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

NCT04827381 | Completed

• 3 other identifiers: D2105002000763R01LM012815
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Multimorbidity

Keywords

Patient recording; Personal health library; Patient communication

Outcome Measures

Primary Outcomes (6)

• 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

Other Outcomes (9)

• Change in patient activation as reported by the Patient Activation Measure - Short Form (PAM-SF)

  Baseline and two weeks from baseline

• Change in health literacy as measured by the eHealth Literacy Scale (eHEALS)

  Baseline and two weeks from baseline

• Brief Health Literacy Scale (BHLS)

  Baseline

Study Arms (3)

Usual care

NO INTERVENTION

Patients visiting their clinician will receive the normal, written after-visit-summary (available on paper or via the patient portal).

Annotated Audio

EXPERIMENTAL

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

Audio

EXPERIMENTAL

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

Interventions

Annotated Audio OTHER

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.

Annotated Audio

Audio OTHER

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.

Audio

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Library of Medicine (NLM): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Manchester, New Hampshire, 03104, United States

Location

Study Officials

• Paul J Barr, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, The Dartmouth Institute for Health Policy & Clinical Practice Geisel School of Medicine at Dartmouth

Model Details: Single-site, three-arm, parallel group, patient-randomized, blocked, controlled, pilot trial with two-week follow up

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: April 15, 2021
• Primary Completion: December 27, 2021
• Study Completion: February 4, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)