Health LiteracyNCT01986790

Effective Communication to Improve Decision Making About Health Care Plans

A study testing Plain Language, Plain Language + Visuals and Plain Language + Narratives in people with Health Literacy and Health Insurance, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall goal of the study is to better understand how communication strategies can help people make decisions about health insurance plans. This study aims to: (Aim 1) Examine currently uninsured individuals' understanding of terminology and details of health insurance plans; (Aim 2) Apply three recommended… Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Health Literacy, Health Insurance, Health Services Accessibility
What is being tested?: Plain Language, Plain Language + Visuals and Plain Language + Narratives
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 343 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Must be without health insurance currently
Must have been without health insurance at some point in the past 12 months
Must speak English

Who cannot join

Currently has health insurance and has not had any lapses in coverage in the past 12 months
Does not speak English

Trial locations and contacts

1 site in 1 country.

United States1 site

The Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

The overall goal of the study is to better understand how communication strategies can help people make decisions about health insurance plans.

This study aims to:

(Aim 1) Examine currently uninsured individuals' understanding of terminology and details of health insurance plans;
(Aim 2) Apply three recommended strategies for communicating information about health insurance plans;
(Aim 3) Test the effects of these strategies in a randomized experiment.

Read the detailed description

First, this study will examine people's understanding of health insurance plan terminology and details through qualitative interviews with 50 uninsured individuals. These responses will then lead to the development of three communication strategies to improve understanding of health insurance plans: 1) plain language, 2) plain language plus visual displays and 3) plain language plus narratives.

The strategies will the be pilot tested with 30 individuals to assess readability, clarity of language, and layout. The revised communication strategies will be tested with 280 individuals in a randomized experiment. Individuals will be randomly assigned to either a plain language condition alone, a plain language + visual displays condition, and a plain language + narrative condition.

Conditions: Health Literacy, Health Insurance, Health Services Accessibility
Being tested: Plain Language, Plain Language + Visuals, Plain Language + Narratives
Keywords: Health insurance, Health services accessibility, Decision making, Health literacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Plain LanguageBehavioural
Plain Language + VisualsBehavioural
Plain Language + NarrativesBehavioural

Study groups in NCT01986790
Study group	Role	What they receive
Plain Language	Experimental	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. Receives: Behavioral: Plain Language
Plain Language + Visuals	Experimental	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. Receives: Behavioral: Plain Language + Visuals
Plain Language + Narratives	Experimental	This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans. Receives: Behavioral: Plain Language + Narratives

What is being measured

The primary outcome is the main question the study is designed to answer.

Knowledge
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.
Measured: 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)
Uncertainty
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.
Measured: 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)
Satisfaction
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.
Measured: 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jun 2014

First posted18 Nov 2013 (estimated)
Study startApr 2012
Primary completionMar 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Health LiteracyStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 343 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01986790
Sponsor's protocol ID: HS020309
Status last verified: May 2016
First submitted: 4 Nov 2013
Last updated: 9 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gold M, Wooldridge J. Surveying consumer satisfaction to assess managed-care quality: current practices. Health Care Financ Rev. 1995 Summer;16(4):155-73.
PubMed 10151887
Harris-Kojetin LD, McCormack LA, Jael EF, Sangl JA, Garfinkel SA. Creating more effective health plan quality reports for consumers: lessons from a synthesis of qualitative testing. Health Serv Res. 2001 Jul;36(3):447-76.
PubMed 11482584
Hibbard JH, Jewett JJ, Engelmann S, Tusler M. Can Medicare beneficiaries make informed choices? Health Aff (Millwood). 1998 Nov-Dec;17(6):181-93. doi: 10.1377/hlthaff.17.6.181.
PubMed 9916368
Peters E, Dieckmann N, Dixon A, Hibbard JH, Mertz CK. Less is more in presenting quality information to consumers. Med Care Res Rev. 2007 Apr;64(2):169-90. doi: 10.1177/10775587070640020301.
PubMed 17406019
Hibbard JH, Slovic P, Jewett JJ. Informing consumer decisions in health care: implications from decision-making research. Milbank Q. 1997;75(3):395-414. doi: 10.1111/1468-0009.00061.
PubMed 9290635
Knutson DJ, Kind EA, Fowles JB, Adlis S. Impact of report cards on employees: a natural experiment. Health Care Financ Rev. 1998 Fall;20(1):5-27.
PubMed 10387425
Scanlon DP, Chernew M, Lave JR. Consumer health plan choice: current knowledge and future directions. Annu Rev Public Health. 1997;18:507-28. doi: 10.1146/annurev.publhealth.18.1.507.
PubMed 9143729
Kreuter MW, Green MC, Cappella JN, Slater MD, Wise ME, Storey D, Clark EM, O'Keefe DJ, Erwin DO, Holmes K, Hinyard LJ, Houston T, Woolley S. Narrative communication in cancer prevention and control: a framework to guide research and application. Ann Behav Med. 2007 Jun;33(3):221-35. doi: 10.1007/BF02879904.
PubMed 17600449
McCormack LA, Uhrig JD. How does beneficiary knowledge of the Medicare program vary by type of insurance? Med Care. 2003 Aug;41(8):972-8. doi: 10.1097/00005650-200308000-00010.
PubMed 12886176
Hoadley J. Medicare Part D: simplifying the program and improving the value of information for beneficiaries. Issue Brief (Commonw Fund). 2008 May;39:1-15.
PubMed 18536148
Lubalin JS, Harris-Kojetin LD. What do consumers want and need to know in making health care choices? Med Care Res Rev. 1999;56 Suppl 1:67-102; discussion 103-12. doi: 10.1177/1077558799056001S04.
PubMed 10354679
Kolstad JT, Chernew ME. Quality and consumer decision making in the market for health insurance and health care services. Med Care Res Rev. 2009 Feb;66(1 Suppl):28S-52S. doi: 10.1177/1077558708325887. Epub 2008 Nov 24.
PubMed 19029288
Hibbard JH, Jewett JJ. Will quality report cards help consumers? Health Aff (Millwood). 1997 May-Jun;16(3):218-28. doi: 10.1377/hlthaff.16.3.218.
PubMed 9141339
Uhrig JD, Harris-Kojetin L, Bann C, Kuo TM. Do content and format affect older consumers' use of comparative information in a Medicare health plan choice? Results from a controlled experiment. Med Care Res Rev. 2006 Dec;63(6):701-18. doi: 10.1177/1077558706293636.
PubMed 17099122
Kreuter MW, Wray RJ. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav. 2003 Nov-Dec;27 Suppl 3:S227-32. doi: 10.5993/ajhb.27.1.s3.6.
PubMed 14672383

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effective Communication to Improve Decision Making About Health Care Plans
ClinicalTrials.gov ID: NCT01986790
Acronym / sponsor ID: HS020309
Conditions: Health Literacy, Health Insurance, Health Services Accessibility
Keywords: Health insurance, Health services accessibility, Decision making, Health literacy
Study type: Interventional
Recruitment status: Completed
Enrolment: 343 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Agency for Healthcare Research and Quality (AHRQ)
Study start: Apr 2012
Primary completion: Mar 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 18 Nov 2013 (estimated)
Results: Posted 9 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall goal of the study is to better understand how communication strategies can help people make decisions about health insurance plans.

This study aims to:

(Aim 1) Examine currently uninsured individuals' understanding of terminology and details of health insurance plans;
(Aim 2) Apply three recommended strategies for communicating information about health insurance plans;
(Aim 3) Test the effects of these strategies in a randomized experiment.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Plain Language	Experimental	Behavioral: Plain LanguageThis 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 + Visuals	Experimental	Behavioral: Plain Language + VisualsThis 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 + Narratives	Experimental	Behavioral: Plain Language + NarrativesThis intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Must be without health insurance currently
Must have been without health insurance at some point in the past 12 months
Must speak English

Key exclusion criteria (2 listed)

Currently has health insurance and has not had any lapses in coverage in the past 12 months
Does not speak English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Plain Language	Behavioural	Plain Language
Plain Language + Visuals	Behavioural	Plain Language + Visuals
Plain Language + Narratives	Behavioural	Plain Language + Narratives

Primary outcome

Knowledge
Time frame: 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)
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.
Uncertainty
Time frame: 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)
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.
Satisfaction
Time frame: 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)
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.

Results and safety

Results posted to the registry on 9 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Plain Language	91	91
Plain Language + Visuals	154	154
Plain Language + Narratives	98	98

Primary outcome: Knowledge

Time frame: 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives). Mean (Standard Deviation). Unit: Units on a scale

Measure	Plain Language n = 91	Plain Language + Visuals n = 154	Plain Language + Narratives n = 98
Value	6.0 (1.2)	5.7 (1.3)	5.5 (1.5)

Population analysed: Analysis is represented as mean (standard deviation) of calculated knowledge.

Primary outcome: Uncertainty

Measure	Plain Language n = 91	Plain Language + Visuals n = 154	Plain Language + Narratives n = 98
Value	9.6 (21.6)	10.6 (23.3)	7.2 (18.8)

Population analysed: Analysis is represented as mean (standard deviation) of calculated uncertainty.

Primary outcome: Satisfaction

Measure	Plain Language n = 91	Plain Language + Visuals n = 154	Plain Language + Narratives n = 98
Value	2.7 (0.5)	2.6 (0.5)	2.7 (0.4)

Population analysed: Analysis is represented as mean (standard deviation) of calculated satisfaction.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Plain Language	0 of 0	0 of 0	Not reported
Plain Language + Visuals	0 of 0	0 of 0	Not reported
Plain Language + Narratives	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10151887Gold M, Wooldridge J. Surveying consumer satisfaction to assess managed-care quality: current practices. Health Care Financ Rev. 1995 Summer;16(4):155-73.
Background: PubMed 11482584Harris-Kojetin LD, McCormack LA, Jael EF, Sangl JA, Garfinkel SA. Creating more effective health plan quality reports for consumers: lessons from a synthesis of qualitative testing. Health Serv Res. 2001 Jul;36(3):447-76.
Background: PubMed 9916368Hibbard JH, Jewett JJ, Engelmann S, Tusler M. Can Medicare beneficiaries make informed choices? Health Aff (Millwood). 1998 Nov-Dec;17(6):181-93. doi: 10.1377/hlthaff.17.6.181.
Background: PubMed 17406019Peters E, Dieckmann N, Dixon A, Hibbard JH, Mertz CK. Less is more in presenting quality information to consumers. Med Care Res Rev. 2007 Apr;64(2):169-90. doi: 10.1177/10775587070640020301.
Background: PubMed 9290635Hibbard JH, Slovic P, Jewett JJ. Informing consumer decisions in health care: implications from decision-making research. Milbank Q. 1997;75(3):395-414. doi: 10.1111/1468-0009.00061.
Background: PubMed 10387425Knutson DJ, Kind EA, Fowles JB, Adlis S. Impact of report cards on employees: a natural experiment. Health Care Financ Rev. 1998 Fall;20(1):5-27.
Background: PubMed 9143729Scanlon DP, Chernew M, Lave JR. Consumer health plan choice: current knowledge and future directions. Annu Rev Public Health. 1997;18:507-28. doi: 10.1146/annurev.publhealth.18.1.507.
Background: PubMed 17600449Kreuter MW, Green MC, Cappella JN, Slater MD, Wise ME, Storey D, Clark EM, O'Keefe DJ, Erwin DO, Holmes K, Hinyard LJ, Houston T, Woolley S. Narrative communication in cancer prevention and control: a framework to guide research and application. Ann Behav Med. 2007 Jun;33(3):221-35. doi: 10.1007/BF02879904.
Background: PubMed 12886176McCormack LA, Uhrig JD. How does beneficiary knowledge of the Medicare program vary by type of insurance? Med Care. 2003 Aug;41(8):972-8. doi: 10.1097/00005650-200308000-00010.
Background: PubMed 18536148Hoadley J. Medicare Part D: simplifying the program and improving the value of information for beneficiaries. Issue Brief (Commonw Fund). 2008 May;39:1-15.
Background: PubMed 10354679Lubalin JS, Harris-Kojetin LD. What do consumers want and need to know in making health care choices? Med Care Res Rev. 1999;56 Suppl 1:67-102; discussion 103-12. doi: 10.1177/1077558799056001S04.
Background: PubMed 19029288Kolstad JT, Chernew ME. Quality and consumer decision making in the market for health insurance and health care services. Med Care Res Rev. 2009 Feb;66(1 Suppl):28S-52S. doi: 10.1177/1077558708325887. Epub 2008 Nov 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Politi, PhD principal investigator

The Washington University in St. Louis School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge (time frame: 1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01986790, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.