NCT02522624

Brief Summary

The overall purpose of the study is to better understand how the investigators previously developed decision support (DS) tool can help people make decisions about health insurance plans available through the federal exchanges created by the Affordable Care Act (ACA). The investigators will evaluate the DS tool compared to the federal government website. The investigators will also evaluate the feasibility of disseminating this tool. There are two primary aims to be completed in this project: (1) examine the reach and effectiveness of the health insurance DS tool; and (2) collect stakeholders' feedback to improve the likelihood of implementation of the DS tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 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

August 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 11, 2017

Completed
Last Updated

February 28, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

August 6, 2015

Results QC Date

August 25, 2016

Last Update Submit

January 30, 2018

Conditions

Keywords

Health insuranceHealth services accessibilityDecision makingHealth literacy

Outcome Measures

Primary Outcomes (3)

  • Knowledge Score (% Correct)

    8 questions developed in researchers' past work. Assessed health insurance knowledge.

    Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.

  • Decision Self-efficacy

    The decision self-efficacy (DSE) scale measured participants' perceived ability to understand insurance info and resist unwanted decision pressure. The 6 items on the DSE scale were each rated on a 3-point scale (0=Not confident; 2=A little confident; 4=Very confident). The sum of the DSE items was divided by 6 and multiplied by 25 to obtain a score on a 0-100 scale. Higher values indicate more confidence in one's decision-making ability.

    Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.

  • Confidence in Choice

    The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) decisional conflict scale assessed confidence in plan choice. Each item could be answered dichotomously (1=yes; 0=no). Responses were summed and a group average was obtained. Higher SURE values indicate more confidence in choice. The scale ranged from 0-4.

    Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.

Secondary Outcomes (3)

  • Improvements in HILM 1 (Health Insurance Literacy Measure)

    Pre-intervention and post-intervention

  • Improvements in HILM 2 (Health Insurance Literacy Measure)

    Pre-intervention and post-intervention

  • Intended Choice Metal Level

    Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.

Study Arms (2)

Decision Aid (DA)

EXPERIMENTAL

The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.

Behavioral: Decision Aid (DA)

Control

NO INTERVENTION

Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.

Interventions

Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care.

Decision Aid (DA)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be without health insurance currently; or
  • Must be enrolled in one of the ACA exchange plans in the past 1 year; and
  • Must speak English

You may not qualify if:

  • Currently has health insurance that was not provided by being enrolled in one of the ACA exchange plans in the past year
  • Currently has health insurance that is provided through public insurance or private employer-based insurance
  • Does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Politi MC, Barker AR, Kaphingst KA, McBride T, Shacham E, Kebodeaux CS. Show Me My Health Plans: a study protocol of a randomized trial testing a decision support tool for the federal health insurance marketplace in Missouri. BMC Health Serv Res. 2016 Feb 16;16:55. doi: 10.1186/s12913-016-1314-9.

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Mary C. Politi, PhD
Organization
Washington University's School of Medicine

Study Officials

  • Mary C Politi, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2015

First Posted

August 13, 2015

Study Start

September 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 28, 2018

Results First Posted

January 11, 2017

Record last verified: 2018-01

Locations