MultimorbidityNCT04827381
Improving Patient and Caregiver Engagement by Sharing Annotated Audio-recorded Clinic Visits
A study testing Annotated Audio and Audio in people with Multimorbidity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Annotated Audio and Audio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 4 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Manchester, New Hampshire, 03104
About this study
Official title: Improving Patient and Caregiver Engagement Through the Application of Data Science Methods to Audio Recorded Clinic Visits Stored in Personal Health Libraries
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.
Read the detailed 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.
- Conditions
- Multimorbidity
- Being tested
- Annotated Audio, Audio
- Keywords
- Patient recording, Personal health library, Patient communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annotated AudioOther
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.
AudioOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Audio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant retention (Feasibility)
The proportion of included participants completing the two-week (T1) follow up assessment.
Measured: Two weeks from baseline
Listening rates (Acceptability)
The proportion of patients who listen to their recordings.
Measured: Two weeks from baseline
System Usability Scale (SUS)
10-item PROM. A score ≥68 points (0-100) indicates above average usability
Measured: Two weeks from baseline
Acceptability of Intervention Measure (AIM)
Four-item PROM assessing acceptability of intervention. Higher score indicates higher acceptability of the intervention.
Measured: Two weeks from baseline
Intervention Appropriateness Measure (IAM)
Four-item PROM assessing feasibility of intervention. Higher score indicates greater appropriateness of the intervention.
Measured: Two weeks from baseline
Feasibility of Intervention Measure (FIM)
Four-item PROM assessing feasibility of intervention. Higher score indicates higher feasibility of the intervention.
Measured: Two weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Apr 2021
- Primary completion27 Dec 2021
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-site, three-arm, parallel group, patient-randomized, blocked, controlled, pilot trial with two-week follow up
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Paul J. Barr, Dartmouth-Hitchcock Medical Center
- Investigators
- Paul J Barr, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827381
- Sponsor's protocol ID
- D21050
- Other IDs
- 02000763, R01LM012815
- Status last verified
- Feb 2022
- First submitted
- 30 Mar 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient and Caregiver Engagement Through the Application of Data Science Methods to Audio Recorded Clinic Visits Stored in Personal Health Libraries
- ClinicalTrials.gov ID
- NCT04827381
- Acronym / sponsor ID
- D21050
- Conditions
- Multimorbidity
- Keywords
- Patient recording, Personal health library, Patient communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single-site, three-arm, parallel group, patient-randomized, blocked, controlled, pilot trial with two-week follow up
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Annotated AudioIn 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 | Experimental | Other: AudioIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (4 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annotated AudioIn 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 |
| AudioIn 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 |
Primary outcome
Participant retention (Feasibility)
Time frame: Two weeks from baseline
The proportion of included participants completing the two-week (T1) follow up assessment.
Listening rates (Acceptability)
Time frame: Two weeks from baseline
The proportion of patients who listen to their recordings.
System Usability Scale (SUS)
Time frame: Two weeks from baseline
10-item PROM. A score ≥68 points (0-100) indicates above average usability
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Barr, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annotated Audio and Audio in people with Multimorbidity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant retention (Feasibility) (time frame: Two weeks from baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.