Underperforming Nursing HomesNCT00572221
Improving the Quality of Care in Nursing Homes
A study testing Continuing Quality Improvement and Quality Assurance system and CQI and QA System with Best-Practice Care Protocols in people with Underperforming Nursing Homes, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The overall goal of this project is to increase the number of high quality nursing homes in Massachusetts. The study will evaluate an intervention involving two active treatment arms: one implementing a CQI program and a second implementing the CQI program and specific protocol programming. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Underperforming Nursing Homes
- What is being tested?
- Continuing Quality Improvement and Quality Assurance system and CQI and QA System with Best-Practice Care Protocols
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,316 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jan 2010
- 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
- Men and Women
- Residents of long-term care facilities in Massachusetts who have had
- a Minimum Data Set assessment completed by the facility in the last 90 days.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Aging Research, Hebrew Senior Life
Roslindale, Massachusetts, 02131
About this study
The overall goal of this project is to increase the number of high quality nursing homes in Massachusetts. The study will evaluate an intervention involving two active treatment arms: one implementing a CQI program and a second implementing the CQI program and specific protocol programming. The intervention will be implemented in 24 nursing homes identified as performing, over multiple quality indicator domains, at a poor or average level across multiple outcome domains.
Read the detailed description
Nursing facilities as well as CMS and state governments are under pressure to find cost-effective methods to improve quality, particularly in poor and average facilities. In our prior work, we found that better performing facilities make more extensive use of CQI mechanisms, have more protocol driven problem advanced resolution mechanisms and systematically address multiple areas Both arms of the study apply the same standardized approach to CQI, while one arm will include specific best-practice care strategies targeted at identified problems. The study will evaluate whether the CQI program improves quality indicator scores in multiple domains, relative to control facilities, and whether improvement is greater in facilities that also utilize the study's best-practice protocols.
The study consent form describes the MDS assessment (used to evaluate the reliability of the facility's assessment), including items to be reviewed and how information will be obtained. The subject is informed that there is no known risk for participating in research, the purpose of which is to determine if the intervention improves nursing home care in Massachusetts
The outcomes will be reviewed by means of a change in twelve quality indicator scores: ADL decline, ADL decline following improvement, Mobility change, walking improvement, cognitive change, communication change, bowel continence change, bladder continence change, depressed mood change, new insertion of an indwelling urinary catheter, infection prevalence, worsening pain.
- Conditions
- Underperforming Nursing Homes
- Being tested
- Continuing Quality Improvement and Quality Assurance system, CQI and QA System with Best-Practice Care Protocols
- Keywords
- CQI, QA, Best Practice, Quality Improvement, Nursing Facilities, Nursing Homes, Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuing Quality Improvement and Quality Assurance systemBehavioural
The main intervention is a facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation.
CQI and QA System with Best-Practice Care ProtocolsBehavioural
A facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. Research clinical staff will also provide best-practice care protocols designed by our research team to address targeted problem conditions.
| Study group | Role | What they receive |
|---|---|---|
| CQI Program Only | Other | The main intervention is a facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. (The SAVE+ intervention, the CQI system with facility responsible for identifying or designing care protocols for the identified problem condition.) Receives: Behavioral: Continuing Quality Improvement and Quality Assurance system |
| CQI Program and Best-Practice Care Protocols | Other | A facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. Research clinical staff will also provide best-practice care protocols designed by our research team to address targeted problem conditions. (The SAVE+ intervention, a CQI system plus best-practice protocols designed by study team to address identified problem condition.) Receives: Behavioral: CQI and QA System with Best-Practice Care Protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in twelve quality indicator scores
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startFeb 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underperforming Nursing HomesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- John N Morris, PhD, Principal investigator, Institute of Aging Research, Hebrew Rehabilitation Center for the Aged
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572221
- Sponsor's protocol ID
- 06-002
- Other IDs
- R01NR009071, 5R01NR009071-02
- Status last verified
- Mar 2013
- First submitted
- 11 Dec 2007
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Care in Nursing Homes
- ClinicalTrials.gov ID
- NCT00572221
- Acronym / sponsor ID
- 06-002
- Conditions
- Underperforming Nursing Homes
- Keywords
- CQI, QA, Best Practice, Quality Improvement, Nursing Facilities, Nursing Homes, Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,316 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Feb 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Dec 2007 (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.
The overall goal of this project is to increase the number of high quality nursing homes in Massachusetts. The study will evaluate an intervention involving two active treatment arms: one implementing a CQI program and a second implementing the CQI program and specific protocol programming. The intervention will be implemented in 24 nursing homes identified as performing, over multiple quality indicator domains, at a poor or average level across multiple outcome domains.
Detailed description
Nursing facilities as well as CMS and state governments are under pressure to find cost-effective methods to improve quality, particularly in poor and average facilities. In our prior work, we found that better performing facilities make more extensive use of CQI mechanisms, have more protocol driven problem advanced resolution mechanisms and systematically address multiple areas Both arms of the study apply the same standardized approach to CQI, while one arm will include specific best-practice care strategies targeted at identified problems. The study will evaluate whether the CQI program improves quality indicator scores in multiple domains, relative to control facilities, and whether improvement is greater in facilities that also utilize the study's best-practice protocols.
The study consent form describes the MDS assessment (used to evaluate the reliability of the facility's assessment), including items to be reviewed and how information will be obtained. The subject is informed that there is no known risk for participating in research, the purpose of which is to determine if the intervention improves nursing home care in Massachusetts
The outcomes will be reviewed by means of a change in twelve quality indicator scores: ADL decline, ADL decline following improvement, Mobility change, walking improvement, cognitive change, communication change, bowel continence change, bladder continence change, depressed mood change, new insertion of an indwelling urinary catheter, infection prevalence, worsening pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CQI Program Only | Other | Behavioral: Continuing Quality Improvement and Quality Assurance systemThe main intervention is a facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. (The SAVE+ intervention, the CQI system with facility responsible for identifying or designing care protocols for the identified problem condition.) |
| CQI Program and Best-Practice Care Protocols | Other | Behavioral: CQI and QA System with Best-Practice Care ProtocolsA facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. Research clinical staff will also provide best-practice care protocols designed by our research team to address targeted problem conditions. (The SAVE+ intervention, a CQI system plus best-practice protocols designed by study team to address identified problem condition.) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Men and Women
- Residents of long-term care facilities in Massachusetts who have had
- a Minimum Data Set assessment completed by the facility in the last 90 days.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Continuing Quality Improvement and Quality Assurance systemThe main intervention is a facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. | Behavioural | CQI Program Only |
| CQI and QA System with Best-Practice Care ProtocolsA facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation. Research clinical staff will also provide best-practice care protocols designed by our research team to address targeted problem conditions. | Behavioural | CQI Program and Best-Practice Care Protocols |
Primary outcome
Change in twelve quality indicator scores
Time frame: 15 Months
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 20 Mar 2013.
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.
John N Morris, PhD principal investigator
Institute of Aging Research, Hebrew Rehabilitation Center for the Aged
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuing Quality Improvement and Quality Assurance system and CQI and QA System with Best-Practice Care Protocols in people with Underperforming Nursing Homes, run by Hebrew SeniorLife 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 3 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 20 Mar 2013. 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?
Change in twelve quality indicator scores (time frame: 15 Months). 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 20 Mar 2013.