CDM RCT: Computerized Contraceptive Decision Aid

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01479985
• Collaborator: Society of Family Planning (Other)
• Enrollment: 253
• Arms: 2
• Duration (Months): 17.9

Study Details

Study Description

Brief Summary

The purpose of this study is to conduct a randomized clinical trial of a web-based contraceptive decision aid compared to routine contraceptive counseling to evaluate the effect of the contraceptive decision aid on the contraceptive method selected by the participant.

The investigators primary hypothesis is that women utilizing a computerized Contraceptive Decision Aid (CDA) will be more likely to choose highly effective contraception than women who undergo standard clinical contraceptive counseling.

Condition or Disease	Intervention/Treatment	Phase
Contraception; Decision Making; Satisfaction; Evaluation	Other: CDM Tool	N/A

Detailed Description

Our primary specific aim is to test the CDA by conducting a randomized clinical trial comparing the CDA to routine contraceptive counseling. Our primary outcome of interest will be selection of highly effective contraception including the intrauterine device (IUD), the implant, and injectable contraception compared to all other reversible contraceptive methods.

We will also complete the following secondary specific aims:

1. We will use the validated Decisional Conflict Scale to measure decisional conflict pre- and post-intervention and compare the change in decisional conflict score in women randomized to the CDA to women undergoing routine counseling.

2. We will also evaluate satisfaction with contraceptive counseling and contraceptive continuation and satisfaction at 3 and 6 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 253 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Randomized Clinical Trial of a Computerized Contraceptive Decision Aid
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CDM Tool participants will be randomized to completing the CDM tool	Other: CDM Tool; Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
No Intervention: Control Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out

Outcome Measures

Primary Outcome Measures

1. Decisional Conflict Scale Score [Pre-Visit and Post-Visit (same day)]

   Pre-Visit, Post-Visit and change in Decisional Conflict Scale (DCS) Score between Post-Visit (immediately following visit) and Pre-Visit (immediately prior to visit). The Decisional Conflict Scale scores range from 0 to 100; 0 represents no decisional conflict and 100 represents high decisional conflict.

Secondary Outcome Measures

1. Contraceptive Method Chosen [Post-visit (immediately after visit)]

   Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Ages 18-45 years old

• At risk for unintended pregnancy and seeking reversible contraception at Center of Advanced Medicine or Washington University Resident's Clinic

• Willing and able to complete Contraceptive Decision Making tool

• English speaking

Exclusion Criteria:

• Have had a hysterectomy, bilateral oophorectomy, have undergone female sterilization

• Unable to give informed consent secondary to language barrier or cognitive limitation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Washington University School of Medicine
• Society of Family Planning

Investigators

• Principal Investigator: Tessa E Madden, MD, MPH, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01479985
• Other Study ID Numbers: SFP5-8 -201112047
• First Posted: Nov 28, 2011
• Last Update Posted: Sep 29, 2020
• Last Verified: Sep 1, 2020

Study Results

Participant Flow

Arm/Group Title	CDM Tool	Control
Arm/Group Description	participants will be randomized to completing the CDM tool CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers	Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
Period Title: Overall Study
STARTED	167	86
Baseline Survey	166	85
COMPLETED	161	80
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	CDM Tool	Control	Total
Arm/Group Description	participants will be randomized to completing the CDM tool CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers	Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out	Total of all reporting groups
Overall Participants	166	85	251
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.5 (6.2)	28.4 (6.2)	28.5 (6.2)
Sex: Female, Male (Count of Participants)
Female	166 100%	85 100%	251 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Black	62 37.3%	23 27.1%	85 33.9%
White	84 50.6%	55 64.7%	139 55.4%
Other	20 12%	7 8.2%	27 10.8%
Region of Enrollment (participants) [Number]
United States	166 100%	85 100%	251 100%

Outcome Measures

1. Primary Outcome

Title	Decisional Conflict Scale Score
Description	Pre-Visit, Post-Visit and change in Decisional Conflict Scale (DCS) Score between Post-Visit (immediately following visit) and Pre-Visit (immediately prior to visit). The Decisional Conflict Scale scores range from 0 to 100; 0 represents no decisional conflict and 100 represents high decisional conflict.
Time Frame	Pre-Visit and Post-Visit (same day)

Outcome Measure Data

Analysis Population Description

8 subjects did not complete the post-visit survey, so a post-visit DCS score and change in DCS score could not be calculated

Arm/Group Title	CDM Tool	Control
Arm/Group Description	participants will be randomized to completing the CDM tool CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers	Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
Measure Participants	166	83
Pre-Visit Score	15	10
Post-Visit Score	0	0
Change in Score	-10	-10

2. Secondary Outcome

Title	Contraceptive Method Chosen
Description	Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey
Time Frame	Post-visit (immediately after visit)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CDM Tool	Control
Arm/Group Description	participants will be randomized to completing the CDM tool CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers	Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
Measure Participants	161	80
LNG-IUS	45 27.1%	21 24.7%
Copper IUD	9 5.4%	3 3.5%
Implant	9 5.4%	6 7.1%
DMPA	19 11.4%	4 4.7%
Pills	57 34.3%	29 34.1%
Contraceptive patch	1 0.6%	0 0%
Vaginal ring	8 4.8%	5 5.9%
Sterilization	0 0%	3 3.5%
Condoms	7 4.2%	4 4.7%
Other	1 0.6%	3 3.5%
No method/undecided	5 3%	2 2.4%

Adverse Events

Arm/Group Title	CDM Tool		Control
Arm/Group Description	participants will be randomized to completing the CDM tool CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers		Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
All Cause Mortality
	CDM Tool		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/167 (0%)		0/86 (0%)
Serious Adverse Events
	CDM Tool		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/167 (0%)		0/86 (0%)
Other (Not Including Serious) Adverse Events
	CDM Tool		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/167 (0%)		0/86 (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.