The Impact of Life Context and Social Determinants of Health on Treatment Burden in Diabetes and Multiple Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pilot acceptability)
研究概览
简要总结
The objective of this proposal is to pilot test two types of pre-visit planning, where clinical staff reviews charts and talks to patients before their doctors appointments, to reduce the burden of diabetes care on the patient without increasing the visit workload during busy primary care clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •patient at the UCD ACC family medicine residency clinic
- •has diabetes per Diabetes Registry (HealthyPlanet2020)
- •PLUS at least one other chronic condition
- •attends a primary care office visit (in-person or telehealth) during the study initial data collection period with a physician who is participating in the study
- •speaks and writes English well enough to complete a written or oral survey
- •consents to participate
- •sees patients as a primary care physician at the study clinic site
排除标准
- •does not meet inclusion criteria
结局指标
主要结局
Pilot acceptability)
时间窗: after each clinic visit, within 2 weeks; at end of study
a short survey measuring PCPs perception of the visit's difficulty, hassle and effort; qualittive interviews with patients, providers and those conducting the intervention PVP calls
Pilot feasibility
时间窗: at completion of study, 4 months after last study visit
patients reached by phone for PVP call after assigned to call; # patients recruited successfully who were eligible; # questions completed on the surveys; # calls made to each patient and to patients total per # patients reached and # patients enrolled; # patients who completed all surveys; qualitative interviews will discuss challenges, barriers, and other feasability concerns to scaling this pilot trial to a definitive multi-center trial
次要结局
- HgbA1c value(change from baseline to 4 months post visit)
- Treatment Burden of Diabetes Care Questionnaire (TBQ)(change from baseline to 4 months post visit)
- Healthcare Climate Questionnaire (HCQ)(change from baseline to 4 months post visit)
- Patient Experience with Treatment and Self-Management (PETS) Questionnaire Medical Expenses Subsection(change from baseline to 4 months post visit)
- Patient Self-Activation Measure (PAM-13) short form(change from baseline to 4 months post visit)
- Discussion of social determinants of health (SDH) during clinic visit, self-reported(after each clinic visit, within 2 weeks)
- Perceived Diabetes Self-Management Scale(change from baseline to 4 months post visit)
- SF-12, Short Form 12 questions Health Survey(change from baseline to 4 months post visit)
- Blood pressure measurement(change from baseline to 4 months post visit)
- Body Mass Index(change from baseline to 4 months post visit)
- Physician Job Satisfaction Scale(change from baseline to 4 months post visit)
- Maslach Burnout Inventory Human Services Survey for Medical Personnel(change from baseline to 4 months post visit)
- Anxiety Symptoms(change from baseline to 4 months post visit)
- Depression symptoms(change from baseline to 4 months post visit)
研究者
Elizabeth Marianne Magnan
Associate Professor
University of California, Davis