Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults

NCT ID: NCT05955339

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2027-06-14

Brief Summary

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CHRONICLE is a randomized trial assessing the comparative effectiveness of providing written visit information via the patient portal (NOTES) versus NOTES plus visit audio recording (AUDIO) to older adult patients with chronic diseases on quality of life and other outcomes. During the trial, the team will also invite caregivers identified by patients to join the project.

Detailed Description

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The research team is working with primary care clinics at three health systems across the country to enroll adults ages 65 and older who are managing diabetes or high blood pressure, plus one other disease. The team is assigning patients by chance to one of two groups. Each group will have an equal numbers of patients. Patients in one group will get access to visit notes through the patient portal. The research team will give patients guidance on how to find and use their visit notes. Patients in the other group will not only have access to their visit notes patients but also get access to audio-recordings of their visits. After each visit, patients in both groups will receive emails to review their visit information: 1) two days after their visit to remind them of their visit discussion and any tasks they may have, and 2) three days before their next visit, they will be asked to think of any changes from their last visit and to make a list of three things they want to talk to their doctor about. The team is comparing changes reported by patients over six months in quality of life, satisfaction, self-management ability, treatment adherence, and visit communication. The team will also invite caregivers identified by patients to join the project. They will show patients how to share their visit notes or recordings with caregivers. Caregivers will report on changes in how prepared they feel to provide care, burden related to caregiving, and how much they felt part of the patient's visit conversation.

Conditions

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Diabetes Mellitus Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly allocated to NOTES or NOTES+AUDIO using a block randomization technique with the clinician acting as the blocking variable. This strategy will ensure an equal number of patients per clinician will be randomly assigned to each study arm.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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NOTES

Patients in this arm will receive only the NOTES intervention.

Group Type ACTIVE_COMPARATOR

NOTES

Intervention Type OTHER

The intervention will include: (1) a brief training on using the patient portal to access written visit information with assistance in setting up patient portal accounts where necessary (including strategies to share notes with a caregiver), (2) post-visit reminders to use the patient portal to access written visit information.

NOTES + AUDIO

Patients in this arm will receive both the NOTES and AUDIO intervention.

Group Type ACTIVE_COMPARATOR

NOTES

Intervention Type OTHER

The intervention will include: (1) a brief training on using the patient portal to access written visit information with assistance in setting up patient portal accounts where necessary (including strategies to share notes with a caregiver), (2) post-visit reminders to use the patient portal to access written visit information.

AUDIO

Intervention Type OTHER

The intervention will include: (1) audio recording all visits with the study clinician for six months, (2) training on how to record visits and access visit recordings, and (3) post-visit reminders listen to the visit recordings.

Interventions

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NOTES

The intervention will include: (1) a brief training on using the patient portal to access written visit information with assistance in setting up patient portal accounts where necessary (including strategies to share notes with a caregiver), (2) post-visit reminders to use the patient portal to access written visit information.

Intervention Type OTHER

AUDIO

The intervention will include: (1) audio recording all visits with the study clinician for six months, (2) training on how to record visits and access visit recordings, and (3) post-visit reminders listen to the visit recordings.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥ 65 years;
* With multimorbidity (diabetes or hypertension plus one of the following: arthritis (osteoarthritis and rheumatoid arthritis), asthma, atrial fibrillation, Alzheimer's disease and related dementia (not severe), cancer, chronic obstructive pulmonary disease, depression, heart disease, heart failure, hyperlipidemia, osteoporosis, kidney disease and stroke. Patients with diabetes plus hypertension are eligible.
* Have had two or more clinic visits in the previous 12 months;
* Plan on receiving ongoing care at the clinic with the enrolled clinician for the subsequent 6 months;
* Do not have vision or hearing problems that cannot be corrected; and
* Have not recorded a clinic visit for personal use in the past 6 months


* Agree to their identified role as a caregiver;
* Speak English or Spanish;
* Have capacity to consent to research participation; and
* ≥ 18 years.

Exclusion Criteria

* With no capacity to consent to the project;
* With schizophrenia and other psychotic disorders, current substance-use disorders, uncorrected hearing or visual impairment;
* Living in skilled nursing homes or hospice, because they engage less in self-management;
* With cognitive impairment as identified by a score of ≤3 on the six-item screener (SIS)
* Lacking internet access;
* Who do not speak English or Spanish;
* Who (i) do not have access to a personal email, (ii) do not have an email address shared with a family member or patient-identified caregiver, and/or (iii) are not interested in creating a personal email as this would prevent them from engaging with the intervention(s); and
* Who do not wish to create a patient portal account, if they do not already have one as this would prevent them from engaging with the intervention(s).

CAREGIVERS:


* No capacity to consent to the project;
* Living in skilled nursing homes or hospice;
* Lacking internet access; or
* Do not speak English or Spanish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Paul J. Barr

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul J Barr, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Kerri L Cavanaugh, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilit University Medical Center

Meredith C Masel, PhD

Role: PRINCIPAL_INVESTIGATOR

University Texas Medical Branch

Locations

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Dartmouth Hitchcock Clinics Manchester

Manchester, New Hampshire, United States

Site Status RECRUITING

Vanderbit University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

University of Texas Medical Branch

Galveston, Texas, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Paul J Barr, PhD

Role: CONTACT

603-646-7016

Renata W. Yen, PhD

Role: CONTACT

603-646-5670

Facility Contacts

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Paul J Bar, PhD

Role: primary

603-646-7016

Renata W Yen, PhD

Role: backup

603-646-5670

Kerri L Cavanaugh, MD

Role: primary

615-875-2737

Sonya Williams

Role: backup

615 875 2737

Meredith C Masel, PhD

Role: primary

409-747-6009

Isamar Ortiz

Role: backup

409-266-3009

Related Links

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https://www.openrecordings.org/projects-chronicle

Information about the CHRONICLE Trial

Other Identifiers

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STUDY02002056

Identifier Type: -

Identifier Source: org_study_id

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