B0395 - Patient Activation and Clinical Trial Participation in a Racially/Ethnically Diverse Population With Inflammatory Bowel Disease: Results From the National Health and Wellness Survey

Monday, October 24, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

AP

Aarti A. Patel, PharmD, MBA

Janssen Scientific Affairs, LLC
Titusville, NJ

Sabree Burbage, PharmD, MPH¹, Kathryn Krupsky, PhD², M. Janelle Cambron-Mellott, PhD³, Nate Way, PhD³, Aarti A. Patel, PharmD, MBA⁴, Julia Liu, MD, MS⁵
¹Janssen Scientific Affairs, LLC, Horsham, PA; ²Cerner Enviza, North Kansas City, MO; ³Cerner Enviza, Malvern, PA; ⁴Janssen Scientific Affairs, LLC, Titusville, NJ; ⁵Morehouse School of Medicine, Decatur, GA

Introduction: Black, Indigenous, and People of Color (BIPOC) are often underrepresented in clinical trials, limiting the generalizability of study results. However, research has shown BIPOC enrollment rates are similar to White participants when offered the opportunity to partake in culturally sensitive settings that address social needs. Patient activation measure (PAM) scores, which assess a patient’s engagement in their health care, may also influence clinical trial participation. In this study, the relationship between race/ethnicity, PAM scores, and clinical trial participation was evaluated in participants with inflammatory bowel disease (IBD).

Methods: Data were obtained from the 2018–2020 United States National Health and Wellness Survey. Adults with self-reported, known diagnosed Crohn’s disease (CD) or ulcerative colitis (UC) and a valid PAM score were included. Bivariate analyses were conducted to compare sociodemographic characteristics, PAM scores, and clinical trial participation across racial/ethnic groups.

Results: Analyses included 1,077 participants with CD (818 White, 109 Black, and 150 Hispanic) and 1,500 with UC (1,150 White, 99 Black, and 251 Hispanic). Significant differences were observed in sociodemographic characteristics and disease severity across racial/ethnic groups for CD and UC. Mean PAM scores were significantly lower in Black (56.90 [SD 12.95]) and Hispanic (58.16 [13.76]) participants with CD than in White participants (62.31 [12.30], P< 0.001 and P=0.001, respectively). PAM scores were also lower in Black (58.41 [14.25]) and Hispanic (58.03 [13.55]) participants with UC than in White participants (62.28 [11.44], P=0.007 and P< 0.001, respectively). Despite these differences, 33.9% and 39.4% of Black and 45.3% and 38.6% of Hispanic participants with CD and UC, respectively, had previously enrolled in clinical trials, compared with 20.0% of White participants with CD and 16.6% with UC (all P≤0.003).

Discussion: Contrary to conventional belief, these findings using data from a nationally representative source indicate that a higher proportion of BIPOC participants had previously enrolled in clinical trials than White participants, despite lower PAM scores. Notably, sampling bias of the survey population and across participants, as well as respondent misinterpretation of the survey, may influence these results. Further research is needed to better understand the factors influencing BIPOC participation in clinical trials.

	CD (N = 1,077)			UC (N = 1,500)
	White (n = 818)	Black (n = 109)	Hispanic (n = 150)	White (n = 1,150)	Black (n = 199)	Hispanic (n = 251)
Sociodemographics
Female, n (%)	421 (51.5%)	55 (50.5%)	55 (36.7%)	696 (60.5%)	47 (47.5%)	138 (55.0%)
Age in years, mean (SD)	48.34 (16.48)	36.84 (14.39)*	34.05 (11.05)^†	52.48 (16.28)	38.48 (16.08)	38.45 (14.27)^†
Education, n (%) Less than a college graduate College graduate or higher Decline to answer	383 (46.8%) 434 (53.1%) 1 (0.1%)	66 (60.6%)* 43 (39.4%)* 0 (0.0%)	81 (54.0%) 69 (46.0%) 0 (0.0%)	564 (49.0%) 582 (50.6%) 4 (0.3%)	59 (59.6%) 39 (39.4%) 1 (1.0%)	133 (53.0%) 118 (47.0%) 0 (0.0%)
Employment status, n (%) Employed full time Self-employed Employed part-time Homemaker Retired Student Long-Term Disability Not employed (whether looking for work or not)	364 (44.5%) 54 (6.6%) 83 (10.1%) 39 (4.8%) 159 (19.4%) 21 (2.6%) 56 (6.8%) 42 (5.1%)	56 (51.4%) 9 (8.3%) 14 (12.8%) 7 (6.4%) 2 (1.8%)* 9 (8.3%)* 5 (4.6%) 7 (6.4%)	94 (62.7%)^† 13 (8.7%) 12 (8.0%) 3 (2.0%) 9 (6.0%)^† 7 (4.7%) 5 (3.3%) 7 (4.7%)	424 (36.9%) 78 (6.8%) 85 (7.4%) 73 (6.3%) 321 (27.9%) 16 (1.4%) 84 (7.3%) 69 (6.0%)	44 (44.4%) 9 (9.1%) 17 (17.2%)* 3 (3.0%) 9 (9.1%) 8 (8.1%) 2 (2.0%) 7 (7.1%)	132 (52.6%)^† 15 (6.0%) 30 (12.0%) 19 (7.6%) 29 (11.6%) 8 (3.2%) 12 (4.8%) 6 (2.4%)
Household income, n (%) < $25,000 $25,000 to < $50,000 $50,000 to < $100,000 $100,000+ Decline to answer	102 (12.5%) 163 (19.9%) 289 (35.3%) 246 (30.1%) 18 (2.2%)	32 (29.4%)* 20 (18.3%) 29 (26.6%) 27 (24.8%) 1 (0.9%)	16 (10.7%) 29 (19.3%) 47 (31.3%) 57 (38.0%) 1 (0.7%)	166 (14.4%) 235 (20.4%) 409 (35.6%) 299 (26.0%) 41 (3.6%)	22 (22.2%)* 25 (25.3%) 29 (29.3%) 23 (23.2%) 0 (0.0%)	39 (15.5%) 53 (21.1%) 74 (29.5%) 77 (30.7%) 8 (3.2%)
Health insurance, n (%) Not insured Commercially insured Medicaid Medicare Other type of insurance/unsure	58 (7.1%) 456 (55.7%) 81 (9.9%) 203 (24.8%) 20 (2.4%)	16 (14.7%)* 65 (59.6%) 10 (9.2%) 15 (13.8%)* 3 (2.8%)	21 (14.0%)^† 91 (60.7%) 11 (7.3%) 14 (9.3%)^† 13 (8.7%)^†	88 (7.7%) 583 (50.7%) 85 (7.4%) 362 (31.5%) 32 (2.8%)	11 (11.1%) 54 (54.5%) 13 (13.1%) 16 (16.2%)* 5 (5.1%)	37 (14.7%)^† 149 (59.4%)^† 21 (8.4%) 27 (10.8%)^† 17 (6.8%)^†
Severity of condition, n (%) Mild Moderate Severe	514 (62.8%) 249 (30.4%) 55 (6.7%)	51 (46.8%)* 43 (39.4%) 15 (13.8%)*	83 (55.3%) 50 (33.3%) 17 (11.3%)	789 (68.6%) 300 (26.1%) 61 (5.3%)	61 (61.6%) 27 (27.3%) 11 (11.1%)	134 (53.4%)^† 93 (37.1%)^† 24 (9.6%)^†
PAM score and clinical trial participation
PAM score^a, mean (SD)	62.31 (12.30)	56.90 (13.95)*	58.16 (13.76)^†	62.28 (11.44)	58.41 (14.25)*	58.03 (13.55)^†
Ever participated in a clinical trial, n (%)	164 (20.0%)	37 (33.9%)*	68 (45.3%)^†	191 (16.6%)	39 (39.4%)*	97 (38.6%)^†

Table: Sociodemographic characteristics and study outcomes in White, Black, and Hispanic participants with IBD.
a PAM scores range from 0 to 100 where higher scores indicate higher levels of activation.
* P < 0.05 between Black and White participants. † P < 0.05 between Hispanic and White participants. ‡ P < 0.05 between Hispanic and Black participants.
Note: P values were calculated using Bonferroni-adjusted pairwise comparisons.
Abbreviations: BMI = body mass index; CCI = Charlson comorbidity index; GAD = general anxiety disorder; HRCU = healthcare resource utilization; HRQoL = health-related quality of life; PAM = patient activation measure; PHQ = patient health questionnaire; SD = standard deviation; USD = United States dollar; WPAI = work productivity and activity impairment.

Disclosures:

Sabree Burbage: Janssen Scientific Affairs – Employee, Stock-privately held company.

Kathryn Krupsky: Janssen – Employee of Cerner Enviza, who received funding to conduct this study.

M. Janelle Cambron-Mellott: Janssen – Employee of Cerner Enviza, who received funding to conduct this study.

Nate Way: Janssen Scientific Affairs – mployee of Cerner Enviza, who received funding to conduct this study.

Aarti Patel: Janssen Scientific Affairs, LLC – Employee, Stock-publicly held company(excluding mutual/index funds).

Julia Liu indicated no relevant financial relationships.

Sabree Burbage, PharmD, MPH¹, Kathryn Krupsky, PhD², M. Janelle Cambron-Mellott, PhD³, Nate Way, PhD³, Aarti A. Patel, PharmD, MBA⁴, Julia Liu, MD, MS⁵. B0395 - Patient Activation and Clinical Trial Participation in a Racially/Ethnically Diverse Population With Inflammatory Bowel Disease: Results From the National Health and Wellness Survey, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.