboard (Table 2). The investigators selected the VISN level as a unit of randomization, because there is integration between VAMCs within a VISN. With approximately 4 VAMCs in each VISN, this release schedule is robust, but manageable with support from this award. The investigators will pilot test the CNH Dashboard in 3 VISNs to finalize the information upload, dashboard, and educational program.
Table 2: Stepped wedge plan for CNH Dashboard roll out Randomized VISN Group Months
-6 to 0 Months 1-3 Months 4-6 Months 7-9 Months 10-12 Pilot VISNs CNH Dashboard CNH Dashboard CNH Dashboard CNH Dashboard CNH Dashboard
- Usual CNH Quality CNH Dashboard CNH Dashboard CNH Dashboard CNH Dashboard
- Usual CNH Quality Usual CNH Quality CNH Dashboard CNH Dashboard CNH Dashboard
- Usual CNH Quality Usual CNH Quality Usual CNH Quality CNH Dashboard CNH Dashboard
- Usual CNH Quality Usual CNH Quality Usual CNH Quality Usual CNH Quality CNH Dashboard
Dashboard Hosting The CNH Dashboard will be hosted on a VA GEC intranet website. The advantage of a intranet site is that it allows controlled access to the site for the stepped wedge implementation. As the project continues, the investigators will enlist the assistance of the Indianapolis VAMC Center for Applied Systems Engineering to guide the transition toward an electronic dashboard that is accessible throughout the VA intranet.
Educational Program The investigators will design an educational program with the goals of a) understanding about the quality of CNH as presented in the five star rating system, b) orientation to the dashboard, c) identifying low performing CNH facilities, and d) available options for contracting with higher quality facilities. This educational program will include elements of didactic training, as well as coaching throughout the implementation. The effectiveness of this educational program will be determined by anonymous participant survey. The education program will be rolled out to VISN and facility geriatric program leaders.
Primary Analysis While the investigators are randomizing by VISN, the investigators will analyze by VAMC, because that is where purchased CNH selection occurs. For each VAMC, we will measure the ratio of the average quality of purchased CNH facilities (observed) to non-contracted CNH (expected) in the VAMC market. The VAMC average observed to expected (O/E) ratio will serve as the primary measure for this analysis. The primary reference baseline period will consist of the average O/E in the 6 months prior to CNH Dashboard implementation. The intervention period, during which the CNH Dashboard is released to the randomized group, will last for 3 months during which the educational program will be delivered and assessed. The primary outcome will be the average O/E in the 12 months after the roll out period ends. Each VAMC will act as their own control. Our primary analyses will consist of the VAMC average O/E ratio of Contracted CNH facilities in the 6 months prior to the intervention and the 12 months post-intervention (Figure 6). From Figure 3, the investigators expect that this will be a normal distribution and, therefore, will use a Student's t-test to compare the average O/E ratios.
Currently, CNH contracts are generally written with annual renewals of a 5-year master contract. Thus, if quality is low, a contract can be discontinued annually. However, there is substantial overhead in establishing a 5-year contract. While the investigators do not expect the CNH quality to be the only measure of CNH selection, we anticipate that it will become a factor in non-renewal and new contract initiation. Presently, each VAMC contracts with an average of 12 CNHs and thus, there are 2-3 facilities per year which are up for contract. Changing the contracting process will take time and with GEC resources; the investigators are thus committed to follow up for 12 months for each of the four groups after CNH Dashboard roll out.
Secondary Analysis To protect the internal validity of the stepped wedge implementation, the investigators must perform secondary analyses with additional reference periods.12 This helps to account for secular trends and intervening events which can influence the study outcome. For example, if CMS were to revise the criteria for the 5-star ranking system downward during the CNH Dashboard implementation, the investigators would introduce a type 2 error (incorrect acceptance of the null). In addition to the changes in contracted CNH quality as the dashboard is released, the investigators expect that there will be movement toward higher quality facilities among VAMCs prior to their randomized roll out. This change is a result of VAMCs taking action because they know they are being examined with respect to their contracted CNH quality prior to seeing the CNH Dashboard. VAMCs will either pressure contracted CNHs to improve or change contracting practices. As a result, we expect that the O/E ratio will rise naturally during the course of the study. Additionally, secular trends in CNH selection, VA approval for fee authority, OIG investigations, news stories, and VA organizational decisions could influence the selection and focus on CNH quality.
To address this natural change, the investigators propose secondary analyses with additional reference periods. Our first additional reference period for the randomized groups will be the O/E in the 6 months prior to CNH Dashboard implementation (months -6 to 0), which will be compared to the O/E of the primary analysis period. Second, we will examine the change O/E for the primary reference period. We will compare the O/E of randomized group 1 to the other randomized groups using Student's t-tests to determine if there has been significant baseline change over the course of the evaluation. Finally, the investigators will examine the O/E in the reference period as a function of time. This will particularly pertain to Groups 3 and 4 which have a longer window (12 and 15 months respectively) by which we can examine the temporal change in O/E without the intervention.
- Conditions
- Nursing Home, Veterans, Functional Impairment, Quality of Care
- Being tested
- Access to the CNH Dashboard Step 1, Access to the CNH Dashboard Step 2, Access to the CNH Dashboard Step 3, Access to the CNH Dashboard Step 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to the CNH Dashboard Step 1Other
Also called Step 1
VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard
Access to the CNH Dashboard Step 2Other
VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard
Access to the CNH Dashboard Step 3Other
VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard
Access to the CNH Dashboard Step 4Other
VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard
| Study group | Role | What they receive |
|---|---|---|
| VA Integrated Service Networks Group 1 | Other | Access to the CNH Dashboard Step 1 Receives: Other: Access to the CNH Dashboard Step 1; Other: Access to the CNH Dashboard Step 2; Other: Access to the CNH Dashboard Step 3; Other: Access to the CNH Dashboard Step 4 |
| VA Integrated Service Networks Group 2 | Other | Access to the CNH Dashboard Step 2 Receives: Other: Access to the CNH Dashboard Step 2; Other: Access to the CNH Dashboard Step 3; Other: Access to the CNH Dashboard Step 4 |
| VA Integrated Service Networks Group 3 | Other | Access to the CNH Dashboard Step 3 Receives: Other: Access to the CNH Dashboard Step 3; Other: Access to the CNH Dashboard Step 4 |
| VA Integrated Service Networks Group 4 | Other | Access to the CNH Dashboard Step 4 Receives: Other: Access to the CNH Dashboard Step 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
O/E ratio for CMS Nursing Home Compare Star Ranking for VA-Paid CNH Facilities relative to local market
We will use the CMS NH Compare Star Ranking for VA-Paid facilities relative to the local market
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing HomeStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, James Rudolph, Providence VA Medical Center
- Investigators
- James L Rudolph, MD, SM, Principal investigator, Providence VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674698
- Sponsor's protocol ID
- PEC-15-465
- Acronym
- CNHDashboard
- Status last verified
- Oct 2016
- First submitted
- 2 Feb 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating a Dashboard for VA Purchased Community Nursing Homes
- ClinicalTrials.gov ID
- NCT02674698
- Acronym / sponsor ID
- CNHDashboard / PEC-15-465
- Conditions
- Nursing Home, Veterans, Functional Impairment, Quality of Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 4 Feb 2016 (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.
Objectives: The purpose of this proposal is to evaluate the impact of the CNH Dashboard implementation on the quality of VA Purchased CNH care relative to other CNH facilities, and to evaluate the quality of Veteran-specific care in purchased CNH facilities by transition and safety outcome measures derived from Veteran-specific CMS data.
Methods: The investigators will evaluate the effect of the CNH Dashboard release in a randomized, stepped-wedge dissemination. This dissemination design allows us to determine the impact of the CNH Dashboard on the quality of purchased CNH facility more systematically than a single phase roll-out. In each of the 4 steps, The investigators will release the CNH Dashboard to a randomly selected set of VISNs. Dashboard release will be accompanied by education.
Findings: The CNH Dashboard has actionable information to leaders in GEC at the local, regional, and national levels.
Impact: When completed, this program will improve the quality of care Veterans receive in VA purchased CNH programs as demonstrated by improved selection of CNH facilities and Veteran-specific measures.
Detailed description
Objective: To evaluate the impact of the CNH Dashboard implementation on the quality of contracted CNHs relative to non-contracted CNH in a VAMC Market.
Stepped wedge Dashboard Implementation The investigators propose a stepped wedge implementation of the CNH Dashboard, randomized at the VISN level (n=3-4 per period). The stepped wedge allows for maximization of GEC resources with a systematic roll out to provide sufficient education to every randomized VISN (see education program below). Every 3 months, we will bring a new randomized group of VISNs 'online' with the CNH Dashboard (Table 2). The investigators selected the VISN level as a unit of randomization, because there is integration between VAMCs within a VISN. With approximately 4 VAMCs in each VISN, this release schedule is robust, but manageable with support from this award. The investigators will pilot test the CNH Dashboard in 3 VISNs to finalize the information upload, dashboard, and educational program.
Table 2: Stepped wedge plan for CNH Dashboard roll out Randomized VISN Group Months
-6 to 0 Months 1-3 Months 4-6 Months 7-9 Months 10-12 Pilot VISNs CNH Dashboard CNH Dashboard CNH Dashboard CNH Dashboard CNH Dashboard
- Usual CNH Quality CNH Dashboard CNH Dashboard CNH Dashboard CNH Dashboard
- Usual CNH Quality Usual CNH Quality CNH Dashboard CNH Dashboard CNH Dashboard
- Usual CNH Quality Usual CNH Quality Usual CNH Quality CNH Dashboard CNH Dashboard
- Usual CNH Quality Usual CNH Quality Usual CNH Quality Usual CNH Quality CNH Dashboard
Dashboard Hosting The CNH Dashboard will be hosted on a VA GEC intranet website. The advantage of a intranet site is that it allows controlled access to the site for the stepped wedge implementation. As the project continues, the investigators will enlist the assistance of the Indianapolis VAMC Center for Applied Systems Engineering to guide the transition toward an electronic dashboard that is accessible throughout the VA intranet.
Educational Program The investigators will design an educational program with the goals of a) understanding about the quality of CNH as presented in the five star rating system, b) orientation to the dashboard, c) identifying low performing CNH facilities, and d) available options for contracting with higher quality facilities. This educational program will include elements of didactic training, as well as coaching throughout the implementation. The effectiveness of this educational program will be determined by anonymous participant survey. The education program will be rolled out to VISN and facility geriatric program leaders.
Primary Analysis While the investigators are randomizing by VISN, the investigators will analyze by VAMC, because that is where purchased CNH selection occurs. For each VAMC, we will measure the ratio of the average quality of purchased CNH facilities (observed) to non-contracted CNH (expected) in the VAMC market. The VAMC average observed to expected (O/E) ratio will serve as the primary measure for this analysis. The primary reference baseline period will consist of the average O/E in the 6 months prior to CNH Dashboard implementation. The intervention period, during which the CNH Dashboard is released to the randomized group, will last for 3 months during which the educational program will be delivered and assessed. The primary outcome will be the average O/E in the 12 months after the roll out period ends. Each VAMC will act as their own control. Our primary analyses will consist of the VAMC average O/E ratio of Contracted CNH facilities in the 6 months prior to the intervention and the 12 months post-intervention (Figure 6). From Figure 3, the investigators expect that this will be a normal distribution and, therefore, will use a Student's t-test to compare the average O/E ratios.
Currently, CNH contracts are generally written with annual renewals of a 5-year master contract. Thus, if quality is low, a contract can be discontinued annually. However, there is substantial overhead in establishing a 5-year contract. While the investigators do not expect the CNH quality to be the only measure of CNH selection, we anticipate that it will become a factor in non-renewal and new contract initiation. Presently, each VAMC contracts with an average of 12 CNHs and thus, there are 2-3 facilities per year which are up for contract. Changing the contracting process will take time and with GEC resources; the investigators are thus committed to follow up for 12 months for each of the four groups after CNH Dashboard roll out.
Secondary Analysis To protect the internal validity of the stepped wedge implementation, the investigators must perform secondary analyses with additional reference periods.12 This helps to account for secular trends and intervening events which can influence the study outcome. For example, if CMS were to revise the criteria for the 5-star ranking system downward during the CNH Dashboard implementation, the investigators would introduce a type 2 error (incorrect acceptance of the null). In addition to the changes in contracted CNH quality as the dashboard is released, the investigators expect that there will be movement toward higher quality facilities among VAMCs prior to their randomized roll out. This change is a result of VAMCs taking action because they know they are being examined with respect to their contracted CNH quality prior to seeing the CNH Dashboard. VAMCs will either pressure contracted CNHs to improve or change contracting practices. As a result, we expect that the O/E ratio will rise naturally during the course of the study. Additionally, secular trends in CNH selection, VA approval for fee authority, OIG investigations, news stories, and VA organizational decisions could influence the selection and focus on CNH quality.
To address this natural change, the investigators propose secondary analyses with additional reference periods. Our first additional reference period for the randomized groups will be the O/E in the 6 months prior to CNH Dashboard implementation (months -6 to 0), which will be compared to the O/E of the primary analysis period. Second, we will examine the change O/E for the primary reference period. We will compare the O/E of randomized group 1 to the other randomized groups using Student's t-tests to determine if there has been significant baseline change over the course of the evaluation. Finally, the investigators will examine the O/E in the reference period as a function of time. This will particularly pertain to Groups 3 and 4 which have a longer window (12 and 15 months respectively) by which we can examine the temporal change in O/E without the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VA Integrated Service Networks Group 1 | Other | Other: Access to the CNH Dashboard Step 1, Other: Access to the CNH Dashboard Step 2, Other: Access to the CNH Dashboard Step 3, Other: Access to the CNH Dashboard Step 4Access to the CNH Dashboard Step 1 |
| VA Integrated Service Networks Group 2 | Other | Other: Access to the CNH Dashboard Step 2, Other: Access to the CNH Dashboard Step 3, Other: Access to the CNH Dashboard Step 4Access to the CNH Dashboard Step 2 |
| VA Integrated Service Networks Group 3 | Other | Other: Access to the CNH Dashboard Step 3, Other: Access to the CNH Dashboard Step 4Access to the CNH Dashboard Step 3 |
| VA Integrated Service Networks Group 4 | Other | Other: Access to the CNH Dashboard Step 4Access to the CNH Dashboard Step 4 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- No individual patients will be randomized
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Access to the CNH Dashboard Step 1Also: Step 1VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard | Other | VA Integrated Service Networks Group 1 |
| Access to the CNH Dashboard Step 2VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard | Other | VA Integrated Service Networks Group 1, VA Integrated Service Networks Group 2 |
| Access to the CNH Dashboard Step 3VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard | Other | VA Integrated Service Networks Group 1, VA Integrated Service Networks Group 2, VA Integrated Service Networks Group 3 |
| Access to the CNH Dashboard Step 4VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard | Other | VA Integrated Service Networks Group 1, VA Integrated Service Networks Group 2, VA Integrated Service Networks Group 3, VA Integrated Service Networks Group 4 |
Primary outcome
O/E ratio for CMS Nursing Home Compare Star Ranking for VA-Paid CNH Facilities relative to local market
Time frame: 1 year
We will use the CMS NH Compare Star Ranking for VA-Paid facilities relative to the local market
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: No. No data will be shared
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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.
James L Rudolph, MD, SM principal investigator
Providence VA Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Access to the CNH Dashboard Step 1, Access to the CNH Dashboard Step 2 and Access to the CNH Dashboard Step 3 in people with Nursing Home and Veterans, run by Providence VA Medical Center.
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 0 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: status not confirmed, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
O/E ratio for CMS Nursing Home Compare Star Ranking for VA-Paid CNH Facilities relative to local market (time frame: 1 year). 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 4 Oct 2016.