NCT02696551

Brief Summary

This is a retrospective and prospective designed study, included hospitals are 1:1 assigned into two groups: ①Interventional hospital, which will receive 3-month medical education; ②Non-interventional hospital, which will not receive 3-month medical education. During 1 month before education, all the electronic records of outpatients and inpatients who visit the included rheumatologists will be collected and the data of test and evaluation results of spondyloarthritis (SpA) patients diagnosed according to new Assessment of Spondylo-Arthritis International Society (ASAS) criteria will be collected from outpatient electronic records and inpatients medical charts; in the 3 months after education, the same data will be collected and compared with the data before education, and the impact of medical education on physician behaviour will be analyzed. Meanwhile, the understanding and acceptance level will be evaluated by the questionnaire, the differences before and after education and the impact of education on physician cognition will be evaluated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 23, 2016

Last Update Submit

March 1, 2016

Conditions

Spondyloarthritis

Keywords

Medical educationSpondyloarthritisPhysician action

Outcome Measures

Primary Outcomes (3)

  • Mean of number of positive SpA feature of newly diagnosed patients with inflammatory back pain, before and after the (no-)event

    1 month before (no-) education vs. 3 months after (no-) education

  • Proportion of patients with a image examination of sacroiliitis ( x-rays, CT, or MRI) in the audit period, before and after the (no-)event

    1 month before (no-) education vs. 3 months after (no-) education

  • Proportion of patients with a assessment of disease activity in the audit period, before and after the (no-)event

    1 month before (no-) education vs. 3 months after (no-) education

Secondary Outcomes (5)

  • Proportion of patients with a clear diagnosis (Diagnostic for Spondyloarthritis with new ASAS criteria) or receiving a new diagnosis in the audit period, before and after the (no-)event

    1 month before (no-) education vs. 3 months after (no-) education

  • Mean of the number of physical examinations of disease activity in the audit period, before and after the (no-)event

    1 month before (no-) education vs. 3 months after (no-) education

  • Change of questionnaire scores of physician in the audit period, before and after the (no-)event

    1 month before (no-) education vs. 3 months after (no-) education

  • Change of utilization rate of Non Steroidal Anti Inflammatory Drugs (NSAIDs) before and after the (no-)event

    1 month before (no-) education vs. 3 months after (no-) education

  • Change of utilization rate of biological medication before and after the (no-)event

    1 month before (no-) education vs. 3 months after (no-) education

Study Arms (2)

Interventional hospital

EXPERIMENTAL

Interventional hospital, which will receive 3-month medical education

Other: Medical education

Non-interventional hospital

NO INTERVENTION

Non-interventional hospital, which will not receive 3-month medical education.

Interventions

Medical educationOTHER
Interventional hospital

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Interventional hospital will be selected based on following criteria: 1. having complete outpatients and inpatients electronic records; 2. more than 50% of registrars and/or consultants in the department participated the professional education event; 3. the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection; 4. except for rheumatic diseases have been clearly diagnosed. Non-interventional hospital will be selected based on following criteria: 1. having complete outpatients and inpatients electronic records; 2. no professional education event covered; 3. the department head is willing to participate the clinical audit and provide the information from outpatients and inpatients records for data collection; 4. except for rheumatic diseases have been clearly diagnosed.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Shanxi Dayi Hospital

Taiyuan, Shanxi, 030032, China

Location

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Central Study Contacts

Liyun Zhang, MD

CONTACT

86-351-8368114

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 2, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-02

Locations

CN(1)