Evaluation of A Multidisciplinary Lipid Clinic To
Evaluation of A Multidisciplinary Lipid Clinic To
Evaluation of A Multidisciplinary Lipid Clinic To
Abstract
Background: Individuals with complex dyslipidemia, or those with medication intolerance, are often difficult to
manage in primary care. They require the additional attention, expertise, and adherence counseling that occurs in
multidisciplinary lipid clinics (MDLCs). We conducted a program evaluation of the first year of a newly implemented
MDLC utilizing the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework to provide
empirical data not only on program effectiveness, but also on components important to local sustainability and
future generalizability.
Methods: The purpose of the MDLC is to increase the uptake of guideline-based care for lipid conditions.
Established in 2019, the MDLC provides care via a centralized clinic location within the healthcare system. Primary
care providers and cardiologists were invited to refer individuals with lipid conditions. Using a pre/post-study
design, we evaluated the implementation outcomes from the MDLC using the RE-AIM framework.
Results: In 2019, 420 referrals were made to the MDLC (reach). Referrals were made by 19% (148) of the 796 active
cardiology and primary care providers, with an average of 35 patient referrals per month in 2019 (SD 12) (adoption).
The MDLC saw 83 patients in 2019 (reach). Additionally, 50% (41/82) had at least one follow-up MDLC visit, and
12% (10/82) had two or more follow-up visits in 2019 (implementation). In patients seen by the MDLC, we found an
improved diagnosis of specific lipid conditions (FH (familial hypercholesterolemia), hypertriglyceridemia, and
dyslipidemia), increased prescribing of evidence-based therapies, high rates of medication prior authorization
approvals, and significant reductions in lipid levels by lipid condition subgroup (effectiveness). Over time, the
operations team decided to transition from in-person follow-up to telehealth appointments to increase capacity
and sustain the clinic (maintenance).
(Continued on next page)
* Correspondence: [email protected]
1
Genomic Medicine Institute, Geisinger, Danville, PA, USA
2
Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA
Full list of author information is available at the end of the article
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household income is 15.3% lower than the US average. Institute, and Community and Family Medicine pro-
Geisinger’s mission and vision are to be a model for viders inviting them to refer patients. The invitation in-
other developing healthcare systems through continued troduced the MDLC, purpose, details on which
learning via clinical research [13]. providers were part of this clinic and how to refer. Table
In January 2019, Geisinger implemented an MDLC to 2 details the MDLC implementation strategy using Proc-
facilitate the translation of evidence-based guidelines [2] tor’s guidelines for defining and specifying implementa-
to the management of high-risk lipid conditions. Patients tion strategies [14] and the template for intervention
referred are currently unable to meet cholesterol and tri- description and publication checklist.
glyceride treatment goals in primary care or cardiology
clinics. The Geisinger MDLC is staffed with a cardiolo- Data collection and outcomes measured
gist boarded in lipidology. The genetic counselor and This study evaluates the first year of MDLC implemen-
pharmacist both have specialized training in lipid condi- tation using the RE-AIM framework. Using a pre/post-
tions. This clinic meets bi-monthly at one clinic location study design, clinical outcomes were assessed for all pa-
within the healthcare system. Patients could have trav- tients 1 year after the implementation of the MDLC.
eled from any of Geisinger’s 45 counties within their ser- Outcomes were collected from administrative data, and
vice area to attend the MDLC. clinical information was collected from the electronic
health record (EHR). Two study staff were trained to
Population search the EHR for laboratory measures, medication
Any individual within the Geisinger system diagnosed profiles, and appointment visits and performed chart re-
with or suspected to have a lipid condition can be re- view after each patient appointment.
ferred to and seen by the MDLC. A variety of lipid Reach is measured at the individual level with the
conditions are evaluated and treated in this clinic, in- numerator defined as the number of patients seen by
cluding, but not limited to, familial hypercholesterol- the MDLC who had both a documented lipid condi-
emia (FH), hypertriglyceridemia, various rare familial tion on their problem list and had been active pa-
dyslipidemias, and other unnamed or undiagnosed tients within the healthcare system (i.e., had a
dyslipidemias (Table 1) [2]. primary care or cardiology visit in 2019). The denom-
inator included those with a problem list diagnosis
Clinical implementation for a lipid condition. Patients could be referred to the
The purpose of the Geisinger MDLC is to increase up- MDLC by any provider using an existing general car-
take of guideline-recommended treatment for all lipid diology outpatient referral for lipid management and
conditions [2]. Prior to implementation of this clinic, in- were requested to note the MDLC in a comment sec-
dividuals with these conditions had to receive specialty tion. At the time of MDLC implementation, the deci-
multidisciplinary lipid care outside the Geisinger system sion for the system was to use the existing referral
at locations that required significant travel to urban sites rather than to create a new referral specific to
in Pennsylvania for specialized management. Preventive MDLC. If the MDLC was not specified in the note,
cardiology leadership within the Heart Institute initiated patients could potentially have been seen by any pro-
the MDLC and sent out an email to the entire Heart vider with an interest in managing lipid patients.
Table 2 Description based on Proctor’s guidelines for specifying implementation strategies: components of the multidisciplinary
lipid clinic
Domain Description
Name it Creation of new clinical teams (a multidisciplinary lipid clinic)
Define it A multidisciplinary clinical team that has complementary roles (i.e., diagnosis and treatment) with lipid expertise that
is formed to improve patient care
Specify it
Actors Cardiologist
Pharmacist
Genetic counselor
Actions Cardiologist—evaluates the patient’s symptoms, lifestyle, medications, and past lab results during an initial in-person
visit; recommends a treatment plan; orders subsequent testing; requests follow-up visits as needed
Pharmacist—evaluates the patient’s current medications; offers input/suggests changes to medications; performs
medication reconciliation; completes medication counseling and education; ensures prior authorizations are
submitted
Genetic counselor—evaluates the patient’s past medical and family histories; assesses the patient’s risk; provides pre-
test genetic counseling; provides genetic testing result disclosure and post-test genetic counseling; discusses cascade
testing of at-risk relatives
Targets of the action All clinicians—have expertise caring for patients with a high-risk lipid condition and knowledge of guideline-
recommended treatment for lipid conditions
Cardiologist—diagnosis of lipid conditions, monitors clinical symptoms
Pharmacist—optimizes treatment and follow-up on prior authorizations
Genetic counselor—knowledge of familial cardiovascular conditions, improvement of identification methods for
concerning past medical/family history, and reassurance to the patient that the testing results will benefit the patient
no matter if the result is positive or negative
Temporality Patients should be referred as soon as the provider identifies a patient with a high-risk lipid condition who would
benefit from the evaluation at the clinic. The initial visit to the clinic should take place as soon as scheduling allows
after the patient has been referred. Subsequent visits should be scheduled on an as needed basis.
Dose Cardiologist—once at an hour-long initial visit. Subsequent visits at 6–8 weeks post-initial visit and further if needed.
The cardiologist will be available to the patient via phone or through patient portal.
Pharmacist—once at an hour-long initial visit. The pharmacist will be available to the patient via phone or patient
portal.
Genetic counselor—once at an hour-long initial visit. The genetic counselor will be available to the patient via phone
or patient portal.
Implementation outcomes Uptake of guideline-recommended testing and treatment for high-risk lipid clinic patients; adoption of the clinic
affected among PCPs and other providers; penetration among eligible patients; fidelity to the protocol of the clinic; sustainabil-
ity of the clinic and its expansion.
Justification MDLCs improve patient outcomes [3–8]
Effectiveness is stratified to create three clinical patient measurements were at least 1 month after their initial
lipid subgroups: FH, hypertriglyceridemia, and dyslipid- visit date.
emia because treatment approaches differ by condition. Adoption has two metrics. Any PCP or cardiologist
The final diagnosis was extracted from cardiologist who saw a patient with a lipid condition documented on
documentation after all relevant information was ob- their problem list diagnoses in 2019 was included in the
tained. The effectiveness measure chosen for this study analyses. The percent of eligible providers referring to
was the change in lipid levels assessed using a baseline the MDLC was calculated as the number of providers
lipid value either from the initial MDLC visit or the making a referral divided by the total number of eligible
most recent lipid panel result prior to the initial MDLC providers multiplied by 100. The percent of eligible pa-
follow-up visit compared with the value from the most tients referred per provider—as measured by having a
recent MDLC visit. Patients without a lipid panel in their lipid condition in the problem list—was calculated as the
health records were documented as having no prior lipid number referred over the total number of lipid patients
measurements. The most recent lipid panel was re- managed by that provider.
corded as post-MDLC measurement, unless that meas- Implementation is measured at the patient level. The
urement was the pre-MDLC value. All post-MDLC numerator is the number of patients with multiple visits,
regimen. This patient did not have any medications pre- intensification of their medication regimens including
or post-MDLC due to pregnancy, which impacts the use starting a medication, increasing the dose of a medica-
of lipid-lowering therapy. The 23 (96%) patients who tion, or addition of a new medication; 1 had a decrease
had a change to their medication regimen fell into one in their dose of a medication; and 10 had other changes
or more of the following categories: 21 patients had an including discontinuations or switches within a
medication class. Fourteen of the 24 individuals with FH patients who had a change to their medication regimen
were prescribed medications for which their insurance fell into one or more of the following categories: 31 pa-
required a prior authorization. A total of 16 prior autho- tients had an intensification of their medication regi-
rizations were submitted (3 individuals had prior autho- mens including starting a medication, increasing the
rizations submitted for both PCSK9 inhibitors and dose of a medication, or addition of a new medication; 1
icosapent ethyl or for two PCSK9 inhibitors). Of the 16 had a decrease in their dose of a medication; and 16 had
medication prior authorizations submitted by the other changes including discontinuations or switches
MDLC, 88% (14/16) were approved (12 for PCSK9 in- within a medication class. Eighteen of the 42 individuals
hibitors and 2 for icosapent ethyl) and 13% (2/16) were with dyslipidemia were prescribed medications for which
denied for PCSK9 inhibitors. their insurance required prior authorization. A total of
18 prior authorizations were submitted. Of those 18, 16
Hypertriglyceridemia were approved (for PCSK9 inhibitors), 1 was denied for
None of the 16 individuals attending MDLC diagnosed icosapent ethyl, and 1 had an unknown status for a
with hypertriglyceridemia had prior genetic testing. Gen- PCSK9 inhibitor.
etic testing was ordered on 14 of the 16 individuals
(88%) and identified 1 positive result for a variant associ- Maintenance
ated with familial lipoprotein lipase deficiency, 2 variants In monthly meetings with the MDLC clinic providers
of unknown significance, and 6 negative results; 3 tests and Heart Institute leadership and administration, we
are pending, and 2 were not completed. At the initial discussed the transition from traditional in-person
MDLC visit, 15 (94%) patients were currently prescribed follow-up visits to telehealth appointments. The ration-
at least one medication to treat their hypertriglyc- ale for this transition was to improve capacity due to a
eridemia. Of the 16 patients in the hypertriglyceridemia limited number of available appointments per clinic day
subgroup, 3 (19%) had no changes to their medication and would increase access as individuals would have the
regimen. The 13 (81%) patients who had a change to opportunity to be seen virtually, either at home or at a
their medication regimen fell into one or more of the clinic site near their home. Additionally, there was a dis-
following categories: 10 patients had an intensification of cussion for the need for a telehealth platform, training of
their medication regimens including starting a medica- schedulers to know where and when to book these ap-
tion, increasing the dose of a medication, or addition of pointments, where and how the MDLC providers would
a new medication; 1 had a decrease in their dose of a join the telehealth visit and obtain access for all pro-
medication; and 4 had other changes including discon- viders, and discuss methods for documenting these types
tinuations or switches within a medication class. One of visits. Additionally, a recent pandemic, COVID-19,
person that switched between medication classes was necessitated the use of telemedicine throughout Gei-
the reconciliation of a drug-drug interaction to prevent singer, but this merely accelerated the transition that
harm to the patient. At the time of analysis, 16 (100%) was already planned for the MDLC.
of the 16 patients in the hypertriglyceridemia subgroup
after being seen by the MDLC were prescribed a medi- Discussion
cation for the treatment of hypertriglyceridemia. Three In our evaluation of the first year after implementing a
of the 16 individuals with hypertriglyceridemia were pre- new care model, we found there are many individuals
scribed medications by the MDLC for which their insur- within our system with lipid conditions, but only a small
ance required a prior authorization, resulting in a total number have been referred to the MDLC (0.25%), indi-
of 3 prior authorizations submitted. All were approved cating additional implementation strategies may be
(2 were for PCSK9 inhibitors and 1 for icosapent ethyl). needed to improve the reach of the MDLC to improve
patient care. At present, in the total population of pa-
Uncharacterized dyslipidemia tients with lipid disorders, we do not know how many
None of the 42 individuals with dyslipidemia had prior would be eligible for referral based on medication in-
genetic testing for the condition. Genetic testing was or- tolerance or failure to achieve the lipid treatment goal.
dered by MDLC for 31 (74%) patients and found no Only by evaluating this can the true care gap be evalu-
positive results, 24 negative results, 6 tests are pending, ated and used to develop strategies to expand referrals.
and 1 was canceled by the patient due to cost. Genetic We found MDLC improved patient prognosis based on
testing was not ordered for 11 individuals. At the initial risk stratification, increase in guideline-recommended
MDLC visit, 32 (76%) patients were prescribed at least treatments prescribed, and clinically significant lowering
one medication to treat their dyslipidemia. Of the 42 pa- of targeted lipid levels necessary for the prevention of fu-
tients in the dyslipidemia subgroup, 7 (17%) had no ture CVD events. A reduction of 40 mg/dL of LDL-C for
changes to their medication regimen. The 35 (81%) individuals with cholesterol conditions is thought to
reduce CV events by 20% which is clinically significant in healthcare systems, mostly in Veteran’s Affairs [8, 16]
and is an accepted intermediate outcome per guidelines or community medical centers [17]. However, it is un-
[15]. In patients with FH seen through the MDLC, the clear from these studies the potential impact MDLCs
mean reduction in LDL-C was 79 mg/dL, which is pre- have had on reach within their patient catchment areas
dicted to reduce CV events by 40%. In addition, through due to lack of description or analysis on the process for
MDLC, the number of patients achieving a target of referrals and number of patients with lipid conditions in
LDL-C below 100 mg/dL increased from 15 to 69%, a these systems. To improve generalizability to other
more than 4-fold increase. healthcare systems, it is important to understand con-
Based on the referral volume after 1 year of MDLC textual factors associated with the implementation of a
implementation with referrals from only PCPs and cardi- MDLC.
ologists, we have shown (1) a need for the MDLC in the It is widely accepted in implementation science that
Geisinger system, (2) a significant clinical impact on simply rolling out a new professional guideline or mak-
those patients managed by the MDLC, and (3) an enor- ing a new model of care available is insufficient to lead
mous care gap with only 0.25% of eligible patients being to practice change that will impact patient or population
seen through MDLC reducing the potential impact on health outcomes [18]. Often, sufficient details are lacking
CV event prevention. to replicate the implementation strategies utilized for
Barriers to MDLC sustainability included the inability the evidence-based intervention or new care model [14].
of the MDLC to see all patients that were referred in the Therefore, evaluation of multi-level outcomes related to
first year. Another barrier was not specifying the MDLC process and context as well as patient outcomes is ne-
in the notes section of the referral by referring providers. cessary when implementing interventions in the real
Due to these barriers, some patients were not seen by world [19].
the MDLC but by the designated lipid expert in their Implementation science frameworks have rarely been
corresponding region which led to some frustration by applied in the field of lipidology or FH [20]. However,
patients and providers who were expecting to be evalu- their use and benefit have been demonstrated in the im-
ated by a team of lipid experts from multiple disciplines. plementation of other chronic disease programs such as
Facilitators of sustainability included the large cadre of diabetes control [21]. Using frameworks such as RE-
providers who referred patients. The MDLC provided a AIM will help lipidologists, and others implementing
more refined clinical diagnosis and treatment plan for MDLCs, understand the full impact of their programs
patients. We believe that this will incentivizes providers and where the barriers and facilitators to access or care
to continue to refer severe lipid disorder patients that exist [22, 23]. In addition, studies like ours will improve
they are unable to diagnose. the generalizability of these programs to other sites.
A systematic approach to implementation and contin- This study has a few limitations. Most patients were
ual evaluation of implementation process outcomes and able to see all providers described within the MDLC;
contextual factors is important to implementing these however, there were rare circumstances where one pro-
types of programs within healthcare systems. To that vider might have been unavailable. A specific outpatient
end, team members and administrative staff have dis- referral for the MDLC was not created within our sys-
cussed initiating telehealth appointments as a potential tem, though dependent upon the success and volume of
solution for the sustainability of these types of programs this clinic, one can be created in the future. The number
in general and the MDLC specifically. By utilizing tele- of patients seen and followed up in the recommended
health, patients would be able to join at their home or time frame with the MDLC was limited by clinical loca-
drive to a local clinic to connect with the providers at tion and capacity (one location in the region and twice
the MDLC located at a central hub. This model could be per month periodicity). However, the Geisinger catch-
generalized to other healthcare systems that have large ment area spans 45 of Pennsylvania’s 67 counties making
service areas. The COVID-19 pandemic resulted in a it over a 2-h drive for some individuals to reach the
system-wide move to telemedicine visits, eliminating current MDLC location. Some individuals seen in the
many barriers that might have otherwise delayed the MDLC require multiple visits for complex diagnoses or
implementation. medication changes, thus limiting the availability of ap-
Other MDLCs have found similar clinical effectiveness pointment slots for new patients. In addition, we used a
outcomes to our clinic [7, 8, 16]. For MDLCs to improve pre/post-study design to analyze our data which comes
the health of the targeted population, they must first with limitations including the possibility of experiencing
reach the intended individuals. While the existence of an a Hawthorne effect. In our analyses, we used a follow-up
MDLC is helpful, it is not sufficient to ensure utilization period defined by time since the clinic was implemented;
of its services. Most of these MDLCs have been imple- therefore, patients seen earlier after implementation had
mented within academic medical centers [10] with fewer longer follow-up intervals than those seen later in the
year. Additional analyses conducted farther out from Consent for publication
MDLC implementation are needed with larger samples Not applicable.
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