Clinical trial NCT04344301: The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults
Official title: The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults: a Multi-site Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Keywords: Audio recording
Diabetes Mellitus
Hypertension
Patient-centered communication
Self-management
Older adults
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: The University of Texas Medical Branch, Galveston
name: Vanderbilt University Medical Center
name: Dartmouth College
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2020-04-14
Enrollment: 91
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with a 3-month follow up in older adults (≥65 years) with diabetes and hypertension. Participants will be randomized to receive AUDIO recordings of their clinic visits (AUDIO) in addition to After Visit Summary (AVS), or their AVS alone (Usual Care (UC). The investigators will recruit 90 adults (30 per site) over the targeted recruitment period of approximately 6 months. The primary outcome of interest is the feasibility of the trial and acceptability of the AUDIO intervention. The investigators will also explore the impact of AUDIO on patients' ability to self-manage care (as well as other exploratory health-related outcomes and healthcare utilization) at regular intervals from enrollment (T1 = 1 week, T2 = 3 months) compared to baseline (T0 = pre-visit) and usual care. The investigators will recruit patients from consented clinicians at three sites: Dartmouth-Hitchcock Primary Care (D-H; Manchester, NH), Vanderbilt University Medical Center (VUMC; Nashville, TN), and University of Texas Medical Branch, (UTMB; Galveston, TX).

Detailed description: Up to eighty percent of clinic visit information is forgotten by patients immediately post-visit. This is a significant barrier to self-management, especially in older adults with multimorbidity leading to poor health outcomes. After visit summaries (AVS) can improve recall, yet concerns exist about their layout, accuracy and low patient uptake. Patients and clinicians have begun audio recording clinic visits. When patients receive an audio recording of the visit, 71% listen and 68% share it with a caregiver, resulting in greater recall. Despite its growing use, to date, there is no research on the impact of recording and sharing clinic visits of patient self-management ability, health-related outcomes or healthcare utilization. The objective of this proposal is to conduct a multi-site pilot trial evaluating the feasibility and acceptability of routinely sharing audio recordings of clinic visits (AUDIO) in older adults (≥65 years) with diabetes and hypertension.

Conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with 3-month follow up, to determine the feasibility and acceptability of sharing audio recordings of clinic visits (AUDIO) on self-management in older adults with diabetes and hypertension, compared to the after visit written summary (AVS) alone (Usual Care). Investigators will determine:

1.1 Feasibility of a larger trial by meeting recruitment targets at each site (n=30 per site; total n=90) and determining the optimal strategy to achieve a high retention rate and adherence to the study protocol.

1.2 Acceptability by assessing the proportion of patients and clinicians who agree to take part in the project and the proportion of patients who listen to the recording.

1.3 Potential effectiveness by collecting data on the impact of audio recordings on self-management, health-related outcomes, healthcare utilization, and clinician behavior. Investigators hypothesize that compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management activation (Patient Activation Measure - Short Form) at 3 months. Investigators will also explore whether the effect of AUDIO on self-management activation compared to UC is greater for patients with low health literacy than those with high health literacy.

Eligibility criteria: Aim 1 Inclusion Criteria

* Age 65 years or older
* Diagnosed with diabetes mellitus (Type 1 or 2) and hypertension, and receiving medication for both
* Are patients of clinicians at the study clinic
* Have had one or more clinic visits in the previous seven months
* Plan on receiving care at the study clinic for the next six months

Exclusion Criteria

* Without the capacity to provide informed consent
* Diagnosis of dementia
* Diagnosis of schizophrenia and other psychotic disorders
* Current substance-abuse use disorder
* Diagnosis of an uncorrectable hearing or visual impairment
* Six item screener of cognitive function score 4 or less
* Living in a skilled nursing home or hospice
* Have audio-recorded a clinic visit for personal use within the past six months
* Do not have a personal email, do not have an email address shared with a family member or patient-identified caregiver, and/or are not willing to create an email account between the first contact from the study team and the initiation of online recording software registration

Primary outcomes:
measure: Participant Retention (Feasibility)
timeFrame: 3 months from baseline
measure: Intervention Fidelity (Feasibility)
timeFrame: 3 months from baseline
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 3 months from baseline
measure: Participant Recruitment Rate (Acceptability)
timeFrame: Baseline
measure: Intervention Use (Acceptability)
timeFrame: 3 months from baseline
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 3 months from baseline
Secondary outcomes:
Other outcomes:
measure: Patient Activation Measure-Short Form (PAM-SF)
timeFrame: 3-Months from enrollment
measure: Interpersonal Processes of Care Scale (IPC)
timeFrame: 1-Week from baseline visit
measure: Patient Satisfaction Questionnaire-18 (PSQ-18)
timeFrame: Baseline,1-Week, and 3-Months from enrollment
measure: Medical Outcomes Study General Adherence Measure
timeFrame: 3-Months from enrollment
measure: Adherence to Refills and Medications (ARMS- 7)
timeFrame: 3-Months from enrollment
measure: Global PROMIS-10
timeFrame: 3-Months from enrollment
measure: EURO-QoL (EQ-5D)
timeFrame: Baseline,1-Week, and 3-Months from enrollment
measure: Primary Care Contact, ER Visits & Hospitalization
timeFrame: 3-Months from enrollment
measure: Quality of Diabetes and Hypertension Care
timeFrame: 3-Months from enrollment
measure: Patient Health Questionnaire (PHQ- 8)
timeFrame: Baseline,1-Week, and 3-Months from enrollment
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 3-Months from enrollment
measure: Comprehensive Diabetes Stigma Scale (CDSS-15)
timeFrame: Baseline,1-Week, and 3-Months from enrollment
measure: Stigma Scale for Chronic Illness (SSCI-8)
timeFrame: Baseline,1-Week, and 3-Months from enrollment
Locations:
city: Manchester
country: United States
facility: Dartmouth-Hitchcock Manchester
state: New Hampshire
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Dartmouth College
name: Paul J Barr, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilit University Medical Center
name: Kerri L Cavanaugh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Texas Medical Branch
name: Meredith C Masel, PhD
role: PRINCIPAL_INVESTIGATOR
References: