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

	N	N=181
Demographics and patient characteristics
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

	N	Crohn's Disease N=158	Ulcerative Colitis N=23
Disease states and medications
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.

Table 2.1: 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

	N=181
Number of missed doses per patient.
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

	N=515
Number of missed doses in the last month per MRQ.
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

Table 3.1: 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

	N=515
Patient reported medication effectiveness.
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

Table 4.1: 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

Table 4.2: 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

Table 5.1: 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

	N	Crohn's Disease N=481	Ulcerative Colitis N=63
Outcomes at PRO level
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.

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