IIR 07-101
An
Integrated Care Model
for Improving HCV
Patient Outcomes
Samuel B. Ho MD
VA San Diego Healthcare
System, San Diego, CA
San Diego, CA
Funding Period: November
2008 - October 2013
BACKGROUND/RATIONALE:
The prevalence of
hepatitis C virus (HCV)
infection among VA
patients is 3x higher
than in the general
population. Recent VA
data indicate that only
about 14% of all
HCV-infected VA patients
have ever received
antiviral therapy, which
has the potential to
reduce complications and
sequelae of HCV
infection. Barriers to
receiving antiviral
treatment include
factors such as
pre-existing psychiatric
illness, ongoing
substance abuse, and
other medical
co-morbidity. Clinical
protocols are needed
that can increase the
number of patients with
chronic HCV able to
receive safe and
effective antiviral
treatment.
OBJECTIVE(S):
Primary Objective: To
determine the
effectiveness of a
protocol-based
integrated care model
for increasing treatment
rates and the number of
patients with successful
antiviral treatment as
measured by an increase
in percentage of all new
HCV patients achieving a
sustained virologic
response (SVR). We
hypothesize that this
model will increase the
proportion of patients
who are fully evaluated
for treatment, who
initiate treatment, and
who complete treatment
compared with patients
that receive usual care.
Secondary Objectives:
Assess the effects of an
integrated care model on
patient involvement in
care (appointment
attendance) and patient
questionnaire forms (PQF)
(substance abuse,
depression, etc). We
hypothesize that
veterans managed with
the integrated care
model will have better
attendance at HCV clinic
appointments, have
improved rates of drug
and alcohol abstinence,
and fewer psychological
symptoms.
METHODS:
This study is a
prospective patient
level randomized design
to study the
effectiveness of this
intervention at 3 major
VA medical centers. All
clinic patients will be
screened for depression,
anxiety, PTSD, or recent
SUDs and all patients
that screen positive on
1 or more of these
measures will be asked
to participate.
Preliminary data suggest
that 85% of HCV clinic
patients screen positive
on at least one measure.
Eligible patients will
be randomized to either
usual or integrated care
at each site. The
integrated care
intervention follows a
manulaized protocol
consisting of a series
of brief intervention
tailored to the
patients' main barriers
to treatment along with
a case management
approach in which the
integrated care mental
health provider actively
tracks each patients
progress through the
evaluation and treatment
process. The integrated
care mental health
provider can be a
clinical nurse
specialist,
psychologist, or
licensed clinical social
worker that has
experience and training
in the provision of
psychiatric and SUD
interventions. They will
receive additional
training on the
integrated care
protocol. Data will be
collected at baseline,
pre-treatment, and
post-treatment
intervals. Clinical data
will be obtained from VA
medical records by the
study coordinator at
each site. PQFs will be
assessed using validated
measures. Data will be
analyzed using
hierarchicall linear
modeling (HLM)
techniques.
FINDINGS/RESULTS:
A total of 1752 unique
patients were screened
at the three HCV
clinics. Of these, 763
(43%) were eligible for
antiviral treatment and
"high risk" screen
positive, and 358
patients were randomized
to either IC or UC.
Overall patient
characteristics included
63% non-White (39%
African American, 18%
Hispanic); 51% homeless
in prior 5 years; 80%
genotype 1; mean BDI
score 15.34; Audit C 4+
=27.7%; PTSD risk
=50.4%. Data suggest
that patients at the San
Diego site were more
favorable for treatment
initiation than at other
sites. With a mean
follow-up of about 16
months across all sites,
there was a significant
increase in the number
of high risk HCV
patients that initiated
antiviral therapy,
(25.0% IC vs. 16.6% UC)
p=0.049, despite a
marked reduction in
antiviral therapy use by
Dec 2010 due to
anticipation of newer
therapies. Adverse event
data indicate non-
significant trends
toward fewer
hospitalizations, mean
hospitalized days, and
mean emergency room for
IC patients. There were
8 deaths in UC compared
to 2 deaths in IC, not
related to antiviral
treatment. Data for
individual sites show
sizable significant
differences at the San
Diego site for antiviral
treatment initiation
(45% IC vs 24% UC) and
deaths (0 in IC vs. 4 in
UC). Other sites had no
significant differences.
IMPACT:
Results to date suggest
that integrated care
models may lead to
sizable increases in
antiviral treatment
initiation along with
decreased adverse events
at certain sites. These
rates occurred during a
widespread hiatus in
initiation of antiviral
therapy for hepatitis C
genotype 1 patients due
to the nearing
availability of more
effective therapies. The
study will continue to
collect longer term
outcomes and study the
implementation science
factors that may have
limited intervention
effects at two of the
sites. Continuation of
this study will enable
us to measure the impact
of this intervention on
the uptake of the more
complicated but more
effective new direct
acting antiviral
treatments.
PUBLICATIONS:
Journal Articles
Calore BL, Cheung RC,
Giori NJ. Prevalence of
hepatitis C virus
infection in the veteran
population undergoing
total joint arthroplasty.
Journal of Arthroplasty.
2012 Dec 1;
27:(10):1772-6.
Yip B, Chaung K, Wong
CR, Trinh HN, Nguyen HA,
Ahmed A, Cheung R,
Nguyen MH. Tenofovir
monotherapy and
tenofovir plus entecavir
combination as rescue
therapy for entecavir
partial responders.
Digestive diseases and
sciences. 2012 Nov 1;
57:(11):3011-6.
Ho SB, Groessl EJ, Brau
N, Cheung RC, Weingardt
KR, Ward MA, Sklar M,
Phelps TE, Marcus SG,
Wasil MM, Tisi AS, Huynh
LK, Robinson SK.
Prospective multisite
randomized trial of
integrated care (IC) vs.
usual care (UC) for
improving access to
antiviral therapy for
high risk patients with
chronic HCV. Journal of
Hepatology. 2012 Apr 1;
2012(56):S386.
Hwang EW, Thomas IC,
Cheung R, Backus LI.
Implications of rapid
virological response in
hepatitis C therapy in
the US veteran
population. Alimentary
pharmacology &
therapeutics. 2012 Jan
1; 35(1):105-15.
Chapman J, Oser M,
Hockemeyer J, Weitlauf
J, Jones S, Cheung R.
Changes in depressive
symptoms and impact on
treatment course among
hepatitis C patients
undergoing interferon-a
and ribavirin therapy: a
prospective evaluation.
The American journal of
gastroenterology. 2011
Dec 1; 106(12):2123-32.
Groessl EJ, Weingart KR,
Gifford AL, Asch SM, Ho
SB. Development of the
hepatitis C
self-management program.
Patient education and
counseling. 2011 May 1;
83(2):252-5.
Groessl EJ, Weingart KR,
Stepnowsky CJ, Gifford
AL, Asch SM, Ho SB. The
hepatitis C
self-management
programme: a randomized
controlled trial.
Journal of Viral
Hepatitis. 2011 May 1;
18:(5):358-68.
Kanwal F, Kramer J, Asch
SM, El-Serag H, Spiegel
BM, Edmundowicz S,
Sanyal AJ, Dominitz JA,
McQuaid KR, Martin P,
Keeffe EB, Friedman LS,
Ho SB, Durazo F, Bacon
BR. An explicit quality
indicator set for
measurement of quality
of care in patients with
cirrhosis. Clinical
Gastroenterology and
Hepatology. 2010 Aug 1;
8(8):709-17.
Dieperink E, Ho SB, Heit
S, Durfee JM, Thuras P,
Willenbring ML.
Significant reductions
in drinking following
brief alcohol treatment
provided in a hepatitis
C clinic.
Psychosomatics. 2010 Mar
1; 51(2):149-56.
Pichetshote N, Groessl
E, Yee H, Ho SB.
Optimizing the dose and
duration of therapy for
chronic hepatitis C. Gut
and Liver. 2009 Mar 31;
3(1):1-13.
Groessl EJ, Weingart KR,
Kaplan RM, Clark JA,
Gifford AL, Ho SB.
Living with hepatitis C:
qualitative interviews
with hepatitis
C-infected veterans.
Journal of general
internal medicine. 2008
Dec 1; 23(12):1959-65.
DRA: Health Systems,
Substance Abuse and
Addiction
DRE: Treatment -
Observational
Keywords: Care
Management, Clinical
practice guidelines,
Hepatitis C
MeSH Terms: none
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