NAFLD Clinical Care Pathway

ConditionsNAFLDMASLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer. Obesity and diabetes, conditions that are very common among Veterans are the main risk factors for NAFLD. Therefore, the burden of NAFLD and its complications among Veterans is substantial. However, most VA patients with NAFLD are undiagnosed and untreated, and their care is not consistent with practice guidelines. The NAFLD Clinical Care Pathway (NCCP) intervention seeks to close this major gap in the care of Veterans by automatically identifying patients at risk of NAFLD, calculating their risk scores of having severe NAFLD, and educating the primary care providers on the diagnosis and treatment of NAFLD. This clinical trial will test the benefit of this NCCP intervention against usual care in increasing the rates of NAFLD diagnosis as well as referral to and enrollment in appropriate treatment. The study will also identify barriers and promotors of future NCCP implementation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

The investigators will exclude PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization.

PACTs participating in the focus groups in Aim 1 will be excluded in Aim 2 to avoid cross contamination.

PACTs who do not treat NAFLD,

PACTs not located at the main hospital,

Trial design

Design model

Parallel

Treatments tested in this trial

  • E-trigger

    Behavioral

    The NCCP Intervention is multicomponent. First, the investigators will apply the e-trigger and calculate FIB-4, and second, will educate and train PACT personnel on how to deal with trigger positive patients as well as make treatment recommendations within an inter-professional team. The e-trigger will be generated every 3 months. The effectiveness of the trigger will be assessed using the outcomes previously mentioned.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: E-triggerExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

NAFLD Diagnosis and risk stratification

The investigators will use chart reviews to extract unstructured data regarding the primary outcome measure: existence of EHR progress note documenting a new NAFLD diagnosis AND complete risk stratification of NAFLD (i.e., fibrosis). The investigators will use our validated process to guide uniform abstraction and classification.

Time frame
Baseline, 6 months

Secondary outcomes

1

Fibroscan Test

The investigators will extract from the EHR if a patient had a fibroscan test.

Time frame
Baseline, 6 & 12 months
2

Referral to hepatology

The investigators will extract from the EHR if a patient was referred to a hepatology clinic.

Time frame
Baseline, 6 and 12 months
3

Hepatology Clinic Visit

The investigators will extract from the EHR if a patient was seen in a hepatology clinic.

Time frame
Baseline, 6 and 12 months
4

NAFLD discussion

The investigators will extract from the patient chart if the provider documented a discussion about NAFLD with the patient.

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

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