Developing a Patient Inventory to Facilitate Patient-centered Care Delivery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 4
- 主要终点
- Consultation and Relational Empathy (CARE) Measure
研究概览
简要总结
This study will use a multi-phase mixed-methods approach to develop and test a patient inventory to facilitate patient-centered care delivery. In Phase I the investigators will identify which factors should be considered for inclusion in the patient inventory. This will involve qualitative data collection with providers and patients using interviews and focus groups, respectively; and developing a question repository. The interviews and focus groups will take place at the six study sites: Hines VA Hospital and two Community Based Outpatient Clinics(CBOCs) in LaSalle, Illinois (IL) and Kankakee, IL; Jesse Brown VA Medical Center; and two CBOCs in Crown Point, IN; and Chicago Heights, IL. The question repository will involve a research assistant (RA) performing a literature review to gather items related to areas of patient context.
Phase II will develop and test an item inventory using a Delphi panel - a panel of stakeholders including Veteran representatives, VA providers, researchers and representatives from the investigators' operations partners. The panel of at least 14 respondents will develop a questionnaire through three rounds of email exchanges ranking the list of items to be included in the patient inventory. Once the patient inventory is finalized, it will be integrated into an iPad application for patient use.
In Phase III the investigators will test the patient inventory in a randomized trial.
The investigators will conduct a randomized trial of the patient inventory to a control condition (e.g., healthy living video) to assess whether use of the inventory results in care that is more patient-centered and decisions that are more collaborative. Eligible participants will be identified and recruited from the Patient Aligned Care Team (PACT) clinics at Hines and Jess Brown VA facilities. Patients will be randomly assigned to either complete the patient inventory on the iPad or watch a health video on the iPad. Patients in the Intervention group will give a copy of the summary of the inventory to their provider. Both groups will be asked to carry a concealed tape recorder during their visit. Following the visit, patients in both groups will complete a set of questionnaires about the encounter including the CARE and CCM. The recordings will be analyzed by the team using a coding system developed in a previous Health Services Research and Development (HSR&D) study to see if the use of the patient inventory facilitated patient-centered care during the encounter. A second coding scheme, the Informed Decision Making (IDM) will also be applied to examine collaborative decision making.
详细描述
Research Design and Methods: This study will utilize a multi-phase mixed-methods approach to develop and test a patient inventory to facilitate patient-centered care delivery. In Phase I the investigators will identify which factors should be considered for inclusion in the patient inventory. This will involve interviews and focus groups with providers and patients, respectively; and a review of the relevant literature. In Phase II the investigators will develop and test an inventory using a Delphi panel and assembling a questionnaire repository. In Phase III the investigators will conduct a randomized trial comparing the patient inventory to a control condition (e.g., healthy living video) to assess whether use of the inventory results in care that is more patient-centered and decisions that are more collaborative.
Phase I: To identify patient contextual factors and preferences, and patients' experiences, awareness, resources, and willingness to use technology for care delivery, the investigators will conduct focus groups with patients at 2 facilities and 4 CBOCs in Veterans Integrated Service Network 12 (VISN 12) representing urban and rural settings and a mix of sociodemographic characteristics.
In order to capture the perspective of Veterans who live in more rural areas and who may represent a broader range of socio-demographic characteristics, the investigators will conduct focus groups at four CBOCs associated with the medical facilities that represent urban/rural and ethnic diversity.
The investigators plan to recruit both patients who have received care through technology (e.g., home telehealth (HT), CVT) and those who have had little or no experience with care delivered through technology. The investigators will conduct separate focus groups with patients who have received care through technology and those who have not used technology for health care. Focus group discussions will be transcribed verbatim and analyzed using constant comparative techniques to code the data thematically. This information will serve as the foundation for developing the inventory.
A total of 8-12 focus groups will be conducted with 5-8 Veteran participants per group (n=40 to 96 patients). The investigators will conduct 2 focus groups at each VA facility, and 1-2 focus groups at each CBOC. Based on prior experience conducting focus groups with Veterans, the investigators believe that this number of focus groups will provide sufficient data to reach saturation, the point at which no new information is uncovered during group discussion. Two members of the research team will manage each focus group.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VA patients who have had some experience with care receipt through technology (e.g., home telehealth, CVT, secure messaging with providers).
- •A second group will be conducted with patients who have not had experience receiving care through technology.
- •There are no other specific inclusion criteria and the investigators plan to recruit both male and female Veterans, as well as minorities.
- •Veterans who receive care from VA and are comfortable using the Internet.
- •There are no other specific inclusion criteria and the investigators plan to recruit both male and female Veterans, as well as minorities.
- •Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT clinic.
- •No subjects will be excluded based on gender, race, or ethnicity. Eligibility criteria include:
- •(1) adult, age 18 or over
- •(2) assigned primary care provider in PACT clinic
- •(3) no history of dementia
- •(4) no blindness (unable to view iPad app).
- •Only patients of participating providers will be eligible for the study, to ensure both patient and provider consent to audio-recordings and study procedures.
- •There are no other specific inclusion criteria and the investigators plan to recruit both male and female Veterans, as well as minorities.
排除标准
- •A history of dementia
- •Blindness
研究组 & 干预措施
patient inventory tool
prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery. This information is presented to the provider to facilitate care delivery.
干预措施: patient inventory (Other)
attention control
prior to the encounter, the patient will view a brief video containing general health information.
干预措施: attention control (Other)
结局指标
主要结局
Consultation and Relational Empathy (CARE) Measure
时间窗: Total time of patient participation 2 to 2.5 hours, including 1 hour prior to provider encounter, encounter (20-40 min) and data collection after encounter (15-30 minutes).
CARE is a process measure of empathy and holistic care in the context of a therapeutic relationship (medical visit). It has 10 items, each rated from poor to excellent. Example items include: How was the provider at 'making you feel at ease'; letting you tell your story.' Score are added for a maximum of 50, min of 10; higher score reflects greater patient-centeredness.
次要结局
- Consultation Care Measure (CCM)(immediately following the encounter with the provider, 5-7 minutes to complete)
- % of Encounters in Which Provider Probed at Least Once for Contextual Information(based on audio-recordings of the patient-provider encounter, no additional time required by participants)
- All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients.(based on audio-recordings of the patient-provider encounter, no additional time required by participants, through study completion)