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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Hypertension

Intervention / Treatment
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* Other: NOTES
* Other: AUDIO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NOTES<br>Patients in this arm will receive only the NOTES intervention. | Other: NOTES<br>* 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.<br>|
| Active Comparator: NOTES + AUDIO<br>Patients in this arm will receive both the NOTES and AUDIO intervention. | Other: NOTES<br>* 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.<br>Other: AUDIO<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Audio Recording, Diabetes Mellitus, Hypertension, Patient-centered communication, Self-management, Older adults, Chronic conditions, After visit summary, Quality of life, Multimorbidity