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Completed

NCT Number: NCT04827381

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

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.

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Key information

Conditions

Multimorbidity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Manchester, New Hampshire, 03104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Participant retention (Feasibility)

    Time frame: Two weeks from baseline

    The proportion of included participants completing the two-week (T1) follow up assessment.

  2. Listening rates (Acceptability)

    Time frame: Two weeks from baseline

    The proportion of patients who listen to their recordings.

  3. System Usability Scale (SUS)

    Time frame: Two weeks from baseline

    10-item PROM. A score ≥68 points (0-100) indicates above average usability

  4. Acceptability of Intervention Measure (AIM)

    Time frame: Two weeks from baseline

    Four-item PROM assessing acceptability of intervention. Higher score indicates higher acceptability of the intervention.

  5. Intervention Appropriateness Measure (IAM)

    Time frame: Two weeks from baseline

    Four-item PROM assessing feasibility of intervention. Higher score indicates greater appropriateness of the intervention.

  6. Feasibility of Intervention Measure (FIM)

    Time frame: Two weeks from baseline

    Four-item PROM assessing feasibility of intervention. Higher score indicates higher feasibility of the intervention.

Other outcomes

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

    Time frame: Baseline and two weeks from baseline

    13-item Patient Reported Outcome Measure. Four domains: Patient: i) recognizes their role; ii) has knowledge and confidence; iii) takes steps to manage care; and iv) can manage care under stress. PAM-SF scores range from 0-100, higher scores indicates greater activation.

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

    Time frame: Baseline and two weeks from baseline

    Eight-item PROM assessing ability to seek, find, use and assess the quality of online health. Scores on eHEALS range between 8 and 40 with higher scores indicating greater subjective health literacy.

    information.

  3. Brief Health Literacy Scale (BHLS)

    Time frame: Baseline

    Three item PROM to assess patient's confidence and ability to understand medical information. Scores on the BHLS range between 3 and 15, with higher scores indicating higher subjective health literacy.

  4. Patient Health Questionnaire Depression Scale (PHQ-8)

    Time frame: Baseline

    Eight item PROM depression scale. Scores are based on a 4-level scale with 0 indicating "Not at all" and 3 indicating "Nearly every day". PHQ-8 scores range from 0 - 24. Higher scores indicate higher levels of depression.

  5. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline

    Seven item PROM of anxiety. Scores are based on a 4-level scale with 0 indicating "Not at all" and 3 indicating "Nearly every day". GAD-7 scores range from 0 - 21. Higher scores indicate higher levels of anxiety.

  6. Change in Medical Outcomes Study General Adherence (MOSGA) score

    Time frame: Baseline and two weeks from baseline

    Five-item PROM of patient adherence to treatment. Scores are measured on a 5-item, 6-level scale, with a score of 1 indicating "None of the time" and a score of 6 indicating "All of the time". Scores range from 6 to 30, with higher scores indicating higher levels of adherence. Items 1 and 3 are scored in reverse.

  7. Change in refill and medication adherence as measured by the Adherence to Refills & Medications-7 (ARMS-7)

    Time frame: Baseline and two weeks from baseline

    Seven-item PROM of medication adherence. Scores are measured on a 7-item, 4-level scale, with a score of 1 indicating "None" and a score of 4 indicating "All". Scores range from 7 to 28, with lower scores indicating higher levels of adherence.

  8. Change in self-reported mental and physical health as measured by the GLOBAL Patient-Reported Outcomes Measurement Information System (PROMIS) 10

    Time frame: Baseline and two weeks from baseline

    The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score.

  9. Change preparedness as measured by the Preparedness for Caregiving Scale (PCS)

    Time frame: Baseline and two weeks from baseline

    Nine-item PROM measuring Caregiver confidence. Scores are based on a 9-item, 5-level scale, with 0 indicating not at all prepared, and 4 indicating very well prepared. Scores range from 0 to 45, with higher scores indicating higher levels of preparedness.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Library of Medicine (NLM)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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