Clinical trial NCT06539988: Advancing Decisions About Virtual Service Encounters
Official title: Advancing Decisions About Virtual Service Encounters (ADViSE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Care Costs
Delivery of Health Care
Keywords: Access
Behavior (patient)
Behavior (provider)
Rural Health
Patient preferences
Decision support
Telemedicine
Patient-centered Care
Communication (doctor-patient)
Cost
Patient outcomes
Primary care
Satisfaction (patient)
Virtual care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-08-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge cluster randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Veterans' perceptions of the value of their healthcare
timeFrame: 6 months prior to intervention and 6-months post intervention
Secondary outcomes:
measure: VA Video Connect (VVC) encounters with assigned Patient Aligned Care Team (PACT)
timeFrame: 6 months prior to intervention and 6-months post intervention
measure: Face-to-Face (F2F) encounters with assigned Patient Aligned Care Team (PACT)
timeFrame: 6 months prior to intervention and 6-months post intervention
measure: Telephone encounters with assigned Patient Aligned Care Team (PACT)
timeFrame: 6 months prior to intervention and 6-months post intervention
measure: Veterans' satisfaction with healthcare
timeFrame: 6 months prior to intervention and 6-months post intervention
measure: Veterans' preferences for virtual care
timeFrame: 6 months prior to intervention and 6-months post intervention
measure: Total healthcare-associated costs for Veterans
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Hemoglobin A1c level <8% among Veterans with diabetes
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Blood pressure (BP) < 140/90 among Veterans with diabetes
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Statin use among Veterans with diabetes
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Statin use among Veterans with ischemic heart disease
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Breast cancer screening among female Veterans
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Cervical cancer screening among female Veterans
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Colon cancer screening among Veterans aged 45-75
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Flu vaccine receipt among Veterans
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Time costs for Veterans
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Travel costs for Veterans
timeFrame: 6 months prior to intervention and 6 months post intervention
measure: Copay costs for Veterans
timeFrame: 6 months prior to intervention and 6 months post intervention
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Jeffrey T. Kullgren, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References: