Accidental FallsCONNECTNCT00636675
CONNECT for Quality: A Study to Reduce Falls in Nursing Homes
A study testing Falls QI and Connect in people with Accidental Falls, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Falls QI and Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,726 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Nursing
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the 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.
- Conditions
- Accidental Falls
- Being tested
- Falls QI, Connect
- Keywords
- Accidental falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falls QIBehavioural
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:
- In-House Falls Coordinator training on content and falls processes.
- Case-based modules about fall prevention and tailored for various team members.
- Academic Detailing in which researcher consults with staff regarding challenging residents with falls.
- 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.
- Toolbox: Handbook of useful measures and worksheets.
ConnectBehavioural
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:
- In-class learning sessions introduce interaction strategies.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Fall QI | Experimental | Falls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel. Receives: Behavioral: Falls QI |
| Connect & Falls QI | Experimental | 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. Receives: Behavioral: Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post intervention
Secondary outcomes (2)
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.
Measured: 6 months post intervention
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.
Measured: baseline to post intervention, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startSep 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Carolinas Center for Medical Excellence, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ruth A Anderson, RN, PhD, Principal investigator, Duke University School of NursingCathleen S Colon-Emeric, MD, MHSc, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636675
- Sponsor's protocol ID
- Pro00018745
- Other IDs
- 5R01NR003178, 2R56NR003178-09
- Acronym
- CONNECT
- Status last verified
- Nov 2018
- First submitted
- 9 Mar 2008
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jordon M, Lanham HJ, Anderson RA, McDaniel RR Jr. Implications of complex adaptive systems theory for interpreting research about health care organizations. J Eval Clin Pract. 2010 Feb;16(1):228-31. doi: 10.1111/j.1365-2753.2009.01359.x.
PubMed 20367840McDaniel RR Jr, Lanham HJ, Anderson RA. Implications of complex adaptive systems theory for the design of research on health care organizations. Health Care Manage Rev. 2009 Apr-Jun;34(2):191-9. doi: 10.1097/HMR.0b013e31819c8b38.
PubMed 19322050Colon-Emeric CS, McConnell E, Pinheiro SO, Corazzini K, Porter K, Earp KM, Landerman L, Beales J, Lipscomb J, Hancock K, Anderson RA. CONNECT for better fall prevention in nursing homes: results from a pilot intervention study. J Am Geriatr Soc. 2013 Dec;61(12):2150-2159. doi: 10.1111/jgs.12550. Epub 2013 Nov 26.
PubMed 24279686Anderson RA, Toles MP, Corazzini K, McDaniel RR, Colon-Emeric C. Local interaction strategies and capacity for better care in nursing homes: a multiple case study. BMC Health Serv Res. 2014 Jun 5;14:244. doi: 10.1186/1472-6963-14-244.
PubMed 24903706Hall RK, Landerman LR, O'Hare AM, Anderson RA, Colon-Emeric CS. Chronic kidney disease and recurrent falls in nursing home residents: a retrospective cohort study. Geriatr Nurs. 2015 Mar-Apr;36(2):136-41. doi: 10.1016/j.gerinurse.2014.12.012. Epub 2015 Jan 20.
PubMed 25616732Marcum ZA, Gurwitz JH, Colon-Emeric C, Hanlon JT. Pills and ills: methodological problems in pharmacological research. J Am Geriatr Soc. 2015 Apr;63(4):829-30. doi: 10.1111/jgs.13371. No abstract available.
PubMed 25900504Mewshaw J, Bailey DE Jr, Porter KA, Anderson AL, Anderson RA, Burd AL, Colon-Emeric C, Corazzini KN. A novel program for ABSN students to generate interest in geriatrics and geriatric nursing research. J Nurs Educ Pract. 2017 Jun;7(6):95-99. doi: 10.5430/jnep.v7n6p95. Epub 2017 Feb 5.
PubMed 28435479Utley-Smith Q, Colon-Emeric CS, Lekan-Rutledge D, Ammarell N, Bailey D, Corazzini K, Piven ML, Anderson RA. The Nature of Staff - Family Interactions in Nursing Homes: Staff Perceptions. J Aging Stud. 2009 Aug;23(3):168-177. doi: 10.1016/j.jaging.2007.11.003.
PubMed 19649311Colon-Emeric CS, Lekan D, Utley-Smith Q, Ammarell N, Bailey D, Corazzini K, Piven ML, Anderson RA. Barriers to and facilitators of clinical practice guideline use in nursing homes. J Am Geriatr Soc. 2007 Sep;55(9):1404-9. doi: 10.1111/j.1532-5415.2007.01297.x.
PubMed 17767682Piven ML, Ammarell N, Lekan-Rutledge D, Utley-Smith Q, Corazzini KN, Colon-Emeric CS, Bailey D, Anderson RA. Paying attention: A leap toward quality care. Director. 2007 Winter;15(1):58-60, 62-3. No abstract available.
PubMed 17710200Corazzini KN, Lekan-Rutledge D, Utley-Smith Q, Piven ML, Colon-Emeric CS, Bailey D, Ammarell N, Anderson RA. "The Golden Rule": Only a starting point for quality care. Director. 2005;14(1):255-293.
PubMed 17334452Utley-Smith Q, Bailey D, Ammarell N, Corazzini K, Colon-Emeric CS, Lekan-Rutledge D, Piven ML, Anderson RA. Exit interview-consultation for research validation and dissemination. West J Nurs Res. 2006 Dec;28(8):955-73. doi: 10.1177/0193945905282301.
PubMed 17099107Piven ML, Ammarell N, Bailey D, Corazzini K, Colon-Emeric CS, Lekan-Rutledge D, Utley-Smith Q, Anderson RA. MDS coordinator relationships and nursing home care processes. West J Nurs Res. 2006 Apr;28(3):294-309. doi: 10.1177/0193945905284710.
PubMed 16585806Colon-Emeric CS, Ammarell N, Bailey D, Corazzini K, Lekan-Rutledge D, Piven ML, Utley-Smith Q, Anderson RA. Patterns of medical and nursing staff communication in nursing homes: implications and insights from complexity science. Qual Health Res. 2006 Feb;16(2):173-88. doi: 10.1177/1049732305284734.
PubMed 16394208Anderson RA, Ammarell N, Bailey D Jr, Colon-Emeric C, Corazzini KN, Lillie M, Piven ML, Utley-Smith Q, McDaniel RR Jr. Nurse assistant mental models, sensemaking, care actions, and consequences for nursing home residents. Qual Health Res. 2005 Oct;15(8):1006-21. doi: 10.1177/1049732305280773.
PubMed 16221876
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Nursing Management Practice in Nursing Homes
- ClinicalTrials.gov ID
- NCT00636675
- Acronym / sponsor ID
- CONNECT / Pro00018745
- Conditions
- Accidental Falls
- Keywords
- Accidental falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,726 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Carolinas Center for Medical Excellence, National Institute of Nursing Research (NINR)
- Study start
- Sep 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fall QI | Experimental | Behavioral: Falls QIFalls QI includes quality improvement training about falls to be implement by indigenous nursing home staff with support of study personnel. |
| Connect & Falls QI | Experimental | Behavioral: ConnectConnect 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Falls QIFalls 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. | Behavioural | Fall QI |
| ConnectConnect, 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. | Behavioural | Connect & Falls QI |
Primary outcome
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.
2 secondary outcomes
Fall Rates
Time frame: 6 months post intervention
Change in Weighted Average of Staff Interaction Scales
Time frame: baseline to post intervention, an average of 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20367840Jordon M, Lanham HJ, Anderson RA, McDaniel RR Jr. Implications of complex adaptive systems theory for interpreting research about health care organizations. J Eval Clin Pract. 2010 Feb;16(1):228-31. doi: 10.1111/j.1365-2753.2009.01359.x.
- Background: PubMed 19322050McDaniel RR Jr, Lanham HJ, Anderson RA. Implications of complex adaptive systems theory for the design of research on health care organizations. Health Care Manage Rev. 2009 Apr-Jun;34(2):191-9. doi: 10.1097/HMR.0b013e31819c8b38.
- Background: PubMed 24279686Colon-Emeric CS, McConnell E, Pinheiro SO, Corazzini K, Porter K, Earp KM, Landerman L, Beales J, Lipscomb J, Hancock K, Anderson RA. CONNECT for better fall prevention in nursing homes: results from a pilot intervention study. J Am Geriatr Soc. 2013 Dec;61(12):2150-2159. doi: 10.1111/jgs.12550. Epub 2013 Nov 26.
- Background: PubMed 24903706Anderson RA, Toles MP, Corazzini K, McDaniel RR, Colon-Emeric C. Local interaction strategies and capacity for better care in nursing homes: a multiple case study. BMC Health Serv Res. 2014 Jun 5;14:244. doi: 10.1186/1472-6963-14-244.
- Background: PubMed 25616732Hall RK, Landerman LR, O'Hare AM, Anderson RA, Colon-Emeric CS. Chronic kidney disease and recurrent falls in nursing home residents: a retrospective cohort study. Geriatr Nurs. 2015 Mar-Apr;36(2):136-41. doi: 10.1016/j.gerinurse.2014.12.012. Epub 2015 Jan 20.
- Background: PubMed 25900504Marcum ZA, Gurwitz JH, Colon-Emeric C, Hanlon JT. Pills and ills: methodological problems in pharmacological research. J Am Geriatr Soc. 2015 Apr;63(4):829-30. doi: 10.1111/jgs.13371. No abstract available.
- Background: PubMed 28435479Mewshaw J, Bailey DE Jr, Porter KA, Anderson AL, Anderson RA, Burd AL, Colon-Emeric C, Corazzini KN. A novel program for ABSN students to generate interest in geriatrics and geriatric nursing research. J Nurs Educ Pract. 2017 Jun;7(6):95-99. doi: 10.5430/jnep.v7n6p95. Epub 2017 Feb 5.
- Results publication: PubMed 19649311Utley-Smith Q, Colon-Emeric CS, Lekan-Rutledge D, Ammarell N, Bailey D, Corazzini K, Piven ML, Anderson RA. The Nature of Staff - Family Interactions in Nursing Homes: Staff Perceptions. J Aging Stud. 2009 Aug;23(3):168-177. doi: 10.1016/j.jaging.2007.11.003.
- Results publication: PubMed 17767682Colon-Emeric CS, Lekan D, Utley-Smith Q, Ammarell N, Bailey D, Corazzini K, Piven ML, Anderson RA. Barriers to and facilitators of clinical practice guideline use in nursing homes. J Am Geriatr Soc. 2007 Sep;55(9):1404-9. doi: 10.1111/j.1532-5415.2007.01297.x.
- Results publication: PubMed 17710200Piven ML, Ammarell N, Lekan-Rutledge D, Utley-Smith Q, Corazzini KN, Colon-Emeric CS, Bailey D, Anderson RA. Paying attention: A leap toward quality care. Director. 2007 Winter;15(1):58-60, 62-3. No abstract available.
- Results publication: PubMed 17334452Corazzini KN, Lekan-Rutledge D, Utley-Smith Q, Piven ML, Colon-Emeric CS, Bailey D, Ammarell N, Anderson RA. "The Golden Rule": Only a starting point for quality care. Director. 2005;14(1):255-293.
- Results publication: PubMed 17099107Utley-Smith Q, Bailey D, Ammarell N, Corazzini K, Colon-Emeric CS, Lekan-Rutledge D, Piven ML, Anderson RA. Exit interview-consultation for research validation and dissemination. West J Nurs Res. 2006 Dec;28(8):955-73. doi: 10.1177/0193945905282301.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth A Anderson, RN, PhD principal investigator
Duke University School of Nursing
Cathleen S Colon-Emeric, MD, MHSc principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Falls QI and Connect in people with Accidental Falls, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Related Process Measures (time frame: 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636675, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.