- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05317468
Assessing Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits
October 29, 2024 updated by: Washington University School of Medicine
Pilot Randomized Controlled Trial to Assess Satisfaction With Contraceptive Counseling Using Telephone Versus Video Telehealth Visits
The Contraceptive Choice Center (C3) will compare the patient experience between patients receiving contraceptive counseling using a telephone versus video telehealth model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Contraceptive Choice Center (C3) will offer contraceptive counseling to patients via telehealth.
Participants will be randomized to receive counseling via video or telephone.
We will compare patient satisfaction with contraceptive counseling, receipt of desired contraceptive method, and identification of barriers with technology use.
Study Type
Interventional
Enrollment (Actual)
214
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Able to speak and read English
- Access to video-capable technology
Exclusion Criteria:
- Incarceration
- Unable to provide informed consent secondary to language barrier or cognitive limitation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video
Patients will complete contraceptive counseling using a video-based platform.
Patients and counselors will have an audio and video connection.
|
Patients will receive contraceptive counseling to review all available contraceptive methods prior to their visit with a clinician.
|
|
Experimental: Telephone
Patients will complete contraceptive counseling on a telephone call.
Patients and counselors will have an audio connection only.
|
Patients will receive contraceptive counseling to review all available contraceptive methods prior to their visit with a clinician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction Assessed by IQFP
Time Frame: Baseline
|
Interpersonal Quality in Family Planning (IQFP) scale Continuous score: 11-55, higher scores indicate higher patient satisfaction Dichotomous: highest score (55) versus lower scores, highest score indicates highest patient satisfaction |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% of Patients Receiving Desired Contraceptive Method Assessed by Medical Record Review
Time Frame: 30 Days Post Baseline
|
30 Days Post Baseline
|
|
|
% of Patients Reporting Barriers to Technology Use Assessed by Baseline Questionnaire
Time Frame: Baseline
|
Percentage of patients reporting limited access to mobile telephone or computer with video capabilities, unreliable telephone or internet service, and environmental distractors (i.e.
loud noises, lack of privacy)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jennifer A Reeves, MD, MPH, Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
June 14, 2023
Study Completion (Actual)
June 26, 2023
Study Registration Dates
First Submitted
March 23, 2022
First Submitted That Met QC Criteria
April 5, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Estimated)
November 1, 2024
Last Update Submitted That Met QC Criteria
October 29, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202203067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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