Health BehaviorNCT05010395
Increasing Health Insurance Enrollment Among Uninsured Americans
A study testing Letter intervention in people with Health Behavior, run by Office of Evaluation Sciences.
Trial summary
This randomized evaluation used behaviorally-informed letters to increase health insurance take-up on the Affordable Care Act (ACA) Marketplaces. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Behavior
- What is being tested?
- Letter intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 811,795 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2015to 1 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Those with an English language preference; those who had not enrolled in an ACA plan as of early February 2015
Who cannot join
- Those with a Spanish language preference
- This intervention was a program evaluation and did not go through Human Subjects Protection Review.
About this study
This randomized evaluation used behaviorally-informed letters to increase health insurance take-up on the Affordable Care Act (ACA) Marketplaces.
Read the detailed description
During Open Enrollment Periods for the ACA Marketplaces, qualifying individuals can purchase health insurance plans through the Federal Health Insurance Marketplace (FHIM). As of early February 2015, many people had visited HealthCare.gov and started an online account, but not yet selected a plan. The Department of Health and Human Services (HHS), in collaboration with the Office of Evaluation Sciences (OES), developed and sent letters to assist these individuals with completing their enrollment before the deadline.
To evaluate the effect of the letters, the team used a randomized controlled trial.
- Conditions
- Health Behavior
- Being tested
- Letter intervention
- Keywords
- health insurance enrollment
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letter interventionBehavioural
Letter intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Individuals in this arm did not receive a letter. |
| Arm 1: Basic Letter | Experimental | Individuals received a letter with information about the benefits of enrolling, the February 15th sign-up deadline, the HealthCare.gov website, and the call center phone number. Receives: Behavioral: Letter intervention |
| Arm 2: Action | Experimental | Individuals in this arm received a letter that emphasized only minimal marginal effort is required; and used adjectives and verbs connoting action (e.g., "almost done," "quick," "act now," and "fast"). Receives: Behavioral: Letter intervention |
| Arm 3: Action, Implementation | Experimental | Individuals in this arm received a letter similar to Arm 2, but with the addition of a calendar that draws attention to the February 15th deadline; and provided fill-in blanks in which the recipient can write the planned month, day, and time when they intend to enroll. Receives: Behavioral: Letter intervention |
| Arm 4: Action, Implementation, Picture | Experimental | Individuals in this arm received a letter similar to Arms 2 and 3, but with the addition of an image of then HealthCare.gov Chief Executive Officer Kevin Counihan Receives: Behavioral: Letter intervention |
| Arm 5: Norm | Experimental | Individuals in this arm received a letter that included the following social norm sentence: "Americans are enrolling but you haven't joined them." Receives: Behavioral: Letter intervention |
| Arm 6: Norm, Pledge | Experimental | Individuals in this arm received a letter that included a statement, to be checked in agreement, that "I pledge to Get Covered at Healthcare.gov." Receives: Behavioral: Letter intervention |
| Arm 7: Loss Aversion | Experimental | Individuals in this arm received a letter that warned "You risk paying a fee of $325 or 2% of your income-whichever is higher." Receives: Behavioral: Letter intervention |
| Arm 8: Kitchen Sink | Experimental | Individuals in this arm received a letter that includes all behavioral dynamics except for the pledge (due to space limitations). Receives: Behavioral: Letter intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of individuals enrolling in an ACA plan by the end of the Open Enrollment period.
Percent of individuals enrolling in an ACA plan during the observation period.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Jan 2015
- Primary completion15 Feb 2015
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 811,795 participants (actual)
Sponsor and investigators
- Lead sponsor
- Office of Evaluation Sciences
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, David Yokum, Brown University
- Investigators
- David Yokum, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010395
- Sponsor's protocol ID
- 02152015
- Status last verified
- Aug 2021
- First submitted
- 9 Jul 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified replication data will be posted to OSF upon manuscript acceptance.
Publications
Yokum D, Hopkins DJ, Feher A, Safran E, Peck J. Effectiveness of Behaviorally Informed Letters on Health Insurance Marketplace Enrollment: A Randomized Clinical Trial. JAMA Health Forum. 2022 Mar 4;3(3):e220034. doi: 10.1001/jamahealthforum.2022.0034. eCollection 2022 Mar.
PubMed 35977283
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Health Insurance Enrollment Among Uninsured Americans
- ClinicalTrials.gov ID
- NCT05010395
- Acronym / sponsor ID
- 02152015
- Conditions
- Health Behavior
- Keywords
- health insurance enrollment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 811,795 participants (actual)
- Lead sponsor
- Office of Evaluation SciencesUS federal agency
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 15 Feb 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized evaluation used behaviorally-informed letters to increase health insurance take-up on the Affordable Care Act (ACA) Marketplaces.
Detailed description
During Open Enrollment Periods for the ACA Marketplaces, qualifying individuals can purchase health insurance plans through the Federal Health Insurance Marketplace (FHIM). As of early February 2015, many people had visited HealthCare.gov and started an online account, but not yet selected a plan. The Department of Health and Human Services (HHS), in collaboration with the Office of Evaluation Sciences (OES), developed and sent letters to assist these individuals with completing their enrollment before the deadline.
To evaluate the effect of the letters, the team used a randomized controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Individuals in this arm did not receive a letter. |
| Arm 1: Basic Letter | Experimental | Behavioral: Letter interventionIndividuals received a letter with information about the benefits of enrolling, the February 15th sign-up deadline, the HealthCare.gov website, and the call center phone number. |
| Arm 2: Action | Experimental | Behavioral: Letter interventionIndividuals in this arm received a letter that emphasized only minimal marginal effort is required; and used adjectives and verbs connoting action (e.g., "almost done," "quick," "act now," and "fast"). |
| Arm 3: Action, Implementation | Experimental | Behavioral: Letter interventionIndividuals in this arm received a letter similar to Arm 2, but with the addition of a calendar that draws attention to the February 15th deadline; and provided fill-in blanks in which the recipient can write the planned month, day, and time when they intend to enroll. |
| Arm 4: Action, Implementation, Picture | Experimental | Behavioral: Letter interventionIndividuals in this arm received a letter similar to Arms 2 and 3, but with the addition of an image of then HealthCare.gov Chief Executive Officer Kevin Counihan |
| Arm 5: Norm | Experimental | Behavioral: Letter interventionIndividuals in this arm received a letter that included the following social norm sentence: "Americans are enrolling but you haven't joined them." |
| Arm 6: Norm, Pledge | Experimental | Behavioral: Letter interventionIndividuals in this arm received a letter that included a statement, to be checked in agreement, that "I pledge to Get Covered at Healthcare.gov." |
| Arm 7: Loss Aversion | Experimental | Behavioral: Letter interventionIndividuals in this arm received a letter that warned "You risk paying a fee of $325 or 2% of your income-whichever is higher." |
| Arm 8: Kitchen Sink | Experimental | Behavioral: Letter interventionIndividuals in this arm received a letter that includes all behavioral dynamics except for the pledge (due to space limitations). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Those with an English language preference; those who had not enrolled in an ACA plan as of early February 2015
Key exclusion criteria (2 listed)
- Those with a Spanish language preference
- This intervention was a program evaluation and did not go through Human Subjects Protection Review.
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 |
|---|---|---|
| Letter interventionLetter intervention | Behavioural | Arm 1: Basic Letter, Arm 2: Action, Arm 3: Action, Implementation, Arm 4: Action, Implementation, Picture, Arm 5: Norm, Arm 6: Norm, Pledge, Arm 7: Loss Aversion, Arm 8: Kitchen Sink |
Primary outcome
Percent of individuals enrolling in an ACA plan by the end of the Open Enrollment period.
Time frame: Two weeks
Percent of individuals enrolling in an ACA plan during the observation period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Derived from this study: PubMed 35977283Yokum D, Hopkins DJ, Feher A, Safran E, Peck J. Effectiveness of Behaviorally Informed Letters on Health Insurance Marketplace Enrollment: A Randomized Clinical Trial. JAMA Health Forum. 2022 Mar 4;3(3):e220034. doi: 10.1001/jamahealthforum.2022.0034. eCollection 2022 Mar.
- Individual participant dataSharing planned: Yes. Deidentified replication data will be posted to OSF upon manuscript acceptance.
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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.
David Yokum, PhD principal investigator
Brown University
Questions about this trial
What is this clinical trial studying?
A study testing Letter intervention in people with Health Behavior, run by Office of Evaluation Sciences.
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 1 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of individuals enrolling in an ACA plan by the end of the Open Enrollment period. (time frame: Two weeks). 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 NCT05010395, which also lists 1 linked publication.
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 18 Aug 2021.