1 Study Details

1.1 Study title

Assessing patient-reported outcomes, pharmacist interventions and medication adherence in Dermatology and Asthma, Sinus and Allergy Program (ASAP)

1.2 Background

Patient reported outcomes (PROs), defined as a measurement of any aspect of a patient’s health status that comes directly from the patient, are an effective took for understanding patient insights into their disease management, quality of life and functioning and can help inform clinical decision making and improve quality of care. VSP’s current workflow captures specific PROs during monthly refill assessments and alerts the pharmacist of any negative findings. An integrated clinic pharmacist then performs a variety of interventions to facilitate medication adherence and identify medication safety or effectiveness or further coordination of care.

1.3 Objectives

  • Quantify patient-reported response to therapy

  • Quantify number and type of pharmacist interventions performed during monthly refill assessments.

1.4 Inclusion criteria

  • Patients with at least two medication fills through VSP between January and March 2020.

  • Prescribed specialty therapy by a VUMC ASAP or dermatology clinic provider.

  • Patient associated with the ASAP (Asthma and allergy) or dermatology clinic.

2 Dermatology

2.1 Descriptive statistics

2.1.1 Demographics

There were 144 unique Dermatology patients that completed 455 MRQs.

Demographics
N
N=144
Age at start 144 40 53 63  (51 ±16)
Gender 144
    Female 58% (83)
    Male 42% (61)
Race 144
    White 79.2% (114)
    Black or African American 15.3% ( 22)
    Other Asian 2.1% ( 3)
    Unknown 2.8% ( 4)
    Asian Indian 0.7% ( 1)
Ethnicity 144
    Not Hispanic, Latino/a, or Spanish origin 90.3% (130)
    Unknown 8.3% ( 12)
    Decline to Answer 0.7% ( 1)
    Mexican, Mexican American, or Chicano/a 0.7% ( 1)
Insurance type 144
    Commercial 66.0% (95)
    Medicare 30.6% (44)
    Medicaid 2.8% ( 4)
    Other 0.7% ( 1)
a b c represent the lower quartile a, the median b, and the upper quartile c for continuous variables. x ± s represents X ± 1 SD.   N is the number of non-missing values. Numbers after proportions are frequencies.

2.1.2 Medications

Medications and indications
N
N=144
Administration route 144
    Oral 10% ( 15)
    Subcutaneous 90% (129)
Speciality medication 144
    Cimzia (certolizumab) 1.4% ( 2)
    Cosentyx (secukinumab) 13.9% (20)
    Dupixent (dupilumab) 21.5% (31)
    Taltz (ixekizumab) 2.8% ( 4)
    Humira (adalimumab) 24.3% (35)
    Otezla (apremilast) 16.7% (24)
    Enbrel (etanercept) 6.9% (10)
    Siliq (brodalumab) 0.7% ( 1)
    Simponi (golimumab) 0.7% ( 1)
    Stelara (ustekinumab) 2.1% ( 3)
    Targretin (bexarotene) 4.9% ( 7)
    Tremfya (guselkumab) 3.5% ( 5)
    Xeljanz (tofacitinib) 0.7% ( 1)
Indication 144
    Plaque psoriasis 63.9% (92)
    Atopic dermatitis 21.5% (31)
    Hidradenitis suppurativa 8.3% (12)
    Other 2.8% ( 4)
    Mycosis fungoides 3.5% ( 5)
Medication switch 144
    Yes 2.8% ( 4)
    No 2.1% ( 3)
    NA 95.1% (137)
Medication change 144
    Otezla 0.7% ( 1)
    taltz 0.7% ( 1)
    tremfya 0.7% ( 1)
    Xeljanz 0.7% ( 1)
    NA 97.2% (140)
N is the number of non-missing values. Numbers after proportions are frequencies.

2.1.3 Previous biologics

2.1.3.1 Count of medications

Previous Dermatology biologics
Medication Count
No previous treatments 78
Humira (adalimumab) 35
Stelara (ustekinumab) 24
Enbrel (etanercept) 23
Cosentyx (secukinumab) 10
Otezla (apremilast) 9
Unknown/not documented 9
Remicade (infliximab) 5
Tremfya (guselkumab) 4
Taltz (ixekizumab) 3
Cimzia (certolizumab) 2
Dupixent (dupilumab) 2
Skyrizi (risankizumab) 1

2.1.3.2 Count of medications per patient

Count of previous biologics per patient
NumberPreviousMeds Count
0 87
1 26
2 13
3 10
4 6
5 1
7 1

2.2 MRQs

2.2.1 Number of MRQs per patient

2.2.2 Missed doses

2.2.2.1 Missed doses per patient

Missed doses per patient.

N=144
Number of Missed Doses
    0 0.96 (138)
    1 0.04 ( 6)
Numbers after proportions are frequencies.

2.2.2.2 Missed doses in the last month per MRQ

Missed doses in the last month per MRQ.

N=455
Number of missed doses
    1-2 doses 0.01 ( 6)
    NA 0.99 (449)
Numbers after proportions are frequencies.

2.2.2.3 Reasons for missed doses

Reasons for Missed Doses by MRQ
Reasons Frequency
Purposefully Held Due to Illness or Procedure 4
Forgetfulness 2

2.2.3 Patient perceived efficacy

2.2.3.1 Table

Patient reported medication effectiveness.

N=455
Effectiveness
    Fair 0.01 ( 6)
    Good 0.91 (412)
    Excellent 0.08 ( 36)
    NA 0.00 ( 1)
Numbers after proportions are frequencies.

2.2.3.2 Visualization

2.2.4 Adverse effects

Descriptive Statistics (N=455).

N=455
Adverse effects
    No 0.99 (451)
    Yes 0.01 ( 4)
Numbers after proportions are frequencies.

2.3 Pharmacist Intervention

2.3.1 Interventions per Patient

2.3.2 Types of Interventions

Total count of types of pharmacist interventions by intervention
Interventions Frequency
Adherence/Missed Dose 7
Common Side Effect/Toxicity 4
ED/Hospitalization/Urgent Care Visit 3
Medication List Change 3
Other 3
Condition-Related Concern or Exacerbation 2

2.4 Discontinuations

Therapy Discontinuations
Discontinuation Reason Frequency
Common side effects 1
Major side effects/complication 1
No longer being seen or followed by a Vanderbilt Provider 2
No response / suboptimal response to therapy 4

3 ASAP

3.1 Descriptive statistics

There were 46 unique ASAP patients that completed 142 MRQS.

3.1.1 Demographics

Demographics, medications, and disease states
N
N=46
Age at start 46 41 50 62  (50 ±19)
Gender 46
    Female 59% (27)
    Male 41% (19)
Race 46
    White 67.4% (31)
    Black or African American 28.3% (13)
    Other 2.2% ( 1)
    Decline to Answer 2.2% ( 1)
Ethnicity 46
    Not Hispanic, Latino/a, or Spanish origin 89.1% (41)
    Unknown 4.3% ( 2)
    Other Hispanic, Latino/a, or Spanish origin 6.5% ( 3)
Insurance type 46
    Commercial 52.2% (24)
    Medicare 39.1% (18)
    Medicaid 8.7% ( 4)
Patient status 46
    Living 100% (46)
Specialty medication 46
    Dupixent (dupilumab) 82.6% (38)
    Fasenra (benralizumab) 2.2% ( 1)
    Gamunex-C (immune globulin injection) 2.2% ( 1)
    Hizentra (immune globulin injection) 2.2% ( 1)
    Nucala (mepolizumab) 6.5% ( 3)
    Xolair (omalizumab) 4.3% ( 2)
Indication 46
    Moderate to severe asthma 93.5% (43)
    Primary humoral immunodeficiency 4.3% ( 2)
    Rhinosinusitis (chronic) with nasal polyposis 2.2% ( 1)
Smoking 46
    Never smoker 65.2% (30)
    Former smoker 30.4% (14)
    Current smoker 4.3% ( 2)
a b c represent the lower quartile a, the median b, and the upper quartile c for continuous variables. x ± s represents X ± 1 SD.   N is the number of non-missing values. Numbers after proportions are frequencies.

3.1.2 Disease state and indication by specialty medication

Disease state by indication
N
 Moderate to severe asthma
N=43		 Primary humoral immunodeficiency
N=2		 Rhinosinusitis (chronic) with nasal polyposis
N=1
Specialty medication 46
    Dupixent (dupilumab) 86.0% (37) 0.0% ( 0) 100.0% ( 1)
    Fasenra (benralizumab) 2.3% ( 1) 0.0% ( 0) 0.0% ( 0)
    Gamunex-C (immune globulin injection) 0.0% ( 0) 50.0% ( 1) 0.0% ( 0)
    Hizentra (immune globulin injection) 0.0% ( 0) 50.0% ( 1) 0.0% ( 0)
    Nucala (mepolizumab) 7.0% ( 3) 0.0% ( 0) 0.0% ( 0)
    Xolair (omalizumab) 4.7% ( 2) 0.0% ( 0) 0.0% ( 0)
N is the number of non-missing values. Numbers after proportions are frequencies.

3.1.3 Previous ASAP biologics

3.1.3.1 Count of medications

Previous ASAP biologics
Medication Count
Xolair (omalizumab) 16
Nucala (mepolizumab) 11
Fasenra (benralizumab) 4
Dupixent (dupilumab) 2
Cinqair (reslizumab) 2

3.1.3.2 Count of medications per patient

Count of previous biologics per patient
NumberPreviousMeds Count
1 20
0 19
2 6
3 1

3.2 MRQs

3.2.1 Number of MRQs per patient

3.2.2 Missed doses

Descriptive Statistics (N=46).

N=46
Number of Missed Doses
    0 1 (46)
    1 0 ( 0)
Numbers after proportions are frequencies.

3.2.3 Patient perceived efficacy

3.2.3.1 Count per MRQ

3.2.3.2 Count per patient

Patients had multiple MRQs. The proportion of patients that gave each effectiveness measurement at least once are provided to count effectiveness at a patient level.

MRQ Effectiveness - patient level.

N=46
Fair
    No 0.98 (45)
    Yes 0.02 ( 1)
Good
    No 0 ( 0)
    Yes 1 (46)
Excellent
    No 0.85 (39)
    Yes 0.15 ( 7)
Numbers after proportions are frequencies.

3.2.4 Adverse effects per MRQ

Descriptive Statistics (N=142).

N=142
Adverse effects
    No 0.99 (141)
    Yes 0.01 ( 1)
Numbers after proportions are frequencies.

3.3 Pharmacist Interventions

3.3.1 Number of Interventions per Patient

3.3.2 Types of Interventions

Total count of types of pharmacist interventions by intervention
Interventions Frequency
Other 3
Condition-Related Concern or Exacerbation 2
Coordination of Care 1
Medication List Change 1

3.3.3 Intervention count details

Unique intervention count from raw data
. Freq
Condition-Related Concern or Exacerbation 2
Medication List Change 1
Other General Drug Information Needed 2
Other General Drug Information Needed;Coordination of Care 1

3.4 Discontinuations

1 patients discontinued medication for the following reasons:

Therapy Discontinuations
Discontinuation Reason Frequency
No response / suboptimal response to therapy 1