Trial Outcomes & Findings for Supporting Decisions About Health Insurance to Improve Care for the Uninsured (NCT NCT02522624)
NCT ID: NCT02522624
Last Updated: 2018-02-28
Results Overview
8 questions developed in researchers' past work. Assessed health insurance knowledge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
328 participants
Primary outcome timeframe
Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.
Results posted on
2018-02-28
Participant Flow
Recruitment occurred between 10/2015 - 1/2016 via community events, online advertisements, social service organizations, and the recruitment/retention arm of our Center for Community-Engaged Research.
482 participants were assessed for eligibility. Participants were excluded (n=154) if they did not meet the inclusion criteria (n=82) or could not be reached (n=65).
Participant milestones
| Measure |
Decision Aid (DA)
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
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.
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
163
|
|
Overall Study
COMPLETED
|
164
|
163
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Decision Aid (DA)
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
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.
|
|---|---|---|
|
Overall Study
Technical failure
|
1
|
0
|
Baseline Characteristics
Only participants specifying they have a chronic condition were asked to provide the number of chronic conditions.
Baseline characteristics by cohort
| Measure |
Decision Aid (DA)
n=164 Participants
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
n=163 Participants
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.
|
Total
n=327 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 13.2 • n=164 Participants
|
41.4 years
STANDARD_DEVIATION 12.5 • n=163 Participants
|
42.3 years
STANDARD_DEVIATION 12.9 • n=327 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=164 Participants
|
94 Participants
n=163 Participants
|
191 Participants
n=327 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=164 Participants
|
69 Participants
n=163 Participants
|
136 Participants
n=327 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic
|
156 participants
n=164 Participants
|
159 participants
n=163 Participants
|
315 participants
n=327 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 participants
n=164 Participants
|
4 participants
n=163 Participants
|
12 participants
n=327 Participants
|
|
Race/Ethnicity, Customized
African American only
|
96 participants
n=164 Participants
|
107 participants
n=163 Participants
|
203 participants
n=327 Participants
|
|
Race/Ethnicity, Customized
Caucasian only
|
46 participants
n=164 Participants
|
41 participants
n=163 Participants
|
87 participants
n=327 Participants
|
|
Race/Ethnicity, Customized
Other (Including Mixed)
|
22 participants
n=164 Participants
|
15 participants
n=163 Participants
|
37 participants
n=327 Participants
|
|
Education
Less than HS
|
12 participants
n=164 Participants
|
15 participants
n=163 Participants
|
27 participants
n=327 Participants
|
|
Education
HS or GED
|
111 participants
n=164 Participants
|
99 participants
n=163 Participants
|
210 participants
n=327 Participants
|
|
Education
College +
|
41 participants
n=164 Participants
|
49 participants
n=163 Participants
|
90 participants
n=327 Participants
|
|
% Federal Poverty Line
< 100
|
72 participants
n=164 Participants
|
94 participants
n=163 Participants
|
166 participants
n=327 Participants
|
|
% Federal Poverty Line
100-249
|
64 participants
n=164 Participants
|
47 participants
n=163 Participants
|
111 participants
n=327 Participants
|
|
% Federal Poverty Line
250-399
|
15 participants
n=164 Participants
|
10 participants
n=163 Participants
|
25 participants
n=327 Participants
|
|
% Federal Poverty Line
400+
|
13 participants
n=164 Participants
|
8 participants
n=163 Participants
|
21 participants
n=327 Participants
|
|
Urbanicity
Rural
|
9 participants
n=164 Participants
|
11 participants
n=163 Participants
|
20 participants
n=327 Participants
|
|
Urbanicity
Suburban
|
97 participants
n=164 Participants
|
99 participants
n=163 Participants
|
196 participants
n=327 Participants
|
|
Urbanicity
Urban
|
58 participants
n=164 Participants
|
53 participants
n=163 Participants
|
111 participants
n=327 Participants
|
|
Total number covering
1
|
97 participants
n=164 Participants
|
106 participants
n=163 Participants
|
203 participants
n=327 Participants
|
|
Total number covering
2
|
32 participants
n=164 Participants
|
21 participants
n=163 Participants
|
53 participants
n=327 Participants
|
|
Total number covering
3+
|
35 participants
n=164 Participants
|
36 participants
n=163 Participants
|
71 participants
n=327 Participants
|
|
Smoking status - Participant
Yes
|
55 participants
n=164 Participants
|
47 participants
n=163 Participants
|
102 participants
n=327 Participants
|
|
Smoking status - Participant
No
|
109 participants
n=164 Participants
|
116 participants
n=163 Participants
|
225 participants
n=327 Participants
|
|
Smoking status - Dependent (n=124)
Yes
|
10 participants
n=164 Participants
|
9 participants
n=163 Participants
|
19 participants
n=327 Participants
|
|
Smoking status - Dependent (n=124)
No
|
57 participants
n=164 Participants
|
48 participants
n=163 Participants
|
105 participants
n=327 Participants
|
|
Chronic Conditions - Participant (n=207)
|
2.27 Number chronic conditions
STANDARD_DEVIATION 1.53 • n=96 Participants • Only participants specifying they have a chronic condition were asked to provide the number of chronic conditions.
|
2.17 Number chronic conditions
STANDARD_DEVIATION 1.35 • n=111 Participants • Only participants specifying they have a chronic condition were asked to provide the number of chronic conditions.
|
2.22 Number chronic conditions
STANDARD_DEVIATION 1.43 • n=207 Participants • Only participants specifying they have a chronic condition were asked to provide the number of chronic conditions.
|
|
Chronic Conditions - Participant + Dependents (n=107)
|
2.69 Number chronic conditions
STANDARD_DEVIATION 2.35 • n=107 Participants • Only participants with dependents were asked to provide the number of chronic conditions anyone in their household had (if any).
|
NA Number chronic conditions
STANDARD_DEVIATION NA • n=163 Participants • Only participants with dependents were asked to provide the number of chronic conditions anyone in their household had (if any).
|
NA Number chronic conditions
STANDARD_DEVIATION NA • n=270 Participants • Only participants with dependents were asked to provide the number of chronic conditions anyone in their household had (if any).
|
|
Insurance Status (Uninsured)
Uninsured
|
85 participants
n=164 Participants
|
93 participants
n=163 Participants
|
178 participants
n=327 Participants
|
|
Insurance Status (Uninsured)
Insured
|
79 participants
n=164 Participants
|
70 participants
n=163 Participants
|
149 participants
n=327 Participants
|
|
Health Literacy (SILS)
Adequate
|
139 participants
n=164 Participants
|
128 participants
n=163 Participants
|
267 participants
n=327 Participants
|
|
Health Literacy (SILS)
Limited
|
25 participants
n=164 Participants
|
34 participants
n=163 Participants
|
59 participants
n=327 Participants
|
|
Subjective Numeracy (SNS)
|
3.9 units on a scale
n=164 Participants
|
3.6 units on a scale
n=163 Participants
|
3.8 units on a scale
n=327 Participants
|
|
Objective Numeracy (Lipkus)
|
2.6 units on a scale
n=164 Participants
|
2.3 units on a scale
n=163 Participants
|
2.4 units on a scale
n=327 Participants
|
PRIMARY outcome
Timeframe: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.8 questions developed in researchers' past work. Assessed health insurance knowledge.
Outcome measures
| Measure |
Decision Aid (DA)
n=164 Participants
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
n=163 Participants
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.
|
|---|---|---|
|
Knowledge Score (% Correct)
|
77.6 percentage of 8 items correctly answered
Standard Deviation 18.2
|
58.8 percentage of 8 items correctly answered
Standard Deviation 21.0
|
PRIMARY outcome
Timeframe: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.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.
Outcome measures
| Measure |
Decision Aid (DA)
n=164 Participants
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
n=163 Participants
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.
|
|---|---|---|
|
Decision Self-efficacy
|
81.5 units on a scale
Standard Deviation 22.5
|
73.0 units on a scale
Standard Deviation 20.4
|
PRIMARY outcome
Timeframe: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.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.
Outcome measures
| Measure |
Decision Aid (DA)
n=164 Participants
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
n=163 Participants
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.
|
|---|---|---|
|
Confidence in Choice
|
3.5 units on a scale
Standard Deviation 0.9
|
2.9 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Pre-intervention and post-interventionPopulation: One participant in healthcare.gov (Control) condition did not finish HILM (n=162)
Assessed confidence estimating costs of care.Improvement in HILM was defined as moving from "not confident" pre-intervention to "a little confident" or "very confident" post-intervention, or from "a little confident" pre-intervention to "very confident" post-intervention.
Outcome measures
| Measure |
Decision Aid (DA)
n=164 Participants
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
n=162 Participants
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.
|
|---|---|---|
|
Improvements in HILM 1 (Health Insurance Literacy Measure)
Yes
|
66 participants
|
49 participants
|
|
Improvements in HILM 1 (Health Insurance Literacy Measure)
No
|
98 participants
|
113 participants
|
SECONDARY outcome
Timeframe: Pre-intervention and post-interventionPopulation: One participant in healthcare.gov (Control) condition did not finish HILM (n=162)
Assessed confidence understanding terms.Improvement in HILM was defined as moving from "not confident" pre-intervention to "a little confident" or "very confident" post-intervention, or from "a little confident" pre-intervention to "very confident" post-intervention.
Outcome measures
| Measure |
Decision Aid (DA)
n=164 Participants
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
n=162 Participants
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.
|
|---|---|---|
|
Improvements in HILM 2 (Health Insurance Literacy Measure)
Yes
|
88 participants
|
51 participants
|
|
Improvements in HILM 2 (Health Insurance Literacy Measure)
No
|
76 participants
|
111 participants
|
SECONDARY outcome
Timeframe: Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.Population: Intended plan choice metal level data were not available for 2 participants in SMHP (Show Me My Health Plans decision aid) condition (n=162) and for 11 participants in healthcare.gov (Control) condition (n=152)
Participants indicated the plan they would choose that day. We categorized plans by governmental classifications of metal level (catastrophic, bronze, silver, gold).
Outcome measures
| Measure |
Decision Aid (DA)
n=162 Participants
The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.
Decision Aid (DA): 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.
|
Control
n=152 Participants
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.
|
|---|---|---|
|
Intended Choice Metal Level
Catastrophic
|
0 participants
|
5 participants
|
|
Intended Choice Metal Level
Bronze
|
41 participants
|
108 participants
|
|
Intended Choice Metal Level
Silver
|
121 participants
|
30 participants
|
|
Intended Choice Metal Level
Gold
|
0 participants
|
9 participants
|
|
Intended Choice Metal Level
Platinum
|
0 participants
|
0 participants
|
Adverse Events
Decision Aid (DA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary C. Politi, PhD
Washington University's School of Medicine
Phone: 314-747-1968
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place