Hepatitis CCARE-CNCT03581383
Community Access, Retention in Care, and Engagement for Hepatitis C Treatment
A study testing PREP-C, Modified ECHO and Patient Telemedicine Questionnaire in people with Hepatitis C, run by Jens Rosenau at 1 site in United States.
Trial summary
The main goals of the CARE-C study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- PREP-C, Modified ECHO and Patient Telemedicine Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First office visit for hepatitis C management
- Referred either (a) to the Hepatology Outpatient Clinic at the University of Kentucky in Lexington, Kentucky or (b) to a local community provider who can provide comprehensive care for HCV including HCV treatment in collaboration with the University of Kentucky as a spoke of the ECHO program
- Age 18 years and older
Who cannot join
- Life expectancy less than one year
- Less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Two Novel Interdisciplinary Care Models and the Impact on Hepatitis C Treatment Uptake, Completion, Sustained Virologic Response, and Retention in Care
The main goals of the CARE-C study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. To achieve these goals the following two systems interventions will be separately implemented: (1) Implementation of the Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) and related standard of care best practice PREP-C related interventions facilitated by a social worker-patient navigator team, and (2) implementation of a modified ECHO model (with one patient visit at specialty center to include PREP-C and fibrosis assessment in contrast to standard ECHO model). To test the effectiveness of our two systems interventions 600 patients will be equally distributed into three study arms representing 3 care models: Arm 1: Current Care Model (management with current interdisciplinary team); Arm 2: PREP-C Model (management with expanded interdisciplinary team (social worker, patient navigator, PREP-C); and Arm 3: Modified ECHO Model (management with expanded team in collaboration with community providers). An additional Arm 4 was started January 2021 to follow subjects experience with HCV management and treatment via telemedicine.
Read the detailed description
Hepatitis C virus (HCV) related complications (end-stage liver disease, liver cancer, and death) are increasing in the U.S., and extrapolated from U.S. data most of the estimated 49,200 patients with chronic hepatitis C in the state of Kentucky are untreated. In addition, the state of Kentucky is at the center of the rural opioid epidemic in the United States which has led to a dramatic increase in the transmission of hepatitis C virus (HCV) infection. HCV treatment uptake has been suboptimal in Kentucky despite the availability of highly effective, well-tolerated, timely limited treatment options due to multiple patient-, provider-, and system related barriers. Effective models of linkage to care, treatment, and retention in care are urgently needed to overcome the epidemiological challenges facing our rural state and put Kentucky on a path to planned elimination of HCV infection in the state. The demonstration of the effectiveness of new models of care in Kentucky which are appropriate to rural states will have great relevance and value to other states struggling with new HCV transmission and similar urgent need for effective models of linkage to care, treatment, and retention. Standardized care interventions expanding the reach of specialty providers (Project ECHO) and overcoming patient and provider related barriers to HCV treatment initiation (PREP-C assessment and interventions) have been evaluated, but the implementation of both models has been hampered by a lack of financial incentive, PREP-C has not been evaluated in rural populations, and the two models have never been used in conjunction.
The main goals of the study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. To achieve these goals the following two systems interventions will be separately implemented: (1) Implementation of the Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) and related standard of care best practice PREP-C related interventions facilitated by a social worker-patient navigator team, and (2) implementation of a modified ECHO model (with one patient visit at specialty center to include PREP-C and fibrosis assessment in contrast to standard ECHO model). To test the effectiveness of our two systems interventions up to 1000 participants will be distributed into four study arms representing 4 care models: Arm 1, Current Care Model (management with current interdisciplinary team);arm 2, PREP-C Model (management with expanded interdisciplinary team (social worker, patient navigator, PREP-C); arm 3, Modified ECHO Model (management with expanded team in collaboration with community providers); and Arm 4, current Telemedicine care model (management with current interdisciplinary team).
The specific aims are:
Aim 1: To compare HCV treatment uptake within 12 months after the first clinic visit (time of enrollment) in all Arms 1, 2, and 3. It is hypothesized that (A) treatment uptake will be higher in Arms 2 (PREP-C model) and 3 (modified ECHO model) as compared to Arm 1 (current care model) as a result of overcoming patient level treatment barriers (such as ongoing substance use, psychiatric instability, non-compliance, loss to follow up) facilitated by implementation of the PREP-C assessment, PREP-C related interventions, and assistance of the social worker-patient navigator team, and (B) treatment uptake in Arm 3 will be non-inferior to Arm 2.
Aim 2: To compare HCV treatment outcomes (treatment completion and sustained virologic response, SVR12) in all arms 1, 2, and 3. It is hypothesized that treatment completion and SVR12 in arms 2 and 3 will be noninferior to arm 1 due PREP-C enhancement, even though expected additional patients who start treatment in Arms 2 and 3 are expected to have less favorable treatment readiness scores prior to PREP-C interventions due to higher rates of treatment uptake as hypothesized in Aim 1.
Aim 3: To compare retention in care in all 3 arms for patients who do not start treatment (within 12 months after initial appointment). It is hypothesized that retention in care will be higher in arms 2 and 3 due to implementation of PREP-C assessment and interventions, and the support through the patient navigator.
Aim 4: To record the treatment uptake and analyze patient experiences with telemedicine appointments in Arm 4, the telemedicine arm.
- Conditions
- Hepatitis C
- Being tested
- PREP-C, Modified ECHO, Patient Telemedicine Questionnaire
- Keywords
- Hepatitis C, Hep C, CARE-C, Kentucky
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREP-CBehavioural
The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) is an interactive online tool that enables providers to provide a thorough assessment of a patient's psychosocial readiness to begin Hepatitis C treatment, and make a treatment plan to improve treatment readiness.
Modified ECHOBehavioural
The heart of the ECHO (Extension for Community Health Outcomes) model is its hub-and-spoke knowledge-sharing networks, led by expert teams who use multi-point videoconferencing to conduct virtual clinics with community providers. The key modification is one patient visit in the specialty center resulting in co-management of patients with data sharing.
Patient Telemedicine QuestionnaireBehavioural
The patient questionnaire includes questions about patient experiences with telemedicine visits with providers
| Study group | Role | What they receive |
|---|---|---|
| Current Care Model (Control) | No intervention | The Current Care Model will not have any intervention beyond the standard of care for Hepatitis C provided by an interdisciplinary team at the University of Kentucky. |
| PREP-C Model | Experimental | The PREP-C care model will provide Hepatitis C care with the standard interdisciplinary team expanded by a social worker and a patient navigator team. The social worker/ patient navigator team will use the standardized Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) tool and will guide PREP-C related interventions to overcome barriers to HCV treatment uptake and completion. Receives: Behavioral: PREP-C |
| Modified ECHO Model | Experimental | The modified Extension for Community Healthcare Outcomes (ECHO) Model will provide patient care through collaboration of the expanded interdisciplinary team (including social worker patient navigator team) with community providers. Receives: Behavioral: PREP-C; Behavioral: Modified ECHO |
| Telemedicine Arm | Experimental | The telemedicine Model will track outcomes and record patient experiences with HCV management and treatment with telemedicine. Receives: Behavioral: Patient Telemedicine Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV treatment initiation
The overall number of patients who have started HCV treatment by month12 after the first clinic visit will be divided by the number of patients enrolled and presented as a percentage of participants per group.
Measured: 12 months
HCV treatment completion
The number of patients who have completed HCV treatment will be divided by the number of patients who have started treatment and presented as a percentage of participants per group.
Measured: 12 months
Sustained Virologic Response (SVR)
The number of patients who achieve sustained virologic response (negative HCV RNA 12 weeks after completion of HCV treatment) will be divided by the number of patients who have started treatment and presented as a percentage of participants per group.
Measured: 12 weeks from treatment completion
Secondary outcomes (5)
Missed clinic visits
The total number of missed clinic visits will be counted for each group. Data will be presented as the number of missed visits divided by the number of total visits scheduled and presented as a percentage of total clinic appointments.
Measured: 18 months
Clinic visit consistency
This outcome will measure the number of participants attending clinical visits with less than six month intervals between visits. Data will be presented as the number of participants maintaining an appointment interval less than six months divided by the total number of participants.
Measured: 18 months
Gaps in clinical care
The average time between clinical appointments will be calculated between groups. Data will be presented as the mean amount of time +/- SEM.
Measured: 18 months
Appointment adherence
This outcome will measure the number of clinical appointments the participant attended compared to the number of appointments they were scheduled to attend. Data presented as the ratio of attended/scheduled appointments
Measured: 18 months
Visit frequency within a twelve month period
This outcome will track the number of participants attending two or more clinical appointments in a 12 month period with at least 3 months between visits. Data will be presented as the ratio of participants in each group attending multiple visits compared to the total number of participants in each group.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start21 Aug 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Factorial
- Model description
- 3 Arms: Two intervention models plus a control group representing standard practice Arm 4: And intervention model to record patient experiences with telemedicine
- Masking
- None (open label)
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rosenau
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Jens Rosenau, University of Kentucky
- Investigators
- Jens Rosenau, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581383
- Sponsor's protocol ID
- 17-0812-F2L
- Acronym
- CARE-C
- Status last verified
- Jan 2023
- First submitted
- 26 Jun 2018
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Two Novel Interdisciplinary Care Models and the Impact on Hepatitis C Treatment Uptake, Completion, Sustained Virologic Response, and Retention in Care
- ClinicalTrials.gov ID
- NCT03581383
- Acronym / sponsor ID
- CARE-C / 17-0812-F2L
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Hep C, CARE-C, Kentucky
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Jens RosenauUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goals of the CARE-C study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. To achieve these goals the following two systems interventions will be separately implemented: (1) Implementation of the Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) and related standard of care best practice PREP-C related interventions facilitated by a social worker-patient navigator team, and (2) implementation of a modified ECHO model (with one patient visit at specialty center to include PREP-C and fibrosis assessment in contrast to standard ECHO model). To test the effectiveness of our two systems interventions 600 patients will be equally distributed into three study arms representing 3 care models: Arm 1: Current Care Model (management with current interdisciplinary team); Arm 2: PREP-C Model (management with expanded interdisciplinary team (social worker, patient navigator, PREP-C); and Arm 3: Modified ECHO Model (management with expanded team in collaboration with community providers). An additional Arm 4 was started January 2021 to follow subjects experience with HCV management and treatment via telemedicine.
Detailed description
Hepatitis C virus (HCV) related complications (end-stage liver disease, liver cancer, and death) are increasing in the U.S., and extrapolated from U.S. data most of the estimated 49,200 patients with chronic hepatitis C in the state of Kentucky are untreated. In addition, the state of Kentucky is at the center of the rural opioid epidemic in the United States which has led to a dramatic increase in the transmission of hepatitis C virus (HCV) infection. HCV treatment uptake has been suboptimal in Kentucky despite the availability of highly effective, well-tolerated, timely limited treatment options due to multiple patient-, provider-, and system related barriers. Effective models of linkage to care, treatment, and retention in care are urgently needed to overcome the epidemiological challenges facing our rural state and put Kentucky on a path to planned elimination of HCV infection in the state. The demonstration of the effectiveness of new models of care in Kentucky which are appropriate to rural states will have great relevance and value to other states struggling with new HCV transmission and similar urgent need for effective models of linkage to care, treatment, and retention. Standardized care interventions expanding the reach of specialty providers (Project ECHO) and overcoming patient and provider related barriers to HCV treatment initiation (PREP-C assessment and interventions) have been evaluated, but the implementation of both models has been hampered by a lack of financial incentive, PREP-C has not been evaluated in rural populations, and the two models have never been used in conjunction.
The main goals of the study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. To achieve these goals the following two systems interventions will be separately implemented: (1) Implementation of the Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) and related standard of care best practice PREP-C related interventions facilitated by a social worker-patient navigator team, and (2) implementation of a modified ECHO model (with one patient visit at specialty center to include PREP-C and fibrosis assessment in contrast to standard ECHO model). To test the effectiveness of our two systems interventions up to 1000 participants will be distributed into four study arms representing 4 care models: Arm 1, Current Care Model (management with current interdisciplinary team);arm 2, PREP-C Model (management with expanded interdisciplinary team (social worker, patient navigator, PREP-C); arm 3, Modified ECHO Model (management with expanded team in collaboration with community providers); and Arm 4, current Telemedicine care model (management with current interdisciplinary team).
The specific aims are:
Aim 1: To compare HCV treatment uptake within 12 months after the first clinic visit (time of enrollment) in all Arms 1, 2, and 3. It is hypothesized that (A) treatment uptake will be higher in Arms 2 (PREP-C model) and 3 (modified ECHO model) as compared to Arm 1 (current care model) as a result of overcoming patient level treatment barriers (such as ongoing substance use, psychiatric instability, non-compliance, loss to follow up) facilitated by implementation of the PREP-C assessment, PREP-C related interventions, and assistance of the social worker-patient navigator team, and (B) treatment uptake in Arm 3 will be non-inferior to Arm 2.
Aim 2: To compare HCV treatment outcomes (treatment completion and sustained virologic response, SVR12) in all arms 1, 2, and 3. It is hypothesized that treatment completion and SVR12 in arms 2 and 3 will be noninferior to arm 1 due PREP-C enhancement, even though expected additional patients who start treatment in Arms 2 and 3 are expected to have less favorable treatment readiness scores prior to PREP-C interventions due to higher rates of treatment uptake as hypothesized in Aim 1.
Aim 3: To compare retention in care in all 3 arms for patients who do not start treatment (within 12 months after initial appointment). It is hypothesized that retention in care will be higher in arms 2 and 3 due to implementation of PREP-C assessment and interventions, and the support through the patient navigator.
Aim 4: To record the treatment uptake and analyze patient experiences with telemedicine appointments in Arm 4, the telemedicine arm.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3 Arms: Two intervention models plus a control group representing standard practice Arm 4: And intervention model to record patient experiences with telemedicine
| Arm | Type | Receives |
|---|---|---|
| Current Care Model (Control) | No intervention | –The Current Care Model will not have any intervention beyond the standard of care for Hepatitis C provided by an interdisciplinary team at the University of Kentucky. |
| PREP-C Model | Experimental | Behavioral: PREP-CThe PREP-C care model will provide Hepatitis C care with the standard interdisciplinary team expanded by a social worker and a patient navigator team. The social worker/ patient navigator team will use the standardized Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) tool and will guide PREP-C related interventions to overcome barriers to HCV treatment uptake and completion. |
| Modified ECHO Model | Experimental | Behavioral: PREP-C, Behavioral: Modified ECHOThe modified Extension for Community Healthcare Outcomes (ECHO) Model will provide patient care through collaboration of the expanded interdisciplinary team (including social worker patient navigator team) with community providers. |
| Telemedicine Arm | Experimental | Behavioral: Patient Telemedicine QuestionnaireThe telemedicine Model will track outcomes and record patient experiences with HCV management and treatment with telemedicine. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First office visit for hepatitis C management
- Referred either (a) to the Hepatology Outpatient Clinic at the University of Kentucky in Lexington, Kentucky or (b) to a local community provider who can provide comprehensive care for HCV including HCV treatment in collaboration with the University of Kentucky as a spoke of the ECHO program
- Age 18 years and older
Key exclusion criteria (2 listed)
- Life expectancy less than one year
- Less than 18 years old
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 |
|---|---|---|
| PREP-CThe Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) is an interactive online tool that enables providers to provide a thorough assessment of a patient's psychosocial readiness to begin Hepatitis C treatment, and make a treatment plan to improve treatment readiness. | Behavioural | Modified ECHO Model, PREP-C Model |
| Modified ECHOThe heart of the ECHO (Extension for Community Health Outcomes) model is its hub-and-spoke knowledge-sharing networks, led by expert teams who use multi-point videoconferencing to conduct virtual clinics with community providers. The key modification is one patient visit in the specialty center resulting in co-management of patients with data sharing. | Behavioural | Modified ECHO Model |
| Patient Telemedicine QuestionnaireThe patient questionnaire includes questions about patient experiences with telemedicine visits with providers | Behavioural | Telemedicine Arm |
Primary outcome
HCV treatment initiation
Time frame: 12 months
The overall number of patients who have started HCV treatment by month12 after the first clinic visit will be divided by the number of patients enrolled and presented as a percentage of participants per group.
HCV treatment completion
Time frame: 12 months
The number of patients who have completed HCV treatment will be divided by the number of patients who have started treatment and presented as a percentage of participants per group.
Sustained Virologic Response (SVR)
Time frame: 12 weeks from treatment completion
The number of patients who achieve sustained virologic response (negative HCV RNA 12 weeks after completion of HCV treatment) will be divided by the number of patients who have started treatment and presented as a percentage of participants per group.
5 secondary outcomes
Missed clinic visits
Time frame: 18 months
Clinic visit consistency
Time frame: 18 months
Gaps in clinical care
Time frame: 18 months
Appointment adherence
Time frame: 18 months
Visit frequency within a twelve month period
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Jens Rosenau, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREP-C, Modified ECHO and Patient Telemedicine Questionnaire in people with Hepatitis C, run by Jens Rosenau 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 3 inclusion and 2 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 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HCV treatment initiation (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2023.