1 Study Details

1.1 Study title

Assessing patient-reported outcomes, pharmacist interventions and medication adherence in inflammatory bowel disease

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 inflammatory bowel disease clinic provider.

  • Patient associated with the Adult GI/IBD clinic

2 Descriptive Statistics

2.1 Demographics and patient characteristics

Demographics and patient characteristics
N

N=181
Age at start 181 33 42 55  (44 ±15)
Gender 181
    Female 52% (95)
    Male 48% (86)
Race 181
    White 92.3% (167)
    Black or African American 5.0% ( 9)
    Other Asian 1.7% ( 3)
    Other 0.6% ( 1)
    Unknown 0.6% ( 1)
Ethnicity 181
    Not Hispanic, Latino/a, or Spanish origin 93.9% (170)
    Unknown 2.2% ( 4)
    Decline to Answer 1.7% ( 3)
    Other Hispanic, Latino/a, or Spanish origin 2.2% ( 4)
Insurance Type 181
    Commercial 77.3% (140)
    Medicare 18.2% ( 33)
    Medicaid 2.2% ( 4)
    Other 2.2% ( 4)
Other insurance 181
    J&J Patient Assistance 2.2% ( 4)
    NA 97.8% (177)
Patient status 181
    Living 100% (181)
Indication 181
    Crohn's Disease 87% (158)
    Ulcerative Colitis 13% ( 23)
Previous IBD surgery 181
    0 55.8% (101)
    1 18.8% ( 34)
    2 12.7% ( 23)
    3 6.6% ( 12)
    4 3.3% ( 6)
    5 1.1% ( 2)
    6 1.1% ( 2)
    7 0.6% ( 1)
Specialty GI med 181
    Cimzia (certolizumab) 3.3% ( 6)
    Humira (adalimumab) 57.5% (104)
    Simponi (golimumab) 3.3% ( 6)
    Stelara (ustekinumab) 31.5% ( 57)
    Xeljanz/Xeljanz XR (tofacitinib) 4.4% ( 8)
Administration route 181
    Oral 4.4% ( 8)
    Subcutaneous 95.6% (173)
IBD surgery 181
    Yes 42% ( 77)
    No 58% (104)
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.

2.2 Disease states and medications

Disease states and medications
N
Crohn's Disease
N=158
Ulcerative Colitis
N=23
Previous IBD surgery 181
    0 50.0% (79) 95.7% (22)
    1 21.5% (34) 0.0% ( 0)
    2 13.9% (22) 4.3% ( 1)
    3 7.6% (12) 0.0% ( 0)
    4 3.8% ( 6) 0.0% ( 0)
    5 1.3% ( 2) 0.0% ( 0)
    6 1.3% ( 2) 0.0% ( 0)
    7 0.6% ( 1) 0.0% ( 0)
Specialty GI med 181
    Cimzia (certolizumab) 3.8% ( 6) 0.0% ( 0)
    Humira (adalimumab) 56.3% (89) 65.2% (15)
    Simponi (golimumab) 0.6% ( 1) 21.7% ( 5)
    Stelara (ustekinumab) 35.4% (56) 4.3% ( 1)
    Xeljanz/Xeljanz XR (tofacitinib) 3.8% ( 6) 8.7% ( 2)
Administration route 181
    Oral 3.8% ( 6) 8.7% ( 2)
    Subcutaneous 96.2% (152) 91.3% ( 21)
IBD surgery 181
    Yes 48.1% (76) 4.3% ( 1)
    No 51.9% (82) 95.7% (22)
Ulcerative colitis extent 181
    proctitis 0% ( 0) 17% ( 4)
    left sided 0% ( 0) 30% ( 7)
    pancolitis 0% ( 0) 52% ( 12)
    NA 100% (158) 0% ( 0)
Crohn's extent 181
    ileal 4.4% ( 7) 0.0% ( 0)
    colonic 19.6% (31) 0.0% ( 0)
    both small bowel and colonic 36.7% (58) 0.0% ( 0)
    small bowel only 21.5% (34) 0.0% ( 0)
    all sites 17.7% (28) 0.0% ( 0)
    NA 0.0% ( 0) 100.0% (23)
Perianal IBD 181
    Yes 38% (60) 0% ( 0)
    No 62% (98) 0% ( 0)
    NA 0% ( 0) 100% (23)
Fistulizing disease 181
    Yes 47% (74) 0% ( 0)
    No 53% (84) 0% ( 0)
    NA 0% ( 0) 100% (23)
Stricturing disease 181
    Yes 44% (69) 0% ( 0)
    No 56% (89) 0% ( 0)
    NA 0% ( 0) 100% (23)
N is the number of non-missing values. Numbers after proportions are frequencies.
Count of IBD biologics per patient
Number of previous biologics Count
1 118
2 31
3 19
5 6
4 5
6 2

3 MRQ Data

3.1 Missed Doses

3.1.1 Count of missed doses

3.1.1.1 Per Patient

Number of missed doses per patient.

N=181
Number of Missed Doses
    0 0.94 (170)
    1 0.06 ( 11)
Numbers after proportions are frequencies.

3.1.1.2 In last month per MRQ

Number of missed doses in the last month per MRQ.

N=515
Number of missed doses
    1-2 doses 0.02 ( 11)
    No missed doses 0.98 (504)
Numbers after proportions are frequencies.

3.1.2 Reasons for missed doses

Reasons for Missed Doses
Reasons Frequency
Patient was in Hospital 4
Purposefully Held Due to Illness or Procedure 3
Forgetfulness 2
Other 2
Ran Out of Medication 1

3.2 Patient Perceived Efficacy

3.2.1 Table

Patient reported medication effectiveness.

N=515
Effectiveness
    Fair 0.02 ( 10)
    Good 0.84 (434)
    Excellent 0.13 ( 69)
    NA 0.00 ( 2)
Numbers after proportions are frequencies.

3.2.2 Visualization

4 Pharmacist Interventions

4.1 Count of interventions

4.2 Types of Interventions

Count of types of pharmacist interventions by intervention
Interventions Frequency
Adherence/Missed Dose 12
ED/Hospitalization/Urgent Care Visit 9
Therapeutic Monitoring - Efficacy 6
Medication List Change 3
Condition-Related Concern or Exacerbation 2
Common Side Effect/Toxicity 1
Drug Administration Question 1
New Condition or Diagnosis Identified 1

4.3 Outcomes of Interventions

Total count of outcomes of pharmacist interventions by intervention
Interventions Frequency
Identified Issue Resolved 18
Medication Administration Held 1
Recommendation to Provider Accepted 1
Unknown 7

5 IBD Outcomes

5.1 Outcomes per patient

Number of PRO and Labs per patient
. Freq
1 17
2 60
3 60
4 18
5 6
6 12
7 4
8 2
9 1

5.2 Summary Statistics of outcomes

Outcomes at PRO level
N
Crohn's Disease
N=481
Ulcerative Colitis
N=63
IBD Subset Score 349 2 11 19  (13 ±11) 0 0 0  ( 0 ± 0)
PHQ9 Score 418 1.0 3.0 7.0  (4.2 ±4.3) 0.0 1.0 3.0  (2.4 ±3.3)
CRP 374 0.8 2.6 7.7  ( 9.0 ±20.7) 0.4 0.7 2.5  ( 2.7 ± 5.4)
SIBDQ 417 50.0 58.0 62.0  (55.5 ± 9.1) 57.5 62.0 64.5  (60.6 ± 7.3)
HBI 356 1.0 3.0 6.0  (4.1 ±3.9) 0.0 0.0 0.0  (0.0 ±0.0)
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.

5.3 Outcomes over time

5.3.1 HBI

5.3.2 SIBDQ

5.3.3 PHQ9

5.3.4 IBD Subset

5.3.5 CRP