DementiaNCT00875706
Training and Coaching to Promote High Performance in Veteran Affairs (VA) Nursing Home Care
A study testing Educational Intervention in people with Dementia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study aimed to explore the feasibility of an educational intervention to strengthen workplace learning systems in four VA Community Living Centers (CLCs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VA Employees: psychologists, nurse-managers and front-line nursing care staff assigned to CLCs will be included
Who cannot join
- Those not working in the CLC,
- Those working in the CLC but not involved in the training intervention that is the focus of the study (e.g. Environment Management Service personnel, dietary personnel)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
Official title: Training and Coaching to Promote High Performance in VA Nursing Home Care
This study aimed to explore the feasibility of an educational intervention to strengthen workplace learning systems in four VA Community Living Centers (CLCs).
Read the detailed description
Background:
The study explored the feasibility of an educational intervention to strengthen workplace-learning systems in four VA Community Living Centers (CLCs).
Objectives:
Specific aims were to 1) conduct a feasibility study to assess whether the educational intervention is practical to implement as designed and 2) conduct a pilot study to validate the methodology proposed for assessing outcomes of this educational intervention.
Methods:
A multi-level intervention targeting the translation of workplace learning into practice was implemented. The Direct Care Worker (DCW) intervention targeted both clinical knowledge and effective communication. The Coaching Supervision training addressed management and supervision practices for nurses, combined with effective communication. Four CLCs received both interventions, administered by the Paraprofessional Health Institute (PHI), using a train-the-trainer approach over the course of four 3-day sessions. Quantitative and qualitative data were collected to assess factors influencing effectiveness of implementation and to understand the impact of the trainings on participants.
Status:
The study has been completed with educational interventions implemented and qualitative and quantitative data collected.
- Conditions
- Dementia
- Being tested
- Educational Intervention
- Keywords
- Nursing Homes, Implementation of innovative programs, Nursing staff, Nurses' aides, Educational models
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
The intervention consists of two (2) different types of training, both to be delivered through a train-the-trainer approach. The first of these is coaching-supervision training for nurse managers and other supervisory personnel in the CLC units. The second component is a one-day training for DCWs on communication and managing problem behaviors associated with dementia. These two trainings build on validated training models that have been developed by PHINational, but will be adapted and customized to include VA-developed clinical content on the management of problem behaviors associated with dementia.
| Study group | Role | What they receive |
|---|---|---|
| Training Feasibility | Other | 4 sites will receive the training intervention to determine the feasibility of the train-the trainer approach.
The educational intervention is included in this arm. Receives: Behavioral: Educational Intervention |
| Data Collection - Survey | Other | Survey data collection tools will be piloted to assess feasibility of survey administration and development of the survey for future studies. This tools were piloted in sites where the educational intervention was administered. Receives: Behavioral: Educational Intervention |
| Data Collection - Interview | Other | Interview data collection tools will be piloted to assess feasibility of interview administration and development of the interview protocol for future studies. This tools were piloted in sites where the educational intervention was administered. Receives: Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Training Intervention
This outcome measures the number of participants that fully completed the training intervention.
Measured: This outcome was assessed at the end of the 1 year pilot study.
Facility Implementation of Trainings
This measure assesses the number of participating facilities (4) that implemented trainings in their own facilities upon completion of our educational training intervention.
Measured: This outcome was assessed at the end of the 1 year pilot study.
Number of Participants in Pilot Surveys
This outcome measures the number of participants that completed the survey during the pilot in order to assess the feasibility of conducting a larger study.
Measured: This outcome was assessed at the end of the 1 year pilot study.
Number of Participants in Pilot Interviews
This outcome measures the number of participants that participated in interviews that were conducted during the pilot in order to assess the feasibility of conducting a larger study.
Measured: This outcome was assessed at the end of the 1 year pilot study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionMar 2011
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.
- Other trials for DementiaStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carol VanDeusen-Lukas, EdD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875706
- Sponsor's protocol ID
- EDU 08-427
- Status last verified
- Aug 2014
- First submitted
- 1 Apr 2009
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Training and Coaching to Promote High Performance in VA Nursing Home Care
- ClinicalTrials.gov ID
- NCT00875706
- Acronym / sponsor ID
- EDU 08-427
- Conditions
- Dementia
- Keywords
- Nursing Homes, Implementation of innovative programs, Nursing staff, Nurses' aides, Educational models
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 24 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to explore the feasibility of an educational intervention to strengthen workplace learning systems in four VA Community Living Centers (CLCs).
Detailed description
Background:
The study explored the feasibility of an educational intervention to strengthen workplace-learning systems in four VA Community Living Centers (CLCs).
Objectives:
Specific aims were to 1) conduct a feasibility study to assess whether the educational intervention is practical to implement as designed and 2) conduct a pilot study to validate the methodology proposed for assessing outcomes of this educational intervention.
Methods:
A multi-level intervention targeting the translation of workplace learning into practice was implemented. The Direct Care Worker (DCW) intervention targeted both clinical knowledge and effective communication. The Coaching Supervision training addressed management and supervision practices for nurses, combined with effective communication. Four CLCs received both interventions, administered by the Paraprofessional Health Institute (PHI), using a train-the-trainer approach over the course of four 3-day sessions. Quantitative and qualitative data were collected to assess factors influencing effectiveness of implementation and to understand the impact of the trainings on participants.
Status:
The study has been completed with educational interventions implemented and qualitative and quantitative data collected.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training Feasibility | Other | Behavioral: Educational Intervention4 sites will receive the training intervention to determine the feasibility of the train-the trainer approach. The educational intervention is included in this arm. |
| Data Collection - Survey | Other | Behavioral: Educational InterventionSurvey data collection tools will be piloted to assess feasibility of survey administration and development of the survey for future studies. This tools were piloted in sites where the educational intervention was administered. |
| Data Collection - Interview | Other | Behavioral: Educational InterventionInterview data collection tools will be piloted to assess feasibility of interview administration and development of the interview protocol for future studies. This tools were piloted in sites where the educational intervention was administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- VA Employees: psychologists, nurse-managers and front-line nursing care staff assigned to CLCs will be included
Key exclusion criteria (2 listed)
- Those not working in the CLC,
- Those working in the CLC but not involved in the training intervention that is the focus of the study (e.g. Environment Management Service personnel, dietary personnel)
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 |
|---|---|---|
| Educational InterventionThe intervention consists of two (2) different types of training, both to be delivered through a train-the-trainer approach. The first of these is coaching-supervision training for nurse managers and other supervisory personnel in the CLC units. The second component is a one-day training for DCWs on communication and managing problem behaviors associated with dementia. These two trainings build on validated training models that have been developed by PHINational, but will be adapted and customized to include VA-developed clinical content on the management of problem behaviors associated with dementia. | Behavioural | Data Collection - Interview, Data Collection - Survey, Training Feasibility |
Primary outcome
Completion of Training Intervention
Time frame: This outcome was assessed at the end of the 1 year pilot study.
This outcome measures the number of participants that fully completed the training intervention.
Facility Implementation of Trainings
Time frame: This outcome was assessed at the end of the 1 year pilot study.
This measure assesses the number of participating facilities (4) that implemented trainings in their own facilities upon completion of our educational training intervention.
Number of Participants in Pilot Surveys
Time frame: This outcome was assessed at the end of the 1 year pilot study.
This outcome measures the number of participants that completed the survey during the pilot in order to assess the feasibility of conducting a larger study.
Number of Participants in Pilot Interviews
Time frame: This outcome was assessed at the end of the 1 year pilot study.
This outcome measures the number of participants that participated in interviews that were conducted during the pilot in order to assess the feasibility of conducting a larger study.
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.
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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.
Carol VanDeusen-Lukas, EdD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Dementia, run by US Department of Veterans Affairs 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 2 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 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 24 Nov 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?
Completion of Training Intervention (time frame: This outcome was assessed at the end of the 1 year pilot study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.