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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00636675
Collaborator
The Carolinas Center for Medical Excellence (Other), National Institute of Nursing Research (NINR) (NIH)
1,726
1
2
76
22.7

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Falls QI
  • Behavioral: Connect
N/A

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

Study Type:
Interventional
Actual Enrollment :
1726 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Outcomes of Nursing Management Practice in Nursing Homes
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

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: 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.

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: 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.

Outcome Measures

Primary Outcome Measures

  1. Fall Related Process Measures [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.

Secondary Outcome Measures

  1. Fall Rates [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.

  2. Change in Weighted Average of Staff Interaction Scales [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University School of Nursing Durham North Carolina United States 27710

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT00636675
Other Study ID Numbers:
  • Pro00018745
  • 5R01NR003178
  • 2R56NR003178-09
First Posted:
Mar 14, 2008
Last Update Posted:
Dec 11, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Duke University

Study Results

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.
Pre-assignment Detail
Arm/Group Title Fall QI Connect & Falls QI
Arm/Group Description 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: 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. 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: 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.
Period Title: Overall Study
STARTED 951 775
COMPLETED 811 734
NOT COMPLETED 140 41

Baseline Characteristics

Arm/Group Title Falls Qualty Improvement (QI) Connect & Falls Quality Improviement (QI) Total
Arm/Group Description 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: 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. 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: 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. Total of all reporting groups
Overall Participants 743 658 1401
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
615
82.8%
509
77.4%
1124
80.2%
>=65 years
116
15.6%
137
20.8%
253
18.1%
Sex: Female, Male (Count of Participants)
Female
600
80.8%
554
84.2%
1154
82.4%
Male
106
14.3%
72
10.9%
178
12.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
13
1.7%
21
3.2%
34
2.4%
Not Hispanic or Latino
681
91.7%
599
91%
1280
91.4%
Unknown or Not Reported
49
6.6%
38
5.8%
87
6.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
0.1%
3
0.5%
4
0.3%
Asian
21
2.8%
11
1.7%
32
2.3%
Native Hawaiian or Other Pacific Islander
0
0%
2
0.3%
2
0.1%
Black or African American
337
45.4%
281
42.7%
618
44.1%
White
316
42.5%
296
45%
612
43.7%
More than one race
11
1.5%
14
2.1%
25
1.8%
Unknown or Not Reported
57
7.7%
51
7.8%
108
7.7%
Region of Enrollment (Count of Participants)
United States
743
100%
658
100%
1401
100%

Outcome Measures

1. Primary Outcome
Title Fall Related Process Measures
Description 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

Outcome Measure Data

Analysis Population Description
Residents with prior fall
Arm/Group Title Fall QI Connect & Falls QI
Arm/Group Description 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: 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. 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: 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.
Measure Participants 907 887
Mean (Standard Deviation) [number of fall risk reduction indicators]
3.3
(1.6)
3.2
(1.5)
2. Secondary Outcome
Title Fall Rates
Description 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

Outcome Measure Data

Analysis Population Description
Residents with at least one prior fall
Arm/Group Title Fall QI Connect & Falls QI
Arm/Group Description 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: 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. 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: 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.
Measure Participants 907 887
Median (Inter-Quartile Range) [fall rate]
4.06
4.06
3. Secondary Outcome
Title Change in Weighted Average of Staff Interaction Scales
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Fall QI Connect & Falls QI
Arm/Group Description 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: 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. 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: 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.
Measure Participants 743 658
Mean (Standard Error) [units on a scale]
NA
(NA)
.03
(0.02)

Adverse Events

Time Frame 6 months
Adverse Event Reporting Description Adverse events for participating staff
Arm/Group Title Fall QI Connect & Falls QI
Arm/Group Description 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: 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. 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: 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.
All Cause Mortality
Fall QI Connect & Falls QI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/811 (0%) 0/734 (0%)
Serious Adverse Events
Fall QI Connect & Falls QI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/811 (0%) 0/734 (0%)
Other (Not Including Serious) Adverse Events
Fall QI Connect & Falls QI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/811 (0%) 0/734 (0%)

Limitations/Caveats

While randomized, the relatively small number of nursing homes (N = 24) likely resulted in imbalances in facility, staff, and resident-level factors by chance alone. We were limited to one geographic region.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Ruth A. Anderson
Organization University of North Carolina Chapel HIll
Phone 919-966-8785
Email rutha@email.unc.edu
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT00636675
Other Study ID Numbers:
  • Pro00018745
  • 5R01NR003178
  • 2R56NR003178-09
First Posted:
Mar 14, 2008
Last Update Posted:
Dec 11, 2018
Last Verified:
Nov 1, 2018