Human Papillomavirus vaccination clinical decision support for young adults in an upper midwestern healthcare system: a clinic cluster-randomized control trial

Figures & data

Figure 1. Study CONSORT diagram.

† Ineligible for analysis includes patients with delayed documentation of screening (n = 460) and those whose age at follow-up was higher than ages included in algorithms (n = 694).

Table 1. The effect of clinical decision support with or without shared decision-making tools on HPV vaccination compared to usual care in young adults ages 18–26 in the 12 months following a study index visit from 08/01/2018–03/15/2019 in randomized primary care study clinics: patient characteristics (N = 5,054) and study clinic characteristics (N = 34) by study arm

Characteristic	CDS (n = 1,511) n (%)	CDS+SDMT (n = 1,470) n (%)	UC (n = 2,073) n (%)
Patient-level summaries
Age (years)^a	21.5 (2.3)	21.5 (2.4)	21.5 (2.4)
Female	665 (44.0)	631 (42.9)	879 (42.4)
Race
African American	54 (3.6)	48 (3.3)	71 (3.4)
Asian	13 (.9)	14 (1.0)	16 (.8)
American Indian/Alaska Native	47 (3.1)	23 (1.6)	20 (1.0)
Native Hawaiian/Other Pacific Islander	4 (.3)	2 (.1)	7 (.3)
White	1361 (90.1)	1348 (91.7)	1915 (92.4)
Unknown	32 (2.1)	35 (2.4)	44 (2.1)
Hispanic ethnicity	27 (1.8)	39 (2.7)	55 (2.7)
Insurance type at index visit
Private	1028 (68.0)	1020 (69.4)	1283 (61.9)
Medicare^b	9 (.6)	12 (.8)	13 (.6)
Public payor^c	336 (22.2)	298 (20.3)	546 (26.3)
Other^d	14 (.9)	19 (1.3)	28 (1.4)
Unknown	124 (8.2)	121 (8.2)	203 (9.8)
Any outpatient visits in prior year	345 (22.8)	314 (21.4)	457 (22.1)
Current smoker	251 (16.6)	176 (12.0)	344 (16.6)
Number of HPV vaccinations as of index date
0	1,172 (77.6)	1,155 (78.6)	1,583 (76.4)
1	183 (12.1)	159 (10.8)	262 (12.6)
2	156 (10.3)	156 (10.6)	228 (11.0)
Clinic-level summaries at the time of randomization	(n = 11 clinics)	(n = 11 clinics)	(n = 12 clinics)
Urban clinic location	3 (27.3)	3 (27.3)	3 (25.0)
Unique patient visits at randomization^a	5,530.3 (2,376.0)	5,295.1 (3,930.7)	6,651.9 (4,055.6)
Percentage of patients with Medicaid coverage^a	17.5 (7.6)	17.1 (4.9)	18.0 (5.7)
Percentage of patients who are smokers^a	14.0 (2.6)	15.2 (3.3)	15.3 (3.1)
Percentage of patients up-to-date on breast cancer screening^a	74.9 (8.5)	77.2 (6.2)	79.3 (5.1)

CDS = Clinical decision support. SDMT = Shared decision-making tool. UC = Usual care.

^aMean (SD).

^bFor those receiving Social Security Disability Insurance or otherwise eligible for Medicare.

^cMedicaid, Federal, and Indian Health Services.

^dOther, workers compensation, government other, automobile, program.

Table 2. The effect of clinical decision support with or without shared decision-making tools on HPV vaccination compared to usual care in young adults ages 18–26 in the 12 months following a study index visit from 08/01/2018–03/15/2019 in randomized primary care study clinics: patient predicted percentages and between arm comparisons of patients either completing a HPV vaccination series or receiving at least one new vaccination dose in the 12 months following a study index visit date by study arm

	Model-Derived Estimates by Study Arm^a			CDS vs. UC		CDS+SDMT vs. UC
Model	CDS (95% CI)	CDS+SDMT (95% CI)	UC (95% CI)	OR (97.5% CI)	p	OR (97.5% CI)	p
Completion of a HPV vaccination series by 12 months following a study index visit date
	(n = 1,511)	(n = 1,470)	(n = 2,073)
Unadjusted^b	5.7% (4.3%-7.5%)	4.4% (3.2%-6.0%)	5.8% (4.5%-7.4%)	0.99 (.62–1.57)	0.942	0.76 (.46–1.24)	0.195
Adjusted^c	2.3% (1.6%-3.2%)	1.6% (1.1%-2.3%)	2.2% (1.6%-3.0%)	1.04 (.68–1.59)	0.827	0.71 (.46–1.12)	0.086
	(n = 1,661)	(n = 1,600)	(n = 2,253)
Composite endpoint^d,f	11.3% (9.7%-13.2%)	9.2% (7.7%-10.9%)	10.4% (9.0%-12.0%)	1.10 (.85–1.43)	0.379	0.88 (.67–1.1)	0.245
At least one HPV vaccination in the 12 months following the study index visit date
	(n = 1,511)	(n = 1,470)	(n = 2,073)
Unadjusted^b	15.8% (12.8%-19.4%)	11.6% (9.1%-14.6%)	14.3% (11.6%-17.4%)	1.13 (.76–1.68)	0.477	0.79 (.52–1.19)	0.178
Adjusted^c	13.1 (10.6%-16.1%)	9.2% (7.3%-11.6%)	11.2% (9.1%-13.7%)	1.19 (.82–1.74)	0.282	0.80 (.55–1.18)	0.191
	(n = 1,661)	(n = 1,600)	(n = 2,253)
Composite endpoint^e,f	21.1% (18.2%-24.4%)	16.3% (13.7%-19.1%)	18.6% (16.1%-21.4%)	1.17 (.88–1.57)	0.206	0.85 (.63–1.15)	0.211

Note. Boldface indicates statistical significance (p < .025). Patients (N = 5,054) and Study Clinics (N = 34). CDS = Clinical decision support. HPV = Human papillomavirus. SDMT = Shared decision-making tool. UC = Usual care.

aPredicted percentages from a generalized linear mixed model.

bUnadjusted models include fixed effects for study arm and a random intercept for clinic.

cAdjusted models include fixed effects for study arm, clinic-level (urbanicity, percent of patients up-to-date on breast cancer screening at baseline), patient-level (age, sex, race, insurance type, number of completed vaccinations as of index date), and a random intercept for clinic.

dHPV vaccination series complete and/or new documentation of HPV vaccination series completed prior to the index date.

eAny HPV vaccination and/or new documentation of HPV vaccination series completed prior to the index date.

fAdjusted models include fixed effects for study arm, clinic-level (urbanicity, percent of patients up-to-date on breast cancer screening at baseline), patient-level (age, sex, race, insurance type), and a random intercept for clinic.

Table 3. The effect of clinical decision support with or without shared decision-making tools on HPV vaccination compared to usual care in young adults ages 18–26 in the 12 months following a study index visit from 08/01/2018–03/15/2019 in randomized primary care study clinics: independent variables in the adjusted models presented in Table 2

Independent Variables	OR (95% CI)	p
Completion of the HPV vaccination series by 12 months following a study index visit date
Study arm^a
CDS	1.04 (.72–1.51)	0.827
CDS+SDMT	0.71 (.49–1.05)	0.086
Clinic urban status^b	1.75 (1.28–2.39)	0.001
Clinic percentage of women up-to-date on breast cancer screening	1.01 (.98–1.04)	0.604
Female patient	2.55 (1.92–3.40)	<0.001
Age at index visit	0.97 (.91–1.03)	0.265
Patient race^c
Nonwhite	1.64 (.96–2.81)	0.072
Unknown	1.96 (.85–4.50)	0.113
Insurance type^d
Public payor	0.72 (.52–1.00)	0.053
Unknown/other	0.30 (.15–.62)	0.001
Number of HPV vaccinations as of index date^e
1	5.70 (3.80–8.55)	<0.001
2	34.56(24.74–48.29)	<0.001
At least one HPV vaccination in the 12 months following the study index visit date
Study arm^a
CDS	1.19 (.86–1.65)	0.282
CDS+SDMT	0.80 (.58–1.12)	0.191
Clinic urban status^b	1.48 (1.12–1.96)	0.008
Clinic percentage of women up-to-date on breast cancer screening	1.00 (.97–1.03)	0.951
Female patient	2.27 (1.91–2.69)	<0.001
Age at index visit	0.86 (.83–.89)	<0.001
Patient race^c
Nonwhite	1.14 (.80–1.61)	0.476
Unknown	1.81 (1.09–3.00)	0.023
Insurance type^d
Public payor	0.82 (.67–1.01)	0.056
Unknown/other	0.44 (.30–.64)	<0.001
Number of HPV vaccinations as of index date^e
1	4.36 (3.53–5.37)	<0.001
2	3.97 (3.20–4.94)	<0.001

Note. Boldface indicates statistical significance (p < .05). Patients (N = 5,054) and Study Clinics (N = 34). CDS = Clinical decision support. Public payor = Medicaid, Federal, Indian Health Services. SDMT = Shared decision-making tool. Unknown/other = Blank/missing, workers compensation, government other, automobile, program, other.

aReference = Usual care.

bReference = Rural.

cReference = White.

dReference = Private insurance or Medicare.

eReference = 0.