TRIO: Text Reminders to Immunize in a Managed Care Organization

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT01806714
• Collaborator: (none)
• Enrollment: 3,812
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 224

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the effectiveness of a managed care-based HPV vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse practices and patient populations. The trial will measure the effectiveness of text messaging reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive visits for adolescents

The hypotheses are that text-messaged reminders to parents of adolescents will result in improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease the intervals between vaccine doses and will improve rates of preventive care among adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV vaccination, well child care visits) for which their adolescent is due will be compared to a control group of parents receiving general health tips through text messages.

Condition or Disease	Intervention/Treatment	Phase
Human Papilloma Virus	Other: Text-based reminder for recommended HPV vaccine or WCC; Other: Non-specific text-based reminder (general health tip)	N/A

Detailed Description

The study setting is western New York State and the Southern Tier of New York State (15 counties total). Investigators will work with the Monroe Plan for Medical Care, an IPA-model managed care organization (MCO) that serves Medicaid managed care and SCHIP enrollees. The MCO will conduct regular reviews of insurance claims data and the New York State Immunization Information System of adolescents ages 11-<16 years. Parents (all over 18 years of age) of adolescents will receive the texted messages on their phones.

There are no enrollment restrictions based upon race or ethnic origin. The inclusion criteria are that the adolescents are a) enrolled in Medicaid or SCHIP through the Monroe Plan, b) have been enrolled greater than 6 months with the Monroe Plan (in order to have sufficient claims data to determine whether they are due for a well child care visit or recommended immunizations), c) the Monroe Plan has received their consent to send preventive care text messages, d) their child attend a primary care practice that has agreed to participate and d) they are between the ages of 11-<16 years at the start of the study.

The key independent measure is group allocation (intervention vs. control); an intention-to-treat strategy will be used to assess the effectiveness of text messaging reminders. Key outcome measures will be: 1) receipt of 0, 1, 2 or 3 doses of HPV vaccine 2) interval (in days) between doses and 3) having a preventive visit in the 6 month period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3812 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Text Reminders to Immunize in a Managed Care Organization
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Text-based reminder for HPV vaccine/WCC Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit	Other: Text-based reminder for recommended HPV vaccine or WCC; Patients due for a well visit or HPV vaccine received a text reminder
Active Comparator: Control arm Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)	Other: Non-specific text-based reminder (general health tip); Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Receiving HPV Vaccination (Dose 1) [9 months]

   Participants who received HPV vaccine dose 1 Kaplan-Meier failure function

Secondary Outcome Measures

1. Percentage of Participants Receiving HPV Vaccination (Dose 2) [9 months]

   Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function

2. Percentage of Participants Receiving HPV Vaccination (Dose 3) [9 months]

   Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 11-<18 years

• Member of MCO for >6 months

• Opted in to receive texted reminders from MCO

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Cynthia M Rand, MD, MPH, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cynthia Rand, Associate Professor of Pediatrics, University of Rochester
• ClinicalTrials.gov Identifier: NCT01806714
• Other Study ID Numbers: 056103-002
• First Posted: Mar 7, 2013
• Last Update Posted: Jun 26, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Cynthia Rand, Associate Professor of Pediatrics, University of Rochester: HPV vaccination; Adolescent well care; Adolescent HPV immunization; HPV
• Additional relevant MeSH terms: Papilloma

Study Results

Participant Flow

Recruitment Details	4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers
Pre-assignment Detail	For this study, there was a waiver of consent; 4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers.

Arm/Group Title	Text-based Reminder for HPV Vaccine/WCC	Control Arm
Arm/Group Description	Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit	Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Period Title: Overall Study
STARTED	2093	2089
COMPLETED	1893	1919
NOT COMPLETED	200	170

Baseline Characteristics

Arm/Group Title	Text-based Reminder for HPV Vaccine/WCC	Control Arm	Total
Arm/Group Description	Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit	Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)	Total of all reporting groups
Overall Participants	1893	1919	3812
Age, Customized (participants) [Number]
11 year olds	428 22.6%	407 21.2%	835 21.9%
12 year olds	341 18%	380 19.8%	721 18.9%
13 year olds	307 16.2%	324 16.9%	631 16.6%
14 year olds	281 14.8%	288 15%	569 14.9%
15 year olds	271 14.3%	270 14.1%	541 14.2%
16 year olds	265 14%	250 13%	515 13.5%
Sex: Female, Male (Count of Participants)
Female	863 45.6%	868 45.2%	1731 45.4%
Male	1030 54.4%	1051 54.8%	2081 54.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Receiving HPV Vaccination (Dose 1)
Description	Participants who received HPV vaccine dose 1 Kaplan-Meier failure function
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1.

Arm/Group Title	Text-based Reminder for HPV Vaccine/WCC	Control Arm
Arm/Group Description	Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit	Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Measure Participants	964	961
Number [percentage of eligible participants]	16 0.8%	13 0.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Text-based Reminder for HPV Vaccine/WCC, Control Arm
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.04
	Comments
	Method	clustered stratified Proportional Hazard
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	We determined hazard ratios using a clustered stratified Cox model with the Efron method to handle tied events and the Huber/White variance estimator that clustered on primary care provider and stratified on practice.

2. Secondary Outcome

Title	Percentage of Participants Receiving HPV Vaccination (Dose 2)
Description	Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Only subjects with a valid phone number at the time dose 2 was dispensed received the vaccine. The number of subjects receiving dose 2 is higher than dose 1 because some phones numbers that were inactive during dose 1 were active during dose 2.

Arm/Group Title	Text-based Reminder for HPV Vaccine/WCC	Control Arm
Arm/Group Description	Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit	Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Measure Participants	1007	1014
Number [percentage of eligible participants]	6 0.3%	7 0.4%

3. Secondary Outcome

Title	Percentage of Participants Receiving HPV Vaccination (Dose 3)
Description	Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Only subjects with valid phone numbers were included and not all recipients got the 2nd dose. Only subjects who got the 2nd dose were then given the 3rd dose and only if they had working phone numbers.

Arm/Group Title	Text-based Reminder for HPV Vaccine/WCC	Control Arm
Arm/Group Description	Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit	Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Measure Participants	958	966
Number [percentage of eligible participants]	2 0.1%	2 0.1%

Adverse Events

Time Frame	July 2013 - December 2014
Arm/Group Title	Text-based Reminder for HPV Vaccine/WCC		Control Arm
Arm/Group Description	Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit Text-based reminder for recommended HPV vaccine or well care visit		Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
All Cause Mortality
	Text-based Reminder for HPV Vaccine/WCC		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Text-based Reminder for HPV Vaccine/WCC		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1893 (0%)		0/1919 (0%)
Other (Not Including Serious) Adverse Events
	Text-based Reminder for HPV Vaccine/WCC		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1893 (0%)		0/1919 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.