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Sponsored by: |
National Institute of Nursing Research (NINR) |
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Information provided by: | National Institute of Nursing Research (NINR) |
ClinicalTrials.gov Identifier: | NCT00572221 |
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.
Condition | Intervention |
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Underperforming Nursing Homes |
Behavioral: Continuing Quality Improvement and Quality Assurance system Behavioral: CQI and QA System with Best-Practice Care Protocols |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Improving the Quality of Care in Nursing Homes |
Estimated Enrollment: | 720 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | January 2010 |
Arms | Assigned Interventions |
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CQI Program Only
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.)
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Behavioral: Continuing Quality Improvement and Quality Assurance system
The main intervention is a facility-wide Continuing Quality Improvement and Quality Assurance system, with problem recognition and ongoing evaluation.
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CQI Program and Best-Practice Care Protocols
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.)
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Behavioral: CQI and QA System with Best-Practice Care Protocols
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.
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Institute for Aging Research, Hebrew Senior Life | |
Roslindale, Massachusetts, United States, 02131 |
Principal Investigator: | John N Morris, PhD | Institute of Aging Research, Hebrew Rehabilitation Center for the Aged |
Responsible Party: | Institute for Aging Research, Hebrew SeniorLife ( John N. Morris, Ph. D., Co-Director ) |
Study ID Numbers: | 06-002, 5 R01 NR009071-02 |
Study First Received: | December 11, 2007 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00572221 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
CQI QA Best Practice Quality Improvement |
Nursing Facilities Nursing Homes Care |