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| Name | Class |
|---|---|
| Trustees of Dartmouth College | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity Restriction | Active Comparator | Discharge orders for activity restriction |
|
| Activity As Tolerated | Active Comparator | Discharge orders written for activity as tolerated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity Restriction | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance Rate With Assigned Treatment | Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions. | Upon completion of surgery approximately 24 days post-randomization |
| Percentage Eligible Patients Participating in Study | Percentage of those identified as being eligible who were enrolled. | 1 day, during the recruitment period from October 23 2020 to August 7, 2021 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tor Tosteson, ScD | Dartmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-HItchcock | Lebanon | New Hampshire | 03756 | United States |
No plans at this time share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Activity As Tolerated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compliance Rate With Assigned Treatment | Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions. | Posted | Number | 95% Confidence Interval | percentage of eligible patients | Upon completion of surgery approximately 24 days post-randomization |
|
Duration of follow-up for adverse events ranged from 288 days for the first patient randomized to 31 days for the last patient randomized.
Attending surgeon and clinical reports.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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Primary limitations of the trial include limited enrollment compared to the original goal of 60 randomized patients due in part to the limitations in elective surgery during the Covid-19 pandemic. By design, the study is pragmatic, and primarily intended to evaluated methodologies for embedding randomization in the electronic record system of a regional health care center.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tor D. Tosteson, ScD | Dartmouth Geisel School of Medicine | 603 646-5724 | tor.d.tosteson@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2021 | Jun 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Activity as Tolerated | Behavioral | Instructions advising activity as tolerated and return to work based on patient discretion |
|
Discharge orders written for activity as tolerated Activity as Tolerated: Instructions advising activity as tolerated and return to work based on patient discretion |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage Eligible Patients Participating in Study | Percentage of those identified as being eligible who were enrolled. | All patients who were identified as being eligible and invited to participate. | Posted | Number | 95% Confidence Interval | percentage of eligible patients | 1 day, during the recruitment period from October 23 2020 to August 7, 2021 |
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|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
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