Disk Herniated Lumbar
Conditions
Brief summary
Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.
Detailed description
EHR Embedded Comparative Effectiveness Studies-CPS will be held in the Center for Pain and Spine at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either activity restriction or no activity restriction following lumbar discectomy.
Interventions
BEHAVIORALActivity 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).
BEHAVIORALActivity as Tolerated
Instructions advising activity as tolerated and return to work based on patient discretion
Sponsors
Trustees of Dartmouth College
Patient-Centered Outcomes Research Institute
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults (\>18) able to consent * Sufficient fluency in English * Indications for discectomy * Able to restrict activities or to resume activities as tolerated
Exclusion criteria
* Pregnant women * Prisoners * Children (\<18).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance Rate With Assigned Treatment | Upon completion of surgery approximately 24 days post-randomization | Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions. |
| Percentage Eligible Patients Participating in Study | 1 day, during the recruitment period from October 23 2020 to August 7, 2021 | Percentage of those identified as being eligible who were enrolled. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 19 |
| 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 | 18 |
| Total | 37 |
Baseline characteristics
| Characteristic | Activity Restriction | Total | Activity As Tolerated |
|---|---|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 13.2 | 46.5 years STANDARD_DEVIATION 15.1 | 46.8 years STANDARD_DEVIATION 17.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 35 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 36 Participants | 17 Participants |
| Region of Enrollment United States | 19 participants | 37 participants | 18 participants |
| Sex: Female, Male Female | 9 Participants | 23 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
Compliance Rate With Assigned Treatment
Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions.
Time frame: Upon completion of surgery approximately 24 days post-randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Activity Restriction | Compliance Rate With Assigned Treatment | 89 percentage of eligible patients |
| Activity as Tolerated | Compliance Rate With Assigned Treatment | 50 percentage of eligible patients |
Primary
Percentage Eligible Patients Participating in Study
Percentage of those identified as being eligible who were enrolled.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Activity Restriction | Percentage Eligible Patients Participating in Study | 77 percentage of eligible patients |