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

Outcomes of Nursing Management Practice in Nursing Homes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00636675
Acronym
CONNECT
Enrollment
1726
Registered
2008-03-14
Start date
2009-09-30
Completion date
2016-01-31
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls

Keywords

Accidental falls

Brief summary

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.

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.

Interventions

BEHAVIORALFalls 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.

BEHAVIORALConnect

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.

Sponsors

The Carolinas Center for Medical Excellence
CollaboratorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fall Related Process Measures6 months post interventionMean 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.

Secondary

MeasureTime frameDescription
Fall Rates6 months post interventionNumerator: 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 Scalesbaseline to post intervention, an average of 6 monthsThis 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.

Countries

United States

Participant flow

Recruitment details

We invited 69 nursing homes (NHs) with \> 89 beds participating in Medicare and Medicaid within 100 miles of Duke, and included the first 24 homes responding. Staff were invited as part of their facility's quality improvement (QI) initiatives. We used a random sample of 50 residents from each facility for chart abstraction.

Participants by arm

ArmCount
Falls Qualty Improvement (QI)
Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel. Falls QI: Falls uses the Falls Management Program; 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.
743
Connect & Falls Quality Improviement (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: 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.
658
Total1,401

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up12131
Overall StudyWithdrawal by Subject1910

Baseline characteristics

CharacteristicFalls Qualty Improvement (QI)Connect & Falls Quality Improviement (QI)Total
Age, Categorical
Age
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
Age
>=65 years
116 Participants137 Participants253 Participants
Age, Categorical
Age
Between 18 and 65 years
615 Participants509 Participants1124 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants21 Participants34 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
681 Participants599 Participants1280 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
49 Participants38 Participants87 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Asian
21 Participants11 Participants32 Participants
Race (NIH/OMB)
Black or African American
337 Participants281 Participants618 Participants
Race (NIH/OMB)
More than one race
11 Participants14 Participants25 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
57 Participants51 Participants108 Participants
Race (NIH/OMB)
White
316 Participants296 Participants612 Participants
Region of Enrollment
United States
743 Participants658 Participants1401 Participants
Sex: Female, Male
Female
600 Participants554 Participants1154 Participants
Sex: Female, Male
Male
106 Participants72 Participants178 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 8110 / 734
other
Total, other adverse events
0 / 8110 / 734
serious
Total, serious adverse events
0 / 8110 / 734

Outcome results

Primary

Fall Related Process Measures

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.

Time frame: 6 months post intervention

Population: Residents with prior fall

ArmMeasureValue (MEAN)Dispersion
Fall QIFall Related Process Measures3.3 number of fall risk reduction indicatorsStandard Deviation 1.6
Connect & Falls QIFall Related Process Measures3.2 number of fall risk reduction indicatorsStandard Deviation 1.5
Secondary

Change in Weighted Average of Staff Interaction Scales

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.

Time frame: baseline to post intervention, an average of 6 months

ArmMeasureValue (MEAN)Dispersion
Fall QIChange in Weighted Average of Staff Interaction ScalesNA units on a scale
Connect & Falls QIChange in Weighted Average of Staff Interaction Scales.03 units on a scaleStandard Error 0.02
Secondary

Fall Rates

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.

Time frame: 6 months post intervention

Population: Residents with at least one prior fall

ArmMeasureValue (MEDIAN)
Fall QIFall Rates4.06 fall rate
Connect & Falls QIFall Rates4.06 fall rate

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026