Trial Outcomes & Findings for A Randomized Controlled Trial of Mandatory Naps for Physicians in Training (NCT NCT00874510)
NCT ID: NCT00874510
Last Updated: 2016-02-19
Results Overview
Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
352 participants
Primary outcome timeframe
12 months
Results posted on
2016-02-19
Participant Flow
Participant milestones
| Measure |
Standard Schedule
interns work standard schedule, being on duty for 30 continuous hours
|
Mandatory Naps
interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.
Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am
|
|---|---|---|
|
Year 1
STARTED
|
88
|
85
|
|
Year 1
COMPLETED
|
88
|
85
|
|
Year 1
NOT COMPLETED
|
0
|
0
|
|
Year 2
STARTED
|
92
|
87
|
|
Year 2
COMPLETED
|
92
|
87
|
|
Year 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Controlled Trial of Mandatory Naps for Physicians in Training
Baseline characteristics by cohort
| Measure |
Standard Schedule
n=180 Participants
interns work standard schedule, being on duty for 30 continuous hours
|
Mandatory Naps
n=172 Participants
interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.
Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Year 1 PVAMC
|
27.5 years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
27.3 years
STANDARD_DEVIATION 2.3 • n=107 Participants
|
27.4 years
STANDARD_DEVIATION 2.3 • n=206 Participants
|
|
Age, Customized
Year 1 HUP
|
28.1 years
STANDARD_DEVIATION 2.2 • n=99 Participants
|
27.7 years
STANDARD_DEVIATION 2.0 • n=107 Participants
|
27.9 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
Age, Customized
Year 2 PVAMC
|
27.9 years
STANDARD_DEVIATION 2.4 • n=99 Participants
|
27.9 years
STANDARD_DEVIATION 3.5 • n=107 Participants
|
27.9 years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
Age, Customized
Year 2 HUP
|
28.1 years
STANDARD_DEVIATION 2.9 • n=99 Participants
|
28.3 years
STANDARD_DEVIATION 3.0 • n=107 Participants
|
28.2 years
STANDARD_DEVIATION 3.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
178 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=99 Participants
|
172 participants
n=107 Participants
|
352 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTwo sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.
Outcome measures
| Measure |
Arm 1 - Standard Schedule for Years 1 and Year 2
n=4159 Days studied
interns work standard schedule, being on duty for 30 continuous hours
|
Arm 2 - Mandatory Nap
n=4354 Days studied
In Year 1 interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am and were asked to nap during this time
For Year 2, the mandatory sign out of cell phones and cross-coverage responsibilities was split between two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am and were asked to nap during this time
|
|---|---|---|
|
Hours Slept on Overnight Extended Duty Call Shifts
Sleep time Year 2 late shift HUP
|
1.55 hours
Interval 1.36 to 1.73
|
2.44 hours
Interval 2.17 to 2.71
|
|
Hours Slept on Overnight Extended Duty Call Shifts
Sleep time Year 1 PVAMC
|
1.98 hours
Interval 1.68 to 2.28
|
2.86 hours
Interval 2.57 to 3.1
|
|
Hours Slept on Overnight Extended Duty Call Shifts
Sleep time Year 1 HUP
|
2.04 hours
Interval 1.79 to 2.24
|
3.04 hours
Interval 2.77 to 3.45
|
|
Hours Slept on Overnight Extended Duty Call Shifts
Sleep time Year 2 early shift PVAMC
|
1.90 hours
Interval 1.71 to 2.1
|
2.33 hours
Interval 2.07 to 2.58
|
|
Hours Slept on Overnight Extended Duty Call Shifts
Sleep time Year 2 late shift PVAMC
|
1.90 hours
Interval 1.71 to 2.1
|
2.40 hours
Interval 2.12 to 2.69
|
|
Hours Slept on Overnight Extended Duty Call Shifts
Sleep time Year 2 early shift HUP
|
1.55 hours
Interval 1.36 to 1.73
|
2.40 hours
Interval 2.12 to 2.67
|
Adverse Events
Arm 1 - Standard Schedule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 - Mandatory Naps
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kevin Volpp, MD, PhD
Center for Health Incentives and Behavioral Economics
Phone: 215.573-0270
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place