Trial Outcomes & Findings for HPV Vaccination: An Investigation of Physician Reminders and Recommendation Scripts (NCT NCT02551887)

Results Overview

The outcome of primary interest, HPV vaccine uptake, is recorded as the number of patients who receive the first dose of HPV vaccine.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

647 participants

Primary outcome timeframe

Nine Months

Results posted on

2016-03-11

Participant Flow

Recruitment Period: May 15, 2014 - April 30, 2015 Locations: The 5 CHICA clinic study sites were located throughout metropolitan Indianapolis. These clinics serve largely low income (70% Medicaid) and minority (33% Hispanic, 49% African American) children. CHICA has provided data to over 37,000 children since first implemented in 2004.

Participant milestones

Participant milestones
Measure	Usual Care Non-interventional study arm. Patients receive usual care.	Automated Reminder Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.	Automated Reminder Plus Recommended Script Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
Overall Study STARTED	301	124	222
Overall Study COMPLETED	301	124	222
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HPV Vaccination: An Investigation of Physician Reminders and Recommendation Scripts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=301 Participants Non-interventional study arm. Patients receive usual care.	Automated Reminder n=124 Participants Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.	Automated Reminder Plus Recommended Script n=222 Participants Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.	Total n=647 Participants Total of all reporting groups
Age, Categorical <=18 years	301 Participants n=5 Participants	124 Participants n=7 Participants	222 Participants n=5 Participants	647 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	56 Participants n=7 Participants	105 Participants n=5 Participants	291 Participants n=4 Participants
Sex: Female, Male Male	171 Participants n=5 Participants	68 Participants n=7 Participants	117 Participants n=5 Participants	356 Participants n=4 Participants
Region of Enrollment United States	301 Participants n=5 Participants	124 Participants n=7 Participants	222 Participants n=5 Participants	647 Participants n=4 Participants

PRIMARY outcome

Timeframe: Nine Months

Population: Number of patients that received the first dose of HPV vaccine.

The outcome of primary interest, HPV vaccine uptake, is recorded as the number of patients who receive the first dose of HPV vaccine.

Outcome measures

Outcome measures
Measure	Usual Care n=301 Participants Non-interventional study arm. Patients receive usual care.	Automated Reminder n=124 Participants Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.	Automated Reminder Plus Recommended Script n=222 Participants Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
First Dose HPV Vaccine Uptake	118 Participants	63 Participants	117 Participants

SECONDARY outcome

Timeframe: Nine Months

Population: Number in the control condition who were eligible for 2 doses of vaccine.

The rate of second dose of HPV vaccine uptake, is recorded as the number of patients who receive the second dose of HPV vaccine.

Outcome measures

Outcome measures
Measure	Usual Care n=235 Participants Non-interventional study arm. Patients receive usual care.	Automated Reminder n=97 Participants Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.	Automated Reminder Plus Recommended Script n=172 Participants Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
Second Dose HPV Vaccine Uptake	20 Participants	8 Participants	17 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Automated Reminder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Automated Reminder Plus Recommended Script

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

Dr. Gregory Zimet

Indiana University

Phone: 317-274-8812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place