Trial Outcomes & Findings for High Dose Influenza Vaccine in Nursing Home - Pilot Study (NCT NCT01720277)
NCT ID: NCT01720277
Last Updated: 2018-05-23
Results Overview
The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).
COMPLETED
PHASE4
2957 participants
1 year
2018-05-23
Participant Flow
Cluster--We included nursing homes (NHs) within 50 miles of a CDC surveillance. We identified and contacted individual facilities and organizations. Each recruited NH completed a site feasibility form and was notified of its eligibility based on the exclusion criteria. Subject--Eligible nursing home residents in each participating facility.
Unit of analysis: nursing home
Participant milestones
| Measure |
High-Dose Vaccine for Residents
NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
|
Standard-dose for Residents
NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
|
|---|---|---|
|
Overall Study
STARTED
|
1461 20
|
1496 19
|
|
Overall Study
COMPLETED
|
958 20
|
938 19
|
|
Overall Study
NOT COMPLETED
|
503 0
|
558 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Dose Influenza Vaccine in Nursing Home - Pilot Study
Baseline characteristics by cohort
| Measure |
High-Dose Vaccine for Residents
n=20 nursing homes
NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
|
Standard-dose for Residents
n=19 nursing homes
NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
|
Total
n=39 nursing homes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Average age
|
84.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
83.4 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
84.0 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex/Gender, Customized
Percent of female nursing home residents
|
1094 Participants
n=5 Participants
|
1113 Participants
n=7 Participants
|
2207 Participants
n=5 Participants
|
|
Number of residents per nursing home
|
108 participants
STANDARD_DEVIATION 49 • n=5 Participants
|
124 participants
STANDARD_DEVIATION 54 • n=7 Participants
|
116 participants
STANDARD_DEVIATION 51 • n=5 Participants
|
|
Percent of residents who are long-stay
|
88.0 percent
STANDARD_DEVIATION 6.5 • n=5 Participants
|
86.5 percent
STANDARD_DEVIATION 12.1 • n=7 Participants
|
87.2 percent
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Number of long-stay residents who are over 65 years of age
|
78 participants
STANDARD_DEVIATION 37 • n=5 Participants
|
78 participants
STANDARD_DEVIATION 44 • n=7 Participants
|
78 participants
STANDARD_DEVIATION 40 • n=5 Participants
|
|
Percent of residents with Medicaid as payer
|
62.5 percent
STANDARD_DEVIATION 12.8 • n=5 Participants
|
62.9 percent
STANDARD_DEVIATION 17.4 • n=7 Participants
|
62.7 percent
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Percent of residents in for-profit nursing facilities
|
70.0 percent
STANDARD_DEVIATION 47.0 • n=5 Participants
|
73.6 percent
STANDARD_DEVIATION 45.2 • n=7 Participants
|
71.8 percent
STANDARD_DEVIATION 45.6 • n=5 Participants
|
|
Number of nursing facilities that are part of a chain
|
10 nursing homes
n=20 nursing homes
|
6 nursing homes
n=19 nursing homes
|
16 nursing homes
n=39 nursing homes
|
PRIMARY outcome
Timeframe: 1 yearPopulation: We identified long-stay nursing home residents and evaluated outcomes (e.g. hospitalizations, functional status).
The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).
Outcome measures
| Measure |
High-Dose Vaccine for Residents
n=1461 Participants
NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
|
Standard-dose for Residents
n=1496 Participants
NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
|
|---|---|---|
|
Total All-cause Hospitalizations
|
197 events
|
301 events
|
SECONDARY outcome
Timeframe: 1 yearThe secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale.
Outcome measures
| Measure |
High-Dose Vaccine for Residents
n=1461 Participants
NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
|
Standard-dose for Residents
n=1496 Participants
NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
|
|---|---|---|
|
Change in Residents' Functional Status
|
196 Participants
|
206 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: Nursing home facilities randomized to receive high dose or standard dose vaccine.
This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine
Outcome measures
| Measure |
High-Dose Vaccine for Residents
n=20 Nursing Homes
NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents.
|
Standard-dose for Residents
n=19 Nursing Homes
NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
|
|---|---|---|
|
Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size
|
20 Nursing Homes
|
19 Nursing Homes
|
Adverse Events
High-Dose Vaccine for Residents
Standard-dose for Residents
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stefan Gravenstein
Brown University and Providence VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place