Accidental FallsPhase 3CONNECTNCT00836433
CONNECT for Better Falls Prevention in VA Community Living Centers
A Phase 3 study testing CONNECT educational intervention and FALLS educational intervention in people with Accidental Falls, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
This is a randomized trial of 2 nursing home staff educational approaches to reduce falls in VA nursing home (CLC) residents. One is a traditional falls education program using web-based modules, feedback of quality indicators, and meetings with influential peers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Accidental Falls
- What is being tested?
- CONNECT educational intervention and FALLS educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 689 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2010to Aug 2012
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All clinical and support staff in participating VA Community Living Centers
Who cannot join
- Inability to speak and understand English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Medical Center, Asheville
Asheville, North Carolina, 28805
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
VA Medical Center, Salem VA
Salem, Virginia, 24153
About this study
This is a randomized trial of 2 nursing home staff educational approaches to reduce falls in VA nursing home (CLC) residents. One is a traditional falls education program using web-based modules, feedback of quality indicators, and meetings with influential peers. The other is a 12 week program that trains staff to form better connections and use effective communication strategies with a diverse network of co-workers, so that problem solving about resident problems is enhanced. The study will test whether the second intervention increases the effectiveness of the traditional falls education program.
Read the detailed description
Background:
The current standard to improve resident outcomes in VA nursing homes combines educational programs and quality improvement processes. These educational programs typically focus on individual staff members' behavior and mastery of content, and use such instructional techniques as didactic modules, audit and feedback of individual performance, and academic detailing by influential peers. However, social constructivism theory and complexity science suggests that learning is a social process that occurs within the context of the relationships and interactions of the individual in their environment. Thus, traditional QI educational programs will not result in optimal changes in staff behavior unless a context is present which allows social learning to occur.
Objectives:
Based on social constructivist theory, complexity science, and prior research we have developed an educational intervention (CONNECT) that teaches staff to improve connections within and between disciplines, improve information flow, and seek out cognitive diversity in problem-solving about resident issues. The objectives of this study are to: (a) determine whether CONNECT improves staff interaction measures, fall-related process measures, and fall rates when combined with standard training on fall risk factor reduction, and (b) use the insights gained about social constructivist learning in CLCs to develop other educational interventions that address multi-factorial geriatric syndromes and system issues such as patient safety in VA nursing homes.
Methods:
To achieve these objectives we are conducting a randomized, controlled, single-blind study in which nursing homes receive either CONNECT plus a falls QI educational intervention (FALLS) or FALLS alone. Four VA CLCs in VISN-6 will participate, with an estimated n=144 participating staff members, and n=340 unique individuals with falls. The CONNECT intervention will be delivered over 3 months, and includes interactive in-class learning sessions, unit-based mentoring, and relationship mapping, all focused on helping staff build networks and relationships for problem-solving. The FALLS intervention will be delivered over 3 months either alone or after the CONNECT intervention. It includes web-based modules, audit and feedback, and academic detailing, all focused on individual fall reduction behaviors. Measurement is performed prior to intervention (all measures), at the conclusion of intervention (staff interaction measures, work environment measures, and social constructivist learning focus groups), and 6 months after the intervention (fall-related process and outcome measures). Analysis will use mixed models to account for the complex nesting of patients and staff within facilities.
Status:
Funding will begin on August 1, 2009 with anticipated intervention start time of January, 2010.
- Conditions
- Accidental Falls
- Being tested
- CONNECT educational intervention, FALLS educational intervention
- Keywords
- staff education, complexity science, social constructivist theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONNECT educational interventionBehavioural
The CONNECT educational intervention is a training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving. Includes in class sessions, group and individual mapping exercises, self-monitoring of interactions, and individual staff coaching.
FALLS educational interventionBehavioural
FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
| Study group | Role | What they receive |
|---|---|---|
| FALLS only | Active comparator | Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit. Receives: Behavioral: FALLS educational intervention |
| CONNECT and FALLS | Experimental | CONNECT educational intervention is designed to improve relationship-building and communication. The intervention includes 2 in-class session, group mapping exercise, individual relationship mapping exercises, Self-monitoring of interactions, individual staff coaching sessions. FALLS is a traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit. Receives: Behavioral: CONNECT educational intervention; Behavioral: FALLS educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall-related Process Measures
The proportion of applicable fall quality indicators documented for residents with falls during the study period. Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.
Measured: 6 months
Secondary outcomes (1)
Change in Facility Fall Rates
Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionAug 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Cathleen S. Colon-Emeric, MD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836433
- Sponsor's protocol ID
- EDU 08-417
- Acronym
- CONNECT
- Status last verified
- Oct 2014
- First submitted
- 2 Feb 2009
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Colon-Emeric CS, Lyles KW, Su G, Pieper CF, Magaziner JS, Adachi JD, Bucci-Rechtweg CM, Haentjens P, Boonen S; HORIZON Recurrent Fracture Trial. Clinical risk factors for recurrent fracture after hip fracture: a prospective study. Calcif Tissue Int. 2011 May;88(5):425-31. doi: 10.1007/s00223-011-9474-4. Epub 2011 Feb 18.
PubMed 21331567Anderson RA, Corazzini K, Porter K, Daily K, McDaniel RR Jr, Colon-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.
PubMed 22376375
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONNECT for Better Falls Prevention in VA Community Living Centers
- ClinicalTrials.gov ID
- NCT00836433
- Acronym / sponsor ID
- CONNECT / EDU 08-417
- Conditions
- Accidental Falls
- Keywords
- staff education, complexity science, social constructivist theory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Duke University
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 30 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized trial of 2 nursing home staff educational approaches to reduce falls in VA nursing home (CLC) residents. One is a traditional falls education program using web-based modules, feedback of quality indicators, and meetings with influential peers. The other is a 12 week program that trains staff to form better connections and use effective communication strategies with a diverse network of co-workers, so that problem solving about resident problems is enhanced. The study will test whether the second intervention increases the effectiveness of the traditional falls education program.
Detailed description
Background:
The current standard to improve resident outcomes in VA nursing homes combines educational programs and quality improvement processes. These educational programs typically focus on individual staff members' behavior and mastery of content, and use such instructional techniques as didactic modules, audit and feedback of individual performance, and academic detailing by influential peers. However, social constructivism theory and complexity science suggests that learning is a social process that occurs within the context of the relationships and interactions of the individual in their environment. Thus, traditional QI educational programs will not result in optimal changes in staff behavior unless a context is present which allows social learning to occur.
Objectives:
Based on social constructivist theory, complexity science, and prior research we have developed an educational intervention (CONNECT) that teaches staff to improve connections within and between disciplines, improve information flow, and seek out cognitive diversity in problem-solving about resident issues. The objectives of this study are to: (a) determine whether CONNECT improves staff interaction measures, fall-related process measures, and fall rates when combined with standard training on fall risk factor reduction, and (b) use the insights gained about social constructivist learning in CLCs to develop other educational interventions that address multi-factorial geriatric syndromes and system issues such as patient safety in VA nursing homes.
Methods:
To achieve these objectives we are conducting a randomized, controlled, single-blind study in which nursing homes receive either CONNECT plus a falls QI educational intervention (FALLS) or FALLS alone. Four VA CLCs in VISN-6 will participate, with an estimated n=144 participating staff members, and n=340 unique individuals with falls. The CONNECT intervention will be delivered over 3 months, and includes interactive in-class learning sessions, unit-based mentoring, and relationship mapping, all focused on helping staff build networks and relationships for problem-solving. The FALLS intervention will be delivered over 3 months either alone or after the CONNECT intervention. It includes web-based modules, audit and feedback, and academic detailing, all focused on individual fall reduction behaviors. Measurement is performed prior to intervention (all measures), at the conclusion of intervention (staff interaction measures, work environment measures, and social constructivist learning focus groups), and 6 months after the intervention (fall-related process and outcome measures). Analysis will use mixed models to account for the complex nesting of patients and staff within facilities.
Status:
Funding will begin on August 1, 2009 with anticipated intervention start time of January, 2010.
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 |
|---|---|---|
| FALLS only | Active comparator | Behavioral: FALLS educational interventionTraditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit. |
| CONNECT and FALLS | Experimental | Behavioral: CONNECT educational intervention, Behavioral: FALLS educational interventionCONNECT educational intervention is designed to improve relationship-building and communication. The intervention includes 2 in-class session, group mapping exercise, individual relationship mapping exercises, Self-monitoring of interactions, individual staff coaching sessions. FALLS is a traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All clinical and support staff in participating VA Community Living Centers
Key exclusion criteria (1 listed)
- Inability to speak and understand English
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 |
|---|---|---|
| CONNECT educational interventionThe CONNECT educational intervention is a training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving. Includes in class sessions, group and individual mapping exercises, self-monitoring of interactions, and individual staff coaching. | Behavioural | CONNECT and FALLS |
| FALLS educational interventionFALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions | Behavioural | CONNECT and FALLS, FALLS only |
Primary outcome
Fall-related Process Measures
Time frame: 6 months
The proportion of applicable fall quality indicators documented for residents with falls during the study period. Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.
1 secondary outcome
Change in Facility Fall Rates
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21331567Colon-Emeric CS, Lyles KW, Su G, Pieper CF, Magaziner JS, Adachi JD, Bucci-Rechtweg CM, Haentjens P, Boonen S; HORIZON Recurrent Fracture Trial. Clinical risk factors for recurrent fracture after hip fracture: a prospective study. Calcif Tissue Int. 2011 May;88(5):425-31. doi: 10.1007/s00223-011-9474-4. Epub 2011 Feb 18.
- Results publication: PubMed 22376375Anderson RA, Corazzini K, Porter K, Daily K, McDaniel RR Jr, Colon-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.
- Pubmed reference linkLink provided by the sponsor.
- Pubmed reference linkLink provided by the sponsor.
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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.
Cathleen S. Colon-Emeric, MD principal investigator
Durham VA Medical Center, Durham, NC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CONNECT educational intervention and FALLS educational intervention in people with Accidental Falls, run by US Department of Veterans Affairs at 4 sites 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 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2014). 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). 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 NCT00836433, which also lists 2 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 24 Apr 2015.