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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OAA Intervention | Experimental | Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit |
|
| OAA Physician Aware Control | Sham Comparator | Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit |
|
| OAA Physician Unaware Control | Placebo Comparator | Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Access Audio | Other | Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saul J. Weiner, MD | Jesse Brown VA Medical Center, Chicago, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States | ||
| Louis Stokes VA Medical Center, Cleveland, OH |
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Although providers are also engaged as part of the intervention, all trial enrollment, randomization, assignment, and analysis is by patient visit. It is only the patient's assignment that affects which study arm a visit with a provider falls into. Accordingly, providers are not considered "participants enrolled" for purposes of study result reporting.
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| ID | Title | Description |
|---|---|---|
| FG000 | OAA Intervention | Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device. |
| FG001 | OAA Physician Aware Control | Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded. |
| FG002 | OAA Physician Unaware Control | Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit No Access, Provider Unaware of Recording: Patient does not obtain access to audio recording and provider is unaware visit is being recorded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OAA Intervention | Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mmHg | 6 months |
|
At recorded trial visit only
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OAA Intervention | Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit Open Access Audio: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan Schwartz | University of Illinois Chicago | 3129962070 | alansz@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2022 | Dec 19, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2022 | Aug 7, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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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.
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Arm 1 is the intervention, with both provider and patient aware of the recording. It is designed to represent how OAA would be utilized in actual practice. In Arm 2 all parties are also aware of the audio recording, but this time neither gets access to the audio after the visit (although the research team does). Arm 2 is a control for isolating the effect of patient access after the visit to the audio in Arm 1. Both patient and physician are blind to whether they are in Arm 1 or 2 until after the visit. Arm 3 is a second kind of control, as the audio is again not shared with the patient. In this arm, however, the patient conceals the audio recorder, so that the provider is unaware they are being audio recorded until after the visit.
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| No Access, Patient and Provider Aware of Recording | Other | Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded. |
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| No Access, Provider Unaware of Recording | Other | Patient does not obtain access to audio recording and provider is unaware visit is being recorded. |
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| 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. | 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. | 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. | Recorded visit |
| 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. | 6 months |
| Glycated Hemoglobin (Access vs. Non-access) | Comparison of HgA1c among Arm 1 patients who did and did not access their visit recording | 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. | 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. | 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. | 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 | Six month |
| Cleveland |
| Ohio |
| 44106-1702 |
| United States |
| OAA Physician Aware Control |
Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded. |
| BG002 | OAA Physician Unaware Control | Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit No Access, Provider Unaware of Recording: Patient does not obtain access to audio recording and provider is unaware visit is being recorded. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Clinical setting | Count of Participants | Participants |
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Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded. |
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | percent | 4-6 months |
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| Primary | 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. | Posted | Number | 95% Confidence Interval | Proportion of future visits attended | From index visit to end of study data collection, an average of 512 days | scheduled visits | scheduled visits |
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| Primary | 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. | Posted | Number | 95% Confidence Interval | Probability of >=80% PDC | 6 months |
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| Primary | 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. | Random samples from arms 1 and 2 | Posted | Mean | 95% Confidence Interval | score on a scale | 2 weeks |
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| Primary | 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. | Arm 2 random subsample compared with Arm 3, excluding visits with no recordings due to recorder failure. | Posted | Mean | 95% Confidence Interval | score on a scale | Recorded visit |
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| Primary | 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. | Arm 2 random subsample vs. Arm 3, excluding visits with recorder failure or on phone | Posted | Number | 95% Confidence Interval | Predicted probability of contextual plan | Recorded visit |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | ED visits | 6 months |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Hospital admissions | 6 months |
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| Secondary | Glycated Hemoglobin (Access vs. Non-access) | Comparison of HgA1c among Arm 1 patients who did and did not access their visit recording | Posted | Mean | 95% Confidence Interval | percent | Six month |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | ED visits | Six month |
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| Secondary | 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. | Patients in OAA intervention arm (accessed and not access) exclude 11 patients who did not have the opportunity to access a recording due to recorder failure. | Posted | Number | 95% Confidence Interval | Proportion of return visits attended | From recorded visit to study end date, an average of 512 days |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | Probability of at least 80% PDC | 6 months |
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| Secondary | Blood Pressure (Access vs. Non-access) | Comparison of blood pressure among Arm 1 patients who did and did not access their visit recording | Posted | Mean | 95% Confidence Interval | mmHg | Six month |
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| 0 |
| 691 |
| 0 |
| 691 |
| 0 |
| 691 |
| EG001 | OAA Physician Aware Control | Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit No Access, Patient and Provider Aware of Recording: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded. | 0 | 694 | 0 | 694 | 0 | 694 |
| EG002 | OAA Physician Unaware Control | Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit No Access, Provider Unaware of Recording: Patient does not obtain access to audio recording and provider is unaware visit is being recorded. | 0 | 168 | 0 | 168 | 0 | 168 |
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Superiority |
| Superiority |
| Superiority |
Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.
| 0.98 |
| Superiority |
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| 0.82 |
| Superiority |
| Diastolic BP | Regression, Linear | 0.12 | Superiority |
| Diastolic BP | Regression, Linear | 0.10 | Superiority |