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

Hypertension Clinical Trial

— CHRONICLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955339
• Other study ID #: STUDY02002056
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2024
• Est. completion date: June 14, 2027

Study information

• Verified date: March 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Paul J Barr, PhD
• Phone: 603-646-7016
• Email: paul.j.barr[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 14, 2027
• Est. primary completion date: April 7, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus
• Hypertension

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas
United States	Dartmouth Hitchcock Clinics Manchester	Manchester	New Hampshire
United States	Vanderbit University Medical Center	Nashville	Tennessee

Sponsors (5)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Beth Israel Deaconess Medical Center, Patient-Centered Outcomes Research Institute, The University of Texas Medical Branch, Galveston, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Information about the CHRONICLE Trial