Accidental Falls Clinical Trial
— CONNECTOfficial title:
Outcomes of Nursing Management Practice in Nursing Homes
Verified date | November 2018 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1726 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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: |
Country | Name | City | State |
---|---|---|---|
United States | Duke University School of Nursing | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute of Nursing Research (NINR), The Carolinas Center for Medical Excellence |
United States,
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Anderson RA, Ammarell N, Bailey DE, Colon-Emeric C, Corazzini K, Lekan-Rutledge D, Piven ML, Utley-Smith Q. The power of relationship for high-quality long-term care. J Nurs Care Qual. 2005 Apr-Jun;20(2):103-6. — View Citation
Anderson RA, Corazzini K, Porter K, Daily K, McDaniel RR Jr, Colón-Emeric C. CONNECT for quality: protocol of a cluster randomized controlled trial to improve fall prevention in nursing homes. Implement Sci. 2012 Feb 29;7:11. doi: 10.1186/1748-5908-7-11. — View Citation
Anderson RA, Crabtree BF, Steele DJ, McDaniel RR Jr. Case study research: the view from complexity science. Qual Health Res. 2005 May;15(5):669-85. — View Citation
Anderson RA, Toles MP, Corazzini K, McDaniel RR, Colón-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. — View Citation
Ausserhofer D, Anderson RA, Colón-Emeric C, Schwendimann R. First evidence on the validity and reliability of the Safety Organizing Scale-Nursing Home version (SOS-NH). J Am Med Dir Assoc. 2013 Aug;14(8):616-22. doi: 10.1016/j.jamda.2013.03.016. Epub 2013 — View Citation
Colón-Emeric C, Toles M, Cary MP Jr, Batchelor-Murphy M, Yap T, Song Y, Hall R, Anderson A, Burd A, Anderson RA. Sustaining complex interventions in long-term care: a qualitative study of direct care staff and managers. Implement Sci. 2016 Jul 16;11:94. d — View Citation
Colón-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; — View Citation
Colón-Emeric CS, Corazzini K, McConnell E, Pan W, Toles M, Hall R, Batchelor-Murphy M, Yap TL, Anderson AL, Burd A, Anderson RA. Study of Individualization and Bias in Nursing Home Fall Prevention Practices. J Am Geriatr Soc. 2017 Apr;65(4):815-821. doi: — View Citation
Colón-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. — View Citation
Colon-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):2150-9. doi: 10.1111/jgs.12550. Epub 2013 Nov 26. — View Citation
Colón-Emeric CS, Pinheiro SO, Anderson RA, Porter K, McConnell E, Corazzini K, Hancock K, Lipscomb J, Beales J, Simpson KM. Connecting the learners: improving uptake of a nursing home educational program by focusing on staff interactions. Gerontologist. 2 — View Citation
Colón-Emeric CS, Plowman D, Bailey D, Corazzini K, Utley-Smith Q, Ammarell N, Toles M, Anderson R. Regulation and mindful resident care in nursing homes. Qual Health Res. 2010 Sep;20(9):1283-94. doi: 10.1177/1049732310369337. Epub 2010 May 17. — View Citation
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Hall RK, Landerman LR, O'Hare AM, Anderson RA, Colón-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. — View Citation
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. — View Citation
Marcum ZA, Gurwitz JH, Colón-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. — View Citation
McDaniel 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. — View Citation
Mewshaw J, Bailey DE Jr, Porter KA, Anderson AL, Anderson RA, Burd AL, Colón-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. — View Citation
Piven ML, Ammarell N, Bailey D, Corazzini K, Colón-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. — View Citation
Piven 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. — View Citation
Simpson KM, Porter K, McConnell ES, Colón-Emeric C, Daily KA, Stalzer A, Anderson RA. Tool for evaluating research implementation challenges: a sense-making protocol for addressing implementation challenges in complex research settings. Implement Sci. 201 — View Citation
Toles M, Anderson RA. State of the science: relationship-oriented management practices in nursing homes. Nurs Outlook. 2011 Jul-Aug;59(4):221-7. doi: 10.1016/j.outlook.2011.05.001. Review. — View Citation
Utley-Smith Q, Bailey D, Ammarell N, Corazzini K, Colón-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. — View Citation
Utley-Smith Q, Colón-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. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 6 months post intervention | |
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. | 6 months post intervention | |
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. | baseline to post intervention, an average of 6 months |
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