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Improving the Quality of Care in Nursing Homes
This study is enrolling participants by invitation only.
Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT00572221
  Purpose

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
Underperforming Nursing Homes
Behavioral: Continuing Quality Improvement and Quality Assurance system
Behavioral: CQI and QA System with Best-Practice Care Protocols

MedlinePlus related topics: Nursing Homes
U.S. FDA Resources
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

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • Change in twelve quality indicator scores [ Time Frame: 15 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: February 2006
Estimated Study Completion Date: January 2010
Arms Assigned Interventions
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.)
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.
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.)
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572221

Locations
United States, Massachusetts
Institute for Aging Research, Hebrew Senior Life
Roslindale, Massachusetts, United States, 02131
Sponsors and Collaborators
Investigators
Principal Investigator: John N Morris, PhD Institute of Aging Research, Hebrew Rehabilitation Center for the Aged
  More Information

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

Keywords provided by National Institute of Nursing Research (NINR):
CQI
QA
Best Practice
Quality Improvement
Nursing Facilities
Nursing Homes
Care

ClinicalTrials.gov processed this record on January 16, 2009