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Effective Communication to Improve Decision Making About Health Care Plans

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ClinicalTrials.gov Identifier: NCT01986790
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Health Literacy
Health Insurance
Health Services Accessibility
Interventions Behavioral: Plain Language
Behavioral: Plain Language + Visuals
Behavioral: Plain Language + Narratives
Enrollment 343
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plain Language Plain Language + Visuals Plain Language + Narratives
Hide Arm/Group Description

This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.

Plain Language

This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.

Plain Language + Visuals

This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.

Plain Language + Narratives

Period Title: Overall Study
Started 91 154 98
Completed 91 154 98
Not Completed 0 0 0
Arm/Group Title Plain Language Plain Language + Visuals Plain Language + Narratives Total
Hide Arm/Group Description

This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.

Plain Language

This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.

Plain Language + Visuals

This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.

Plain Language + Narratives

Total of all reporting groups
Overall Number of Baseline Participants 91 154 98 343
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 154 participants 98 participants 343 participants
38.9  (12.0) 38.7  (11.7) 37.8  (12.1) 38.5  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 154 participants 98 participants 343 participants
Female
61
  67.0%
79
  51.3%
63
  64.3%
203
  59.2%
Male
30
  33.0%
75
  48.7%
35
  35.7%
140
  40.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 154 participants 98 participants 343 participants
Hispanic or Latino
2
   2.2%
4
   2.6%
1
   1.0%
7
   2.0%
Not Hispanic or Latino
80
  87.9%
136
  88.3%
88
  89.8%
304
  88.6%
Unknown or Not Reported
9
   9.9%
14
   9.1%
9
   9.2%
32
   9.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 91 participants 154 participants 98 participants 343 participants
African American 48 87 59 194
White 31 42 24 97
Other 5 11 6 22
Not Reported 7 14 9 30
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 91 participants 154 participants 98 participants 343 participants
91 154 98 343
Rapid Estimate of Adult Literacy in Medicine-SF (REALM-SF)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 91 participants 154 participants 98 participants 343 participants
Inadequate 6 11 8 25
Marginal 31 56 42 129
Adequate 52 85 44 181
Not Reported 2 2 4 8
[1]
Measure Description: Health literacy was assessed by the REALM-SF. 9th grade reading level or above=adequate, 7th or 8th grade reading level=marginal, 6th grade reading level or below=inadequate.
Subjective Numeracy Scale (SNS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants 154 participants 98 participants 343 participants
4.1  (1.1) 4.2  (1.0) 3.7  (1.2) 4.0  (1.1)
[1]
Measure Description: Subjective numeracy was measured using the validated Subjective Numeracy ability subscale. All questions were scored as marked (range 1-6), using the average rating across all 4 questions. A higher value is considered to be a better outcome.
1.Primary Outcome
Title Knowledge
Hide Description Knowledge measures the degree at which participants understand the details about health insurance plans. Knowledge was scored on a scale from 0 to 7 based on number of correct answers to the 7 items. A higher value is considered to be a better outcome. Bivariate outcome data can be found below.
Time Frame 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is represented as mean (standard deviation) of calculated knowledge.
Arm/Group Title Plain Language Plain Language + Visuals Plain Language + Narratives
Hide Arm/Group Description:

This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.

Plain Language

This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.

Plain Language + Visuals

This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.

Plain Language + Narratives

Overall Number of Participants Analyzed 91 154 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.0  (1.2) 5.7  (1.3) 5.5  (1.5)
2.Primary Outcome
Title Uncertainty
Hide Description A survey will be administered in order to measure participants' confidence in the features of health insurance plans that matter most to them and the insurance plan they chose of the ones presented. Confidence in choice is scored on a scale from 0 to 100, with higher scores indicating more decisional conflict/more uncertainty/less confidence in choice. Bivariate outcome data can be found below.
Time Frame 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is represented as mean (standard deviation) of calculated uncertainty.
Arm/Group Title Plain Language Plain Language + Visuals Plain Language + Narratives
Hide Arm/Group Description:

This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.

Plain Language

This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.

Plain Language + Visuals

This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.

Plain Language + Narratives

Overall Number of Participants Analyzed 91 154 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.6  (21.6) 10.6  (23.3) 7.2  (18.8)
3.Primary Outcome
Title Satisfaction
Hide Description A survey will be administered in order to measure the extent to which participants are satisfied with the information presented to them. Satisfaction was scored on a scale from 1 to 4, with higher scores indicating higher levels of satisfaction. Bivariate outcome data can be found below.
Time Frame 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is represented as mean (standard deviation) of calculated satisfaction.
Arm/Group Title Plain Language Plain Language + Visuals Plain Language + Narratives
Hide Arm/Group Description:

This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.

Plain Language

This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.

Plain Language + Visuals

This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.

Plain Language + Narratives

Overall Number of Participants Analyzed 91 154 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.7  (0.5) 2.6  (0.5) 2.7  (0.4)
Time Frame [Not Specified]
Adverse Event Reporting Description "Serious" and "Other" adverse events were not collected/assessed.
 
Arm/Group Title Plain Language Plain Language + Visuals Plain Language + Narratives
Hide Arm/Group Description

This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.

Plain Language

This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.

Plain Language + Visuals

This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.

Plain Language + Narratives

All-Cause Mortality
Plain Language Plain Language + Visuals Plain Language + Narratives
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Plain Language Plain Language + Visuals Plain Language + Narratives
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plain Language Plain Language + Visuals Plain Language + Narratives
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary C. Politi, PhD
Organization: Washington University's School of Medicine
Phone: 314-747-1968
EMail: politim@wudosis.wustl.edu
Publications:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01986790    
Other Study ID Numbers: HS020309
First Submitted: November 4, 2013
First Posted: November 18, 2013
Results First Submitted: February 11, 2016
Results First Posted: June 9, 2016
Last Update Posted: June 9, 2016