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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Improving the Quality of Care in Nursing Homes

Resource links provided by NLM:


Further study details as provided by Hebrew Rehabilitation Center, Boston:

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

Enrollment: 4316
Study Start Date: February 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hebrew Rehabilitation Center, Boston
Investigators
Principal Investigator: John N Morris, PhD Institute of Aging Research, Hebrew Rehabilitation Center for the Aged
  More Information

No publications provided

Responsible Party: Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT00572221     History of Changes
Other Study ID Numbers: 06-002, R01NR009071, 5 R01 NR009071-02
Study First Received: December 11, 2007
Last Updated: March 18, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Hebrew Rehabilitation Center, Boston:
CQI
QA
Best Practice
Quality Improvement
Nursing Facilities
Nursing Homes
Care

Additional relevant MeSH terms:
Cytarabine
Methotrexate
Etoposide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Folic Acid Antagonists
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014