MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02100124
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 987
• Location: 1
• Arms: 3
• Duration (Months): 29
• Patients Per Site Per Month: 34

Study Details

Study Description

Brief Summary

The purpose of this web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group.

Condition or Disease	Intervention/Treatment	Phase
Contraceptive Use; Unintended Pregnancy	Behavioral: Reproductive Life Planning (RLP); Behavioral: Contraceptive Action Planning; Behavioral: Contraception information	N/A

Detailed Description

Most US families want 2 children, resulting in the average woman spending 3 decades of her life trying to avoid pregnancy. However, most women have at least one unintended pregnancy, resulting in 1.5 million abortions and 1.7 million unintended births annually. Women and couples try to avoid unintended pregnancy for a range of personal, social, and economic reasons, but also due to the increased physical and mental health effects for children that result from unintended pregnancy. Healthcare reform now requires that private health insurance companies cover all FDA-approved contraceptive methods with no copays or deductibles to the patient, creating a great opportunity for women with health insurance to get contraceptive methods they previously could not afford. In this study, women with health insurance will be randomly assigned to one of three groups: (1) Reproductive Life Planning (RLP)-women will complete a reproductive life plan that guides them to think about if and when they would want any future pregnancies, and to determine what contraceptive method(s) are best suited to them; (2) Reproductive Life Planning Plus (RLP+) which additionally includes "if-then planning," where women determine what they will do when they encounter difficult situations that make it difficult to use their contraceptive method perfectly; or (3) an information-only control group. The online format of the study allows for the potential of wide dissemination. The RLP and RLP+ interventions are expected to result in greater likelihood of contraceptive use, continuity of contraceptive use, and contraceptive adherence, and thus reduce overall risk of unintended pregnancy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 987 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reproductive Life Planning (RLP) RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.	Behavioral: Reproductive Life Planning (RLP); Behavioral: Contraception information
Experimental: Reproductive Life Planning Plus (RLP+) RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.	Behavioral: Reproductive Life Planning (RLP); Behavioral: Contraceptive Action Planning; Behavioral: Contraception information
Active Comparator: Information-only control The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.	Behavioral: Contraception information

Outcome Measures

Primary Outcome Measures

1. Contraceptive Use [24 months]

   Percentage of surveys with any contraceptive use

Secondary Outcome Measures

1. Effectiveness of Contraceptive Method [24 months]

   Percentage of surveys where most effective contraceptive method used

2. Contraceptive Method Satisfaction [24 months]

   percentage of surveys where very satisfied with contraceptive method

3. Contraceptive Adherence [24 months]

   Percentage of surveys where contraceptive adherence was high

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• not currently pregnant

• sexually active with a male partner in the past 6 months OR anticipate being sexually active with a male partner in the next 6 months

• does not intend pregnancy in the next 12 months

• has Internet access and email address

Exclusion Criteria:

• tubal sterilization

• hysterectomy

• partner with vasectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State College of Medicine	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Cynthia H Chuang, MD, MSc, Penn State College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cynthia Chuang, Associate Professor of Medicine and Public Health Sciences, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02100124
• Other Study ID Numbers: CD-1304-6117; CD-1304-6117
• First Posted: Mar 31, 2014
• Last Update Posted: Jul 11, 2018
• Last Verified: Sep 1, 2017

• Keywords provided by Cynthia Chuang, Associate Professor of Medicine and Public Health Sciences, Milton S. Hershey Medical Center: reproductive life planning; action planning; contraceptive use; unintended pregnancy
• Additional relevant MeSH terms: Contraceptive Agents

Study Results

Participant Flow

Arm/Group Title	Reproductive Life Planning (RLP)	Reproductive Life Planning Plus (RLP+)	Information-only Control
Arm/Group Description	RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information	RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information	The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information
Period Title: Overall Study
STARTED	329	329	326
COMPLETED	323	318	323
NOT COMPLETED	6	11	3

Baseline Characteristics

Arm/Group Title	Reproductive Life Planning (RLP)	Reproductive Life Planning Plus (RLP+)	Information-only Control	Total
Arm/Group Description	RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information	RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information	The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information	Total of all reporting groups
Overall Participants	329	329	326	984
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	329 100%	329 100%	326 100%	984 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.02 (5.95)	27.08 (6.13)	27.28 (5.92)	27.13 (5.99)
Sex: Female, Male (Count of Participants)
Female	329 100%	329 100%	326 100%	984 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	329 100%	329 100%	326 100%	984 100%

Outcome Measures

1. Primary Outcome

Title	Contraceptive Use
Description	Percentage of surveys with any contraceptive use
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reproductive Life Planning (RLP)	Reproductive Life Planning Plus (RLP+)	Information-only Control
Arm/Group Description	RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information	RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information	The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information
Measure Participants	308	298	312
Mean (Standard Deviation) [percentage of surveys]	93.43 (20.59)	94.46 (20.53)	94.10 (19.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning (RLP), Information-only Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.56 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning Plus (RLP+), Information-only Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning (RLP), Reproductive Life Planning Plus (RLP+)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.30
	Confidence Interval	(2-Sided) 95%; 0.82 to 2.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Effectiveness of Contraceptive Method
Description	Percentage of surveys where most effective contraceptive method used
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reproductive Life Planning (RLP)	Reproductive Life Planning Plus (RLP+)	Information-only Control
Arm/Group Description	RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information	RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information	The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information
Measure Participants	308	298	312
Mean (Standard Deviation) [percentage of surveys]	60.66 (45.11)	63.93 (43.91)	63.19 (43.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning (RLP), Information-only Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95%; 0.71 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning Plus (RLP+), Information-only Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95%; 0.87 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning (RLP), Reproductive Life Planning Plus (RLP+)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.23
	Confidence Interval	(2-Sided) 95%; 0.99 to 1.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Contraceptive Method Satisfaction
Description	percentage of surveys where very satisfied with contraceptive method
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reproductive Life Planning (RLP)	Reproductive Life Planning Plus (RLP+)	Information-only Control
Arm/Group Description	RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information	RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information	The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information
Measure Participants	299	289	304
Mean (Standard Deviation) [percentage of surveys]	58.22 (39.39)	57.09 (41.13)	57.70 (39.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning (RLP), Information-only Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning Plus (RLP+), Information-only Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning (RLP), Reproductive Life Planning Plus (RLP+)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Contraceptive Adherence
Description	Percentage of surveys where contraceptive adherence was high
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reproductive Life Planning (RLP)	Reproductive Life Planning Plus (RLP+)	Information-only Control
Arm/Group Description	RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information	RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information	The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information
Measure Participants	299	289	304
Mean (Standard Deviation) [percentage of surveys]	74.02 (34.19)	73.27 (35.54)	76.37 (32.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning (RLP), Information-only Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning Plus (RLP+), Information-only Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.04
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Reproductive Life Planning (RLP), Reproductive Life Planning Plus (RLP+)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.75 to 1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	1 year, 5 months
Arm/Group Title	Reproductive Life Planning (RLP)		Reproductive Life Planning Plus (RLP+)		Information-only Control
Arm/Group Description	RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information		RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information		The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information
All Cause Mortality
	Reproductive Life Planning (RLP)		Reproductive Life Planning Plus (RLP+)		Information-only Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/329 (0%)		0/329 (0%)		0/326 (0%)
Serious Adverse Events
	Reproductive Life Planning (RLP)		Reproductive Life Planning Plus (RLP+)		Information-only Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/329 (0%)		0/329 (0%)		0/326 (0%)
Other (Not Including Serious) Adverse Events
	Reproductive Life Planning (RLP)		Reproductive Life Planning Plus (RLP+)		Information-only Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/329 (0%)		0/329 (0%)		0/326 (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.