About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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;
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
NOTES
Other interventionThe 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
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
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.
Other outcomes
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.
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.
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.
Sponsors and contacts
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Dartmouth-Hitchcock Medical Center
Lead sponsor
Trustees of Dartmouth College
Sponsor institution
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