Clinical trial NCT03404882: Peer Support Experience for Patients Discharged From Acute Psychiatric Care
Official title: Enhancing Peer-support Experience for Patients Discharged From Acute Psychiatric Care: Protocol for a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Bipolar Disorder
Schizophrenia
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2018-01-19
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a longitudinal, prospective, parallel design, three arm, rater-blinded randomized clinical trial with a recruitment period of six months and an observation period of 12 months for each participant.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

One of the innovative features of this study is the incorporation of text messaging. Text messaging is a relatively low cost, high impact, and easily scalable program that uses existing technology, is devoid of geographic barriers, and is easily accessible to end users. There is evidence that supportive text messaging demonstrates positive effects in terms of symptom improvement and patient satisfaction. For example, patients with depression and comorbid alcohol use disorder showed significantly lower depressive symptoms on standardized self-report than a similar patient group who did not receive messages \[large effect size)(9)\]. A second randomized trial demonstrated similar results \[(Cohen's d= 0.67)(10)\]. In terms of satisfaction, over 80% of subscribers reported that a texting program improved their mental health.

There is also evidence that reminder text messaging improves appointment attendance rates. For example, in a systematic review and meta-analysis of eight randomized controlled trials involving 6615 participants, the authors found moderate quality evidence from seven studies (5841 participants) that mobile text message reminders improved the rate of attendance at healthcare appointments compared to no reminders \[risk ratio (RR) 1.14 (95% confidence interval (CI) 1.03 to 1.26)\]. They also found that text messaging reminders were similar to telephone reminders in terms of their effect on attendance rates, yet cost less than telephone reminders.

Another innovative feature of this study is the incorporation of a peer support incentive system. As discussed, the peer support workforce has been identified as an area in need of development, including role clarity, integration with healthcare professionals, and credentialing. Specifically, a lack of a "career ladder" or a clear movement within positions of peer support work has been identified, with movement possible laterally (but not upward) within many program structures. In this project, peer support workers will participate in an incentive based system that formally recognizes performance. The EPSS is structured as follows:

* Peer support workers are people with lived mental health experience who are at a point in their personal recovery where they consistently demonstrate the ability to share their individual story in a manner that inspires hope and builds relationships with others. Peer support workers who are employed by Alberta Health Services (AHS), our provincial health authority, will be invited to enroll as foundational members of the EPSS.
* Members will be provided with formalized training developed within our health region, involving knowledge training, practice, and ongoing meetings throughout offering the program to assist peer support workers in adhering to principles consistent with a peer support framework and recovery philosophy and problem-solving concerns or challenges that may arise. Peer support workers will receive clinical support/mentorship from mental health therapists.
* Patient beneficiaries of EPSS will receive supportive face-to-face visits, phone calls, and interactive text message support from their peer support workers. They will also receive reminder text messages for their appointments.
* Patient beneficiaries will be enrolled as associate members of the EPSS and will be provided with training to act as peer support workers when they are an advanced stage in their recovery. At this time they can apply for AHS peer support worker roles as available.
* Contributions of peer support workers will be recognized via attainment of different levels of membership (e.g. "star" levels) and certificates of recognition (bearing logos of collaborating institutions) at formal ceremonies. Star-level recognition will be categorized into: Silver Star Memberships (five stars), Gold Star Memberships (ten stars), and Star Fellowships (twenty stars).
* Contributions of mental health therapists towards supporting/mentoring peer support workers will also be recognized through star memberships and certificates at formal ceremonies.

The hope of EPSS is to increase compassion and decrease stigma, foster multi-disciplinary teamwork, incorporate client/caregiver experiences, and strengthen service provider skills and abilities. Our proposed EPSS will provide training for those with mental health challenges that will enable them to contribute providing compassionate care for mental health patients. This program philosophy is aligned with regional goals relating to improvement of mental health services in our province.

Aim and Objectives The aim of the project is to evaluate the effectiveness of an EPSS which incorporates leadership training, mentorship, recognition, reward systems and supportive/reminder text messaging for patients discharged from acute (hospital) care. The client outcomes will be organized according to: recovery variables (e.g., recovery, stigma), functional variables (quality of life, employment), symptom variables (psychological symptoms, general outcomes), and service variables (e.g., heath service utilization, cost, satisfaction), as further described in Methods and Analysis. Peer support worker outcomes will also be evaluated, including effectiveness, job satisfaction, acceptability, and recovery.

The objectives of the project include:

1. To compare mean changes in recovery, functional outcomes, clinical symptoms, and service variables after six weeks, twelve weeks, six months and twelve months for patients in each of the three arms: those discharged from acute care and enrolled in peer support system plus daily supportive/reminder text messages; those with usual follow-up care plus daily supportive/reminder text messages, and those receiving usual follow-up care.
2. To assess job satisfaction, acceptability, and recovery of peer support workers at six and twelve months.
3. To assess job satisfaction among mental health therapists offering support and mentorship for peer support workers.

Hypothesis The investigators hypothesize that patients enrolled in the peer support system plus daily supportive/reminder text messages will achieve superior outcomes compared to patients enrolled in the other arms of the study on each outcome measure used. In turn, patients enrolled in peer support will have superior outcomes to patients enrolled in the treatment as usual condition.

Data Analysis:

Initially, we aimed to deploy intention-to-treat analysis, whereby patient data are analyzed according to their original assigned groups, regardless of time spent in the study. However, after randomization and due to clinical logistic reasons, a significant number of patients did not receive access to the Peer Support Worker service in the two intervention arms of Peer Support Worker. Thus we have made a strategic decision to adapt the protocol to a Controlled Observational Study and to change the analysis approach to as-treated, rather than intention-to-treat to maximize the investigational value of the study without compromising or biasing outcomes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Core Outcome Measure
timeFrame: 6 & 12 Weeks and 6 $ 12 Months
measure: Changes in Health of Nations Outcome Scale (HoNOS) score from Baseline
timeFrame: 6 & 12 Weeks and 6 $ 12 Months
Secondary outcomes:
measure: Perceived Discrimination Scale score
timeFrame: 6 & 12 Weeks and 6 & 12 Months
measure: World Health Organization Quality of Life Brief instrument (WHOQOL-BREF) score
timeFrame: 6 & 12 Weeks and 6 $ 12 Months
measure: Patient Satisfaction/Experience Questionnaire
timeFrame: 6 & 12 Months
measure: Rates of Health services utilization
timeFrame: 6 & 12 Months
measure: Cost of Health services utilized
timeFrame: 6 & 12 Months
measure: Peer Support Worker Effectiveness
timeFrame: 6 & 12 Months
measure: Peer Support Worker Job satisfaction
timeFrame: 6 & 12 Months
measure: Peer Support Worker Acceptability
timeFrame: 6 & 12 Months
measure: Recovery Assessment Scale score for Peer Support workers
timeFrame: 6 & 12 Months
measure: Recovery Assessment Scale score
timeFrame: 6 & 12 Weeks and 6 &12 Months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alex Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Misericordia Community Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Hospital
state: Alberta
Study officials:
References:
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