Health Care CostsADViSENCT06539988
Advancing Decisions About Virtual Service Encounters
A study testing Clinician Coaching Sessions and Personalized text messages to patients in people with Health Care Costs and Delivery of Health Care, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Care Costs, Delivery of Health Care
- What is being tested?
- Clinician Coaching Sessions and Personalized text messages to patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Veteran exclusion criteria are a CDW diagnosis of mild cognitive impairment, dementia, or a psychotic disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Fatima Makki, MPH MSW, 734-845-3623, fatima.makki@va.gov
Nicholas R Yankey, MPH MSW, (734) 222-8987, Nicholas.Yankey@va.gov
About this study
Official title: 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).
Read the 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.
- Conditions
- Health Care Costs, Delivery of Health Care
- Being tested
- Clinician Coaching Sessions, Personalized text messages to patients
- 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
- Medical subject headings
- Behavior, Patient Preference, Communication, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician Coaching SessionsBehavioural
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 patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Receiving the optimized ADviSE Intervention | Experimental | 6 months of selected text messages from a library developed and refined in previous study aims. Receives: Behavioral: Clinician Coaching Sessions; Other: Personalized text messages to patients |
| Control period | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans' perceptions of the value of their healthcare
Measured by survey at baseline and intervention end
Measured: 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)
Measured using Corporate Data Warehouse (CDW) data
Measured: 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
Measured: 6 months prior to intervention and 6-months post intervention
Telephone encounters with assigned Patient Aligned Care Team (PACT)
Measured using CDW data
Measured: 6 months prior to intervention and 6-months post intervention
Veterans' satisfaction with healthcare
Measured by survey at baseline and intervention end
Measured: 6 months prior to intervention and 6-months post intervention
Veterans' preferences for virtual care
Measured by survey at baseline and intervention end
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months prior to intervention and 6 months post intervention
Statin use among Veterans with diabetes
Electronic quality measure (eQM) measured using CDW data
Measured: 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
Measured: 6 months prior to intervention and 6 months post intervention
Breast cancer screening among female Veterans
Electronic quality measure (eQM) measured using CDW data
Measured: 6 months prior to intervention and 6 months post intervention
Cervical cancer screening among female Veterans
Electronic quality measure (eQM) measured using CDW data
Measured: 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
Measured: 6 months prior to intervention and 6 months post intervention
Flu vaccine receipt among Veterans
Electronic quality measure (eQM) measured using CDW data
Measured: 6 months prior to intervention and 6 months post intervention
Time costs for Veterans
Measured using CDW data
Measured: 6 months prior to intervention and 6 months post intervention
Travel costs for Veterans
Measured using CDW data
Measured: 6 months prior to intervention and 6 months post intervention
Copay costs for Veterans
Measured using CDW data
Measured: 6 months prior to intervention and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care CostsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey T. Kullgren, MD MPH MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539988
- Sponsor's protocol ID
- IIR 22-172
- Acronym
- ADViSE
- Status last verified
- Apr 2026
- First submitted
- 26 Jun 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Decisions About Virtual Service Encounters (ADViSE)
- ClinicalTrials.gov ID
- NCT06539988
- Acronym / sponsor ID
- ADViSE / IIR 22-172
- Conditions
- Health Care Costs, Delivery of Health Care
- Keywords
- Access, Behavior (patient), Behavior (provider), Rural Health, Patient preferences, Decision support, Telemedicine, Patient-centered Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Receiving the optimized ADviSE Intervention | Experimental | Behavioral: Clinician Coaching Sessions, Other: Personalized text messages to patients6 months of selected text messages from a library developed and refined in previous study aims. |
| Control period | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Veteran exclusion criteria are a CDW diagnosis of mild cognitive impairment, dementia, or a psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician Coaching SessionsPCPs will receive interactive coaching sessions from a Clinician Coach 2 months into the intervention period and again at 4 months into the intervention period. | Behavioural | Receiving the optimized ADviSE Intervention |
| Personalized text messages to patientsDrawing 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. | Other | Receiving the optimized ADviSE Intervention |
Primary outcome
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
17 secondary outcomes
VA Video Connect (VVC) encounters with assigned Patient Aligned Care Team (PACT)
Time frame: 6 months prior to intervention and 6-months post intervention
Face-to-Face (F2F) encounters with assigned Patient Aligned Care Team (PACT)
Time frame: 6 months prior to intervention and 6-months post intervention
Telephone encounters with assigned Patient Aligned Care Team (PACT)
Time frame: 6 months prior to intervention and 6-months post intervention
Veterans' satisfaction with healthcare
Time frame: 6 months prior to intervention and 6-months post intervention
Veterans' preferences for virtual care
Time frame: 6 months prior to intervention and 6-months post intervention
Total healthcare-associated costs for Veterans
Time frame: 6 months prior to intervention and 6 months post intervention
Hemoglobin A1c level <8% among Veterans with diabetes
Time frame: 6 months prior to intervention and 6 months post intervention
Blood pressure (BP) < 140/90 among Veterans with diabetes
Time frame: 6 months prior to intervention and 6 months post intervention
Statin use among Veterans with diabetes
Time frame: 6 months prior to intervention and 6 months post intervention
Statin use among Veterans with ischemic heart disease
Time frame: 6 months prior to intervention and 6 months post intervention
Breast cancer screening among female Veterans
Time frame: 6 months prior to intervention and 6 months post intervention
Cervical cancer screening among female Veterans
Time frame: 6 months prior to intervention and 6 months post intervention
Colon cancer screening among Veterans aged 45-75
Time frame: 6 months prior to intervention and 6 months post intervention
Flu vaccine receipt among Veterans
Time frame: 6 months prior to intervention and 6 months post intervention
Time costs for Veterans
Time frame: 6 months prior to intervention and 6 months post intervention
Travel costs for Veterans
Time frame: 6 months prior to intervention and 6 months post intervention
Copay costs for Veterans
Time frame: 6 months prior to intervention and 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey T. Kullgren, MD MPH MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician Coaching Sessions and Personalized text messages to patients in people with Health Care Costs and Delivery of Health Care, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey T Kullgren, MD MPH MS ((734) 845-5290, Jeffrey.Kullgren@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veterans' perceptions of the value of their healthcare (time frame: 6 months prior to intervention and 6-months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.