NCT06539988

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress5%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

June 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

June 26, 2024

Last Update Submit

April 2, 2026

Conditions

Keywords

AccessBehavior (patient)Behavior (provider)Rural HealthPatient preferencesDecision supportTelemedicinePatient-centered CareCommunication (doctor-patient)CostPatient outcomesPrimary careSatisfaction (patient)Virtual care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

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

    6 months prior to intervention and 6-months post intervention

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

    6 months prior to intervention and 6-months post intervention

  • Telephone encounters with assigned Patient Aligned Care Team (PACT)

    6 months prior to intervention and 6-months post intervention

  • Veterans' satisfaction with healthcare

    6 months prior to intervention and 6-months post intervention

  • Veterans' preferences for virtual care

    6 months prior to intervention and 6-months post intervention

  • +12 more secondary outcomes

Study Arms (2)

Receiving the optimized ADviSE Intervention

EXPERIMENTAL

6 months of selected text messages from a library developed and refined in previous study aims.

Behavioral: Clinician Coaching SessionsOther: Personalized text messages to patients

Control period

NO INTERVENTION

Usual care.

Interventions

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.

Receiving the optimized ADviSE Intervention

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.

Receiving the optimized ADviSE Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

RECRUITING

MeSH Terms

Conditions

BehaviorPatient PreferenceCommunicationPatient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth Behavior

Study Officials

  • Jeffrey T. Kullgren, MD MPH MS

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey T Kullgren, MD MPH MS

CONTACT

Nora A Metzger, BA MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped wedge cluster randomized controlled trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2024

First Posted

August 6, 2024

Study Start

April 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations