Disk Herniated LumbarEHR-CPSNCT04520009

EHR Embedded Comparative Effectiveness Studies--CPS

A study testing Activity Restriction and Activity as Tolerated in people with Disk Herniated Lumbar, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Disk Herniated Lumbar
What is being tested?: Activity Restriction and Activity as Tolerated
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 23 Oct 2020to 27 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults (>18) able to consent
Sufficient fluency in English
Indications for discectomy
Able to restrict activities or to resume activities as tolerated

Who cannot join

Pregnant women
Prisoners
Children (<18).

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-HItchcock
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems

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.

Read the 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.

Conditions: Disk Herniated Lumbar
Being tested: Activity Restriction, Activity as Tolerated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Activity RestrictionBehavioural
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 ToleratedBehavioural
Instructions advising activity as tolerated and return to work based on patient discretion

Study groups in NCT04520009
Study group	Role	What they receive
Activity Restriction	Active comparator	Discharge orders for activity restriction Receives: Behavioral: Activity Restriction
Activity As Tolerated	Active comparator	Discharge orders written for activity as tolerated Receives: Behavioral: Activity as Tolerated

What is being measured

The primary outcome is the main question the study is designed to answer.

Compliance Rate With Assigned Treatment
Compliance with assigned treatment as measured by presence of appropriate surgical discharge instructions.
Measured: 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.
Measured: 1 day, during the recruitment period from October 23 2020 to August 7, 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 202027 Oct 2021

First posted20 Aug 2020
Study start23 Oct 2020
Primary completion7 Aug 2021
Study completion27 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Disk Herniated LumbarStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04520009
Sponsor's protocol ID: SFD20160
Acronym: EHR-CPS
Status last verified: Jul 2023
First submitted: 10 Jan 2020
Last updated: 1 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plans at this time share IPD

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Disk Herniated Lumbar trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems
ClinicalTrials.gov ID: NCT04520009
Acronym / sponsor ID: EHR-CPS / SFD20160
Conditions: Disk Herniated Lumbar
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: Trustees of Dartmouth College, Patient-Centered Outcomes Research Institute
Study start: 23 Oct 2020 (actual)
Primary completion: 7 Aug 2021 (actual)
Study completion: 27 Oct 2021 (actual)
First posted: 20 Aug 2020 (actual)
Results: Posted 1 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Activity Restriction	Active comparator	Behavioral: Activity RestrictionDischarge orders for activity restriction
Activity As Tolerated	Active comparator	Behavioral: Activity as ToleratedDischarge orders written for activity as tolerated

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults (>18) able to consent
Sufficient fluency in English
Indications for discectomy
Able to restrict activities or to resume activities as tolerated

Key exclusion criteria (3 listed)

Pregnant women
Prisoners
Children (<18).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Activity RestrictionStandard 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).	Behavioural	Activity Restriction
Activity as ToleratedInstructions advising activity as tolerated and return to work based on patient discretion	Behavioural	Activity As Tolerated

Primary outcome

Compliance Rate With Assigned Treatment
Time frame: 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
Time frame: 1 day, during the recruitment period from October 23 2020 to August 7, 2021
Percentage of those identified as being eligible who were enrolled.

Results and safety

Results posted to the registry on 1 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Activity Restriction	19	19
Activity As Tolerated	18	18

Primary outcome: Compliance Rate With Assigned Treatment

Time frame: Upon completion of surgery approximately 24 days post-randomization. Number (95% Confidence Interval). Unit: percentage of eligible patients

Measure	Activity Restriction n = 19	Activity as Tolerated n = 18
Value	89 (65 to 98)	50 (29 to 71)

Primary outcome: Percentage Eligible Patients Participating in Study

Time frame: 1 day, during the recruitment period from October 23 2020 to August 7, 2021. Number (95% Confidence Interval). Unit: percentage of eligible patients

Measure	All Eligible Patients n = 48
Value	77 (62 to 87)

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

Adverse events

Time frame: Duration of follow-up for adverse events ranged from 288 days for the first patient randomized to 31 days for the last patient randomized.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Activity Restriction	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Activity As Tolerated	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plans at this time share IPD

Related trials for Disk Herniated Lumbar

Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
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RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
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Not yet recruiting
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Recruiting
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tor Tosteson, ScD principal investigator

Dartmouth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Activity Restriction and Activity as Tolerated in people with Disk Herniated Lumbar, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance Rate With Assigned Treatment (time frame: Upon completion of surgery approximately 24 days post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520009.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.