CONNECT for Quality: A Study to Reduce Falls in Nursing Homes (CONNECT)

November 26, 2018 updated by: Duke University

Outcomes of Nursing Management Practice in Nursing Homes

Clinical trials have identified interventions that reduce adverse outcomes such as falls in nursing home (NH) residents but attempts to translate these into practice quality improvement (QI) techniques have not been successful. Using a complexity science framework, our previous study showed that low connection, information flow, and cognitive diversity among NH staff explains quality of care for complex problems such as falls. Our pilot of "Connect," a multi-component intervention that encourages staff to engage in network-building and use simple strategies to make new connections with others, enhance information flow, and use cognitive diversity, suggests that staff can improve the density and quality of their interactions. This 5-year study uses a prospective, cluster-randomized, outcome assessment blinded design, with NHs (n=16) randomized to either Connect and a falls QI program (Connect + Falls) or QI alone (Falls). About 800 residents and 576 staff will participate. Specific aims are to, in nursing homes: 1) Compare the impact of the Connect intervention plus a falls reduction QI intervention (Connect+Falls) to a falls reduction QI intervention (Falls) on fall risk reduction indicators (orthostatic blood pressure, sensory impairment, footwear appropriateness, gait; assistive device; toileting needs, environment, and psychotropic medication); 2) Compare the impact of Connect+Falls to Falls alone on fall rates and injurious falls, and determine whether these are mediated by the change in fall risk reduction indicators; 3) Compare the impact of Connect+Falls to Falls alone on complexity science measures (communication, participation in decision making, local interactions, safety climate, staff perceptions of quality) and determine whether these mediate the impact on fall risk reduction indicators and fall rates and injurious falls. Cross-sectional observations of complexity science measures are taken at baseline, at 3 months, at 6 months, and at 9 months. Resident fall risk reduction indicators, fall rates, and injurious falls are measured for the 6 months prior to the first intervention and the 6 months after the final intervention is completed. Analysis will use a 3-level mixed model to account for the complex nesting of patients and staff within nursing homes, and to control for covariates associated with fall risk, including baseline facility fall rates and staff turnover rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although clinical trials have identified interventions that reduce adverse outcomes such as falls in nursing home (NH) residents, attempts to translate those interventions into practice using current standard of care quality improvement (QI) programs[1, 2] have not led to expected improvements.[3, 4] Barriers encountered in previous studies point directly to a need for effective nursing management practices (NMPs).[1, 3, 5] Many studies now show that relationship-oriented NMPs such as open communication, participation in decision-making, teamwork, and leadership result in better resident outcomes.[5-10] Our recent case-studies described how NMPs work in day-to-day practice, and identified new NMPs associated with better NH care. We found that staff at all levels engaged in these NMPs, albeit erratically, suggesting that NHs have substantial untapped capacity to provide better resident care.[11-15] Thus a new intervention that fosters systematic use of NMPs may provide a foundation for more effective QI programs.

QI programs are the current standard for improving resident outcomes for common and costly conditions such as falls, pressure ulcers, pain, and depression. Such geriatric syndromes are inherently multifactorial, requiring modification of multiple risk factors to improve outcomes.[16, 17] Clinical trials using study staff to implement multiple risk factor reduction have improved resident outcomes,[18-20] but QI programs teaching existing NH staff to implement multiple risk factor reduction have not shown significant effects.[1, 21-24] One proposed reason for this failure is that QI programs seek to change individual clinician behavior but fail to account for the interactive dynamics of care. We propose that CONNECT, an intervention to foster systematic use of NMPs, will enhance the effectiveness of a Falls QI program in NHs by strengthening the one-on-one staff interactions that are necessary for clinical problem-solving about geriatric syndromes.

We have developed the Connect intervention based on complexity science and empirical research[25] to target these local interactions among staff in a new approach to facilitating organizational learning. Connect is a multicomponent intervention that includes: 1) helping staff learn new strategies to improve the effectiveness of day-to-day interactions; 2) helping staff identify important relationships and encouraging interaction at the point of care; and 3) mentoring to reinforce and sustain newly acquired interaction behaviors. Complexity science and empirical research suggest that interaction patterns determine information flow, ease of knowledge transfer, and capacity to monitor behaviors and outcomes in health care settings. [10, 26-28] Thus, Connect has the potential to improve resident outcomes when combined with QI programs for clinical problems such as falls. Falls is an excellent outcome for this initial test of Connect because: 1) there is ample evidence that multifactorial risk factor reduction interventions effectively reduce fall rates in NHs; 2) accepted practice guidelines and fall prevention programs exist;[29-32] and 3) falls is an important clinical problem in its own right.

The specific aims of this longitudinal, two arm, randomized intervention study are:

Aim 1: Compare the impact of the Connect intervention plus a falls reduction QI intervention (Connect+Falls) to the falls reduction QI intervention alone (Falls) on fall-related process measures in nursing home residents.

Aim 2 (exploratory): Compare the impact of Connect+Falls to Falls alone on fall-related outcome measures in nursing home residents, and determine whether these are mediated by the change in fall-related process measures.

Aim 3 (exploratory): Compare the impact of Connect+Falls to Falls alone on staff interaction measures as reported by NH staff, and determine whether these mediate the impact on fall-related process measures and fall-related outcome measures.

With its focus on improving local interaction, Connect is an innovative new approach targeting the learning environment to maximize NH staff's ability to adopt content learned in a Falls QI program and integrate it into knowledge and action. Our pilot work shows Connect to be feasible, acceptable and appropriate. Connect results from empirical findings; local interaction behaviors already exist in NHs, albeit to a limited extent and not in a way that effectively enables the staff to adopt evidence-based current practice for falls prevention inherent in the Falls approach. We are confident that in most NHs the capacity exists to develop and focus these behaviors using existing staff and resources and, therefore, the Connect intervention has the potential to enhance the effectiveness of Falls by promoting its adoption. Also, being a system intervention, Connect can be applied in future projects to examine the adoption of evidence-based practices for a wide variety of clinical problems such as pressure ulcers, pain, and depression. This study offers a unique opportunity to understand the circumstances in which such proven interventions (e.g., Falls) are likely to be translated into practice. Our future work will build on this study to establish correlates of the sustainability of the intervention in NHs and examine transferability to other clinical problems and other health care settings. The results of this research will be of interest to NH leadership and policy makers, particularly in light of ongoing state and national initiatives to improve care in NHs.

Study Type

Interventional

Enrollment (Actual)

1726

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible residents will be long-term care residents at least 65 years of age who have resided in the NH at least 6 months and are likely to survive at least 6 months. Residents must be potentially at risk for falls, which we define as ambulatory or transfer-independent as recorded on the Minimum Data Set.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

  1. In-House Falls Coordinator training on content and falls processes.
  2. Case-based modules about fall prevention and tailored for various team members.
  3. Academic Detailing in which researcher consults with staff regarding challenging residents with falls.
  4. Audit and Feedback. Discussions about comparison of nursing home's current practice on fall-related process and outcome measures, and how it compares with the median and the 90th percentile of peer NHs.
  5. Toolbox: Handbook of useful measures and worksheets.
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.
Behavioral: Connect

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:

  1. In-class learning sessions introduce interaction strategies.
  2. Relationship map protocols assist staff to examine existing interaction patterns and agree on goals for improvement. Individuals develop their own relationship maps and use them to practice new horizontal and vertical connections and self-monitoring their own interactions.
  3. Researcher facilitates authentic learning which occurs when learners directly and independently apply concepts. In-house staff volunteers and are facilitated to assume a mentoring role.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post intervention
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.
baseline to post intervention, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Nursing Research (NINR)
The Carolinas Center for Medical Excellence

Investigators

  • Principal Investigator: Ruth A Anderson, RN, PhD, Duke University School of Nursing
  • Principal Investigator: Cathleen S Colon-Emeric, MD, MHSc, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 9, 2008

First Submitted That Met QC Criteria

March 9, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00018745
  • 5R01NR003178 (U.S. NIH Grant/Contract)
  • 2R56NR003178-09 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Accidental Falls

Clinical Trials on Falls QI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe