A Randomized Controlled Trial of Portable Electronic(USB)and Paper Medical Records as an Adjunct to Usual Care (Portable Health File RCT): an Evaluation of Short Term Quality Measures and Long-term Clinical Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 382
- 试验地点
- 2
- 主要终点
- Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events
研究概览
简要总结
The PHF trial will assess the acceptability and long term outcomes resulting from the usage of electronic (carried by the patient on a USB memory device) and paper portable health files in a population with high intensity use of medical services. The rationale is that use of the portable health files provides a conduit of direct communication among health care providers of a patient's important health care information and this leads to better care and patient outcomes.
Primary hypothesis: Addition of a patient-held portable health file (PHF) to usual care improves patient outcome and quality-of-life compared to usual care alone.
Secondary hypothesis: Addition of patient-held portable health file (PHF) to usual care is acceptable and satisfactory to patients and their health care providers.
详细描述
A common problem faced by patients and clinicians in our health system is continuity of care and 'clinical handovers'. Few medical record technologies, paper or electronic, top down or bottom up, have been evaluated in a randomised clinical outcome trial to determine the clinical benefits and costs of 'shared' medical and health information. Furthermore, although there are many studies that have evaluated processes of care only a minority do so within a randomized design. Given that any difference is, possibly, small to moderate in magnitude, and given confounders, the use of a randomisation is an essential design requirement.
The first 12 months of the trial constitutes Stage 1 whose primary objective is to describe the acceptability and satisfaction of the our Portable Health Files, and other key process measures. The subsequent 36 months constitutes Stage 2 whose primary objective it to compare important clinical outcomes. The assigned treatment (i.e., the e-PHF or p-PHF) will be used for 4 years total.
To take into account a probable lag effect of the interventions, patients will also be followed for an additional 3 years beyond the conclusion of the randomised trial to see if there are any longer-term effects.
The trial is un-blinded so there will be a potential for bias in trial conduct and a potential for ascertainment bias in the determination of important clinical outcomes and quality-of-life. To reduce clinical outcome ascertainment bias a blinded Adjudication Committee will make the determination which out-of-hospital events are "serious". The other primary outcomes: mortality and all overnight hospitalizations are objective outcomes and are not subject to ascertainment bias.
Secondary outcomes include quality of life, quality measures uptake, investigations, medication use, medication errors, and adverse drug reactions. Utilities and costs will also be collected for cost-effectiveness analysis. Patient and provider acceptability and satisfaction with the PHFs will be also collected.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Primary outcomes, death and overnight hospitalisations, are obtained through record linkage and are masked outcomes. Outcome assessor, however, is not masked to patient-reported outcomes. Chief Investigator and statistical analyses are masked to randomisation/intervention group.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be of age 60 or greater
- •Patients living independently in the community. Hostel care is acceptable, but patients that are not independent requiring full nursing home care are excluded.
- •Subjects must have had six medical practitioner visits in the previous 12 months
- •Subjects must have at least two of the following confirmed chronic diseases that require prescription oral or parenteral drug treatment or surgery and requiring at least annual specialist consultation: cardiovascular, respiratory, endocrine, renal, neurologic, gastrointestinal, hepatic, genitourinary, haematologic. infective, rheumatic, inflammatory, immunologic or neoplastic disease.
- •6. Subject's GP must have access to a computer during the consultation visit.
- •Subjects must have at least two medical specialists at least one of whom has access to a computer during the consultation visit.
- •8. Subjects must be able to understand the purpose of the trial and undergo full and valid informed consent.
排除标准
- •Life expectancy of less than 12 months.
- •Inability to carry a paper PHF or e-PHF and having no care-giver willing and able to accomplish same.
- •Mentally unable to undertake valid informed consent.
- •Patients who are not independent in the community, that cannot mobilise to see a specialist or requiring full nursing home care
结局指标
主要结局
Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events
时间窗: 48 months + 36 month extension
The primary outcome is the total number of important clinical events (all hospitalisations except same-day hospitalisations, all serious out-of-hospital events and deaths). See above: The assigned treatment (i.e., the e-PHF or p-PHF) will be used for 4 years total. Patients will also be followed for an additional 3 years beyond the conclusion of the randomised trial to see if there are any longer-term lag effects.
次要结局
- guidelines uptake and documentation(every 6 months for 24 months then every 12 months until 48 months)
- health service utilisation and health care costs(every 12 months for 48 months)
- medication errors, duplicative investigations(every 12 months for 48 months)
- information technology and computer expertise(every 6 months for 24 months then every 12 months until 48 months)
- clinical workflow(every 6 months for 2 years then every 12 months until 48 months)
- subject and health care provider acceptability and satisfaction with portable health files (PHF)(every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months)
- health literacy(every 12 months until 48 months)
- Quality of Life(every 12 months for 48 months)
- adverse events(every 3 months for 24 months then every 6 months until 48 months)
研究者
Marissa Lassere
Senior Staff Specialist
St George Hospital, Australia