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NCT Number: NCT06539988

Advancing Decisions About Virtual Service Encounters

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location status: Recruiting

Location contact

Amanda C Blok, PhD MSN

SUB_INVESTIGATOR

Fatima Makki, MPH MSW

CONTACT

[email protected]

734-845-3623

Jeffrey T. Kullgren, MD MPH MS

PRINCIPAL_INVESTIGATOR

Jeremy B. Sussman, MD MS

SUB_INVESTIGATOR

Lewei Lin, MD

SUB_INVESTIGATOR

Nicholas R Yankey, MPH MSW

CONTACT

[email protected]

(734) 222-8987

Sarah T Hawley, PhD MPH BA

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinician Coaching Sessions

Behavioral

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.

Personalized text messages to patients

Other

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.

Primary outcomes

  1. Veterans' perceptions of the value of their healthcare

    Time frame: 6 months prior to intervention and 6-months post intervention

    Measured by survey at baseline and intervention end

Secondary outcomes

  1. VA Video Connect (VVC) encounters with assigned Patient Aligned Care Team (PACT)

    Time frame: 6 months prior to intervention and 6-months post intervention

    Measured using Corporate Data Warehouse (CDW) data

  2. Face-to-Face (F2F) encounters with assigned Patient Aligned Care Team (PACT)

    Time frame: 6 months prior to intervention and 6-months post intervention

    Measured using CDW data

  3. Telephone encounters with assigned Patient Aligned Care Team (PACT)

    Time frame: 6 months prior to intervention and 6-months post intervention

    Measured using CDW data

  4. Veterans' satisfaction with healthcare

    Time frame: 6 months prior to intervention and 6-months post intervention

    Measured by survey at baseline and intervention end

  5. Veterans' preferences for virtual care

    Time frame: 6 months prior to intervention and 6-months post intervention

    Measured by survey at baseline and intervention end

  6. Total healthcare-associated costs for Veterans

    Time frame: 6 months prior to intervention and 6 months post intervention

    Sum of copay costs, travel costs, and time costs measured using CDW data

  7. Hemoglobin A1c level <8% among Veterans with diabetes

    Time frame: 6 months prior to intervention and 6 months post intervention

    Electronic quality measure (eQM) measured using CDW data

  8. Blood pressure (BP) < 140/90 among Veterans with diabetes

    Time frame: 6 months prior to intervention and 6 months post intervention

    Electronic quality measure (eQM) measured using CDW data

  9. Statin use among Veterans with diabetes

    Time frame: 6 months prior to intervention and 6 months post intervention

    Electronic quality measure (eQM) measured using CDW data

  10. Statin use among Veterans with ischemic heart disease

    Time frame: 6 months prior to intervention and 6 months post intervention

    Electronic quality measure (eQM) measured using CDW data

  11. Breast cancer screening among female Veterans

    Time frame: 6 months prior to intervention and 6 months post intervention

    Electronic quality measure (eQM) measured using CDW data

  12. Cervical cancer screening among female Veterans

    Time frame: 6 months prior to intervention and 6 months post intervention

    Electronic quality measure (eQM) measured using CDW data

  13. Colon cancer screening among Veterans aged 45-75

    Time frame: 6 months prior to intervention and 6 months post intervention

    Electronic quality measure (eQM) measured using CDW data

  14. Flu vaccine receipt among Veterans

    Time frame: 6 months prior to intervention and 6 months post intervention

    Electronic quality measure (eQM) measured using CDW data

  15. Time costs for Veterans

    Time frame: 6 months prior to intervention and 6 months post intervention

    Measured using CDW data

  16. Travel costs for Veterans

    Time frame: 6 months prior to intervention and 6 months post intervention

    Measured using CDW data

  17. Copay costs for Veterans

    Time frame: 6 months prior to intervention and 6 months post intervention

    Measured using CDW data

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey T Kullgren, MD MPH MS

CONTACT

[email protected]

(734) 845-5290

Nora A Metzger, BA MSW

CONTACT

[email protected]

(734) 222-7682

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Advancing Decisions About Virtual Service Encounters (ADViSE)

Acronym: ADViSE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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