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

Multimorbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827381
• Other study ID #: D21050
• Secondary ID: 02000763R01LM012
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: February 4, 2022

Study information

• Verified date: February 2022
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 4, 2022
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multimorbidity

Intervention

Other:
• Annotated Audio
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
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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Manchester	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in patient activation as reported by the Patient Activation Measure - Short Form (PAM-SF)	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.	Baseline and two weeks from baseline
Other	Change in health literacy as measured by the eHealth Literacy Scale (eHEALS)	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.	Baseline and two weeks from baseline
Other	Brief Health Literacy Scale (BHLS)	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.	Baseline
Other	Patient Health Questionnaire Depression Scale (PHQ-8)	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.	Baseline
Other	Generalized Anxiety Disorder-7 (GAD-7)	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.	Baseline
Other	Change in Medical Outcomes Study General Adherence (MOSGA) score	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.	Baseline and two weeks from baseline
Other	Change in refill and medication adherence as measured by the Adherence to Refills & Medications-7 (ARMS-7)	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.	Baseline and two weeks from baseline
Other	Change in self-reported mental and physical health as measured by the GLOBAL Patient-Reported Outcomes Measurement Information System (PROMIS) 10	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.	Baseline and two weeks from baseline
Other	Change preparedness as measured by the Preparedness for Caregiving Scale (PCS)	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.	Baseline and two weeks from baseline
Primary	Participant retention (Feasibility)	The proportion of included participants completing the two-week (T1) follow up assessment.	Two weeks from baseline
Primary	Listening rates (Acceptability)	The proportion of patients who listen to their recordings.	Two weeks from baseline
Primary	System Usability Scale (SUS)	10-item PROM. A score =68 points (0-100) indicates above average usability	Two weeks from baseline
Primary	Acceptability of Intervention Measure (AIM)	Four-item PROM assessing acceptability of intervention. Higher score indicates higher acceptability of the intervention.	Two weeks from baseline
Primary	Intervention Appropriateness Measure (IAM)	Four-item PROM assessing feasibility of intervention. Higher score indicates greater appropriateness of the intervention.	Two weeks from baseline
Primary	Feasibility of Intervention Measure (FIM)	Four-item PROM assessing feasibility of intervention. Higher score indicates higher feasibility of the intervention.	Two weeks from baseline