A Pilot Study to Improve Patient-Doctor Communication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Degree of shared medical decision-making
研究概览
简要总结
The purpose of this controlled pilot study is to determine whether an intervention aimed at patients will improve partnering, shared decision-making and open communication. Results from this pilot study will inform how to best proceed with a larger multi-centered randomized controlled trial.
The specific hypothesis for this pilot study is to:
- Test the feasibility of a simple patient-centered intervention.
- Test the correlation between patient readiness to actively engage in conversation (assessed using a pre-visit patient survey) and actual patient behaviors in the encounter.
- Develop a coding tool that will quantify patient activation in clinical encounters.
- Test whether activating patients who are more involved and revealing in the patient-clinician dyad will improve patient and clinician outcomes.
详细描述
Chronic illness requires a greater participation by the patient in the management of their own disease process. Patients now increasingly find themselves dealing with multiple illnesses over the span of their lifetime.
Patient-provider communication is key to optimal patient outcomes. Numerous studies have shown adverse effects of poor communication on a number of outcomes, including patient and provider satisfaction as well as medical compliance and health related outcomes.
An important next step in this field is to study whether it is possible to improve chronic illness care in real world settings by improving the quality of patient-provider interaction through feasible interventions focused on efficient, motivational, and empathic communication, targeted at both patients and providers.
There is little information on the best patterns of communication in dealing with patients with multiple comorbidities. The investigators believe that an optimal healing relationship between these patients and their healthcare providers includes shared decision-making, partnering between patients and clinicians to foster health and healthy behaviors in an environment of trust, and effective open communication.
An important outcome for this pilot study is feasibility. The investigators intend to conduct a follow-up multi-centered trial; planning and budgeting for such a trial will require information gleaned from this study. What is the rate of accrual and how many patients can realistically be enrolled and followed within the current study personnel. What outcomes are sensitive to change and how much change can the investigators expect to see? Will this intervention effect change in patient behavior? This study will give us insight to allow us to build a right-sized project.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Military health care beneficiaries presenting for chronic medical care with their primary care clinician
- •Over the age of 18
- •At least 2 and no more than 10 visits with their primary care provider in the previous year
- •Receiving pharmacological treatment for hypertension
- •At least 2 of the following common chronic illnesses: hyperlipidemia, chronic obstructive pulmonary disease, asthma, congestive heart failure, chronic pain, ischemic heart disease, osteoarthritis, depression, back pain, chronic headaches, or diabetes
排除标准
- •Over the age of 80
- •Incapable of completing the questionnaires, either due to cognitive impairment or lack of English-literacy
结局指标
主要结局
Degree of shared medical decision-making
时间窗: Baseline
Assessed from transcribed audio-tapes of the doctor-patient encounter using Roter Interaction Analysis System (RIAS).
Adherence to anti-hypertensive drug treatment at baseline
时间窗: Baseline
This outcome will be assessed using pill counts by the pharmacists.
Adherence to anti-hypertensive drug treatment at one month
时间窗: One month
This outcome will be assessed using pill counts by the pharmacists.
Adherence to anti-hypertensive drug treatment at three months
时间窗: Three months
This outcome will be assessed using pill counts by the pharmacists.
次要结局
- Patient satisfaction(Baseline)
- Clinician rating of patient as "difficult"(Baseline)
- Patient Trust in their physician at baseline(Baseline)
- Patient Trust in their physician at one month(one month)
- Patient Trust in their physician at three months(Three months)
- Systolic and Diastolic Blood Pressure at baseline(Baseline)
- Systolic and Diastolic Blood Pressure at one month(One month)
- Systolic and Diastolic Blood Pressure at three months(three months)
研究者
Patrick G. O'Malley, MD, MPH
Professor of Medicine
Walter Reed National Military Medical Center