NCT00505596

Brief Summary

The proposed study will determine the impact of providing complete information about all prenatal tests for chromosomal disorders to racially/ethnically and sociodemographically diverse women of all ages and allowing them to make informed choices regarding which tests - if any - to undergo. Specifically, we propose to update a validated prenatal testing decision-assisting tool ("PT Tool") to incorporate new screening options and make it more accessible to lower literacy and culturally diverse populations. We then will conduct a randomized controlled trial comparing the effect of an "informed free choice" approach consisting of providing complete information regarding and access to all prenatal testing options to that of usual care among a diverse population of pregnant women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

5.1 years

First QC Date

July 20, 2007

Last Update Submit

October 17, 2014

Conditions

Pregnancy Related

Keywords

Prenatal testingDecisionmakingDecision aidInformed choice

Outcome Measures

Primary Outcomes (1)

  • Prenatal test use

    Information on prenatal test use was obtained from medical charts and used to classify women according to the testing strategy they underwent: no screening or diagnostic testing for chromosomal problems; starting with a screening test prior to deciding about diagnostic testing; and going straight to invasive diagnostic testing.

    9 months

Secondary Outcomes (1)

  • Patient reported outcome questionnaire

    9 months

Study Arms (2)

Computerized decision aid

EXPERIMENTAL

Participants instructed to view the updated PT Tool and told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study (Informed free choice). They also participate in a baseline pre-randomization interview and one follow-up telephone interview.

Behavioral: Informed free choice

Usual care

NO INTERVENTION

Control group, in which participants receive no intervention beyond a baseline pre-randomization interview and one follow-up telephone interview.

Interventions

Informed free choiceBEHAVIORAL

Women will be instructed to view an updated prenatal testing decision aid and will be told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study

Computerized decision aid

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • No more than 20 weeks pregnant.

You may not qualify if:

  • Inability to speak English or Spanish.
  • Those carrying triplets or higher order gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF

San Francisco, California, 94143-0856, United States

Location

Related Publications (1)

  • Kuppermann M, Pena S, Bishop JT, Nakagawa S, Gregorich SE, Sit A, Vargas J, Caughey AB, Sykes S, Pierce L, Norton ME. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial. JAMA. 2014 Sep 24;312(12):1210-7. doi: 10.1001/jama.2014.11479.

    PMID: 25247517DERIVED

Study Officials

  • Miriam Kuppermann, PhD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 23, 2007

Study Start

December 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations

US(1)