- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04827381
Improving Patient and Caregiver Engagement by Sharing Annotated Audio-recorded Clinic Visits
Improving Patient and Caregiver Engagement Through the Application of Data Science Methods to Audio Recorded Clinic Visits Stored in Personal Health Libraries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New Hampshire
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Manchester, New Hampshire, United States, 03104
- Dartmouth-Hitchcock Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
Patients visiting their clinician will receive the normal, written after-visit-summary (available on paper or via the patient portal).
|
|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant retention (Feasibility)
Time Frame: Two weeks from baseline
|
The proportion of included participants completing the two-week (T1) follow up assessment.
|
Two weeks from baseline
|
Listening rates (Acceptability)
Time Frame: Two weeks from baseline
|
The proportion of patients who listen to their recordings.
|
Two weeks from baseline
|
System Usability Scale (SUS)
Time Frame: Two weeks from baseline
|
10-item PROM.
A score ≥68 points (0-100) indicates above average usability
|
Two weeks from baseline
|
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.
|
Two weeks from baseline
|
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.
|
Two weeks from baseline
|
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.
|
Two weeks from baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and two weeks from baseline
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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. |
Baseline and two weeks from baseline
|
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.
|
Baseline
|
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.
|
Baseline
|
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.
|
Baseline
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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.
|
Baseline and two weeks from baseline
|
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.
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Baseline and two weeks from baseline
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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.
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Baseline and two weeks from baseline
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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.
|
Baseline and two weeks from baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Paul J Barr, PhD, Dartmouth College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- D21050
- 02000763 (Other Identifier: Dartmouth-Hitchcock IRB)
- R01LM012815 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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