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

NCT05955339 | Recruiting DMC

• 1 other identifier: STUDY02002056
• Study Type: interventional
• Target: 1,022
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Diabetes Mellitus; Hypertension

Keywords

Audio Recording; Diabetes Mellitus; Hypertension; Patient-centered communication; Self-management; Older adults; Chronic conditions; After visit summary; Quality of life; Multimorbidity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Self-management ability

  6 months from enrollment

• Medication adherence

  6 months from enrollment

• General satisfaction

  6 months from enrollment

• Visit communication style and shared decision-making

  6 months from enrollment

Other Outcomes (3)

• Caregiver preparedness [Caregiver outcome]

  6 months from enrollment

• Caregiver burden [Caregiver outcome]

  6 months from enrollment

• Caregiver engagement in clinic visit [Caregiver outcome]

  6 months from enrollment

Study Arms (2)

NOTES

ACTIVE COMPARATOR

Patients in this arm will receive only the NOTES intervention.

Other: NOTES

NOTES + AUDIO

ACTIVE COMPARATOR

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

Other: NOTES; Other: AUDIO

Interventions

NOTES 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; NOTES + AUDIO

AUDIO 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.

NOTES + AUDIO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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:
• Agree to their identified role as a caregiver;
• Speak English or Spanish;
• Have capacity to consent to research participation; and
• ≥ 18 years.
• No capacity to consent to the project;
• Living in skilled nursing homes or hospice;

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• The University of Texas Medical Branch, Galveston: collaborator
• Vanderbilt University Medical Center: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Dartmouth Hitchcock Clinics Manchester

Manchester, New Hampshire, 03104, United States

RECRUITING

Vanderbit University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

NOT YET RECRUITING

Related Links

• Information about the CHRONICLE Trial

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul J Barr, PhD

CONTACT

603-646-7016; paul.j.barr@dartmouth.edu

Renata W. Yen, PhD

CONTACT

603-646-5670; renata.west.yen@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 21, 2023
• Study Start: January 24, 2024
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): June 14, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: At the completion of data analysis.
• Access Criteria: All access will be coordinated through PCODR/ICPSR.

Locations

US (3)