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临床试验/NCT01174706
NCT01174706已完成不适用

Impact of Information Prescriptions on Medication Adherence in ED Patients

Johns Hopkins University6 个研究点 分布在 1 个国家目标入组 3,940 人开始时间: 2010年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,940
试验地点
6
主要终点
Medication adherence

研究概览

简要总结

The main objectives of this research are:

  1. To identify factors that influence medication adherence rates in Emergency Department (ED) patients.
  2. To measure the effects of alternative information prescriptions on medication adherence rates of ED patients.
  3. To measure the effects of alternative information prescriptions (IRxs) on health and service utilization.

详细描述

People who are prescribed self-administered medications frequently take less than half the doses. Poor adherence to medication regimens is associated with worsening of disease, death and increased health care costs in the United States. The few studies conducted in the emergency department (ED) setting suggest that between 7 to 45 percent of patients do not fill their prescription; one study conducted in Canada reported that 45% of ED patients did not follow their prescribed regimen. One strategy that may improve medication adherence among ED patients is a better information exchange between the patient, provider and the health care system. This study will use a randomized controlled trial to test the effect that two alternative ways of delivering information prescriptions (IRxs) have on medication adherence and treatment outcomes of ED patients.

ED patients treated and released with a prescribed medication(s) from three hospitals serving different patient populations in the Baltimore metropolitan area over a 9 month period will be included in the study. Research assistants will consent eligible patients, interview them prior to ED discharge and randomize subjects to one of four study groups: (1) usual care (medication prescription and instructions provided at discharge); (2) practical assistance which consists of giving information to help subject obtain medicine (i.e. programs that offer drugs more cheaply, pharmacy hours of operation, etc)(3) an IRx that includes a MedlinePlus referral plus written information from MedlinePlus customized to the subject's health problem and prescribed medication; or (4) an IRx that consists of practical assistance and MedlinePlus referral plus customized written information from MedlinePlus plus access to information services provided by a medical librarian, herein referred to as a clinical informationist or informationist. Subjects will be contacted by telephone one week post ED visit and queried about medication use and patient outcomes (self-reported health, satisfaction with ED visit, and ED revisits or hospitalizations) and use of Internet to access health information. Medication instructions and ED discharge diagnosis data will be extracted from subjects' electronic medical record and use of informationist services documented. Medication adherence rates and patient outcomes will be compared among study groups. Self-reported use of MedlinePlus will also be compared to electronic data for all subjects. Self-reported medication and ED revisits/hospitalizations will be compared to pharmacy claims and utilization data for subjects covered by Medicaid.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (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

入选标准

  • The study population will consist of adult patients who present to one of these three EDs during a 6 - 9 month period and are discharged with a medication regimen, either a prescription or over the counter (OTC) medication.

排除标准

  • Patients will be excluded for the following reasons: (1) less than 18 years of age at time of ED visit; (2) non English or non Spanish speaking; (3) unable to understand consent or complete the baseline interview for cognitive, psychiatric or substance abuse reasons.

研究组 & 干预措施

Usual care arm

Experimental

Patients randomized to this group will receive usual care. Usual care at the three study sites varies but will be defined as whatever information is usually given to patients regarding the prescription medication or over the counter medicine they were prescribed at emergency department discharge.

干预措施: Information prescriptions (Behavioral)

Information prescription

Experimental

Patients randomized to this arm will receive written information from Medline Plus regarding the prescription or over the counter medicine they have been prescribed at ED discharge plus information on their health condition.

干预措施: Information prescriptions (Behavioral)

Informationist

Experimental

Patients in this arm will receive the same information as patients in group 2 but will also be given contact information for a clinical informationist if they have further questions about their prescription medicine or over the counter medicine prescribed at ED discharge.

干预措施: Information prescriptions (Behavioral)

practical assistance

Experimental

Subjects will be offered practical assistance with obtaining prescription such as location of most convenient pharmacy and hours of operation, programs that offer drugs more cheaply, fax prescription from ED to pharmacy

干预措施: Information prescriptions (Behavioral)

结局指标

主要结局

Medication adherence

时间窗: one week after index ED visit

Self-reported medication adherence.For subjects discharged with a prescription medication or an over the counter (OTC) medication with a specified dosage and frequency, medication adherence will be measured by the number of doses taken divided by the number of doses specified.

次要结局

  • Filling of prescription medicine(within one week of index ED visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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