Trial Outcomes & Findings for EHR Embedded Comparative Effectiveness Studies--CPS (NCT NCT04520009)

NCT ID: NCT04520009

Last Updated: 2024-03-01

Results Overview

Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: Upon completion of surgery approximately 24 days post-randomization
• Results posted on: 2024-03-01

Participant Flow

Participant milestones

Measure	Activity Restriction Discharge orders for activity restriction Activity Restriction: Standard post-operative activity instructions (i.e., no bending, twisting, or lifting more than 10 lbs for 4 weeks, no return to work until cleared to do so).	Activity As Tolerated Discharge orders written for activity as tolerated Activity as Tolerated: Instructions advising activity as tolerated and return to work based on patient discretion
Overall Study STARTED	19	18
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EHR Embedded Comparative Effectiveness Studies--CPS

Baseline characteristics by cohort

Measure	Activity Restriction n=19 Participants Discharge orders for activity restriction Activity Restriction: Standard post-operative activity instructions (i.e., no bending, twisting, or lifting more than 10 lbs for 4 weeks, no return to work until cleared to do so).	Activity As Tolerated n=18 Participants Discharge orders written for activity as tolerated Activity as Tolerated: Instructions advising activity as tolerated and return to work based on patient discretion	Total n=37 Participants Total of all reporting groups
Age, Continuous	46.2 years STANDARD_DEVIATION 13.2 • n=5 Participants	46.8 years STANDARD_DEVIATION 17.2 • n=7 Participants	46.5 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Upon completion of surgery approximately 24 days post-randomization

Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions.

Outcome measures

Measure	Activity Restriction n=19 Participants Discharge orders for activity restriction Activity Restriction: Standard post-operative activity instructions (i.e., no bending, twisting, or lifting more than 10 lbs for 4 weeks, no return to work until cleared to do so).	Activity as Tolerated n=18 Participants Discharge orders written for activity as tolerated Activity as Tolerated: Instructions advising activity as tolerated and return to work based on patient discretion
Compliance Rate With Assigned Treatment	89 percentage of eligible patients Interval 65.0 to 98.0	50 percentage of eligible patients Interval 29.0 to 71.0

PRIMARY outcome

Timeframe: 1 day, during the recruitment period from October 23 2020 to August 7, 2021

Population: All patients who were identified as being eligible and invited to participate.

Percentage of those identified as being eligible who were enrolled.

Outcome measures

Measure	Activity Restriction n=48 Participants Discharge orders for activity restriction Activity Restriction: Standard post-operative activity instructions (i.e., no bending, twisting, or lifting more than 10 lbs for 4 weeks, no return to work until cleared to do so).	Activity as Tolerated Discharge orders written for activity as tolerated Activity as Tolerated: Instructions advising activity as tolerated and return to work based on patient discretion
Percentage Eligible Patients Participating in Study	77 percentage of eligible patients Interval 62.0 to 87.0	—

Adverse Events

Activity Restriction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Activity As Tolerated

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

Tor D. Tosteson, ScD

Dartmouth Geisel School of Medicine

Phone: 603 646-5724

Email: tor.d.tosteson@dartmouth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place