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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
336
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.
The Usual Care arm participants will receive After Visit Summaries (AVS) per the standard delivery at each institution
Dartmouth-Hitchcook Manchester
Manchester, New Hampshire, United States
RECRUITINGVanderbit University Medical Center
Nashville, Tennessee, United States
RECRUITINGUniversity of Texas Medical Branch
Galveston, Texas, United States
RECRUITINGPatient 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).
Time frame: Patient activation at 12-months from enrollment
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.
Time frame: Adherence at 12-months from enrollment
Global PROMIS 10
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.
Time frame: 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.
Time frame: Patient satisfaction at 12-months from enrollment
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