Clinical trial NCT05955339: Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults
Official title: Comparing Healthcare Visit Recording and Open Notes to Improve the Chronic Illness Care Experience for Older Adults (The CHRONICLE Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: The University of Texas Medical Branch, Galveston
name: Vanderbilt University Medical Center
name: Beth Israel Deaconess Medical Center
name: Patient-Centered Outcomes Research Institute
First posted: 2023-07-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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;
* 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:

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

Primary outcomes:
measure: Quality of Life - Mental functioning
timeFrame: 6 months from enrollment
measure: Quality of Life - Physical functioning
timeFrame: 6 months from enrollment
Secondary outcomes:
measure: Self-management ability
timeFrame: 6 months from enrollment
measure: Medication adherence
timeFrame: 6 months from enrollment
measure: General satisfaction
timeFrame: 6 months from enrollment
measure: Visit communication style and shared decision-making
timeFrame: 6 months from enrollment
Other outcomes:
measure: Caregiver preparedness [Caregiver outcome]
timeFrame: 6 months from enrollment
measure: Caregiver burden [Caregiver outcome]
timeFrame: 6 months from enrollment
measure: Caregiver engagement in clinic visit [Caregiver outcome]
timeFrame: 6 months from enrollment
Locations:
city: Manchester
country: United States
facility: Dartmouth Hitchcock Clinics Manchester
state: New Hampshire
city: Nashville
country: United States
facility: Vanderbit University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: Dartmouth College
name: Paul J Barr, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilit University Medical Center
name: Kerri L Cavanaugh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Texas Medical Branch
name: Meredith C Masel, PhD
role: PRINCIPAL_INVESTIGATOR
References: