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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG074959-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| The University of Texas Medical Branch, Galveston | OTHER |
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) |
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The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care; UC).
The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to AVS alone (Usual Care; UC). The specific aims are: Aim 1 Conduct a three-site trial in primary care where older patients with multimorbidity including diabetes (n=336) will be randomized to receive an audio recording as well as AVS (AUDIO) versus AVS alone (UC) for all scheduled clinic visits over 12 months; patients will be assessed at baseline, 1 week, 6 months and 12 months. Applicants hypothesize (Main Effect) that: compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management ability (Primary Outcome), with improved quality of life, medication adherence, and satisfaction (Secondary Outcomes) at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audio | Active Comparator | Researchers will audio record both in-person and telehealth visits of participants in the intervention group. |
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| Usual care | Placebo Comparator | Participants will receive Usual Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinic visit audio recordings for self-management in older adults | Other | The intervention is audio-recordings of primary care clinic visits that are shared with participating patients. All scheduled visits with study clinicians will be recorded and shared with patients randomized to the intervention group (AUDIO) for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measure-Short Form | The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation). | Patient activation at 12-months from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Refills and Medications-D (ARMS-D) | Eleven-item measure of medication adherence in diabetes. Two domains: i) Medication taking; and ii) medication refill. | Adherence at 12-months from enrollment |
| Global PROMIS 10 |
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Patients participants:
Inclusion Criteria:
Exclusion Criteria:
Clinician participants:
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul J Barr, PhD | Contact | 603 646 7016 | paul.j.barr@dartmouth.edu | |
| Susan M Tarczewski | Contact | 603 646 7066 | susan.m.tarczewski@dartmouth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul J Barr, PhD | Dartmouth College | Principal Investigator |
| Kerri L Cavanaugh, MD | Vanderbilit University Medical Center | Principal Investigator |
| Meredith C Masel, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcook Manchester | Recruiting | Manchester | New Hampshire | 03104 | United States |
Upon publication of results in peer-reviewed journals, access to the de-identified data for research purposes will be considered if a request is made by a qualified individual (i.e., a researcher from a research institute), IRB secured, and mutually agreed upon by the PIs. Any potential users of the data will sign an agreement that no attempt to reveal personal or private information may be made. The investigators will follow the Safe Harbour Methods outlined in the guidance regarding methods for de-identification of protected health information in accordance with the HIPAA Privacy Rule.
At the completion of data analysis
Contact PI to request data
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000073278 | Self-Management |
| D000375 | Aging |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D048788 | Growth and Development |
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| NIH |
Patients will be randomly allocated to AUDIO or UC alone using a block randomization technique with the clinician acting as the blocking variable; this strategy will ensure an equal number of patients per clinician will be randomly assigned to each study arm
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| Usual Care | Other | The Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution |
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Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.
| Global PROMIS 10 at 12 month from enrollment |
| Patient Satisfaction Questionnaire-18 | Patient Satisfaction Questionnaire-18 (PSQ-18) is a patient reported measure of satisfaction. It assesses seven sub-scales of satisfaction with care with scores ranging from 1 - 5 for each. We will use the two-item domain assessing general satisfaction. | Patient satisfaction at 12-months from enrollment |
| University Texas Medical Branch |
| Principal Investigator |
| Vanderbit University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| University of Texas Medical Branch | Recruiting | Galveston | Texas | 77555 | United States |
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| D010829 | Physiological Phenomena |