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临床试验/NCT03404882
NCT03404882已完成不适用

Enhancing Peer-support Experience for Patients Discharged From Acute Psychiatric Care: Protocol for a Randomized Controlled Pilot Trial

University of Alberta10 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
10
主要终点
Core Outcome Measure

研究概览

简要总结

The aim of the project is to conduct a four arm randomized controlled pilot trial to evaluate the effectiveness of an innovative peer support program that incorporates leadership training, mentorship, recognition, reward systems and supportive/reminder text messaging for patients discharged from acute (hospital) care. Methods and analysis: This is a prospective, rater-blinded, four arm randomized controlled trial. 180 patients discharged from acute psychiatric care in Edmonton, Alberta, Canada will be randomized to one of four conditions: treatment as usual follow-up care, enrollment in usual follow-up care plus daily supportive/reminder text messages, enrollment in a peer support system plus daily supportive/reminder text messages or enrollment in a peer support system without daily supportive text messages. Patients in each group will complete evaluation measures (e.g., recovery, general symptomatology, functional outcomes) at baseline, six and twelve weeks & six and 12 months. Service utilization data and data regarding the experience of the peer support workers will also be collected. Data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. We hypothesize that patients enrolled in the peer support system plus daily supportive/reminder text messages condition will achieve superior outcomes in comparison to other groups. Peer support worker experience will be derived from exploratory data analysis.

详细描述

Background and Rationale Peer support is emotional, social and practical help provided by non-professionals to assist people with sustaining health behaviours. The peer support workers share a similar condition as patients, effectively manage their condition, and have received training to provide support. Peer support is provided to people with psychological health complaints by peer supporter workers with lived experience, and the position of peer support worker may include activities such as advocacy, connecting patients with resources, and experiential sharing, among others .

Peer support is consistent with the recovery paradigm in mental health, and is differentiated from psychiatric models of traditional diagnosis and treatment. The purported mechanisms through which peer support may function are through experiential knowledge sharing, modeling of adaptive coping strategies, social comparison, and enhancing social support. Moreover, peer support may be particularly useful for clients who have difficulty engaging in conventional services . It may be the case that peer support systems can serve as an entry point into the healthcare system for 'hardly reached' individuals and at the very least, serve as a means of providing supportive services for those who would otherwise not engage in treatment. In addition, providing peer support may offer benefits to the peer supporter her/himself, by enhancing feelings of competence and personal value .

Peer support is valued in recovery-oriented models of mental health and is becoming increasingly implemented organizationally [see Myrick and del Vecchio for a discussion]. Many studies have reported positive effects of peer support, including lower inpatient service use, better relationships with providers, and increased engagement. However, a recent rigorous evaluation of randomized controlled trials (RCTs) of peer support studies reported that outcomes were generally mixed and often non-significant. In their review, the authors noted a high degree of bias and methodological limitations in the studies they reviewed, and concluded that "peer support programmes should be implemented within the context of high quality research projects wherever possible".

In addition to methodological improvements of research on peer support, there is a need to further develop the peer support workforce. Identified areas of development for peer support programs include: how to define "peerness", role clarity and integration with existing systems, credentialing, and workforce development. Within our local context, in the province of Alberta, Canada, peer support for patients has been in existence for many years. Anecdotal evidence suggests there is low uptake and high attrition for peer support worker roles within the province. There has been a drive to develop curricula and organizational infrastructure to formally train and support peer support workers. Administrators who have worked with peer support workers suggest the lack of adequate incentives may contribute to peer support workforce challenges. Relatedly, there are often limited incentives for mental health professionals to provide supervision and mentorship for peer support workers locally.

In summary, the existing literature suggests there is opportunity for innovation in peer support programs, and there is a need for rigorous methodology to better evaluate outcomes from peer support programs. There is also a need to further develop the peer support workforce. The current paper describes a randomized controlled trial that is designed to systematically evaluate a novel peer support model termed the "Edmonton Peer Support System" (EPSS), which incorporates innovative features of service delivery (i.e., an incentive-based model of training, text messaging) and rigorous methodological design to minimize bias and confounds (e.g., comprehensive measures of outcome; methodological design features including longitudinal, prospective, three arm parallel design, and rater-blinding).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors will be blinded to treatment group allocation by not involving them in discussions about study participants and not granting them access to the database which contains the randomization code. In addition, study participants will be asked not to reveal their treatment allocation to their assessor. Moreover, these assessors will not be involved in data analysis. To test the success of blinding we will ask the assessor to guess the treatment group for each participant at six and 12-month follow-up. After data collection is complete all data will undergo a blind review for the purposes of finalizing the planned analysis.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are 18-65 years of age, able to provide informed written consent, have been diagnosed with an enduring mental health condition and are ready for discharge from an acute care facility within the Edmonton Zone with community mental health follow-up.
  • Patients should have a mobile handset capable of receiving text messages. Mobile phone handsets and top-up call credit of up to 10 dollars monthly will be provided to those who satisfy the inclusion criteria but do not have mobile phones.

排除标准

  • Patients will be ineligible if they do not meet the above inclusion criteria, if they have only an addictive disorder but no mental health diagnosis, are not capable of reading text messages from a mobile device, or will be out of town during the 12 month follow-up period.
  • Patients are also ineligible if they do not consent to take part in the study.

结局指标

主要结局

Core Outcome Measure

时间窗: 6 & 12 Weeks and 6 $ 12 Months

Core outcome measure has 34 question measure covering 5 sub-scales * Relation to self and others * Daily living and role functioning * Depression and anxiety * Impulsive and addictive behaviour * Psychosis Sub-scale and overall mean scores also range from 0 to 4. Four of the five subscale scores and the BASIS-32 average are computed by averaging the ratings for component items using the number of non-missing items as the denominator. The score range from 0 to 128

Changes in Health of Nations Outcome Scale (HoNOS) score from Baseline

时间窗: 6 & 12 Weeks and 6 $ 12 Months

HoNOS measures the symptom severity and social functioning across time. It has 12 items that measure behaviour, impairment, symptoms and social functioning. The items are rated on a scale of 0-4 and the results or changes in ratings are known as outcomes and may be attributed to services provided. The scores range from 0 to 48.

次要结局

  • World Health Organization Quality of Life Brief instrument (WHOQOL-BREF) score(6 & 12 Weeks and 6 $ 12 Months)
  • Perceived Discrimination Scale score(6 & 12 Weeks and 6 & 12 Months)
  • Peer Support Worker Job satisfaction(6 & 12 Months)
  • Recovery Assessment Scale score(6 & 12 Weeks and 6 &12 Months)
  • Patient Satisfaction/Experience Questionnaire(6 & 12 Months)
  • Rates of Health services utilization(6 & 12 Months)
  • Peer Support Worker Acceptability(6 & 12 Months)
  • Recovery Assessment Scale score for Peer Support workers(6 & 12 Months)
  • Cost of Health services utilized(6 & 12 Months)
  • Peer Support Worker Effectiveness(6 & 12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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