Improving the Quality of Care in Nursing Homes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier:
NCT00572221
First received: December 11, 2007
Last updated: March 18, 2013
Last verified: March 2013

December 11, 2007
March 18, 2013
February 2006
January 2010   (final data collection date for primary outcome measure)
Change in twelve quality indicator scores [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572221 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Improving the Quality of Care in Nursing Homes
Improving the Quality of Care in Nursing Homes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Underperforming Nursing Homes
  • 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.
  • 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.
  • 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.)
    Intervention: Behavioral: Continuing Quality Improvement and Quality Assurance system
  • 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.)
    Intervention: Behavioral: CQI and QA System with Best-Practice Care Protocols
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4316
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00572221
06-002, R01NR009071, 5 R01 NR009071-02
No
Hebrew Rehabilitation Center, Boston
Hebrew Rehabilitation Center, Boston
National Institute of Nursing Research (NINR)
Principal Investigator: John N Morris, PhD Institute of Aging Research, Hebrew Rehabilitation Center for the Aged
Hebrew Rehabilitation Center, Boston
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP