NCT05026684

Brief Summary

The COVID-19 pandemic has transformed the delivery of ambulatory care in the US. One of the most notable changes to ambulatory care practice has been the rapid expansion of telemedicine services. Such expansion sought to preserve access to necessary care for patients while protecting them and their clinicians from undue risk of exposure to COVID-19. This multiphase, Veteran-centered approach to developing and evaluating a novel behavioral intervention to provide full cost transparency to Veterans will achieve the following aims: Aim 1: Create an automated system to generate personalized estimates of Veterans' full costs (travel costs, time costs, and out-of-pocket costs) for different types of primary care visits. Aim 2: Develop and refine a novel behavioral intervention that will help Veterans and their clinicians use personalized information about the full costs of different types of primary care visits in the VHA. Aim 3: Evaluate the acceptability, feasibility, and preliminary effectiveness of the developed intervention to Veterans and their clinicians.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

August 9, 2021

Last Update Submit

April 28, 2022

Conditions

Keywords

CostValueVeteransBehavioral InterventionPersonalized healthcare

Outcome Measures

Primary Outcomes (1)

  • Level of confidence in understanding costs of different visit type options

    Measured by telephone survey

    Within one week of appointment

Secondary Outcomes (3)

  • Conversations about different visit type options

    Within one week of appointment

  • Perceived helpfulness of intervention

    Within one week of appointment

  • Interest in receiving information in future

    Within one week of appointment

Study Arms (1)

Experimental group

EXPERIMENTAL

Personalized cost information group.

Other: Personalized cost handout

Interventions

Patients will be given a personalized cost handout to make transparent the full costs to Veterans of different types of ambulatory visits in order to optimize the value of their health care investments.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older with an upcoming face-to-face, telephone, or VVC appointment with a consenting Primary Care provider at the Ann Arbor VA.

You may not qualify if:

  • Under the age of 18.
  • Mild cognitive impairment, dementia, psychotic disorder, or unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

RECRUITING

Related Publications (17)

  • Wosik J, Fudim M, Cameron B, Gellad ZF, Cho A, Phinney D, Curtis S, Roman M, Poon EG, Ferranti J, Katz JN, Tcheng J. Telehealth transformation: COVID-19 and the rise of virtual care. J Am Med Inform Assoc. 2020 Jun 1;27(6):957-962. doi: 10.1093/jamia/ocaa067.

    PMID: 32311034BACKGROUND
  • Mann DM, Chen J, Chunara R, Testa PA, Nov O. COVID-19 transforms health care through telemedicine: Evidence from the field. J Am Med Inform Assoc. 2020 Jul 1;27(7):1132-1135. doi: 10.1093/jamia/ocaa072.

    PMID: 32324855BACKGROUND
  • Porter ME. What is value in health care? N Engl J Med. 2010 Dec 23;363(26):2477-81. doi: 10.1056/NEJMp1011024. Epub 2010 Dec 8. No abstract available.

    PMID: 21142528BACKGROUND
  • Farmer CM, Hosek SD, Adamson DM. Balancing Demand and Supply for Veterans' Health Care: A Summary of Three RAND Assessments Conducted Under the Veterans Choice Act. Rand Health Q. 2016 Jun 20;6(1):12. eCollection 2016 Jun 20.

    PMID: 28083440BACKGROUND
  • Yabroff KR, Guy GP Jr, Ekwueme DU, McNeel T, Rozjabek HM, Dowling E, Li C, Virgo KS. Annual patient time costs associated with medical care among cancer survivors in the United States. Med Care. 2014 Jul;52(7):594-601. doi: 10.1097/MLR.0000000000000151.

    PMID: 24926706BACKGROUND
  • Kullgren JT, Fagerlin A, Kerr EA. Completing the MISSION: a Blueprint for Helping Veterans Make the Most of New Choices. J Gen Intern Med. 2020 May;35(5):1567-1570. doi: 10.1007/s11606-019-05404-w. Epub 2019 Oct 24.

    PMID: 31646457BACKGROUND
  • Department of Veterans Affairs FY 2018 - 2024 Strategic Plan. Published online February 12, 2018. Accessed April 10, 2018. https://www.va.gov/oei/docs/VA2018-2024strategicPlan.pdf

    BACKGROUND
  • Wait Times at Individual Facilities Search - VA Access to Care. Accessed May 2, 2018. https://www.accesstopwt.va.gov/

    BACKGROUND
  • How Does Your Medical Center Perform? Accessed May 2, 2018. https://www.va.gov/qualityofcare/apps/mcps-app.asp

    BACKGROUND
  • Final Report of the Commission on Care.; 2016. https://s3.amazonaws.com/sitesusa/wp-content/uploads/sites/912/2016/07/Commission-on-Care_Final-Report_063016_FOR-WEB.pdf

    BACKGROUND
  • John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018.; 2018. Accessed June 12, 2018. https://www.congress.gov/115/bills/s2372/BILLS-115s2372enr.xml

    BACKGROUND
  • Kullgren JT, Cliff EQ, Krenz C, West BT, Levy H, Fendrick AM, Fagerlin A. Consumer Behaviors Among Individuals Enrolled in High-Deductible Health Plans in the United States. JAMA Intern Med. 2018 Mar 1;178(3):424-426. doi: 10.1001/jamainternmed.2017.6622.

    PMID: 29181512BACKGROUND
  • Kullgren JT, Cliff BQ, Krenz CD, Levy H, West B, Fendrick AM, So J, Fagerlin A. A Survey Of Americans With High-Deductible Health Plans Identifies Opportunities To Enhance Consumer Behaviors. Health Aff (Millwood). 2019 Mar;38(3):416-424. doi: 10.1377/hlthaff.2018.05018.

    PMID: 30830816BACKGROUND
  • Kullgren JT. Helping Consumers Make High-Value Health Care Choices: The Devil Is in the Details. Health Serv Res. 2018 Aug;53 Suppl 1(Suppl Suppl 1):2655-2661. doi: 10.1111/1475-6773.12860. Epub 2018 Apr 16. No abstract available.

    PMID: 29659010BACKGROUND
  • Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

    PMID: 20053272BACKGROUND
  • Kullgren JT, Krupka E, Schachter A, Linden A, Miller J, Acharya Y, Alford J, Duffy R, Adler-Milstein J. Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial. BMJ Qual Saf. 2018 May;27(5):355-364. doi: 10.1136/bmjqs-2017-006699. Epub 2017 Oct 24.

    PMID: 29066616BACKGROUND
  • Kullgren JT, Youles B, Shetty S, Richardson C, Fagerlin A, Heisler M. ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial. Trials. 2017 Apr 8;18(1):167. doi: 10.1186/s13063-017-1887-6.

    PMID: 28388933BACKGROUND

Central Study Contacts

Jeffrey T. Kullgren, MD, MS, MPH

CONTACT

Nora A. Metzger, MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 30, 2021

Study Start

July 15, 2021

Primary Completion

May 30, 2022

Study Completion

June 30, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations