Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 478
- 试验地点
- 4
- 主要终点
- Change in Patient Activation, as Measured by Patient Activation Measure - 13
研究概览
简要总结
This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.
详细描述
Background:
Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative seeks to provide patients comprehensive, team-based support for following diabetes care regimens. PACT's success, however, hinges on its ability to effectively engage patients in care. One relatively untapped resource for supporting engagement in PACT is patients' family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a 'Care Partner') for ongoing help with diabetes management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources.
Objectives:
The overall objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully enact care plans.
The central hypothesis is that providing health care engagement tools to both Care Partners and patients will increase patient activation and improve management of diabetes complication risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Provide signed and dated informed consent form
- •Plan to be be available for the duration of the study
- •Male or female, age 30-70 years old
- •Plan to get most diabetes care at recruiting VA primary care clinic over the subsequent 12 months
- •Able to use telephone to respond to bi-weekly automated Interactive Voice Response (IVR) calls
- •Be able to identify an adult family member or friend who is regularly involved in their health management or health care (involved with medications, managing sugars, coming to appointments, etc)
- •Have a diagnosis of diabetes and be at high-risk for diabetes complications, defined as: (1) a diagnosis of diabetes based on encounter diagnoses from 1 inpatient or 2 outpatient encounters (OR a diabetes medication (at least one >3 month prescription from VA drug classes HS501 (insulin) or HS502, other than metformin), (2) have an assigned VAprimary care provider and at least 2 visits to VA primary care in the previous 12 months, (3) poor glycemic control (last HbA1C within 9 months >8%) OR poor blood pressure control (last BP 160/100 or mean 6 month BP >150/90)
- •Care Partner Inclusion Criteria:
- •21 years old or older
- •Fluent in English
- •Live in the United States
排除标准
- •Patient Exclusion Criteria:
- •Expect to have >1 month gap in VA care in the 12 months following enrollment (e.g. snowbird travel).
- •Plan to receive the majority of their care for diabetes mainly from a non-Primary Care provider in the 12 months following enrollment
- •Have a VA resident/trainee as their main primary care provider
- •Live in a nursing home OR assisted living
- •Have significant cognitive impairment as measured by an Electronic Medical Record (EMR) diagnosis of Alzheimer's disease or dementia, or a score of <4 on the Callahan screener to identify cognitive impairment
- •Need help with more than two basic activities of daily living (ADLs) as measured by the Katz Basic Activities of Daily Living Scale
- •Do not speak English
- •Have a life-limiting severe illness (such as stage renal disease [ESRD] requiring dialysis, chronic obstructive pulmonary disease (COPD) requiring oxygen, cancer undergoing active treatment, receiving palliative/hospice care)
- •Are concurrently enrolled in another research study or clinical program, at time of enrollment, that could conflict with the current study's protocol (e.g. another diabetes management research intervention, or VA tele-buddy program involving frequent phone calls)
- •Do not have a working phone or are not able to use a telephone to respond to automated IVR calls
- •Currently Pregnant or planning to become pregnant at time of enrollment
- •Have a serious mental illness or active substance abuse issue
- •Care Partner Exclusion Criteria:
- •Receive pay for caring for the patient
- •talks with patient about health less than two times per month
- •Have significant cognitive impairment as measured by a score of 4 or less <4 on the Callahan screener to identify cognitive impairment
- •Need help with more than two basic ADL as measured by the Katz Basic Activities of Daily Living Scale
- •Have a life-limiting severe illness (such as end-stage renal disease requiring dialysis, chronic lung disease requiring oxygen, cancer undergoing active treatment, receiving palliative/hospice care)
- •Ever told by a doctor they have dementia, schizophrenia, or manic depression
结局指标
主要结局
Change in Patient Activation, as Measured by Patient Activation Measure - 13
时间窗: Baseline to 12 months
Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants
Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine
时间窗: Baseline to 12 months
UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months.
次要结局
- Change in Systolic Blood Pressure(Baseline to 12 months)
- Change in Supporter Use of Autonomy-Supportive Communication(Baseline to 12 months)
- Change in Diabetes Self-Management Behavior - Check Feet(Baseline to 12 months)
- Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed(Baseline to 12 months)
- Change in Smoking Status(Baseline to 12 months)
- Change in Diabetes Self-Management Behavior - Healthy Eating(Baseline to 12 months)
- Change in Diabetes Distress(Baseline to 12 months)
- Change in Activation in Health Encounters(Baseline to 12 months)
- Change in Non-Fasting Lipid Levels(Baseline to 12 months)
- Change in Patient Satisfaction With Healthcare System Support for Family Supporter(Baseline to 12 months)
- Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing(Baseline to 12 months)
- Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed(Baseline to 12 months)
- Change in Glycemic Control(Baseline to 12 months)
- Change in Diabetes Self-Management Behavior - Physical Activity(Baseline to 12 months)
- Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing(Baseline to 12 months)