HINT-C: Virtual Health Insurance Navigation Pilot Program for Colorectal Survivors

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05002608
Collaborator
(none)
80
2
2
13.9
40
2.9

Study Details

Study Description

Brief Summary

This trial aims to assess the feasibility and acceptability of colorectal survivors approached and engaged in HINT and aims to assess the preliminary efficacy of HINT to improve

  1. health insurance literacy and 2) financial burden related to medical cost concerns colorectal survivors. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the HINT intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Health Insurance Navigation Program
N/A

Detailed Description

With support from the American Cancer Society, Dr. Park designed a 4-session health insurance navigation treatment program, Health Insurance Navigation Tools (HINT), that is currently being delivered remotely, as a collaboration with the Childhood Cancer Survivor Study. Given the current insurance landscape and the additional insurance burden that adult colorectal cancer survivors face, the present study seeks to conduct a pilot trial with the existing health insurance intervention and adult colorectal cancer survivors seen at MGH Cancer Centers to improve health insurance literacy and decrease financial burden related to medical costs. The present study seeks to develop and pilot a health insurance navigation program with adult colorectal cancer survivors recruited from MGH. Patients diagnosed with colorectal cancer have a higher risk of experiencing financial burden related to health care costs when compared to patients diagnosed with other types of cancer. While many cancer survivors report experiencing financial burden, financial burden is particularly acute among survivors of colorectal cancer. Outcomes of financial burden among colorectal cancer survivors include lower health related quality of life, employment concerns, and delay or lack of engagement in needed surveillance and follow-up care.

Understanding and navigating insurance benefits in the current landscape is crucial for colorectal cancer survivors to obtain and utilize the health care that they need. With this in mind, the study investigators propose to develop and pilot an insurance navigation intervention to examine its feasibility and acceptability among colorectal cancer survivors receiving care at the MGH.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Intervention and Usual careIntervention and Usual care
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Virtual Health Insurance Navigation for Colorectal Survivors
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Navigation Intervention

The intervention will be delivered via synchronous videoconferencing (real-time delivery and communication between the navigator and the participant) by a trained patient navigator and will consist of 4, 30-minute sessions delivered every week, over the span of one month. The navigation intervention group will also receive a mailed copy of the brochure.

Behavioral: Health Insurance Navigation Program
The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.

No Intervention: Enhanced Usual Care

Enhanced usual care will consist of an online or mailed health insurance resource guide.

Outcome Measures

Primary Outcome Measures

  1. acceptability of the health insurance navigation program [5 month follow-up]

    5-point (1-5) scale rating of program quality, including the following (higher scores indicate higher levels of acceptability)- program materials scheduling communication with navigator length and number of sessions (investigator created scale)

  2. change from baseline health insurance literacy to 5-month follow-up [baseline and 5 month follow-up]

    4-point (1-4) scale rating of confidence on understanding of health insurance terms (higher scores indicate higher levels of health insurance literacy) (scale adapted from the Urban Institute Health Reform Monitoring Survey- premium deductible co-payments co-insurance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients who are18-65 years of age

  • patients who are 12-24 months post-treatment for stages I-III colon or rectal cancer

  • patients who had a medical visit at MGH in the past two years

  • patients who have medical insurance

  • patients who speak English

  • patients who have access to an iPad, computer, smartphone or laptop with WIFI access

Exclusion Criteria:
  • patients who are younger than 18 years of age or older than 65 years of age

  • patients who are unable to give consent due to psychiatric or cognitive impairment

  • patients who lack of access to a smartphone, computer, or tablet with internet access

  • patients who do not currently have health insurance

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114
2 MGH Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elyse Park, PhD, Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05002608
Other Study ID Numbers:
  • MGH HINT Colorectal (HINT-C)
First Posted:
Aug 12, 2021
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elyse Park, PhD, Professor, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2022