Trial Outcomes & Findings for CONNECT for Quality: A Study to Reduce Falls in Nursing Homes (NCT NCT00636675)
NCT ID: NCT00636675
Last Updated: 2018-12-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1726 participants
Primary outcome timeframe
6 months post intervention
Results posted on
2018-12-11
Participant Flow
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.
Participant milestones
| Measure |
Fall 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 (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.
|
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: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
951
|
775
|
|
Overall Study
COMPLETED
|
811
|
734
|
|
Overall Study
NOT COMPLETED
|
140
|
41
|
Reasons for withdrawal
| Measure |
Fall 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 (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.
|
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: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
121
|
31
|
|
Overall Study
Withdrawal by Subject
|
19
|
10
|
Baseline Characteristics
Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
Baseline characteristics by cohort
| Measure |
Falls Qualty Improvement (QI)
n=743 Participants
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.
|
Connect & Falls Quality Improviement (QI)
n=658 Participants
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.
|
Total
n=1401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=731 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
0 Participants
n=646 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
0 Participants
n=1377 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
|
Age, Categorical
Age · Between 18 and 65 years
|
615 Participants
n=731 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
509 Participants
n=646 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
1124 Participants
n=1377 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
|
Age, Categorical
Age · >=65 years
|
116 Participants
n=731 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
137 Participants
n=646 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
253 Participants
n=1377 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
|
Sex: Female, Male
Female
|
600 Participants
n=706 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
554 Participants
n=626 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
1154 Participants
n=1332 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
|
Sex: Female, Male
Male
|
106 Participants
n=706 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
72 Participants
n=626 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
178 Participants
n=1332 Participants • Not all participants completed the surveys and/or they did not complete all items and so the baseline numbers differ from the participant flow chart
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=743 Participants
|
21 Participants
n=658 Participants
|
34 Participants
n=1401 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
681 Participants
n=743 Participants
|
599 Participants
n=658 Participants
|
1280 Participants
n=1401 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
49 Participants
n=743 Participants
|
38 Participants
n=658 Participants
|
87 Participants
n=1401 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=743 Participants
|
3 Participants
n=658 Participants
|
4 Participants
n=1401 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=743 Participants
|
11 Participants
n=658 Participants
|
32 Participants
n=1401 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=743 Participants
|
2 Participants
n=658 Participants
|
2 Participants
n=1401 Participants
|
|
Race (NIH/OMB)
Black or African American
|
337 Participants
n=743 Participants
|
281 Participants
n=658 Participants
|
618 Participants
n=1401 Participants
|
|
Race (NIH/OMB)
White
|
316 Participants
n=743 Participants
|
296 Participants
n=658 Participants
|
612 Participants
n=1401 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=743 Participants
|
14 Participants
n=658 Participants
|
25 Participants
n=1401 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
57 Participants
n=743 Participants
|
51 Participants
n=658 Participants
|
108 Participants
n=1401 Participants
|
|
Region of Enrollment
United States
|
743 Participants
n=743 Participants
|
658 Participants
n=658 Participants
|
1401 Participants
n=1401 Participants
|
PRIMARY outcome
Timeframe: 6 months post interventionPopulation: Residents with prior fall
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.
Outcome measures
| Measure |
Fall QI
n=907 Participants
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 (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.
|
Connect & Falls QI
n=887 Participants
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.
|
|---|---|---|
|
Fall Related Process Measures
|
3.3 number of fall risk reduction indicators
Standard Deviation 1.6
|
3.2 number of fall risk reduction indicators
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 6 months post interventionPopulation: Residents with at least one prior fall
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.
Outcome measures
| Measure |
Fall QI
n=907 Participants
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 (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.
|
Connect & Falls QI
n=887 Participants
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.
|
|---|---|---|
|
Fall Rates
|
4.06 fall rate
Interval 2.04 to 8.11
|
4.06 fall rate
Interval 2.03 to 8.11
|
SECONDARY outcome
Timeframe: baseline 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.
Outcome measures
| Measure |
Fall QI
n=743 Participants
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 (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.
|
Connect & Falls QI
n=658 Participants
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.
|
|---|---|---|
|
Change in Weighted Average of Staff Interaction Scales
|
NA units on a scale
Standard Error NA
The CONNECT intervention was not delivered to this group, therefore no change attributable to intervention was calculated.
|
.03 units on a scale
Standard Error 0.02
|
Adverse Events
Fall QI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Connect & Falls QI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ruth A. Anderson
University of North Carolina Chapel HIll
Phone: 919-966-8785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place