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Trial Title:
Virtual Health Insurance Navigation Pilot Program for Childhood Survivors (HINTII)
NCT ID:
NCT05527392
Condition:
Childhood Cancer Survivors
Conditions: Keywords:
Health Insurance
Survivorship
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Enhanced Usual Care HINT Synchronous Intervention Group HINT Asynchronous Intervention
Group
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Health Insurance Navigation Tools Program
Description:
The program will be delivered via videoconferencing by a navigator over approximately a
3-month period and will consist of 5 sessions. The navigation intervention sessions will
be as follows: Section 1- Insurance Plan Basics; Section 2- Your Plan in Relation to
Policy; Section 3- Navigating Your Plan and Overcoming Obstacles; Section 4- Managing
Care Costs; 5-Understanding Your Medical Bills.
Arm group label:
HINT Asynchronous Intervention Group (HINT-A)
Arm group label:
HINT Synchronous Intervention Group (HINT-S)
Summary:
The investigators are conducting a Type I hybrid effectiveness-implementation trial to
assess the effectiveness of HINT-S (synchronous) compared to enhanced usual care (EUC) in
promoting health insurance literacy, thus reducing worry, unmet health care needs, and
financial consequences due to medical costs to improve care and long-term outcomes of
childhood cancer survivors. The investigators will also compare HINT-S to HINT-A
(asynchronous), a prerecorded, asynchronous version of the 5 HINT-S navigator sessions.
Detailed description:
The present study seeks to evaluate a health insurance navigation program with childhood
cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort. Childhood cancer
survivors face health challenges throughout their lives that require monitoring and
ongoing care. This is compounded by the tendency among childhood survivors to have higher
rates of underinsurance, unmet healthcare needs, and burdensome costs related to care.
These burdensome costs also contribute to underutilization of care among survivors. Dr.
Park and her colleagues published findings that suggested LTFU survivors had difficulty
in understanding how to use their insurance, and often experienced financial-related
distress. Understanding and navigating insurance benefits in the current landscape is
crucial for cancer survivors to obtain and utilize the health care that they need. With
this in mind, the study investigators propose to evaluate the effectiveness of an
insurance navigation intervention with LTFU participants, delivered in a synchronous and
asynchronous modality.
The navigation intervention will be delivered by a health insurance navigator via
HIPAA-compliant videoconferencing for the synchronous group (HINT-S) and will be
delivered via pre-recorded video session for the asynchronous group HINT-A). Participants
will be randomized into either the two navigation intervention arms (HINT-S and HINT-A;
approximately 234 per intervention arm), or the enhanced usual care arm (approximately 52
for control arm). The sample size per arm was chosen to enable evaluation of feasibility
and acceptability goals, as well as to explore meaningful differences in the outcomes. To
assess the proposed primary and secondary outcomes, all trial participants will complete
a baseline and 6-month and 12-month post-program follow-up survey.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- are 18 years or older at time of enrollment
- are able to give informed consent
- have access to a smartphone, computer, or tablet with internet access
- have US based health insurance
- current LTFU cohort participants
- having access to the CCSS patient portal.
Exclusion Criteria:
- Participants from the pilot trial will not be eligible
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elyse Park, PhD
Phone:
617-724-6836
Email:
epark@mgh.harvard.edu
Start date:
May 1, 2023
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527392
