Clinical trial NCT04827381: Improving Patient and Caregiver Engagement by Sharing Annotated Audio-recorded Clinic Visits
Official title: Improving Patient and Caregiver Engagement Through the Application of Data Science Methods to Audio Recorded Clinic Visits Stored in Personal Health Libraries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Keywords: Patient recording
Personal health library
Patient communication
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2021-04-01
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-site, three-arm, parallel group, patient-randomized, blocked, controlled, pilot trial with two-week follow up
Primary purpose: OTHER

Brief summary: In this project, the investigators will conduct a three-arm patient-randomized pilot trial in older adults with multimorbidity in ambulatory care settings to determine the feasibility, usability, and acceptability of an audio-based PHL developed with older adults and caregivers, HealthPAL.

Detailed description: Providing digital recordings of clinical visits to patients has emerged as a new strategy to promote patient and family engagement in care. With advances in natural language processing, an opportunity exists to maximize the value of visit recordings for patients by automatically annotate key visit information (e.g., medications, tests \& imaging) with linkages to trustworthy online resources. These resources can be curated in an audio-based personal health library (PHL). In this project, the investigators will conduct a three-arm patient-randomized pilot trial in older adults with multimorbidity in ambulatory care settings to determine the feasibility, usability, and acceptability of an audio-based PHL developed with older adults and caregivers, HealthPAL. Participants in the intervention arms will receive access to an audio-based PHL with either 1) a clinic visit recording where key information is annotated and hyperlinks to trustworthy health information are provided (HealthPAL), 2) a clinic visit recording without annotations or hyperlinks, or 3) the third group of participants will receive usual care (control) with no recordings. Usability metrics and satisfaction will be assessed at two weeks. Preliminary data on the impact of HealthPAL on patient ability to seek, find and use health information with high confidence and patient activation, as well caregiver preparedness will also be gathered.

Eligibility criteria: Inclusion Criteria:

* (1) ≥ 65 years
* (2) with multimorbidity
* (3) plan on receiving ongoing care at the clinic for the subsequent month
* (4) access to internet.

The investigators will only include patients of clinicians (MDs, NPs) who (1) are based at the study clinic; (2) who treat adult patients.

Exclusion Criteria:

* (1) who have a six-item screener (SIS) of cognitive function score ≤ 4 and/or for those with a defined caregiver, whose proxy has not provided consent for the patient's participation
* (2) with schizophrenia, or other psychotic disorders, substance-abuse disorders, and with uncorrectable vision or hearing impairment
* (3) who reside in nursing homes, long-term care, skilled nursing, or hospice.

The investigators will exclude clinicians who (1) are trainees, e.g., medical students or residents; or (2) commonly audio or video record clinic visits for patient's personal use.

Primary outcomes:
measure: Participant retention (Feasibility)
timeFrame: Two weeks from baseline
measure: Listening rates (Acceptability)
timeFrame: Two weeks from baseline
measure: System Usability Scale (SUS)
timeFrame: Two weeks from baseline
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Two weeks from baseline
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Two weeks from baseline
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Two weeks from baseline
Secondary outcomes:
Other outcomes:
measure: Change in patient activation as reported by the Patient Activation Measure - Short Form (PAM-SF)
timeFrame: Baseline and two weeks from baseline
measure: Change in health literacy as measured by the eHealth Literacy Scale (eHEALS)
timeFrame: Baseline and two weeks from baseline
measure: Brief Health Literacy Scale (BHLS)
timeFrame: Baseline
measure: Patient Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Baseline
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: Change in Medical Outcomes Study General Adherence (MOSGA) score
timeFrame: Baseline and two weeks from baseline
measure: Change in refill and medication adherence as measured by the Adherence to Refills & Medications-7 (ARMS-7)
timeFrame: Baseline and two weeks from baseline
measure: Change in self-reported mental and physical health as measured by the GLOBAL Patient-Reported Outcomes Measurement Information System (PROMIS) 10
timeFrame: Baseline and two weeks from baseline
measure: Change preparedness as measured by the Preparedness for Caregiving Scale (PCS)
timeFrame: Baseline and two weeks from baseline
Locations:
city: Manchester
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Paul J Barr, PhD
role: PRINCIPAL_INVESTIGATOR
References: