CONNECT for Quality: A Study to Reduce Falls in Nursing Homes (CONNECT)
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|ClinicalTrials.gov Identifier: NCT00636675|
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Accidental Falls||Behavioral: Falls QI Behavioral: Connect||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1726 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Outcomes of Nursing Management Practice in Nursing Homes|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Fall QI
Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel.
Behavioral: Falls QI
Falls uses the Falls Management Program (AHRQ); it is familiar to nursing homes, uses minimal researcher time, is adaptable, and simulates real word quality improvement practices. Falls is delivered over 3 months. Components include:
Experimental: Connect & Falls QI
Connect is delivered, followed by Falls. Behavioral intervention to improve staff interaction for better care planning and execution. Connect will be delivered, followed by the Falls quality improvement intervention.
Connect, delivered over 12 weeks, helps nursing home staff learn interactions that increase exchange of new information, number and quality of connections among staff, and improve problem-solving about patient care. Protocols:
- Fall Related Process Measures [ Time Frame: 6 months post intervention ]Mean of the total number of fall risk reduction indicators (steps staff have taken to reduce fall risk) that were documented in residents with high fall risk. These included orthostatic blood pressure measurement/intervention; sensory impairment evaluation/intervention; footwear; exercise/assistive device intervention; toileting schedule; environmental modification; psychoactive medication reduction; and vitamin D supplements. Note that this measure is NOT related to staff but rather residents in the nursing home, therefore the numbers are different from participant flow. The residents were not considered enrolled participants in the study.
- Fall Rates [ Time Frame: 6 months post intervention ]Numerator: number of falls occurring in a 6 month period, denominator: number of bed days for resident. Rate adjusted for baseline rate and casemix. Note that this measure is NOT related to staff but rather residents in the nursing home. The residents were not considered enrolled participants in the study.
- Change in Weighted Average of Staff Interaction Scales [ Time Frame: baseline to post intervention, an average of 6 months ]This is a summary measure of 7 staff surveys using the weighted average on a 1-5 Likert scale with 5 indicating the highest (best) quality. Scales include Communication Openness, Accuracy, and Timeliness; Participation in Decision Making, Local Interaction Strategies, Safety Climate, and Staff Perceptions of Quality. Number presented is the change from baseline attributable to the intervention. Higher numbers represent a greater change attributable to the intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636675
|United States, North Carolina|
|Duke University School of Nursing|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Ruth A Anderson, RN, PhD||Duke University School of Nursing|
|Principal Investigator:||Cathleen S Colon-Emeric, MD, MHSc||Duke University|