Comparing Healthcare Visit Recording and Open Notes to Improve the Chronic Illness Care Experience for Older Adults (The CHRONICLE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,022
- 试验地点
- 6
- 主要终点
- Quality of Life - Physical functioning
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
研究组 & 干预措施
NOTES + AUDIO
Patients in this arm will receive both the NOTES and AUDIO intervention.
干预措施: NOTES (Other)
NOTES
Patients in this arm will receive only the NOTES intervention.
干预措施: NOTES (Other)
NOTES + AUDIO
Patients in this arm will receive both the NOTES and AUDIO intervention.
干预措施: AUDIO (Other)
结局指标
主要结局
Quality of Life - Physical functioning
时间窗: 6 months from enrollment
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 - Mental functioning
时间窗: 6 months from enrollment
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.
次要结局
- Self-management ability(6 months from enrollment)
- Medication adherence(6 months from enrollment)
- Visit communication style and shared decision-making(6 months from enrollment)
- General satisfaction(6 months from enrollment)
研究者
Paul J. Barr
Associate Professor
Trustees of Dartmouth College