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临床试验/NCT00307697
NCT00307697已完成1 期

A Randomised Controlled Trial of a Letter Intervention in Primary Care Patients to Improve Depression and Anxiety Disorders

Bayside Health2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年6月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
score on a depression/anxiety rating scale at 1 month and 3 months

研究概览

简要总结

Currently patients thought to have anxiety or depression by their GPs are referred to the Primary Mental Health Team (PMHEIT) for psychiatric assessment. This assessment consists of a one-hour interview with a senior psychiatry registrar or psychiatrist, who then writes a letter to the referring GP. The letter contains diagnostic information and management recommendations. It is not current practice to send a copy of this letter to the patient. We hypothesize that patients who receive a copy of the psychiatric assessment letter that is sent to GPs will improve adherence to treatment recommendations; and that patients who receive a copy of the letter will have improved outcomes.

GPs will be asked to agree to the participation of their patients. Participants will be persons over the age of 18 years who are referred to the PMHEIT for assessment and who receive primary diagnoses of depression or anxiety. After the assessment interview, the patient will be given an explanatory letter and a consent form. Consenting patients will complete the Depression and Anxiety Stress Scales (DASS) and a SF12 questionnaire to measure the level of disability they are experiencing due to their mental condition.

Participants will be randomly allocated into two groups: a control group who will not receive a copy of the assessment letter, and an experimental group who will be mailed a copy of the same information that their GP receives. The registrar who conducts the assessment and writes the report will not know to which group each participant has been assigned. Thus, the content of the letter will not be affected by knowledge that the patient will or will not see it. The letter will be sent simultaneously to the referring GP and to experimental group participants. To ensure confidentiality, the letter will be sent by registered mail.

Three weeks later, participants will be mailed a copy of the DASS. After a week, they will be contacted by phone and asked for their DASS responses. They will also be asked a brief series of questions regarding their adherence to the treatment recommendations given in their assessment letter. When adherence is partial or absent, the interviewer will attempt to ascertain the reason. This procedure will be repeated at 3 months, except that assessment on the SF12 will also take place.

详细描述

In 2004, the UK National Health Service mandated the practice of sending patients copies of all correspondence between clinicians involved in their care. Such a policy is consistent with the principle of autonomy and with the right of the patient to access information about themselves (Somerville, 1994). It is also supportive of a collaborative model of service delivery in which patients are viewed as active agents in their own wellbeing, as opposed to passive recipients of treatment.

Letter interventions have boosted attendance rates for cervical screening (McDowell, Newell & Rosser, 1989a), blood pressure checks (McDowell, Newell & Rosser, 1989b), and mammography follow-up (Saywell et al., 2003). They have also resulted in improved adherence to antihypertensive medications and lipid lowering agents (Atthobari, Monster & de Jong-van den Berg, 2004). However, caution has been urged in relation to the use of letters in some patient subpopulations, such as persons who lack the capacity to consent and patients who have psychiatric diagnoses (Jelley, van Zwanenberg & Walker, 2002).

Despite these cautions, psychiatric patients react positively to the idea of receiving a copy of the letters containing clinical information that are routinely sent to their GP. At least three quarters of patients who had never received such a letter wished to do so (Dale, Tadros, Adams & Deshpande, 2004; Marzanski, Musunuri & Coupe, 2005), and at least 80% of patients who had received a letter supported the practice (Asch, Price & Hawks, 1991; Nandhra, Murray, Hymas & Hunt, 2004). Most psychiatric patients wished to continue to receive such letters, and a number commented that "seeing their problems understood and described objectively helped them to gain perspective" (Nandhra et al., 2004, p. 41).

Some psychiatric patients and practitioners, even those who favour letter interventions in principle, have expressed reservations. One commonly expressed concern is over the preservation of patient confidentiality, especially with regard to psychiatric reports that containing highly personal information (see, for example, Marzanski et al., 2005; Nandhra et al., 2004). To date, however, there have been no reported breaches of confidentiality in Britain. In fact, most patients are happy for letters to be mailed to them, as are the carers of patients with dementia (Harris & Boaden, 2003). Some patients and practitioners are also concerned that the contents of the letter may cause distress (Marzanski et al., 2005; Nandhra et al., 2004). However, the reaction reported by most psychiatric patients themselves was that when they read the letter they did not experience any distress at all. A minority of patients did initially feel distress, but they reported that once they had regained composure they found the letter helpful and were glad they had received it (Nandhra et al.).

An issue that has not yet been clarified is whether receipt of a letter improves adherence to treatment recommendations in cases of psychiatric illness. This is a critical issue; a recent review of adherence to antidepressant medication found drop out rates as high as 33% (Pampallona & Bollini, 2002). The major aim of the current study is to establish whether adherence to treatment is boosted by a letter intervention. If such an effect is found, it should follow that increased adherence leads to improved reduction in the severity of symptoms, and consequently to improved patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

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

  • diagnosis of primary depressive or anxiety disorder
  • gender (males and females both eligible)

排除标准

  • primary substance abuse disorder (though co-morbid substance abuse will not be an exclusion criterion)
  • significant personality disorder
  • psychosis
  • high suicidal risk or risk of harm to others
  • inability to speak and read English to a standard that allows independent completion of the questionnaires
  • under 18 years of age
  • incapable of giving consent
  • significant medical condition
  • clinician discretion

结局指标

主要结局

score on a depression/anxiety rating scale at 1 month and 3 months

score on a quality of life scale at 1 month and 3 months

次要结局

未报告次要终点

研究者

发起方
Bayside Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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