Embedded Clinical Trial of Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 3
- 主要终点
- Documentation of PPC Discussion
研究概览
简要总结
The goal of this pragmatic, embedded clinical trial is to analyze the implementation of Patient Priorities Care in primary care and geriatrics clinics with patients living with dementia or mild cognitive impairment. This study aims are:
- demonstrate the feasibility of using the electronic health record to identify a diverse cohort of eligible patients who will engage in a Patient Priorities Care conversation with a trained facilitator.
- demonstrate feasibility of pragmatically assessing clinical outcomes using the electronic health record, including a) number of days at home, b) total medications, and c) new referrals to specialist physicians.
- examine key feasibility measures across racial, ethnic, and socioeconomic subgroups.
Participants will receive a packet of information about Patient Priorities Care from their primary care clinic, in advance of their next upcoming clinic appointment. Individuals who receive a packet will have the opportunity to engage in a conversation about what matters most to them and what their priorities are, with trained facilitators at the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria
- •Patients must meet all of the following criteria to participate in this study:
- •40 years or older
- •English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site
- •Receiving care with a participating physician
- •Has a scheduled outpatient care visit within 1-2 months (60 days)
- •Individual has a diagnosis of MCI or dementia
- •Definition: To identify individuals with dementia and MCI, we will use two or more instances of use of an ICD-10 code for either diagnosis in the EHR within 24 months. Typically, we would include instances of these billing codes within a year of each other but, due to the COVID-19 pandemic, recognize that there may be less frequent clinical visits and less robust billing. Diagnostic codes include:
- •F01.50, F01.51, F02.80, F02.81, F03.90, G30.0, G30.1, G30.8, G30.9, G31.01, G31.09, G31.1, G31.2, F41.81, G31.84 and F03.
- •Care Partner Inclusion Criteria
- •Care partners must meet all of the following criteria to participate in the study:
- •18 years or older
- •English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site
- •A note about inclusion of care partners: Clinician determination of a patient's capacity to participate in a visit independently is part of a pragmatic approach. This means that clinic staff will determine when a care partner is needed. Generally, we act under the assumption that patients who require a care partner will have already included them in previous visits and/or provider communications (and we anticipate that this will be documented in the EHR), whereas patients who attend clinic visits independently and have no documentation indicating the involvement of a care partner in their medical decisions, or a need for one, will be determined to have the capacity to also participate in a PPC visit.
排除标准
- •Participants who meet any of the following criteria will be excluded from the study:
- •Is not community-dwelling- e.g. lives in a nursing home
- •Is enrolled in hospice
- •Individuals who decline to receive the PPC intervention (i.e. decline to have the PPC conversation) will be excluded from the study.
- •Note that declining to receive the PPC intervention will in no way impact the care that patients receive now or in the future.
研究组 & 干预措施
Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment
Patients will receive a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) will initiate a Patient Priorities Care conversation with the patient. This conversation will be documented in the Electronic Health Record.
干预措施: Patient Priorities Care (Behavioral)
结局指标
主要结局
Documentation of PPC Discussion
时间窗: From enrollment to participating clinic visit
Review of the electronic health record will be used to assess for the presence of documentation of patient priorities care for each enrolled patient. Documentation can occur from enrollment through enrolled patient's visit with the participating physician in clinic. Enrollment (mailing of packet) occurred from two months prior to scheduled appointment with participating physician to clinic appointment. Documentation of discussion could occur from two months prior up to within 24 hours of clinic appointment with participating physician.
次要结局
- Number of Patients with Social Factors Indicated in the Electronic Health Record(Baseline and up to 2 months post baseline)
- Appropriateness(Baseline and up to 2 months post baseline)
- Acceptability(Baseline and up to 2 months post baseline)
- Identification of a Care Partner(Baseline and up to 2 months post baseline)
- Feasibility of the Intervention(Baseline and up to 2 months post baseline)
- Fidelity to the Intervention(Baseline and up to 2 months post baseline)
- Potential for Future Adoption of Patient Priorities Care Intervention(Baseline and up to 2 months post baseline)
- Number of Patient Days at Home(2 months pre and 2 months post baseline)
- Number of Total Medications(2 months pre and 2 months post baseline)
- Number of New Referrals to Specialist Physicians(2 months pre and 2 months post baseline)
- Number of Patients Across Racial, Ethnic, and Socioeconomic Subgroups With Documentation of Patient Priorities Care Discussion in the Electronic Health Record(2 months pre and 2 months post baseline)
- Acceptability Across Racial, Ethnic, and Socioeconomic Subgroups.(Baseline and up to 2 months post baseline)
- Number of Patients With Social Factors Indicated in the Electronic Health Record(Baseline and up to 2 months post baseline)
研究者
Jennifer L Carnahan
Research Scientist
Indiana University