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

Comparing Healthcare Visit Recording and Open Notes to Improve the Chronic Illness Care Experience for Older Adults (The CHRONICLE Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Diabetes Mellitus
• Intervention / Treatment: Other: NOTES; Other: AUDIO

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1022
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul J Barr, PhD; Phone Number: 603-646-7016; Email: paul.j.barr@dartmouth.edu
• Study Contact Backup: Name: Renata W. Yen, PhD; Phone Number: 603-646-5670; Email: renata.west.yen@dartmouth.edu

Study Locations

• United States
  • New Hampshire
    • Manchester, New Hampshire, United States, 03104
      • Recruiting
      • Dartmouth Hitchcock Clinics Manchester
      • Contact: Paul J Bar, PhD; Phone Number: 603-646-7016; Email: paul.j.barr@dartmouth.edu
      • Contact: Renata W Yen, PhD; Phone Number: 603-646-5670; Email: renata.west.yen@dartmouth.edu
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbit University Medical Center
      • Contact: Kerri L Cavanaugh, MD; Phone Number: 615-875-2737; Email: kerri.cavanaugh@vumc.org
      • Contact: Sonya Williams; Phone Number: 615 875 2737; Email: sonya.I.williams@vumc.org
  • Texas
    • Galveston, Texas, United States, 77555
      • Not yet recruiting
      • University of Texas Medical Branch
      • Contact: Meredith C Masel, PhD; Phone Number: 409-747-6009; Email: mcmasel@utmb.edu
      • Contact: Isamar Ortiz; Phone Number: 409-266-3009; Email: iiortiz@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

PATIENTS:

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

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 with no adjustments to support accessing the interventions or surveys;
• Living in skilled nursing homes or hospice, because they engage less in self-management;
• With cognitive impairment as identified by a score of ≤4 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:

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NOTES; Patients in this arm will receive only the NOTES intervention.	Other: 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.
Active Comparator: NOTES + AUDIO; Patients in this arm will receive both the NOTES and AUDIO intervention.	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life - Mental functioning	Quality of life using Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.	6 months from enrollment
Quality of Life - Physical functioning	Quality of life using Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.	6 months from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-management ability	Self-management ability using the Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores are range from 0 (low activation) to 100 (high activation).	6 months from enrollment
Medication adherence	Medication adherence using Adherence to Refills and Medications (ARMS-7), an seven-item measure with two domains: i) medication taking and ii) medication refilling. ARMS-7 scores range from 7 (high adherence) to 28 (low adherence).	6 months from enrollment
General satisfaction	General satisfaction using the two-item general satisfaction sub-scale from the Patient Satisfaction Questionnaire-18 (PSQ-18). The subscale is scored as a mean of the two questions with a potential score ranging from 1 to 5. Higher scores indicate more satisfaction.	6 months from enrollment
Visit communication style and shared decision-making	Visit communication style and shared decision making using 14 items (6 of 7 subscales) from the Interpersonal Process of Care (IPC) survey. Each of the 6 subscales has a potential score of 1 to 5. Direction of the score depends on the subscale.	6 months from enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver preparedness [Caregiver outcome]	Caregiver preparedness using the 9-item Preparedness for Caregiving Scale. Scores range from 0 to 4 with higher scores corresponding to caregivers feeling more prepared for caregiving.	6 months from enrollment
Caregiver burden [Caregiver outcome]	Caregiver burden using the 10-item Burden Scale for Family Caregivers-Short Form (BSFC-s). BSFC-s scores range from 0 to 30 with higher scores indicating greater caregiver burden.	6 months from enrollment
Caregiver engagement in clinic visit [Caregiver outcome]	Caregiver engagement in clinic visit using the 12-item CAregiver Perceptions About CommunIcaTion with Clinical Team members (CAPACITY). Potential scores range from 12 to 48 with higher score indicating perceptions of better quality communication and capacity-assessment from the care team.	6 months from enrollment

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute; Beth Israel Deaconess Medical Center; Vanderbilt University Medical Center; The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Paul J Barr, PhD, Dartmouth College; Principal Investigator: Kerri L Cavanaugh, MD, Vanderbilit University Medical Center; Principal Investigator: Meredith C Masel, PhD, University Texas Medical Branch

Publications and helpful links

Helpful Links

• Information about the CHRONICLE Trial

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): June 14, 2027

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Diabetes Mellitus; Quality of life; Older adults; Self-management; Multimorbidity; Chronic conditions; Patient-centered communication; Audio Recording; After visit summary
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus; Chronic Disease
• Other Study ID Numbers: STUDY02002056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon completion of this research, the research data from this project will be deposited with the Patient-Centered Outcomes Data Repository (PCODR), based at the Inter-university Consortium for Political and Social Research (ICPSR), University of Michigan to ensure that the research community has long-term access to the data. This will include all deidentified data from surveys and/or transcripts from recorded interviews or encounters. For those who consent, we will also put identifiable recordings into the repository.
• IPD Sharing Time Frame: At the completion of data analysis.
• IPD Sharing Access Criteria: All access will be coordinated through PCODR/ICPSR.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No