Dementia, Infection, Bacterial
Conditions
Keywords
Nursing home, Palliative Care, Dementia, Infection, Antimicrobials
Brief 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) 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.
Interventions
BEHAVIORALTRAIN-AD
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.
Sponsors
Hebrew SeniorLife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The research assistants collecting outcome data through chart reviews and follow-up proxy interviews will be blinded to nursing home randomization. The Principal Investigator, data programmers, and statistician will be blinded to treatment assignment
Intervention model description
Cluster Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Facility inclusion criteria 1. More than 60 beds 2. Within 60 miles of Boston Resident inclusion eligibility criteria * Age \> or = to 60 years * A diagnosis of dementia (any type) * 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.
Exclusion criteria
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Antimicrobial Use for LRI and UTIs | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs | 12 months | 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. |
| Burdensome Interventions | 12 months | 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 |
| Total Antimicrobial Use | 12 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TRAIN-AD Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections | 199 |
| Control Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections | 227 |
| Total | 426 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Control | Total | TRAIN-AD |
|---|---|---|---|
| Age, Continuous | 85.3 years STANDARD_DEVIATION 8.6 | 86.3 years STANDARD_DEVIATION 8.4 | 87.7 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 49 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 200 Participants | 366 Participants | 166 Participants |
| Sex: Female, Male Female | 190 Participants | 353 Participants | 163 Participants |
| Sex: Female, Male Male | 37 Participants | 73 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 82 / 199 | 102 / 227 |
| other Total, other adverse events | 0 / 199 | 0 / 227 |
| serious Total, serious adverse events | 0 / 199 | 0 / 227 |
Outcome results
Primary
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
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TRAIN-AD | Total Antimicrobial Use for LRI and UTIs | 0.55 antimicrobial courses per person-year |
| Control | Total Antimicrobial Use for LRI and UTIs | 0.82 antimicrobial courses per person-year |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TRAIN-AD | Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs | 0.37 antimicrobial courses per person-year |
| Control | Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs | 0.43 antimicrobial courses per person-year |
Secondary
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
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TRAIN-AD | Burdensome Interventions | 1.07 interventions per person-year |
| Control | Burdensome Interventions | 1.69 interventions per person-year |
Secondary
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
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TRAIN-AD | Total Antimicrobial Use | 0.82 antimicrobial courses per person-year |
| Control | Total Antimicrobial Use | 1.19 antimicrobial courses per person-year |