Back to resultsComparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults (CHRONICLE)
Primary Purpose
Diabetes Mellitus, Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOTES
AUDIO
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus focused on measuring Audio Recording, Diabetes Mellitus, Hypertension, Patient-centered communication, Self-management, Older adults, Chronic conditions, After visit summary, Quality of life, Multimorbidity
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
Sites / Locations
- Dartmouth Hitchcock Clinics Manchester
- Vanderbit University Medical Center
- University of Texas Medical Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NOTES
NOTES + AUDIO
Arm Description
Patients in this arm will receive only the NOTES intervention.
Patients in this arm will receive both the NOTES and AUDIO intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
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.
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.
Full Information
NCT ID
NCT05955339
First Posted
July 12, 2023
Last Updated
July 13, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
The University of Texas Medical Branch, Galveston, Vanderbilt University Medical Center, Beth Israel Deaconess Medical Center, Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05955339
Brief Title
Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults
Acronym
CHRONICLE
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
April 7, 2027 (Anticipated)
Study Completion Date
June 14, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
The University of Texas Medical Branch, Galveston, Vanderbilt University Medical Center, Beth Israel Deaconess Medical Center, Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NOTES
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive only the NOTES intervention.
Arm Title
NOTES + AUDIO
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive both the NOTES and AUDIO intervention.
Intervention Type
Other
Intervention Name(s)
NOTES
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
AUDIO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life - Mental functioning
Description
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.
Time Frame
6 months from enrollment
Title
Quality of Life - Physical functioning
Description
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.
Time Frame
6 months from enrollment
Secondary Outcome Measure Information:
Title
Self-management ability
Description
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).
Time Frame
6 months from enrollment
Title
Medication adherence
Description
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).
Time Frame
6 months from enrollment
Title
General satisfaction
Description
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.
Time Frame
6 months from enrollment
Title
Visit communication style and shared decision-making
Description
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.
Time Frame
6 months from enrollment
Other Pre-specified Outcome Measures:
Title
Caregiver preparedness [Caregiver outcome]
Description
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.
Time Frame
6 months from enrollment
Title
Caregiver burden [Caregiver outcome]
Description
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.
Time Frame
6 months from enrollment
Title
Caregiver engagement in clinic visit [Caregiver outcome]
Description
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.
Time Frame
6 months from enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul J Barr, PhD
Phone
603-646-7016
Email
paul.j.barr@dartmouth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Renata W. Yen, PhD
Phone
603-646-5670
Email
renata.west.yen@dartmouth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Barr, PhD
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kerri L Cavanaugh, MD
Organizational Affiliation
Vanderbilit University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meredith C Masel, PhD
Organizational Affiliation
University Texas Medical Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Clinics Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul J Bar, PhD
Phone
603-646-7016
Email
paul.j.barr@dartmouth.edu
First Name & Middle Initial & Last Name & Degree
Renata W Yen, PhD
Phone
603-646-5670
Email
renata.west.yen@dartmouth.edu
Facility Name
Vanderbit University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerri L Cavanaugh, MD
Phone
615-875-2737
Email
kerri.cavanaugh@vumc.org
First Name & Middle Initial & Last Name & Degree
Sonya Williams
Phone
615 875 2737
Email
sonya.I.williams@vumc.org
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith C Masel, PhD
Phone
409-747-6009
Email
mcmasel@utmb.edu
First Name & Middle Initial & Last Name & Degree
Isamar Ortiz
Phone
409-266-3009
Email
iiortiz@utmb.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.icpsr.umich.edu/web/pages/pcodr/about.html
Links:
URL
https://www.openrecordings.org/projects-chronicle
Description
Information about the CHRONICLE Trial
Learn more about this trial
Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults
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