An interventional study of Annotated Audio and Audio in Multimorbidity, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Other
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.
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.
Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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.
Patients visiting their clinician will receive the normal, written after-visit-summary (available on paper or via the patient portal).
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
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
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.
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.
Participant retention (Feasibility)
The proportion of included participants completing the two-week (T1) follow up assessment.
Time frame: Two weeks from baseline
Listening rates (Acceptability)
The proportion of patients who listen to their recordings.
Time frame: Two weeks from baseline
System Usability Scale (SUS)
10-item PROM. A score ≥68 points (0-100) indicates above average usability
Time frame: Two weeks from baseline
Acceptability of Intervention Measure (AIM)
Four-item PROM assessing acceptability of intervention. Higher score indicates higher acceptability of the intervention.
Time frame: Two weeks from baseline
Intervention Appropriateness Measure (IAM)
Four-item PROM assessing feasibility of intervention. Higher score indicates greater appropriateness of the intervention.
Time frame: Two weeks from baseline
Feasibility of Intervention Measure (FIM)
Four-item PROM assessing feasibility of intervention. Higher score indicates higher feasibility of the intervention.
Time frame: Two weeks from baseline
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.
Time frame: Baseline and two weeks from baseline
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.
Time frame: Baseline and two weeks from baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline and two weeks from baseline
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.
Time frame: Baseline and two weeks from baseline
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.
Time frame: Baseline and two weeks from baseline
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.
Time frame: Baseline and two weeks from baseline
Plan to share: No
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Dartmouth-Hitchcock Medical Center