Improving Patient and Caregiver Engagement by Sharing Annotated Audio-recorded Clinic Visits

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Patient and Caregiver Engagement Through the Application of Data Science Methods to Audio Recorded Clinic Visits Stored in Personal Health Libraries

Conditions
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Multimorbidity

Intervention / Treatment
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* Other: Annotated Audio
* Other: Audio


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-site, three-arm, parallel group, patient-randomized, blocked, controlled, pilot trial with two-week follow up
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Patients visiting their clinician will receive the normal, written after-visit-summary (available on paper or via the patient portal). | |
| Experimental: Annotated Audio<br>In addition to usual care, patients will be given access to an annotated audio-based PHL, HealthPal to listen to outside of the clinic. HealthPAL will allow participants to replay the audio recording of their clinic visit which will be annotated with key information discussed (e.g., medications). The recording will also contain hyperlinks related to annotations, that will direct participants to the online health information resource at Medline Plus. Access to their HealthPAL can also be shared with a caregiver. | Other: Annotated Audio<br>* In addition to usual care, patients will be given access to an annotated audio-based PHL, HealthPal to listen to outside of the clinic. HealthPAL will allow participants to replay the audio recording of their clinic visit which will be annotated with key information discussed (e.g., medications). The recording will also contain hyperlinks related to annotations, that will direct participants to the online health information resource at Medline Plus. Access to their HealthPAL can also be shared with a caregiver.<br>|
| Experimental: Audio<br>In addition to usual care, patients will also be given access to an audio-based PHL, HealthPal to listen to outside of the clinic. HealthPAL will allow participants to replay the audio recording of their clinic visit (no annotations or hyperlinks). Access to their HealthPAL can also be shared with a caregiver. | Other: Audio<br>* In addition to usual care, patients will also be given access to an audio-based PHL, HealthPal to listen to outside of the clinic. HealthPAL will allow participants to replay the audio recording of their clinic visit (no annotations or hyperlinks). Access to their HealthPAL can also be shared with a caregiver.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant retention (Feasibility) | The proportion of included participants completing the two-week (T1) follow up assessment. | Two weeks from baseline | 
| Listening rates (Acceptability) | The proportion of patients who listen to their recordings. | Two weeks from baseline | 
| System Usability Scale (SUS) | 10-item PROM. A score ≥68 points (0-100) indicates above average usability | Two weeks from baseline | 
| Acceptability of Intervention Measure (AIM) | Four-item PROM assessing acceptability of intervention. Higher score indicates higher acceptability of the intervention. | Two weeks from baseline | 
| Intervention Appropriateness Measure (IAM) | Four-item PROM assessing feasibility of intervention. Higher score indicates greater appropriateness of the intervention. | Two weeks from baseline | 
| Feasibility of Intervention Measure (FIM) | Four-item PROM assessing feasibility of intervention. Higher score indicates higher feasibility of the intervention. | Two weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient recording, Personal health library, Patient communication