N/A
N=1,553
Assessing Open Access Audio
Hypertension · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04452331 ↗Enrolled (actual)
1,553
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Blood Pressure — 131.6; 131.8; 78.2; 79.5 mmHg — p=0.06
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Open Access Audio (Other); No Access, Patient and Provider Aware of Recording (Other); No Access, Provider Unaware of Recording (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure |
131.6; 131.8; 78.2; 79.5 | 0.06 |
| PRIMARY Glycosylated Hemoglobin (HgB A1c) |
6.95; 6.83 | — |
| PRIMARY Return Visit Adherence (RVA) |
0.733; 0.732 | .29 |
| PRIMARY Prescription Refill Rate (Probability That Proportion Days Covered >= 80%) |
0.05; 0.04 | .10 |
| PRIMARY Patient Activation Measure (PAM) |
9.44; 9.54 | 0.44 |
| PRIMARY SEGUE Framework for Evaluating and Scoring Communication Behavior. |
0.85; 0.82 | 0.01 sig |
| PRIMARY Contextualization of Care |
0.51; 0.41 | 0.01 sig |
| SECONDARY Emergency Department Utilization |
1.03; 0.96 | 0.54 |
| SECONDARY Hospital Admission Rate |
0.26; 0.28 | 0.74 |
| SECONDARY Glycated Hemoglobin (Access vs. Non-access) |
6.53; 6.95; 6.73 | 0.03 sig |
| SECONDARY ED Visit Rate (Access vs. Non-access) |
0.69; 1.05; 0.93 | <0.001 sig |
| SECONDARY Return Visit Attendance (Access vs. Non-access) |
0.78; 0.71; 0.73 | <0.001 sig |
| SECONDARY Probability That Proportion of Days Covered by Prescription >= 80% (Access vs. Non-access) |
0.09; 0.04; 0.05 | <.001 sig |
| SECONDARY Blood Pressure (Access vs. Non-access) |
130.7; 133.0; 132.7; 78.0; 79.5; 80.5 | 0.20 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04452331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.