DementiaTRAIN-ADNCT03244917
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias
A study testing TRAIN-AD in people with Dementia and Infection, Bacterial, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia (N=480; N=240/arm)… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Infection, Bacterial
- What is being tested?
- TRAIN-AD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 10 Mar 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Facility inclusion criteria
- More than 60 beds
- Within 60 miles of Boston
- Resident inclusion eligibility criteria
- Age > or = to 60 years
- A diagnosis of dementia (any type)
Show all 14Show fewer
- Global Deterioration Scale (GDS) score of 7
- NH length of stay >90 days
- An individual who can communicate in English has been formally or informally designated as a health care proxy
- Not comatose GDS stage 7 features include: profound memory deficits (cannot recognize family), total functional dependence, speech <= 5 words, incontinence, and non-ambulatory. GDS 7 was chosen to define advanced dementia as it has been successfully operationalized and validated in or prior studies, and experts agreed to use this definition in research studies. A 90 day minimum length of stay was chosen to exclude short-stay patients.
- Provider inclusion criteria
- Direct care provider of advanced dementia residents (a nurse, nurse practitioner, physician or physician assistant identified by a senior administrator as an individual who cares for residents with advanced dementia)
- Can communicate in English (because intervention materials are all in English),
- Over 21 years of age.
Who cannot join
- Residents with cognitive impairment due to causes other than dementia (e.g., head trauma and in short-term, sub-acute SNFs) will be excluded.
- Residents' whose proxies cannot communicate in English will be excluded from the study, because the information directed to proxies are only in English.
- Providers that do not provide direct care to residents with advanced dementia or who do not speak English.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world. Analyses will be at the patient level.
Read the detailed description
The final stage of dementia is characterized by recurrent suspected infections. Research has shown these episodes are widely mismanaged, leading to adverse patient and public health outcomes. Antimicrobials are extensively prescribed in advanced dementia, most often in the absence of clinical evidence to support a bacterial infection. Antimicrobial exposure is the main risk factor for multidrug-resistant organisms (MDROs). Nursing home (NH) residents with advanced dementia are three times more likely to be colonized with MDROs compared to other residents. Moreover, as these patients are in the terminal phase of dementia, evidence suggests they may not clinically benefit from antimicrobials. Comfort is the stated goal of care for 90% of advanced dementia patients, and the risks and burdens associated with work-up and treatment of suspected infections generally do not promote that goal, particularly when hospitalization is involved. Taken together, there is a clear need to improve infection management in advanced dementia both to provide better end-of-life care to these patients and reduce the public health threat of MDROs.
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia (N=410; N=205/arm) living in NHs (N=28; N=14/arm). The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world. Analyses will be at the patient level.
- Conditions
- Dementia, Infection, Bacterial
- Being tested
- TRAIN-AD
- Keywords
- Nursing home, Palliative Care, Dementia, Infection, Antimicrobials
- Medical subject headings
- Dementia, Bacterial Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAIN-ADBehavioural
The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education. Intervention components aimed at the provider include: Professionally led infection management training seminars, online infection management course, and infection management guidance algorithms. Additionally participating prescribing providers will be sent bimonthly infection management feedback reports. Proxy Education is completed by providing an infection management in Advanced Dementia booklet to proxies of patients with AD upon resident enrollment in study.
| Study group | Role | What they receive |
|---|---|---|
| TRAIN-AD | Experimental | The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education. Receives: Behavioral: TRAIN-AD |
| CONTROL | No intervention | Facility randomized to the control arm will employ usual care for the management for suspected infections in advanced dementia, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Antimicrobial Use for LRI and UTIs
The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
Measured: 12 months
Secondary outcomes (3)
Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs
The investigators will compare the number of antimicrobial courses prescribed for suspected UTIs and LRIs when minimal criteria for treatment initiation are absent based on consensus guidelines/person-year (secondary outcome) in the intervention vs. control arm over 12 months.
Measured: 12 months
Burdensome Interventions
The investigators will compare the number of burdensome procedures used to evaluate suspected LRIs and UTIs (hospital transfer, bladder catheterization, chest x-ray, blood draws)/person-year between the intervention versus control arm
Measured: 12 months
Total Antimicrobial Use
The investigators will compare the total number of antimicrobial courses prescribed for any reason /person-year over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start15 Oct 2017
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
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 (3)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Mitchell, MD, Hebrew SeniorLife
- Investigators
- Susan L Mitchell, MD. MPH, Principal investigator, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244917
- Sponsor's protocol ID
- TRAIN-AD
- Acronym
- TRAIN-AD
- Status last verified
- Jul 2021
- First submitted
- 7 Aug 2017
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitchell SL, D'Agata EMC, Hanson LC, Loizeau AJ, Habtemariam DA, Tsai T, Anderson RA, Shaffer ML. The Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer Disease and Other Dementias (TRAIN-AD): A Cluster Randomized Clinical Trial. JAMA Intern Med. 2021 Sep 1;181(9):1174-1182. doi: 10.1001/jamainternmed.2021.3098.
PubMed 34251396Shaffer ML, D'Agata EMC, Habtemariam D, Mitchell SL. Covariate-constrained randomization for cluster randomized trials in the long-term care setting: Application to the TRAIN-AD trial. Contemp Clin Trials Commun. 2020 Mar 17;18:100558. doi: 10.1016/j.conctc.2020.100558. eCollection 2020 Jun.
PubMed 32258819Loizeau AJ, D'Agata EMC, Shaffer ML, Hanson LC, Anderson RA, Tsai T, Habtemariam DA, Bergman EH, Carroll RP, Cohen SM, Scott EME, Stevens E, Whyman JD, Bennert EH, Mitchell SL. The trial to reduce antimicrobial use in nursing home residents with Alzheimer's disease and other dementias: study protocol for a cluster randomized controlled trial. Trials. 2019 Oct 15;20(1):594. doi: 10.1186/s13063-019-3675-y.
PubMed 31615540
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (TRAIN-AD)
- ClinicalTrials.gov ID
- NCT03244917
- Acronym / sponsor ID
- TRAIN-AD / TRAIN-AD
- Conditions
- Dementia, Infection, Bacterial
- Keywords
- Nursing home, Palliative Care, Dementia, Infection, Antimicrobials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Posted 10 Aug 2021
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 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia (N=480; N=240/arm) living in NHs (N=24; N=12/arm). The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world. Analyses will be at the patient level.
Detailed description
The final stage of dementia is characterized by recurrent suspected infections. Research has shown these episodes are widely mismanaged, leading to adverse patient and public health outcomes. Antimicrobials are extensively prescribed in advanced dementia, most often in the absence of clinical evidence to support a bacterial infection. Antimicrobial exposure is the main risk factor for multidrug-resistant organisms (MDROs). Nursing home (NH) residents with advanced dementia are three times more likely to be colonized with MDROs compared to other residents. Moreover, as these patients are in the terminal phase of dementia, evidence suggests they may not clinically benefit from antimicrobials. Comfort is the stated goal of care for 90% of advanced dementia patients, and the risks and burdens associated with work-up and treatment of suspected infections generally do not promote that goal, particularly when hospitalization is involved. Taken together, there is a clear need to improve infection management in advanced dementia both to provide better end-of-life care to these patients and reduce the public health threat of MDROs.
This is a 52-month study (8 months preparation; 36 months to conduct the trial; 8 months data analyses and manuscript preparation) of a cluster randomized controlled trial (RCT) of an intervention to improve infection management for suspected UTIs and LRIs among residents with advanced dementia (N=410; N=205/arm) living in NHs (N=28; N=14/arm). The NH is the unit of randomization as the intervention must be delivered at the facility level to avoid contamination and because this is how it would be employed in the real-world. Analyses will be at the patient level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| TRAIN-AD | Experimental | Behavioral: TRAIN-ADThe study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education. |
| CONTROL | No intervention | –Facility randomized to the control arm will employ usual care for the management for suspected infections in advanced dementia, |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Facility inclusion criteria
- More than 60 beds
- Within 60 miles of Boston
- Resident inclusion eligibility criteria
- Age > or = to 60 years
Key exclusion criteria (4 listed)
- Residents with cognitive impairment due to causes other than dementia (e.g., head trauma and in short-term, sub-acute SNFs) will be excluded.
- Residents' whose proxies cannot communicate in English will be excluded from the study, because the information directed to proxies are only in English.
- Providers that do not provide direct care to residents with advanced dementia or who do not speak 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 |
|---|---|---|
| TRAIN-ADThe study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education. Intervention components aimed at the provider include: Professionally led infection management training seminars, online infection management course, and infection management guidance algorithms. Additionally participating prescribing providers will be sent bimonthly infection management feedback reports. Proxy Education is completed by providing an infection management in Advanced Dementia booklet to proxies of patients with AD upon resident enrollment in study. | Behavioural | TRAIN-AD |
Primary outcome
Total Antimicrobial Use for LRI and UTIs
Time frame: 12 months
The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
3 secondary outcomes
Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs
Time frame: 12 months
Burdensome Interventions
Time frame: 12 months
Total Antimicrobial Use
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34251396Mitchell SL, D'Agata EMC, Hanson LC, Loizeau AJ, Habtemariam DA, Tsai T, Anderson RA, Shaffer ML. The Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer Disease and Other Dementias (TRAIN-AD): A Cluster Randomized Clinical Trial. JAMA Intern Med. 2021 Sep 1;181(9):1174-1182. doi: 10.1001/jamainternmed.2021.3098.
- Derived from this study: PubMed 32258819Shaffer ML, D'Agata EMC, Habtemariam D, Mitchell SL. Covariate-constrained randomization for cluster randomized trials in the long-term care setting: Application to the TRAIN-AD trial. Contemp Clin Trials Commun. 2020 Mar 17;18:100558. doi: 10.1016/j.conctc.2020.100558. eCollection 2020 Jun.
- Derived from this study: PubMed 31615540Loizeau AJ, D'Agata EMC, Shaffer ML, Hanson LC, Anderson RA, Tsai T, Habtemariam DA, Bergman EH, Carroll RP, Cohen SM, Scott EME, Stevens E, Whyman JD, Bennert EH, Mitchell SL. The trial to reduce antimicrobial use in nursing home residents with Alzheimer's disease and other dementias: study protocol for a cluster randomized controlled trial. Trials. 2019 Oct 15;20(1):594. doi: 10.1186/s13063-019-3675-y.
- Individual participant dataSharing planned: No
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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.
Susan L Mitchell, MD. MPH principal investigator
Hebrew SeniorLife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAIN-AD in people with Dementia and Infection, Bacterial, run by Hebrew SeniorLife 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 14 inclusion and 4 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 10 Aug 2021. 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 10 Aug 2021). 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?
Total Antimicrobial Use for LRI and UTIs (time frame: 12 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 NCT03244917, which also lists 3 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 10 Aug 2021.