Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05026684
Other study ID # VAAnnArbor
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2021
Est. completion date June 30, 2022

Study information

Verified date April 2022
Source VA Ann Arbor Healthcare System
Contact Jeffrey T. Kullgren, MD, MS, MPH
Phone (734) 845-3502
Email Jeffrey.Kullgren@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Within VA Primary Care, the COVID-19 pandemic has resulted in an abrupt shift from mostly face-to-face visits to almost exclusively telephone and VA Video Connect (VVC) appointments. As the COVID-19 curve has flattened and personal protective equipment (PPE) supplies have stabilized, VA Medical Centers such as the VA Ann Arbor Healthcare System are now grappling with how to match these opportunities for different vehicles for delivering ambulatory care to patients' needs and preferences. One highly promising, Veteran-centered way to match opportunities for face-to-face, telephone, and VVC visits in the COVID-19 era is to consider the value each visit type yields for an individual Veteran. Value for a given health care service is broadly defined as its health outcomes (i.e., benefits) per dollars spent (i.e., costs). From the perspective of patients, costs entail not just out-of-pocket (OOP) expenses but also travel and time costs. These costs are even more salient for many Veterans in the current economic downturn which, unfortunately, is unlikely to abate until the US fully emerges from the COVID-19 pandemic. Careful consideration of these full costs -- which can vary widely across face-to-face, telephone, and VVC visits -- by both Veterans and their clinicians could result in higher-value ambulatory care visits. For example, when services could be provided by telephone rather than a face-to-face visit, the former would result in much higher value for Veterans because there are no copays or travel costs for telephone visits. Similarly, when a face-to-face visit is necessary, transparent cost information could encourage Veterans and their clinicians to maximize the necessary services delivered, amplifying the benefits realized for the relatively higher patient cost of that particular type of visit. Despite the clear benefits of making patient costs more transparent, and of broader policy initiatives within VA to better inform Veterans' health care choices, Veterans and their clinicians currently lack the personalized cost information that they need to make high-value choices about ambulatory visit modalities. This project will make transparent the full costs to Veterans of different types of ambulatory visits in order to optimize the value of their health care investments in the COVID-19 era and beyond.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Under the age of 18. - Mild cognitive impairment, dementia, psychotic disorder, or unable to provide informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Personalized cost handout
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.

Locations

Country Name City State
United States VA Ann Arbor Healthcare System Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
VA Ann Arbor Healthcare System VA Center for Clinical Management Research

Country where clinical trial is conducted

United States, 

References & Publications (17)

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

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. — View Citation

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

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kullgren JT. Helping Consumers Make High-Value Health Care Choices: The Devil Is in the Details. Health Serv Res. 2018 Aug;53 Suppl 1:2655-2661. doi: 10.1111/1475-6773.12860. Epub 2018 Apr 16. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Level of confidence in understanding costs of different visit type options Measured by telephone survey Within one week of appointment
Secondary Conversations about different visit type options Measured by telephone survey Within one week of appointment
Secondary Perceived helpfulness of intervention Measured by telephone survey Within one week of appointment
Secondary Interest in receiving information in future Measured by telephone survey Within one week of appointment
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06144008 - ESCAPE (Evaluating Surge Capacity And PrEparedness)
Completed NCT04594967 - The COPACC Study: Utilization, Health and Economic Evaluation of a Community-Based Primary Care Geriatric Hub at Whampoa
Completed NCT06453954 - Evaluating the Saving Babies Lives Care Bundle Version 2
Completed NCT05703503 - Mental Health and Healthcare in Adults With Intellectual Disabilities
Enrolling by invitation NCT01004276 - Increasing Smoking Cessation Counselling in Primary Care Using a Chronic Disease Management System N/A
Recruiting NCT03946319 - Personalized, Transdiagnostic Approach to Preventative Mental Health N/A
Completed NCT01139398 - Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia N/A
Active, not recruiting NCT05907174 - Siyakhana Peer: Evaluating a Peer Recovery Coach Model to Reduce Substance Use Stigma in South African HIV Care N/A
Completed NCT03862261 - Integrating Pediatric TB Services Into Child Healthcare Services in Africa N/A
Completed NCT00119548 - Improving HIV Screening With Nurse-Based Rapid Testing/Streamlined Counseling N/A
Completed NCT03459664 - Evaluation of a Cross-sectional Coordinated, Severity Stepped, Evidence-based Care Model for Mental Disorders N/A
Completed NCT01137305 - Soft Skills and Surgical Performance N/A
Recruiting NCT05849753 - Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Withdrawn NCT03202745 - The Effect of Informative Letters on the Prescription and Receipt of Opioids N/A
Completed NCT01304108 - Improving Venous Thromboembolism Prophylaxis Phase 4
Completed NCT06450249 - Effects of the Humanitude® Care Methodology on Health Professionals' Perception
Completed NCT02625142 - Family-Centered Rounds Checklist Implementation N/A
Completed NCT02665429 - A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department N/A
Completed NCT04176146 - Nudging Healthcare Organizations to Adopt New Care Delivery Practices N/A
Completed NCT04722289 - The Together on Diabetes Intervention - a Realist Evaluation N/A