Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03400449
• Collaborator: Universidad de Antioquia (Other)
• Enrollment: 240
• Locations: 2
• Arms: 2
• Actual Duration (Months): 15.3
• Patients Per Site: 120
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor.

Condition or Disease	Intervention/Treatment	Phase
Contraceptive Usage; Contraception Behavior	Other: Video counseling; Other: Conversational counseling	N/A

Detailed Description

This was a multi-center randomized, controlled trial examining contraceptive counseling in the setting of long-acting reversible contraception (LARC) uptake and immediate provision. At two urban public hospitals with large adolescent populations, participants were randomized to a structured, in-person conversation with a trained counselor or a 14-minute video providing the same information. Both participant groups were provided written materials and both had the opportunity to ask questions of the counselor. The total time to complete counseling was measured, as well as participant satisfaction, pre- and post-intervention contraceptive knowledge, and intended postpartum contraceptive method.

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two groups randomized to counseling type.Two groups randomized to counseling type.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization: The COMSE Randomized Trial
• Actual Study Start Date: Apr 28, 2015
• Actual Primary Completion Date: Aug 7, 2016
• Actual Study Completion Date: Aug 7, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Video counseling The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end.	Other: Video counseling; Video counseling
Active Comparator: Conversational counseling The conversation group participated in a structured, face-to-face conversation with a trained counselor.	Other: Conversational counseling; Conversational counseling

Outcome Measures

Primary Outcome Measures

1. Total Counseling Time [Immediately following the intervention, an average of less than 30 minutes]

   Duration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.

Secondary Outcome Measures

1. Knowledge Scores [One hour]

   Mean total correct answer (score) to 7 multiple-choice contraceptive knowledge questions. Total possible score is 0-7, with 7 representing 100% correct answers. Score measured after completion of the knowledge questionnaire, on average less than one hour, before (pre) and after (post) counseling.

2. Number of Participants Initiating Postpartum LARC Uptake [Assessed at the time of hospital discharge, on average less than 2 days]

   Number of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Live pregnancy >20 weeks gestation

• Admission to maternity ward for labor

• Age >14

Exclusion Criteria:

• Pain >=8 on Wong-Baker FACES pain scale

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternidad Rafael Calvo	Cartagena		Colombia
2	Metrosalud Manrique	Medellín		Colombia

Sponsors and Collaborators

• Oregon Health and Science University
• Universidad de Antioquia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maureen Baldwin, Assistant Professor, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT03400449
• Other Study ID Numbers: 11331b
• First Posted: Jan 17, 2018
• Last Update Posted: Nov 13, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Video Counseling	Conversational Counseling
Arm/Group Description	The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end. Video counseling: Video counseling	The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling
Period Title: Overall Study
STARTED	121	119
COMPLETED	120	119
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Video Counseling	Conversational Counseling	Total
Arm/Group Description	The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end. Video counseling: Video counseling	The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling	Total of all reporting groups
Overall Participants	120	119	239
Age (Count of Participants)
<=18 years	20 16.7%	23 19.3%	43 18%
Between 18 and 65 years	100 83.3%	96 80.7%	196 82%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	120 100%	119 100%	239 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Colombia	120 100%	119 100%	239 100%

Outcome Measures

1. Primary Outcome

Title	Total Counseling Time
Description	Duration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.
Time Frame	Immediately following the intervention, an average of less than 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video Counseling	Conversational Counseling
Arm/Group Description	The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end. Video counseling: Video counseling	The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling
Measure Participants	120	119
Mean (Standard Deviation) [minutes]	16.8 (4.6)	16.3 (4.6)

2. Secondary Outcome

Title	Knowledge Scores
Description	Mean total correct answer (score) to 7 multiple-choice contraceptive knowledge questions. Total possible score is 0-7, with 7 representing 100% correct answers. Score measured after completion of the knowledge questionnaire, on average less than one hour, before (pre) and after (post) counseling.
Time Frame	One hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conversational Counseling	Video Counseling
Arm/Group Description	The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling	The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end. Video counseling: Video counseling
Measure Participants	119	120
Pre-counseling	3.1 (1.5)	3.1 (1.5)
Post-counseling	5.3 (1.0)	5.1 (1.2)

3. Secondary Outcome

Title	Number of Participants Initiating Postpartum LARC Uptake
Description	Number of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.
Time Frame	Assessed at the time of hospital discharge, on average less than 2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conversational Counseling	Video Counseling
Arm/Group Description	The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling	The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end. Video counseling: Video counseling
Measure Participants	119	120
Count of Participants [Participants]	46 38.3%	44 37%

Adverse Events

Arm/Group Title	Video Counseling		Conversational Counseling
Arm/Group Description	The video group watched a 13.75 minute video of a local Colombian counselor reading a script of the same information provided by conversational counseling and had a chance to ask questions at the end. Video counseling: Video counseling		The conversation group participated in a structured, face-to-face conversation with a trained counselor. Conversational counseling: Conversational counseling
All Cause Mortality
	Video Counseling		Conversational Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/119 (0%)
Serious Adverse Events
	Video Counseling		Conversational Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/119 (0%)
Other (Not Including Serious) Adverse Events
	Video Counseling		Conversational Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/119 (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.