Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03654365
Other study ID # IRB16-00776
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 17, 2016
Est. completion date March 25, 2017

Study information

Verified date August 2018
Source MetroHealth Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study involves randomizing patients due for once in a lifetime Hepatitis C screening based on Center for Disease Control and Prevention and United States Preventative Services Task Force guidelines in one of three primary care clinics within the MetroHealth System to bulk messaging and bulk ordering for HCV antibody vs usual care (routine alerting).


Description:

All patients had to have an active personal health record account at the time of being randomized.

Patients had to have been seen by their primary care provider in the last 6 months to be eligible and therefore had a "missed opportunity" for Hepatitis C screening.

Control group received "usual care" which in our system included alert (health maintenance reminder) to the primary care provider at the time of the visit and passive alert in their personal health record (i.e. an alert if they log into their personal health record and look for reminders for preventative care that it due/overdue).

Intervention group received same care as control group plus automatic ordering of the hepatitis C screening test and active electronic letter their personal health record that they were due for hepatitis C screening, what hepatitis C is, what the testing and if positive, treatment could involve, and instruction to go to one of the laboratories in the healthcare system to have their blood drawn if they were interested in the testing.


Recruitment information / eligibility

Status Completed
Enrollment 1024
Est. completion date March 25, 2017
Est. primary completion date March 25, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 51 Years to 71 Years
Eligibility Inclusion Criteria:

- seen recently in one of the three primary care study sites and have an active person health record at the time of randomization; and meet Centers for Disease Control and Prevention/United States Preventative Services Task Force guidelines for once in a lifetime hepatitis C screening

Exclusion Criteria:

- already had once in a lifetime screen for hepatitis C or positive for hepatitis C (by lab test or International Classification of Disease code)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bulk ordering and bulk messaging
Patients in the intervention group had the hepatitis screening test ordered for them in bulk and then a bulk message sent to them through the personal health record describing hepatitis C and how they could be tested.
Routine alerting
Passive alerting to providers (during face-to-face encounters using the electronic health record) and to patient (when they review preventative screening recommendations through their personal health record).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
MetroHealth Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Impact on hepatitis C antibody testing rates at 12 weeks post direct patient messaging Number of patients who remain untested for HCV at 12 weeks post direct patient messaging 12 weeks post-intervention
Secondary Impact of bulk ordering vs bulk messaging and bulk ordering on HCV antibody testing rates Assessment of if the patient in the intervention group seemed have the hepatitis screening done just because they were having other blood work done versus specifically wanting to be screened for hepatitis C. 12 weeks post-intervention
See also
  Status Clinical Trial Phase
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Recruiting NCT04510246 - Link Hepatitis C Notifications to Treatment in Tasmania N/A
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03118674 - Harvoni Treatment Porphyria Cutanea Tarda Phase 2
Completed NCT03109457 - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed NCT01458054 - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults Phase 1
Completed NCT03740230 - An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Completed NCT00006301 - Immune Response to Hepatitis C Virus
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Recruiting NCT04405024 - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients N/A
Completed NCT04525690 - Improving Inpatient Screening for Hepatitis C N/A
Completed NCT04033887 - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn NCT04546802 - HepATocellular Cancer Hcv Therapy Study Phase 3
Active, not recruiting NCT02961426 - Strategic Transformation of the Market of HCV Treatments Phase 2/Phase 3
Completed NCT03186313 - A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection Phase 3
Completed NCT02992184 - PoC-HCV Genedrive Viral Detection Assay Validation Study N/A
Completed NCT02869776 - Integrating HCV and HIV Screening During the Era of HIV Antigen Testing N/A