Evaluation of A Multidisciplinary Lipid Clinic To

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Jones et al.

Implementation Science Communications


https://doi.org/10.1186/s43058-021-00135-8
(2021) 2:32
Implementation Science
Communications

RESEARCH Open Access

Evaluation of a multidisciplinary lipid clinic


to improve the care of individuals with
severe lipid conditions: a RE-AIM
framework analysis
Laney K. Jones1,2* , Megan McMinn1, David Kann3, Michael Lesko3, Amy C. Sturm1, Nicole Walters1, Nan Chen4,
Kerrianne Fry1, Ross C. Brownson5,6, Samuel S. Gidding1, Marc S. Williams1 and Alanna Kulchak Rahm1

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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Jones et al. Implementation Science Communications (2021) 2:32 Page 2 of 10

(Continued from previous page)


Conclusions: Despite limited reach and adoption of the MDLC, we found a large intervention effect that included
improved diagnosis, increased prescribing of guideline-recommended treatments, and clinically significant
reduction of lipid levels. Attention to factors including solutions to decrease the large burden of unseen referrals,
discussion of the appropriate number and duration of visits, and sustainability of the clinic model could aid in
enhancing the success of the MDLC and improving outcomes for more patients throughout the system.
Keywords: RE-AIM, Hyperlipidemia, Cardiology, Implementation science

adherence, effectively lowering the CVD risk of patients


Contributions to the literature
seen by the MDLC [3, 7].
 Multidisciplinary lipid clinics (MDLCs) lead to better guideline MDLCs have not previously been evaluated using an
concordance, medical management, and patient outcomes implementation science framework [10]. Applying an
for patients within a large healthcare system.
implementation science framework can help standardize
the reporting, examine barriers and facilitators necessary
 Utilizing RE-AIM to analyze a clinical implementation helps
for a successful MDLC program, and evaluate imple-
to standardize reporting of outcomes. mentation efforts within a healthcare system. Outcomes
 Limited capacity and resources for MDLCs may limit their of the implementation science process would include
ability to meet the patient demand within a large healthcare identifying gaps in care missed by the referral process to
system. the specialized clinic, improving sustainability, and de-
veloping generalizability to other healthcare systems.
When there is an implementation gap, implementation
science can help to understand the causes of the gap.
Background Reach, effectiveness, adoption, implementation, and
The reduction of lipid levels has been shown to prevent maintenance (RE-AIM) is one framework that has been
cardiovascular disease (CVD) at individual and popula- used for over 20 years in the planning and evaluation of
tion levels [1]. Evidence-based guidelines for lipid ther- interventions [11, 12]. For this study, we conducted an
apy exist [2]. While primary care is sufficient for many, implementation science evaluation of the first year of a
some individuals have medication side effects or under- newly created MDLC utilizing the RE-AIM framework
lying severe lipid conditions that make management to provide empirical data not only on program effective-
more difficult. These individuals require specialized care ness, but also on components important to local sustain-
in order to achieve lower cholesterol and triglyceride ability and future generalizability and replication.
levels and the corresponding CVD risk reduction
benefit.
Multidisciplinary lipid clinics (MDLCs) focus effort on Methods
reducing CVD risk for individuals with hyperlipidemia Setting
conditions that are complex and hence not easily con- Geisinger is an integrated healthcare system consisting
trolled. Primary care providers (PCPs) refer complex pa- of multiple hospitals, outpatient facilities, and a health
tients to MDLCs with the expertise to more effectively plan located in 45 counties in central and northeast
manage medication options and diagnose underlying Pennsylvania. The system provides care for approxi-
causes of severe dyslipidemia. While MDLCs may vary mately 1.5 million patients annually. Clinical decisions
in staffing, typical clinical staff includes lipid specialist and guidance for procedures and treatments are made
physicians, advanced practitioners, pharmacists, dieti- by designated clinical teams, and full implementation is
cians, and genetic counselors working in concert [3–9]. expected by every healthcare provider in the system.
Successful deployment of evidence-based cholesterol This method not only ensures consistency and high-
guidelines in these complex patients requires several quality care, but also promotes evidence-based care by
clinical skills: nutrition, to improve diet and explain dif- reducing unexplained clinical variation. Additionally,
ferences in saturated versus unsaturated fats; diagnostic coverage by the health plan is synchronized with clinical
expertise regarding common and rare cholesterol disor- decisions made within the healthcare system to ensure
ders; and pharmacology, to focus on medication titra- high-quality care is affordable and accessible to all health
tion, management, and lifelong adherence. Such MDLCs plan members (about a third of Geisinger patients). Gei-
have been shown to increase the number of individuals singer serves a rural, medically underserved, and low-
achieving target low-density lipoprotein cholesterol income population. In Geisinger’s coverage area, 32 of
(LDL-C) goals and improve lipid-lowering medication the 45 counties are designated as rural, and the average

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Jones et al. Implementation Science Communications (2021) 2:32 Page 3 of 10

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 1 Description of lipid conditions and treatment goals


Condition Description Treatment goal
Familial • Inherited lipid condition Reduction in LDL-C level
hypercholesterolemia
• Lifelong elevations in LDL cholesterol levels lead
(FH)
to premature ASCVD
• Important to test family members
Hypertriglyceridemia • Elevated levels of triglycerides Reduction in triglycerides
• Cholesterol levels can be normal
• At risk for or have had episodes of pancreatitis
• Associated with type II diabetes mellitus
• May encompass inherited hypertriglyceridemia
Dyslipidemia • Elevated levels of triglycerides and/or cholesterol According to current guidelines, reduction in the lipid that is
elevated (cholesterol, triglycerides) [2]
• Dyslipidemias that are not FH or
hypertriglyceridemia

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Jones et al. Implementation Science Communications (2021) 2:32 Page 4 of 10

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,

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Jones et al. Implementation Science Communications (2021) 2:32 Page 5 of 10

and the denominator is the number of patients seen in Hypertriglyceridemia


2019. The percentage of patients who underwent genetic Lipid levels were available for comparison before and
testing and medication use details were reported using after MDLC visits in a subset of patients (n = 4) and
descriptive statistics. showed a 467-mg/dL reduction in average triglycerides
Maintenance, for this study, is reported as the current (Table 4). Of the 4 patients with pre- and post-values,
and potential for sustaining the MDLC in the future. only a quarter (1/4) had a triglyceride level less than 150
mg/dL prior to a visit with the MDLC; however, 75% (3/
Statistical analysis 4) met this goal afterwards.
Descriptive statistics were used for the demographics of
both the study cohort and three subgroups. Continuous Uncharacterized dyslipidemia
variables were analyzed using the Kruskal-Wallis test, Lipid levels were available for comparison before and
and categorical variables were analyzed using a Fisher after MDLC visits in a subset of patients (n = 21) and
exact test. We reported the mean ± SD and median showed a 48-mg/dL reduction in average LDL-C (<
(range) of lipid levels for all subgroups and used the 0.001) and reduction in other lipid values (Table 4). Of
Wilcoxon signed-rank test to detect any differences in the 21 patients, 38% (8/21) had an LDL-C less than 100
lipid levels before and after for each subgroup. mg/dL prior to a visit with the MDLC; however, 71%
(15/21) met this goal afterwards.
Results
Reach Adoption
Of the 452,748 unique patients who had a visit to the Of the 796 active PCP or cardiologists in 2019, 19%
healthcare system in 2019, 32% (143,154/452,748) had a (148/796) referred patients to the MDLC. The average
diagnosis of a lipid condition on their problem list. percent of eligible patient referrals from active providers
There were 420 referrals received for the MDLC in 2019 was 0.25% (SD 3.75%). There was an average of 35 pa-
out of the 143,154 individuals with a lipid condition. Of tient referrals per month (SD 12) to the MDLC. Refer-
those 420 referrals, 3 referenced the “MDLC” specifically rals to MDLC were also received from another 48
and 92 referenced the “lipid clinic.” There were 83 pa- providers outside of the targeted cardiologists and PCPs
tients scheduled and seen by the MDLC in 2019 (20% of (genetic counselors, pharmacists, critical care providers)
those referred). Of those 83 patients, 1 patient was self- or from providers whose patients did not have a diag-
referred, and 4 patients did not have a primary care or nosed lipid condition on their problem list.
cardiology visit in 2019 or lipid condition diagnosis
code. Implementation
At the patient level, 50% (41/82) of patients who
Effectiveness attended the MDLC had at least one follow-up visit with
Of the 83 patients seen in the MDLC in 2019, 82 were the MDLC, with 12% (10/82) having two or more
alive at the time of analysis and are presented in the re- follow-up visits in 2019. The 50% (41/82) of patients
sults. Guideline recommendations for management vary who only had one visit were more likely to have been
based on lipid condition. The MDLC patient population seen later in 2019 (October through December). Patient-
was stratified for analysis based on lipid diagnosis: famil- and provider-level implementation outcomes of genetic
ial hypercholesterolemia, hypertriglyceridemia, and testing and prescribing of guideline-recommended treat-
uncharacterized dyslipidemia. Of those 82 patients, 29% ment are described based on lipid subgroup.
(24/82) had a clinical or genetic diagnosis of (FH), 20%
(16/82) had hypertriglyceridemia, and 51% (42/82) had Familial hypercholesterolemia
uncharacterized dyslipidemia. Demographics of these Six of the 24 individuals with FH had prior positive gen-
populations are described in Table 3. etic testing for the condition. Those who did not have a
prior genetic testing result had testing ordered at the
Familial hypercholesterolemia MDLC. Genetic testing ordered through the MDLC (n =
Lipid levels were available for comparison before and 18) yielded 5 positive results, 2 variants of unknown sig-
after MDLC visits in a subset of patients (n = 12) and nificance, and 5 negative results. Six genetic tests are still
showed a 79-mg/dL reduction in average LDL-C (P < pending (e.g., order not signed, order expired, active
0.001) and reduction in other lipid values (Table 4). Of order but sample has not yet been drawn). At the initial
the 12 patients with pre- and post-values, only 17% (2/ MDLC visit, 17 (71%) patients were prescribed at least
12) had an LDL-C less than 100 mg/dL prior to a visit one medication (e.g., prescribed by some other provider
with the MDLC; however, 75% (9/12) met this goal prior to getting to MDLC). Of the 24 patients in the FH
afterwards. subgroup, 1 (4%) had no changes to their medication

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Jones et al. Implementation Science Communications (2021) 2:32 Page 6 of 10

Table 3 Baseline demographics for all patients seen in the MDLC


All patients, N = 82 Familial hypercholesterolemia, N Dyslipidemia, N = Hypertriglyceridemia, N P
(ref) = 24 42 = 16 value
Age in years 56 ± 15 53 ± 16 62 ± 13 45 ± 13 <
0.001
Male 42 (51%) 6 (25%) 25 (60%) 11 (69%) 0.007
BMI 31 ± 8 27 ± 6 32 ± 7 34 ± 10
Tobacco status 0.436
Never 46 (56%) 16 (67%) 20 (48%) 10 (62%)
Former 28 (34%) 5 (21%) 18 (43%) 5 (31%)
Current 8 (10%) 3 (12%) 4 (9%) 1 (7%)
Problem list diagnosis of 36 (44%) 6 (25%) 26 (62%) 4 (25%) 0.004
CAD
Problem list diagnosis of 7 (9%) 2 (8%) 5 (12%) 0 0.502
PVD
No reported MIs 67 (82%) 22 (92%) 30 (71%) 15 (94%) 0.243
Number of appointments 0.011
1 41 (50%) 12 (50%) 16 (38%) 13 (81%)
2 31 (38%) 11 (46%) 19 (45%) 1 (7%)
3 or more 10 (12%) 1 (4%) 7 (17%) 2 (12%)
BMI body mass index, CAD coronary artery disease, PVD peripheral vascular disease, MI myocardial infarction

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

Table 4 Lipid levels pre/post-implementation of the MDLC


Baseline Post P
value
N Mean ± SD Median (range) N Mean ± SD Median (range)
Familial hypercholesterolemia (N = 12)
Total cholesterol 12 237 ± 72 247 (133, 361) 12 162 ± 71 150 (86, 346) < 0.001
HDL-C 12 53 ± 14 53 (25, 79) 12 55 ± 11 57 (33, 73) 0.637
LDL-C 12 163 ± 69 166 (71, 296) 12 87 ± 70 84 (9, 279) < 0.001
TG 12 118 ± 59 118 (34, 238) 12 96 ± 44 90 (37, 173) 0.077
Non-HDL-C 12 184 ± 69 186 (87, 316) 12 106 ± 73 95 (26, 302) < 0.001
Dyslipidemia (N = 21)
Total cholesterol 21 213 ± 68 222 (115, 376) 22 168 ± 67 152 (79, 371) < 0.001
HDL-C 21 44 ± 15 40 (25, 83) 21 46 ± 18 40 (27, 105) 0.223
LDL-C 21 135 ± 67 135 (48, 277) 21 87 ± 56 70 (2, 243) < 0.001
TG 21 226 ± 182 176 (69, 927) 21 204 ± 199 140 (79, 1002) 0.266
Non-HDL-C 21 169 ± 63 184 (65, 305) 21 121 ± 64 105 (34, 312) < 0.001
Hypertriglyceridemia (N = 4)
Total cholesterol 4 239 ± 63 264 (146, 284) 4 162 ± 47 148 (121, 230) NA
HDL-C 4 24 ± 9 27 (11, 31) 4 28 ± 12 32 (11, 37) NA
LDL-C 4 73 ± 50 84 (4, 121) 3 47 ± 32 65 (10, 65) NA
TG 4 1123 ± 452 975 (759, 1784) 4 656 ± 613 428 (232, 1536) NA
Non-HDL-C 4 215 ± 54 236 (135, 254) 4 134 ± 45 112 (110, 202) NA
HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, TG triglycerides

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Jones et al. Implementation Science Communications (2021) 2:32 Page 7 of 10

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

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Jones et al. Implementation Science Communications (2021) 2:32 Page 8 of 10

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

Content courtesy of Springer Nature, terms of use apply. Rights reserved.


Jones et al. Implementation Science Communications (2021) 2:32 Page 9 of 10

year. Additional analyses conducted farther out from Consent for publication
MDLC implementation are needed with larger samples Not applicable.

of individuals with a standard follow-up period (e.g., 1-


Competing interests
year post-visit). Finally, by limiting to the 1-year period The authors declare that they have no competing interests.
after implementation, some individuals with pending
genetic test results in the dyslipidemia category may Author details
1
Genomic Medicine Institute, Geisinger, Danville, PA, USA. 2Center for
move into a different category once the test results are Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA. 3Heart
received. Institute, Geisinger, Danville, PA, USA. 4Department of Population Health
Sciences, Geisinger, Danville, PA, USA. 5Prevention Research Center in St.
Louis, Brown School at Washington University in St. Louis, St. Louis, USA.
Conclusions 6
Department of Surgery, Division of Public Health Sciences, Alvin J. Siteman
Severe lipid conditions require dedicated care for identi- Cancer Center, Washington University School of Medicine, Washington
University in St. Louis, St. Louis, USA.
fication, early intervention, and management. Individuals
treated at the Geisinger MDLC show improved clinical Received: 29 July 2020 Accepted: 9 March 2021
outcomes 1 year after MDLC implementation. More at-
tention is needed regarding context, solutions to de-
References
crease unseen referrals, appropriate number and 1. Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM,
duration of MDLC visits, and sustainability. Attention to Braunwald E, Sabatine MS. Association between lowering LDL-C and
these things will help determine the impact of MDLC on cardiovascular risk reduction among different therapeutic interventions: a
systematic review and meta-analysis. Jama. 2016;316(12):1289–97. https://
patient outcomes and improve reach, adoption, sustain- doi.org/10.1001/jama.2016.13985.
ability, and replication within other healthcare settings. 2. Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, et al.
2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/
Abbreviations PCNA Guideline on the Management of Blood Cholesterol: a report of the
CVD: Cardiovascular disease; EHR: Electronic health record; FH: Familial American College of Cardiology/American Heart Association Task Force on
hypercholesterolemia; LDL-C: Low-density lipoprotein cholesterol; Clinical Practice Guidelines. J Am Coll Cardiol. 2019;139(25):e1082–e143.
MDLC: Multidisciplinary lipid clinic; PCP: Primary care provider; RE-AIM: Reach, 3. Bogden PE, Koontz LM, Williamson P, Abbott RD. The physician and
effectiveness, adoption, implementation, and maintenance pharmacist team: an effective approach to cholesterol reduction. J Gen
Intern Med. 1997;12(3):158–64. https://doi.org/10.1007/s11606-006-5023-7.
Acknowledgements 4. Kellick KA, Burns K, McAndrew E, Haberl E, Hook N, Ellis A. Outcome
Not applicable. monitoring of fluvastatin in a department of veterans affairs lipid clinic.
Am J Cardiol. 1995;76(1-2):62A–4A. https://doi.org/10.1016/S0002-914
9(05)80020-7.
Authors’ contributions
5. Konzem SL, Gray DR, Kashyap ML. Effect of pharmaceutical care on
LKJ conceptualized and designed the study; acquired, analyzed, and
optimum colestipol treatment in elderly hypercholesterolemic veterans.
interpreted the data; and drafted the initial and revised to the final
Pharmacotherapy. 1997;17(3):576–83.
manuscript. MM helped to design the study; acquire, analyze, and
6. O’Donnell DC, Chen NT, Piziak VK. Goal attainment and maintenance of
interpreted the data; and added substantial revisions to the manuscript. DK
serum cholesterol level in a pharmacist-coordinated lipid clinic. Am J Health
helped to design the study, interpret the data, and added substantial
Syst Pharm. 2001;58(4):325–30. https://doi.org/10.1093/ajhp/58.4.325.
revisions to the manuscript. ML helped to interpret the data and added
7. Birtcher KK, Greisinger AJ, Brehm BJ, Wehmanen OA, Furman LM, Salinas CC,
substantial revisions to the manuscript. ACS helped to design the study and
Mirzai-Tehrane M, Nayak A, Rashid H, Mortazavi A. A secondary prevention
interpret the data and added substantial revisions to the manuscript. NW
lipid clinic reaches low-density lipoprotein cholesterol goals more often
acquired and analyzed the data, helped to draft the initial manuscript, and
than usual cardiology care with coronary heart disease. J Clin Lipidol. 2010;
revised it. NC acquired, analyzed, and interpreted the data and added
4(1):46–52. https://doi.org/10.1016/j.jacl.2009.12.001.
substantial contributions to the final manuscript. KF helped to interpret the
8. Shaffer J, Wexler LF. Reducing low-density lipoprotein cholesterol levels in
data and added substantial revisions to the manuscript. RCB helped design
an ambulatory care system: results of a multidisciplinary collaborative
the study and interpret the data and added substantial revisions to the
practice lipid clinic compared with traditional physician-based care. Arch
manuscript. SSG designed the study, interpreted the data, and added
Intern Med. 1995;155(21):2330–5. https://doi.org/10.1001/archinte.1995.0043
substantial revisions to the manuscript. MSW conceptualized and designed
0210080012.
the study and added substantial revisions to the manuscript. AKR
9. Mazzolini TA, Irons BK, Schell EC, Seifert CF. Lipid levels and use of lipid-
conceptualized and designed the study; acquired, analyzed, and interpreted
lowering drugs for patients in pharmacist-managed lipid clinics versus usual
the data; and drafted the initial and revised to the final manuscript. The
care in 2 VA medical centers. J Manag Care Pharm. 2005;11(9):763–71.
author(s) read and approved the final manuscript.
https://doi.org/10.18553/jmcp.2005.11.9.763.
10. Liebeskind A, Warden BA, Sikand G, Duell PB, Guyton JR. JCL Roundtable:
Funding lipid clinic operations. J Clin Lipidol. 2019;13(4):511–21. https://doi.org/10.1
The research reported in this publication was supported by the National 016/j.jacl.2019.07.011.
Heart, Lung, and Blood Institute of the National Institutes of Health under 11. Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG,
Award Number K12HL137942. Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to
New Science and Practice With a 20-Year Review. Front Public Health. 2019;
Availability of data and materials 7:64. https://doi.org/10.3389/fpubh.2019.00064.
All data generated or analyzed during this study are included in this 12. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of
published article. health promotion interventions: the RE-AIM framework. Am J Public Health.
1999;89(9):1322–7. https://doi.org/10.2105/AJPH.89.9.1322.
Declarations 13. Psek W, Davis FD, Gerrity G, Stametz R, Bailey-Davis L, Henninger D, Sellers
D, Darer J. Leadership perspectives on operationalizing the learning health
Ethics approval and consent to participate care system in an integrated delivery system. eGEMs. 2016;4(3):1233. https://
This study was approved by the Geisinger’s Institutional Review Board. doi.org/10.13063/2327-9214.1233.

Content courtesy of Springer Nature, terms of use apply. Rights reserved.


Jones et al. Implementation Science Communications (2021) 2:32 Page 10 of 10

14. Proctor EK, Powell BJ, McMillen JC. Implementation strategies:


recommendations for specifying and reporting. Implement Sci. 2013;8(1):
139. https://doi.org/10.1186/1748-5908-8-139.
15. Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, et al.
Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-
analysis of data from 170,000 participants in 26 randomised trials. Lancet.
2010;376(9753):1670–81. https://doi.org/10.1016/S0140-6736(10)61350-5.
16. Harris DE, Record NB, Gipson GW, Pearson TA. Lipid lowering in a
multidisciplinary clinic compared with primary physician management. Am
J Cardiol. 1998;81(7):929–33. https://doi.org/10.1016/S0002-9149(98)00027-7.
17. Birtcher KK, Bowden C, Ballantyne CM, Huyen M. Strategies for
implementing lipid-lowering therapy: pharmacy-based approach. Am J
Cardiol. 2000;85(3 SUPPL. 1):30–5.
18. Lobb R, Colditz GA. Implementation science and its application to
population health. Annu Rev Public Health. 2013;34(1):235–51. https://doi.
org/10.1146/annurev-publhealth-031912-114444.
19. Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC. RE-AIM
planning and evaluation framework: adapting to new science and practice
with a 20-year review. Front Public Health. 2019;7. https://doi.org/10.3389/
fpubh.2019.00064.
20. Glasgow RE, Chambers D. Developing robust, sustainable, implementation
systems using rigorous, rapid and relevant science. Clin Transl Sci. 2012;5(1):
48–55. https://doi.org/10.1111/j.1752-8062.2011.00383.x.
21. Nhim K, Gruss SM, Porterfield DS, Jacobs S, Elkins W, Luman ET, van Aacken
S, Schumacher P, Albright A. Using a RE-AIM framework to identify
promising practices in National Diabetes Prevention Program
implementation. Implement Sci. 2019;14(1):81. https://doi.org/10.1186/s13
012-019-0928-9.
22. Tabak RG, Khoong EC, Chambers DA, Brownson RC. Bridging research and
practice: models for dissemination and implementation research. Am J Prev
Med. 2012;43(3):337–50. https://doi.org/10.1016/j.amepre.2012.05.024.
23. Nilsen P. Making sense of implementation theories, models and frameworks.
Implement Sci. 2015;10(1):53. https://doi.org/10.1186/s13012-015-0242-0.

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