Trial Outcomes & Findings for Screening for Hesitancy to Optimize Talk (NCT NCT02708745)
NCT ID: NCT02708745
Last Updated: 2019-10-01
Results Overview
Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
562 participants
Primary outcome timeframe
Child's immunization status at 8 months of age
Results posted on
2019-10-01
Participant Flow
Participant milestones
| Measure |
Placebo Arm
Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.
Placebo Survey
|
Intervention Arm
Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.
Intervention Survey
|
Pre-Intervention Providers
Providers at enrolled clinics who completed a survey before the parent-level intervention period
|
Post-Intervention Providers
Providers at enrolled clinics who completed a survey after the parent-level intervention period
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
91
|
69
|
204
|
198
|
|
Overall Study
COMPLETED
|
91
|
65
|
121
|
116
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
83
|
82
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data was not collected from providers for this measure
Baseline characteristics by cohort
| Measure |
Placebo Arm
n=91 Participants
Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.
Placebo Survey
|
Intervention Arm
n=65 Participants
Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.
Intervention Survey
|
Pre-Intervention Providers
n=121 Participants
Providers at enrolled clinics who completed a survey before the parent-level intervention period
|
Post-Intervention Providers
n=116 Participants
Providers at enrolled clinics who completed a survey after the parent-level intervention period
|
Total
n=393 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=91 Participants • Data was not collected from providers for this measure
|
0 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
0 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
Age, Categorical
Between 18 and 65 years
|
91 Participants
n=91 Participants • Data was not collected from providers for this measure
|
65 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
156 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
Age, Categorical
>=65 years
|
0 Participants
n=91 Participants • Data was not collected from providers for this measure
|
0 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
0 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
Sex: Female, Male
Female
|
61 Participants
n=91 Participants • There was missing data from providers on this measure
|
41 Participants
n=65 Participants • There was missing data from providers on this measure
|
84 Participants
n=120 Participants • There was missing data from providers on this measure
|
82 Participants
n=113 Participants • There was missing data from providers on this measure
|
268 Participants
n=389 Participants • There was missing data from providers on this measure
|
|
Sex: Female, Male
Male
|
30 Participants
n=91 Participants • There was missing data from providers on this measure
|
24 Participants
n=65 Participants • There was missing data from providers on this measure
|
36 Participants
n=120 Participants • There was missing data from providers on this measure
|
31 Participants
n=113 Participants • There was missing data from providers on this measure
|
121 Participants
n=389 Participants • There was missing data from providers on this measure
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=91 Participants
|
5 Participants
n=65 Participants
|
3 Participants
n=121 Participants
|
3 Participants
n=116 Participants
|
15 Participants
n=393 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=91 Participants
|
58 Participants
n=65 Participants
|
117 Participants
n=121 Participants
|
108 Participants
n=116 Participants
|
362 Participants
n=393 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=91 Participants
|
2 Participants
n=65 Participants
|
1 Participants
n=121 Participants
|
5 Participants
n=116 Participants
|
16 Participants
n=393 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=91 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=91 Participants
|
14 Participants
n=65 Participants
|
23 Participants
n=121 Participants
|
26 Participants
n=116 Participants
|
88 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=91 Participants
|
7 Participants
n=65 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=116 Participants
|
14 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=91 Participants
|
0 Participants
n=65 Participants
|
5 Participants
n=121 Participants
|
4 Participants
n=116 Participants
|
9 Participants
n=393 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=91 Participants
|
35 Participants
n=65 Participants
|
85 Participants
n=121 Participants
|
80 Participants
n=116 Participants
|
243 Participants
n=393 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=91 Participants
|
8 Participants
n=65 Participants
|
6 Participants
n=121 Participants
|
3 Participants
n=116 Participants
|
23 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=91 Participants
|
1 Participants
n=65 Participants
|
2 Participants
n=121 Participants
|
3 Participants
n=116 Participants
|
16 Participants
n=393 Participants
|
|
Number of parent participants married or living with a partner
|
79 Participants
n=91 Participants • Data was not collected from providers for this measure
|
59 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
138 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
Number of parent participants with a level of education greater than or equal to 4 years of college
|
66 Participants
n=91 Participants • Data was not collected from providers for this measure
|
45 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
111 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
Number of parent participants with a household income of greater than $75,000 per year
|
53 Participants
n=91 Participants • Data was not collected from providers for this measure
|
43 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
96 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
Number of parent participants who were mothers
|
61 Participants
n=91 Participants • Data was not collected from providers for this measure
|
41 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
102 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
Number of parent participants who had 1 child in the household
|
37 Participants
n=91 Participants • Data was not collected from providers for this measure
|
38 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
75 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
PACV-4 Score
2
|
45 Participants
n=91 Participants • Data was not collected from providers for this measure
|
27 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
72 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
PACV-4 Score
3
|
28 Participants
n=91 Participants • Data was not collected from providers for this measure
|
23 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
51 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
PACV-4 Score
4
|
17 Participants
n=91 Participants • Data was not collected from providers for this measure
|
13 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
30 Participants
n=156 Participants • Data was not collected from providers for this measure
|
|
PACV-4 Score
missing
|
1 Participants
n=91 Participants • Data was not collected from providers for this measure
|
2 Participants
n=65 Participants • Data was not collected from providers for this measure
|
—
|
—
|
3 Participants
n=156 Participants • Data was not collected from providers for this measure
|
PRIMARY outcome
Timeframe: Child's immunization status at 8 months of agePopulation: Mean percent days under-immunized of child participants by study arm
Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention
Outcome measures
| Measure |
Placebo Arm
n=91 Participants
Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.
Placebo Survey
|
Intervention Arm
n=65 Participants
Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.
Intervention Survey
|
|---|---|---|
|
Child's Mean Percent Days Under-immunized
|
19.1 percentage of days under-immunized
Interval 12.0 to 26.3
|
25.2 percentage of days under-immunized
Interval 16.0 to 34.5
|
SECONDARY outcome
Timeframe: 24-48 hours after the 6 month health supervision visitPopulation: Proportion of parents with a highly-rated visit experience by study arm, defined as those who scored 90 or higher (out of 105) on the visit experience survey
Score on a 15-item parent-completed visit experience survey (minimum score 15; maximum score 105, with higher scores suggesting a higher rated visit experience)
Outcome measures
| Measure |
Placebo Arm
n=65 Participants
Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.
Placebo Survey
|
Intervention Arm
n=91 Participants
Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.
Intervention Survey
|
|---|---|---|
|
Number of Parents With a Highly Rated Visit Experience
|
44 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Change post-intervention from pre-interventionPopulation: Proportion in arm who rated barrier as significant (3-5 on a 1-5 scale, where 1=not at all significant and 5=very significant)
Provider-reported ratings of the significance of 3 barriers to the vaccine discussion: a) not having enough time to discuss parental vaccine concerns, b) not realizing until late in the visit that a parent had vaccine concerns, and c) not understanding a parent's specific vaccine concerns to be barriers pre- and post-intervention
Outcome measures
| Measure |
Placebo Arm
n=121 Participants
Parent participants will receive a placebo survey about their attitudes toward common child health topics before their child's health supervision visit.
Placebo Survey
|
Intervention Arm
n=116 Participants
Parent participants will also receive the intervention survey about their attitudes toward childhood vaccines before their child's health supervision visit.
Intervention Survey
|
|---|---|---|
|
Provider Perceptions of Barriers to the Vaccine Discussion
Barrier: Not having enough time · Placebo Arm
|
31 Participants
|
6 Participants
|
|
Provider Perceptions of Barriers to the Vaccine Discussion
Barrier: Not having enough time · Intervention Arm
|
31 Participants
|
5 Participants
|
|
Provider Perceptions of Barriers to the Vaccine Discussion
Barrier: Not realizing until late in the visit · Placebo Arm
|
26 Participants
|
9 Participants
|
|
Provider Perceptions of Barriers to the Vaccine Discussion
Barrier: Not realizing until late in the visit · Intervention Arm
|
27 Participants
|
5 Participants
|
|
Provider Perceptions of Barriers to the Vaccine Discussion
Barrier: Not understanding a parent's concerns · Placebo Arm
|
25 Participants
|
6 Participants
|
|
Provider Perceptions of Barriers to the Vaccine Discussion
Barrier: Not understanding a parent's concerns · Intervention Arm
|
28 Participants
|
5 Participants
|
Adverse Events
Placebo Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-Intervention Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-Intervention Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place