Assessing Open Access Audio

Not Applicable

Completed

Conditions: Hypertension
Diabetes

Interventions: Other: No Access, Provider Unaware of Recording
Other: Open Access Audio
Other: No Access, Patient and Provider Aware of Recording

Registration Number: NCT04452331

Lead Sponsor: VA Office of Research and Development

Brief 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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1553

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OAA Physician Unaware Control	No Access, Provider Unaware of Recording	Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit
OAA Intervention	Open Access Audio	Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit
OAA Physician Aware Control	No Access, Patient and Provider Aware of Recording	Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit

Primary Outcome Measures

Name	Time	Method
Blood Pressure	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)	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)	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.
Patient Activation Measure (PAM)	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.
Prescription Refill Rate (Probability That Proportion Days Covered >= 80%)	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.
SEGUE Framework for Evaluating and Scoring Communication Behavior.	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	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.

Secondary Outcome Measures

Name	Time	Method
Emergency Department Utilization	6 months	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.
Hospital Admission Rate	6 months	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.
Glycated Hemoglobin (Access vs. Non-access)	Six month	Comparison of HgA1c among Arm 1 patients who did and did not access their visit recording
ED Visit Rate (Access vs. Non-access)	Six month	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.
Return Visit Attendance (Access vs. Non-access)	From recorded visit to study end date, an average of 512 days	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.
Blood Pressure (Access vs. Non-access)	Six month	Comparison of blood pressure among Arm 1 patients who did and did not access their visit recording
Probability That Proportion of Days Covered by Prescription >= 80% (Access vs. Non-access)	6 months	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.

Trial Locations

Locations (2): Jesse Brown VA Medical Center, Chicago, IL
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Chicago, Illinois, United States
Louis Stokes VA Medical Center, Cleveland, OH
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Cleveland, Ohio, United States