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Treat-to-target in RA: Collaboration To Improve adOption and adhereNce (TRACTION)

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ClinicalTrials.gov Identifier: NCT02260778
Recruitment Status : Active, not recruiting
First Posted : October 9, 2014
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital

Brief Summary:
The purpose of this study is to determine if a Learning Collaborative is an effective tool to improve adoption and adherence to a Treat-to-Target (TTT) treatment strategy in U.S. rheumatology practices for the treatment of Rheumatoid Arthritis (RA). The TTT strategy has been embraced by the American College of Rheumatology through the RA Treatment Guidelines and by EULAR,however several lines of evidence suggest that TTT is not practiced consistently across rheumatology settings.Participating practices will be randomized to receive the Learning Collaborative intervention in one of two phases. Coaching consistent with Learning Collaborative practices will be used to promote adherence to TTT. Chart abstraction will be used to determine if the Learning Collaborative was an effective tool to increase TTT adherence.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Behavioral: Learning Collaborative Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Treat-to-target in RA: Collaboration To Improve adOption and adhereNce (TRACTION)
Study Start Date : September 2014
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase I Intervention
The learning collaborative as designed will be delivered to this arm during phase I, which will last a period of approximately 9 months. After the 9 months, there will be passive follow-up of this arm to see if outcomes following the first 9 months are sustained.
Behavioral: Learning Collaborative
A learning collaborative is an established technique that uses the model for improvement to bridge the gap between what we know and what we do. Structured learning sessions and collaborative coaching are used to guide small cycles of change called Plan-Do-Study-Act (PDSA) cycles. This quality improvement intervention will help providers adopt treat-to-target practices through the structured learning collaborative.

No Intervention: Phase II Intervention
This arm will serve as a control for the Phase I intervention arm during the first 9 months of the study for primary analysis. After the first 9 months, the Phase II intervention arm will receive the learning collaborative during the following 9 months.



Primary Outcome Measures :
  1. Evidence of adherence to TTT by provider [ Time Frame: 9 months ]
    Chart abstraction will determine how strongly providers adhered to treat-to-target principles before and following the Learning Collaborative.


Secondary Outcome Measures :
  1. Patient disease activity and adverse events [ Time Frame: 9 months ]
    Chart abstraction will determine how TTT adherence correlates with patient disease activity and adverse events before and following the Learning Collaborative.

  2. Patient/provider satisfaction [ Time Frame: within 1 month following intervention ]
    Surveys will determine how the TTT principle of shared decision making affects satisfaction with the patient and provider experiences before and following the Learning Collaborative.


Other Outcome Measures:
  1. Resource Utilization [ Time Frame: 9 months ]
    Chart abstraction will determine if a directional relationship exists between adherence to TTT and resource utilization (frequency of medications, labs, clinical exams, etc.) before and following the Learning Collaborative.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • rheumatology practices with at least 50 RA patients for the practice
  • rheumatology practices with at least 2 rheumatologists
  • rheumatology practices utilizing an electronic medical record or typed notes

Exclusion Criteria:

  • rheumatology practices already explicitly employing Treat-to-target principles

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260778


Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Daniel H Solomon, MD MPH Brigham and Women's Hospital
Publications:
McCullagh P, Nelder JA. Generalized Linear Models. 2nd Edition ed: CRC Press; 1989.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel H. Solomon, M.D.,MPH, Chief, Section of Clinical Sciences, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02260778    
Other Study ID Numbers: 2012P000664
P60AR047782 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Keywords provided by Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital:
Learning Collaborative
Treat-to-Target
Arthritis, Rheumatoid
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases