Clinical Trials/NCT04520009

NCT04520009CompletedNot Applicable

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

Dartmouth-Hitchcock Medical Center1 site in 1 country37 target enrollmentStarted: October 23, 2020Last updated: March 1, 2024

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Dartmouth-Hitchcock Medical Center
Enrollment: 37
Locations: 1
Primary Endpoint: Compliance Rate With Assigned Treatment

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Health Services Research
Masking: None

Eligibility Criteria

Ages: 18 Years to 85 Years (Adult, Older Adult)
Sex: All
Accepts 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).

Arms & Interventions

Activity Restriction

Active Comparator

Discharge orders for activity restriction

Intervention: Activity Restriction (Behavioral)

Activity As Tolerated

Active Comparator

Discharge orders written for activity as tolerated

Intervention: Activity as Tolerated (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Dartmouth-Hitchcock Medical Center

Sponsor Class

Other

Responsible Party

Principal Investigator

Tor D. Tosteson

Professor

Dartmouth-Hitchcock Medical Center

Study Sites (1)

Loading locations...

Similar Trials

Active, not recruiting

Not Applicable

Estudio aleatorizado, multicéntrico, abierto y en fase II sobre la eficacia y la seguridad de lapatinib más epirrubicina y ciclofosfamida (EC90-L) seguido de paclitaxel y lapatinib (PX L) semanales en comparación con EC90 seguido de la administración semanal de paclitaxel y trastuzumab (PX-T) como tratamiento neoadyuvante de pacientes con cáncer de mama invasivo en estadio I a IIIA, con sobreexpresión de ErbB2, no tratado previamente y con tumor primario de tamaño > 1 cm.A randomized, multicentre, open-label, Phase II study of the efficacy and safety of lapatinib plus epirubicin and cyclophosphamide (EC90-L) followed by weekly paclitaxel and lapatinib (PX-L) compared with EC90 followed by weekly paclitaxel and trastuzumab (PX-T), as neoadjuvant therapy in patients with previously untreated ErbB2-overexpressing Stage I - IIIA invasive breast cancer with primary tumour size > 1cm.MedDRA version: 13Level: LLTClassification code 10006187Term: Cáncer de mamapacientes con cáncer de mama invasivo en estadio I a IIIA, con sobreexpresión de ErbB2, no tratado previamente y con tumor primario de tamaño > 1 cm.MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancer

EUCTR2010-018389-22-ESGlaxoSmithKline, S.A.164

Active, not recruiting

Phase 1

?Estudio aleatorizado, controlado y abierto, en el que se compara la eficacia y la seguridad de la sustitución de una medicación estimulante por atomoxetina (transición lenta frente a transición rápida), en niños y adolescentes ambulatorios, con trastorno por déficit de atención/hiperactividad (TDAH), según los criterios DSM-IV?A Randomized, Controlled, Open-Label Comparison Study of the Efficacy and Safety of Slow Transitioning compared with Fast Transitioning from a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients with DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD) - LYFJTrastorno de Deficit de Antencion/ HiperactividadMedDRA version: 9.1Level: LLTClassification code 10003735Term: Attention deficit-hyperactivity disorder

EUCTR2008-001767-11-ESilly S.A.111

Active, not recruiting

Phase 1

Estudio aleatorizado, abierto, multicéntrico y en fase 3 de la combinación de Rituximab, Ciclofosfamida, Doxorubicina, VELCADE, y Prednisona (VcR-CAP) o Rituximab, Ciclofosfamida, Doxorubicina, Vincristina y Prednisona (R-CHOP) en pacientes con Linfoma de Células del Manto de nuevo diagnóstico que no son candidatos a trasplante de médula ósea. - n/aPacientes de ambos sexos con diagnóstico molecular confirmado de Linfoma de Células del Manto estadio II, III o IV, que no han recibido otros tratamientos para su enfermedad. Los pacientes deberán ser también no idóneos para el trasplante de médula ósea.Determinar qué régimen (VcR-CAP o R-CHOP) aporta mayores ventajas clínicas a los pacientes con Linfoma de Células del Manto de nuevo diagnóstico, valorado por la prolongación significativa de la supervivencia libre de progresión (SLP).

EUCTR2007-005669-37-ESJanssen-Cilag International N.V.486

Active, not recruiting

Not Applicable

Estudio multicéntrico, aleatorizado, abierto y de grupos paralelos para determinar la eficacia y la seguridad a largo plazo de la albiglutida en comparación con la insulina en sujetos con diabetes mellitus de tipo 2A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Long-Term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes MellitusDiabetes mellitus de tipo 2Type 2 Diabetes MellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

EUCTR2008-007661-24-ESGlaxoSmithKline Research and Development Ltd.750

Active, not recruiting

Phase 1

Estudio multicéntrico, aleatorizado, abierto y de grupos paralelos para determinar la eficacia y la seguridad de albiglutida en comparación con liraglutida en pacientes con diabetes mellitus de tipo 2.A Randomized, Open-Label, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide in Subjects With Type 2 Diabetes MellitusDiabetes mellitus de tipo 2.Type 2 Diabetes Mellitus.MedDRA version: 12.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

EUCTR2010-019690-15-ESGlaxoSmithKline LLC