HypertensionOAANCT04452331
Assessing Open Access Audio
A study testing Open Access Audio, No Access, Patient and Provider Aware of Recording and No Access, Provider Unaware of Recording in people with Hypertension and Diabetes, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The medical encounter can be overwhelming in term of the amount of information discussed, its technical nature, and the anxiety it can generate. Easy access to a secure audio recording from any internet enabled device is an available low cost technology that allows patients to "revisit the visit" either alone or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes
- What is being tested?
- Open Access Audio, No Access, Patient and Provider Aware of Recording and No Access, Provider Unaware of Recording
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,553 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with scheduled appointments at the participating sites: primary care and diabetes clinics at Jesse Brown VA Medical Center and the Louis Stokes Cleveland VA Medical Center
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
About this study
Official title: An Assessment of Open Access Audio of the Clinical Encounter on Veterans and Their Care
The medical encounter can be overwhelming in term of the amount of information discussed, its technical nature, and the anxiety it can generate. Easy access to a secure audio recording from any internet enabled device is an available low cost technology that allows patients to "revisit the visit" either alone or sharing with caretakers and family. It has been introduced and tested outside the VA with evidence that it increases patient recall and understanding and may even improve physician performance. Little is known, however, about whether and to what extent these effects lead to better outcomes, such as improved treatment plan adherence and chronic disease self-management. This study is a randomized controlled trial designed ascertain whether easy access to audio recordings of the medical visit improves patients perception that they understand and can manage their own care, and leads to a variety of improved outcomes, such as better blood pressure and diabetes control, and fewer emergency department visits and hospitalizations.
Read the detailed description
The study aims to assess (1) the impact of an open access audio (OAA) program on two behaviors (patient activation, treatment plan adherence), and two chronic condition measures (glycosylated hemoglobin, blood pressure); (2) the impact of open access audio on provider communication and on their attention to patient contextual factors (i.e. individual Veteran's needs and circumstances relevant to planning effective care); and (3) patient, provider, and leadership perceptions of the extent to which the program is safe, not burdensome, and worthwhile at both the start and at two years into the program. A secondary analysis will descriptively measure the effect size of OAA on ED visits and hospital admissions.
- Conditions
- Hypertension, Diabetes
- Being tested
- Open Access Audio, No Access, Patient and Provider Aware of Recording, No Access, Provider Unaware of Recording
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Access AudioOther
Also called OAA
Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.
No Access, Patient and Provider Aware of RecordingOther
Also called OAA All Aware
Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
No Access, Provider Unaware of RecordingOther
Also called OAA Provider Unaware
Patient does not obtain access to audio recording and provider is unaware visit is being recorded.
| Study group | Role | What they receive |
|---|---|---|
| OAA Intervention | Experimental | Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Receives: Other: Open Access Audio |
| OAA Physician Aware Control | Sham comparator | Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit Receives: Other: No Access, Patient and Provider Aware of Recording |
| OAA Physician Unaware Control | Placebo comparator | Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit Receives: Other: No Access, Provider Unaware of Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
This outcome tests the hypothesis that blood pressure control improves in patients with blood pressure > 140/90 when they have access to an audio recording of their visit with their provider regarding blood pressure management compared to those who do not. An improvement in blood pressure is defined as a reduction of 10 or more mmHg in either the systolic or diastolic blood pressure.
Measured: 6 months
Glycosylated Hemoglobin (HgB A1c)
This outcome tests the hypothesis that HgB A1c improves in patients with Hgb A1c > 7 when they have access to an audio recording of their discussion with their provider regarding diabetes management compared to when they do no. An improvement is defined as a decrease of 1% or more.
Measured: 4-6 months
Return Visit Adherence (RVA)
This outcome tests the hypothesis that return visit adherence (RVA) improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider. The outcome is the predicted proportion of visits scheduled between the time of the index visit and the end of the study that the patient attends (adjusted for clinic). For example, a value of 0.73 means that, adjusted for clinic, a patient in the given arm attends 73% of visits scheduled between their index visit and the study end date.
Measured: From index visit to end of study data collection, an average of 512 days
Prescription Refill Rate (Probability That Proportion Days Covered >= 80%)
This outcome tests the hypothesis that prescription adherence improves in patients when they have access to an audio recording of their discussion with their provider compared to when they do not. Adherence is defined as having at least 80% proportion days covered (PDF). PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC<80% during the 6 months prior to the audio recorded visit. The outcome is the probability that a patient's PDC is at least 80% following their participation, adjusted for clinic.
Measured: 6 months
Patient Activation Measure (PAM)
This outcome tests the hypothesis that patient activation is higher in patients when they have access to an audio recording of their visit with their provider compared to when they do not. Patients are called by phone post visit to answer PAM 10, a 10 item questionnaire with a 5 point Likert response that scores their perceived knowledge, skills, and confident in their capacity to follow their treatment plan with scores from 0-100. A higher score indicates higher patient activation.
Measured: 2 weeks
SEGUE Framework for Evaluating and Scoring Communication Behavior.
This outcome tests the hypothesis that physicians communicate more effectively when they are aware the visit is being recorded for the patient to when they are not. Communication behavior will be rated off the audio recording by a research assistant utilizing the SEGUE checklist. Outcome measure is total proportion achieved score on 32 item SEGUE instrument, ranging from 0 to 1 with a higher score indicating more effective communication.
Measured: Recorded visit
Contextualization of Care
This outcome tests the hypothesis that physicians are more likely to contextualize the care plan when they are aware the visit is being recorded for the patient to when they are not. Contextualization of care will be rated off of the audio recording by a research assistant trained in Content Coding for Contextualization of Care (4C Coding), which determines each contextual red flag audible during the visit, whether the physician probed each red flag, each contextual factor identified by physician probe, and whether the physician addressed the contextual factor in the care plan. Outcome measure is the predicted probability of an encounter in which the care plan was contextualized (either the physician found no contextual factors present after investigating red flags, or physician found a contextual factor(s) and incorporated them into the plan), adjusted for clinic.
Measured: Recorded visit
Secondary outcomes (7)
Emergency Department Utilization
This outcome tests the hypothesis that emergency department visit rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of ED visits made by the patient in the 6 months following the audio recorded visit, adjusted for clinic.
Measured: 6 months
Hospital Admission Rate
This outcome tests the hypothesis that inpatient admission rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of inpatient hospital admissions of the patient (of any duration) during the 6 month period following the audio recorded visit.
Measured: 6 months
Glycated Hemoglobin (Access vs. Non-access)
Comparison of HgA1c among Arm 1 patients who did and did not access their visit recording
Measured: Six month
ED Visit Rate (Access vs. Non-access)
Comparison of ED visit rate among Arm 1 patients who did and did not access their visit recording. The ED visit rate is the number of emergency department visits in the 6 months following the patient's recorded visit, adjusted for clinic.
Measured: Six month
Return Visit Attendance (Access vs. Non-access)
Comparison of RVA among Arm 1 patients who did and did not access their visit recording. The outcome is the predicted proportion of visits scheduled between the time of the index visit and the end of the study that the patient attends (adjusted for clinic). For example, a value of 0.73 means that, adjusted for clinic, a patient in the given arm attends 73% of visits scheduled between their index visit and the study end date.
Measured: From recorded visit to study end date, an average of 512 days
Probability That Proportion of Days Covered by Prescription >= 80% (Access vs. Non-access)
Comparison of probability of prescription refill adherence (PDC>=80%) among Arm 1 patients who did and did not access their visit recording. Adherence is defined as having at least 80% proportion days covered (PDF). PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC<80% during the 6 months prior to the audio recorded visit. The outcome is the probability that a patient's PDC is at least 80% following their participation, adjusted for clinic.
Measured: 6 months
Blood Pressure (Access vs. Non-access)
Comparison of blood pressure among Arm 1 patients who did and did not access their visit recording
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start5 Oct 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies 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
- Parallel groups
- Model description
- The setting will be primary care and diabetes clinics, at two facilities for generalizability. To achieve aims 1 and 2, the investigators plan a randomized controlled three arm design: (1) the encounter is recorded, with provider and patient aware, and uploaded to a server the Veteran, provider, and research team can access post visit; (2) the encounter is recorded, with both parties aware, and uploaded to a server only the research team can access; and (3) the encounter is recorded, with only the patient aware, and uploaded to a server only the research team can access. Resource utilization and disease measures indicated in aims 1 and 2 will be collected in all arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,553 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Saul J. Weiner, MD, Principal investigator, Jesse Brown VA Medical Center, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452331
- Sponsor's protocol ID
- IIR 19-068
- Acronym
- OAA
- Status last verified
- Mar 2025
- First submitted
- 25 Jun 2020
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Open Access Audio of the Clinical Encounter on Veterans and Their Care
- ClinicalTrials.gov ID
- NCT04452331
- Acronym / sponsor ID
- OAA / IIR 19-068
- Conditions
- Hypertension, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,553 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The medical encounter can be overwhelming in term of the amount of information discussed, its technical nature, and the anxiety it can generate. Easy access to a secure audio recording from any internet enabled device is an available low cost technology that allows patients to "revisit the visit" either alone or sharing with caretakers and family. It has been introduced and tested outside the VA with evidence that it increases patient recall and understanding and may even improve physician performance. Little is known, however, about whether and to what extent these effects lead to better outcomes, such as improved treatment plan adherence and chronic disease self-management. This study is a randomized controlled trial designed ascertain whether easy access to audio recordings of the medical visit improves patients perception that they understand and can manage their own care, and leads to a variety of improved outcomes, such as better blood pressure and diabetes control, and fewer emergency department visits and hospitalizations.
Detailed description
The study aims to assess (1) the impact of an open access audio (OAA) program on two behaviors (patient activation, treatment plan adherence), and two chronic condition measures (glycosylated hemoglobin, blood pressure); (2) the impact of open access audio on provider communication and on their attention to patient contextual factors (i.e. individual Veteran's needs and circumstances relevant to planning effective care); and (3) patient, provider, and leadership perceptions of the extent to which the program is safe, not burdensome, and worthwhile at both the start and at two years into the program. A secondary analysis will descriptively measure the effect size of OAA on ED visits and hospital admissions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The setting will be primary care and diabetes clinics, at two facilities for generalizability. To achieve aims 1 and 2, the investigators plan a randomized controlled three arm design: (1) the encounter is recorded, with provider and patient aware, and uploaded to a server the Veteran, provider, and research team can access post visit; (2) the encounter is recorded, with both parties aware, and uploaded to a server only the research team can access; and (3) the encounter is recorded, with only the patient aware, and uploaded to a server only the research team can access. Resource utilization and disease measures indicated in aims 1 and 2 will be collected in all arms.
| Arm | Type | Receives |
|---|---|---|
| OAA Intervention | Experimental | Other: Open Access AudioVisit recorded, both patient and provider aware, both patient and provider have access to audio post-visit |
| OAA Physician Aware Control | Sham comparator | Other: No Access, Patient and Provider Aware of RecordingVisit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit |
| OAA Physician Unaware Control | Placebo comparator | Other: No Access, Provider Unaware of RecordingVisit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with scheduled appointments at the participating sites: primary care and diabetes clinics at Jesse Brown VA Medical Center and the Louis Stokes Cleveland VA Medical Center
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Open Access AudioAlso: OAAPatient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device. | Other | OAA Intervention |
| No Access, Patient and Provider Aware of RecordingAlso: OAA All AwarePatient does not obtain access to audio recording but both patient and provider are aware visit is being recorded. | Other | OAA Physician Aware Control |
| No Access, Provider Unaware of RecordingAlso: OAA Provider UnawarePatient does not obtain access to audio recording and provider is unaware visit is being recorded. | Other | OAA Physician Unaware Control |
Primary outcome
Blood Pressure
Time frame: 6 months
This outcome tests the hypothesis that blood pressure control improves in patients with blood pressure > 140/90 when they have access to an audio recording of their visit with their provider regarding blood pressure management compared to those who do not. An improvement in blood pressure is defined as a reduction of 10 or more mmHg in either the systolic or diastolic blood pressure.
Glycosylated Hemoglobin (HgB A1c)
Time frame: 4-6 months
This outcome tests the hypothesis that HgB A1c improves in patients with Hgb A1c > 7 when they have access to an audio recording of their discussion with their provider regarding diabetes management compared to when they do no. An improvement is defined as a decrease of 1% or more.
Return Visit Adherence (RVA)
Time frame: From index visit to end of study data collection, an average of 512 days
This outcome tests the hypothesis that return visit adherence (RVA) improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider. The outcome is the predicted proportion of visits scheduled between the time of the index visit and the end of the study that the patient attends (adjusted for clinic). For example, a value of 0.73 means that, adjusted for clinic, a patient in the given arm attends 73% of visits scheduled between their index visit and the study end date.
Prescription Refill Rate (Probability That Proportion Days Covered >= 80%)
Time frame: 6 months
This outcome tests the hypothesis that prescription adherence improves in patients when they have access to an audio recording of their discussion with their provider compared to when they do not. Adherence is defined as having at least 80% proportion days covered (PDF). PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC<80% during the 6 months prior to the audio recorded visit. The outcome is the probability that a patient's PDC is at least 80% following their participation, adjusted for clinic.
Patient Activation Measure (PAM)
Time frame: 2 weeks
This outcome tests the hypothesis that patient activation is higher in patients when they have access to an audio recording of their visit with their provider compared to when they do not. Patients are called by phone post visit to answer PAM 10, a 10 item questionnaire with a 5 point Likert response that scores their perceived knowledge, skills, and confident in their capacity to follow their treatment plan with scores from 0-100. A higher score indicates higher patient activation.
SEGUE Framework for Evaluating and Scoring Communication Behavior.
Time frame: Recorded visit
This outcome tests the hypothesis that physicians communicate more effectively when they are aware the visit is being recorded for the patient to when they are not. Communication behavior will be rated off the audio recording by a research assistant utilizing the SEGUE checklist. Outcome measure is total proportion achieved score on 32 item SEGUE instrument, ranging from 0 to 1 with a higher score indicating more effective communication.
Contextualization of Care
Time frame: Recorded visit
This outcome tests the hypothesis that physicians are more likely to contextualize the care plan when they are aware the visit is being recorded for the patient to when they are not. Contextualization of care will be rated off of the audio recording by a research assistant trained in Content Coding for Contextualization of Care (4C Coding), which determines each contextual red flag audible during the visit, whether the physician probed each red flag, each contextual factor identified by physician probe, and whether the physician addressed the contextual factor in the care plan. Outcome measure is the predicted probability of an encounter in which the care plan was contextualized (either the physician found no contextual factors present after investigating red flags, or physician found a contextual factor(s) and incorporated them into the plan), adjusted for clinic.
7 secondary outcomes
Emergency Department Utilization
Time frame: 6 months
Hospital Admission Rate
Time frame: 6 months
Glycated Hemoglobin (Access vs. Non-access)
Time frame: Six month
ED Visit Rate (Access vs. Non-access)
Time frame: Six month
Return Visit Attendance (Access vs. Non-access)
Time frame: From recorded visit to study end date, an average of 512 days
Probability That Proportion of Days Covered by Prescription >= 80% (Access vs. Non-access)
Time frame: 6 months
Blood Pressure (Access vs. Non-access)
Time frame: Six month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Saul J. Weiner, MD principal investigator
Jesse Brown VA Medical Center, Chicago, IL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Access Audio, No Access, Patient and Provider Aware of Recording and No Access, Provider Unaware of Recording in people with Hypertension and Diabetes, run by VA Office of Research and Development at 2 sites 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 1 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: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 6 months). The study lists 7 primary outcomes in all. 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 3 Apr 2025.