Advancing Decisions About Virtual Service Encounters (ADViSE)

Advancing Decisions About Virtual Service Encounters (ADViSE)

Expanded availability of virtual care encounters in Primary Care provides new opportunities to improve Veterans' outcomes by aligning encounter modalities with their needs and preferences. Yet, Veterans and their Primary Care physicians (PCPs) lack personalized information about the benefits and costs of different Primary Care modalities that is needed to maximize the value of Primary Care encounters. To address this problem, in this study the investigators will use surveys and interviews to identify what Veterans and PCPs perceive to be the benefits and optimal uses of different Primary Care encounter modalities. They will then supplement their existing system for communicating encounter costs to Veterans and PCPs with new interactive messaging about benefits and optimal uses of different encounter modalities. Finally, this novel Advancing Decisions about Virtual Service Encounters (ADViSE) intervention will be optimized through user-centered refinement before evaluating its effects on Veteran-centered outcomes, use of virtual care, and intermediate health outcomes in a randomized controlled trial (RCT).

Study Overview

• Status: Recruiting
• Conditions: Delivery of Health Care; Health Care Costs
• Intervention / Treatment: Behavioral: Clinician Coaching Sessions; Other: Personalized text messages to patients

Detailed Description

The investigators will evaluate, in a stepped wedge cluster RCT, the effectiveness of the optimized ADViSE intervention, which will use interactive text messages for Veterans and point-of-care (POC) information and brief coaching for PCPs to help Veterans and their clinicians make well-informed decisions about available encounter types to meet each Veteran's needs and optimize the perceived value of their healthcare. A mixed methods stepped wedge cluster RCT will be conducted in which the optimized ADViSE intervention will be rolled out to PCPs and Veterans in each of 6 VA Ann Arbor Healthcare System (VAAAHS) Patient Aligned Care Teams (PACTs) in a randomly assigned order. For each Veteran participant, pre-post differences in outcomes during the 6-month intervention period will be compared to a 6-month pre-intervention control period.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeffrey T Kullgren, MD MPH MS; Phone Number: (734) 845-5290; Email: Jeffrey.Kullgren@va.gov
• Study Contact Backup: Name: Nora A Metzger, BA MSW; Phone Number: (734) 222-7682; Email: nora.metzger2@va.gov

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-2303
      • Recruiting
      • VA Ann Arbor Healthcare System, Ann Arbor, MI
      • Contact: Fatima Makki, MPH MSW; Phone Number: 734-845-3623; Email: fatima.makki@va.gov
      • Contact: Nicholas R Yankey, MPH MSW; Phone Number: (734) 222-8987; Email: Nicholas.Yankey@va.gov
      • Principal Investigator: Jeffrey T. Kullgren, MD MPH MS
      • Sub-Investigator: Amanda C Blok, PhD MSN
      • Sub-Investigator: Jeremy B. Sussman, MD MS
      • Sub-Investigator: Lewei Lin, MD
      • Sub-Investigator: Sarah T Hawley, PhD MPH BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veteran inclusion criteria are having an upcoming face-to-face (F2F), telephone, or VA Video Connect (VVC) appointment in the next 8 to 12 weeks
• Having at least 3 Primary Care F2F, telephone, or VVC encounters in the previous 12 months
• Able to provide informed consent
• Willing and able to receive text messages from the VA Patient Engagement, Tracking, and Long-term Support (PETALS) platform

Exclusion Criteria:

• Veteran exclusion criteria are a CDW diagnosis of mild cognitive impairment, dementia, or a psychotic disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Receiving the optimized ADviSE Intervention; 6 months of selected text messages from a library developed and refined in previous study aims.	Behavioral: Clinician Coaching Sessions; PCPs will receive interactive coaching sessions from a Clinician Coach 2 months into the intervention period and again at 4 months into the intervention period.; Other: Personalized text messages to patients; Drawing upon a library of messages that have previously been developed and refined, Veterans will receive 6 months of optimized text messages. The frequency of text messages will be determined based on feedback from Veterans in earlier phases of the research.
No Intervention: Control period; Usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Veterans' perceptions of the value of their healthcare	Measured by survey at baseline and intervention end	6 months prior to intervention and 6-months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VA Video Connect (VVC) encounters with assigned Patient Aligned Care Team (PACT)	Measured using Corporate Data Warehouse (CDW) data	6 months prior to intervention and 6-months post intervention
Face-to-Face (F2F) encounters with assigned Patient Aligned Care Team (PACT)	Measured using CDW data	6 months prior to intervention and 6-months post intervention
Telephone encounters with assigned Patient Aligned Care Team (PACT)	Measured using CDW data	6 months prior to intervention and 6-months post intervention
Veterans' satisfaction with healthcare	Measured by survey at baseline and intervention end	6 months prior to intervention and 6-months post intervention
Veterans' preferences for virtual care	Measured by survey at baseline and intervention end	6 months prior to intervention and 6-months post intervention
Total healthcare-associated costs for Veterans	Sum of copay costs, travel costs, and time costs measured using CDW data	6 months prior to intervention and 6 months post intervention
Hemoglobin A1c level <8% among Veterans with diabetes	Electronic quality measure (eQM) measured using CDW data	6 months prior to intervention and 6 months post intervention
Blood pressure (BP) < 140/90 among Veterans with diabetes	Electronic quality measure (eQM) measured using CDW data	6 months prior to intervention and 6 months post intervention
Statin use among Veterans with diabetes	Electronic quality measure (eQM) measured using CDW data	6 months prior to intervention and 6 months post intervention
Statin use among Veterans with ischemic heart disease	Electronic quality measure (eQM) measured using CDW data	6 months prior to intervention and 6 months post intervention
Breast cancer screening among female Veterans	Electronic quality measure (eQM) measured using CDW data	6 months prior to intervention and 6 months post intervention
Cervical cancer screening among female Veterans	Electronic quality measure (eQM) measured using CDW data	6 months prior to intervention and 6 months post intervention
Colon cancer screening among Veterans aged 45-75	Electronic quality measure (eQM) measured using CDW data	6 months prior to intervention and 6 months post intervention
Flu vaccine receipt among Veterans	Electronic quality measure (eQM) measured using CDW data	6 months prior to intervention and 6 months post intervention
Time costs for Veterans	Measured using CDW data	6 months prior to intervention and 6 months post intervention
Travel costs for Veterans	Measured using CDW data	6 months prior to intervention and 6 months post intervention
Copay costs for Veterans	Measured using CDW data	6 months prior to intervention and 6 months post intervention

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jeffrey T. Kullgren, MD MPH MS, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine; Primary care; Access; Cost; Patient outcomes; Rural Health; Virtual care; Decision support; Patient preferences; Patient-centered Care; Behavior (patient); Behavior (provider); Communication (doctor-patient); Satisfaction (patient)
• Additional Relevant MeSH Terms: Treatment Adherence and Compliance; Health Behavior; Communication; Behavior; Patient Preference; Patient Satisfaction
• Other Study ID Numbers: IIR 22-172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No