Clinical trial NCT05133726: Peer and Text Message Support to Reduce Readmission Rates for Patients Discharged From Acute Psychiatric Care
Official title: Reducing Inpatient Readmission Rates for Patients Discharged From Acute Psychiatric Care in Alberta Using Peer and Text Message Support: Protocol for an Innovative Supportive Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychiatric Illness
Keywords: Psychiatric Illness
Peer support
Text Message
Electronic health (eHealth)
Readmission rate
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
First posted: 2021-11-24
Enrollment: 1132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped edge design
Primary purpose: SUPPORTIVE_CARE

Brief summary: Avoidable hospital readmissions are a pressing problem for our healthcare system. They lead to substantial human suffering and higher financial costs. Most discharged psychiatric inpatients in Alberta are offered follow-up appointments with Alberta Health Services (AHS) Addiction and Mental Health (AMH) community providers. Patients often wait 28-38 weeks for their first appointment, which leads many to miss their first appointments, and increases the likelihood of relapse. As a result, patients discharged into the community are readmitted to the Emergency Department (ED). To address this significant revolving door, the investigators will implement a low-cost, evidence-based system that delivers daily supportive texts to patients' mobile phones. The text messages developed by experts and service users, based on cognitive behavioral therapy principles. Our proposed program also includes peer support from previous mental health patients who have had similar challenges as participants, but are now in recovery. In this way, the investigators aim to reduce the psychological treatment and support gap for AMH patients who have been discharged from acute care and are scheduled to receive mental health and psychiatric treatment from A\&MH services after a long wait. Our pilot test of these interventions provide evidence that psychiatric readmissions, and emergency department visits can be reduced by 10-25% if implemented at scale in Alberta, thus resulting in cost-savings for individuals and the province.

Detailed description: Background \& Rational Avoidable hospital readmission is a growing concern in health systems across the world. Readmissions often lead to significant physical, psychological and financial suffering on the part of patients and their families. The health system is also affected by high readmission rates. Infrastructural, human and financial resources, which are limited, often get stretched. This is particularly true in the era of the 2019 corona virus disease (COVID-19) pandemic, which has seen many hospitals overwhelmed by rising emergency presentations. Consequently, there is a renewed interest to seek out solutions to mitigate avoidable readmissions, particularly in acute care.

Patients with psychiatric disorders have the highest early readmission rates among all hospitalized patients. Early readmission is defined as readmission within 30 days of previous discharge. Whereas deinstitutionalization of care and transition to community-based mental health care has been an approach of focus for decades, early hospital readmission remains high. Unmet need for psychological treatment and the limited human resources to address this gap is a major cause of high 30-day readmissions rates in mental acute units.

In Alberta, Canada, about 8.4-11.9% of residents suffer from mental illness, but less than 25% of these patients report that their mental health care needs were fully met. This is despite almost 70% of mental health patients utilizing a provincial mental health service the year before, according to a 2014 mental health gap assessment report. The greatest unmet need cited is the lack of sufficient, accessible, and affordable counselling. Their next greatest concern was an unmet need for tailored information on their own mental health challenges. This is despite the 426 distinct interventions within AHS to address addiction and mental health challenges through community health clinics, and free-standing AMH facilities, among others. Interestingly, 86% of Alberta Health Services direct providers believe that they provide sufficient information to clients. This contradiction between patients and community providers' perspectives reinforces concerns that services may not be well tailored to the diverse perceived needs of various patient groups. A consequence of this gap is the high demand for more specialist services, and high readmissions after discharge from a recent hospital stay with attendant implications on the cost of health services. One study reports 90-day readmission rates of up to 14.0%, with the median time to readmission being 24 days. More findings from the 2014 mental health gap assessment revealed that current management strategies are reactive, with system resources heavily invested in inpatient, residential and crisis services. Technology was noted to be under-utilized in the province. Reducing the felt need for hospital visits by providing alternative effective care will mitigate the existing strain on healthcare human and financial resources due to mental health challenges. To address this challenge, the investigators propose an innovative program which augments peer support from previous mental health patients now in recovery with an evidence-based supportive text messaging developed using the principles of cognitive behavioral therapy (CBT).

Components of the innovation

1. Peer support is valued in recovery-oriented models of mental health and increasingly implemented. Evidence indicates positive effects, including lower inpatient service use, better relationships with providers and increased engagement. Peer Support Workers (PSWs) who are in recovery and have lived experience as former patients will play central roles in this study, including delivering some of the interventions proposed. PSW activities will include supportive face-to-face visits, interactive phone calls/texts/zoom meetings with patients, advocacy, connecting patients with community resources, and experiential sharing. PSWs will be actively engaged through all provincial practice councils, they are embedded within many Alberta addiction and mental health (AMH) programs, making this solution workable. Evidence also shows that peers support may also benefit peer PSWs, enhancing feelings of competence and personal value.
2. Text4Support to be provided through ResilienceNHope online application (https://application.resiliencenhope.com/), is a low cost, evidence-based, supportive text messaging program which will be coupled with or without peer support services to reduce the psychological treatment and support gap for A\&MH patients who have been discharged from acute care into community. Starting a day after enrolment, intervention-group patients will receive daily unidirectional (no-reply) supportive text messages. The messages will be written by cognitive behavior therapists in partnership with patients and preprogramed into ResilienceNHope which will deliver the messages to the patients. The Text4Support program was developed based on knowledge from randomized controlled trials conducted in Ireland and Alberta. The program is also based on knowledge from the highly successful award winning Text4Mood program in Alberta's North Zone which improved the psychological treatment gap and was effective, scalable (i.e., \> 10,000 recipients within 6 months) and the Text4Hope program launched in Alberta during the COVID 19 pandemic which was also effective and scalable (\> 48,000 subscribers within 3 months). Text4Support provides Cognitive Behavioral Therapy (CBT)-based and diagnosis-specific (i.e., mood disorders, anxiety disorders, schizophrenia and other psychotic disorders, substance use disorders, adjustment disorders or personality disorders), daily supportive text messages for 6 months. Some examples of the text messages are:

   * What lies behind you and what lies before you are tiny matters compared to what lies within you. Have faith in yourself, and success can be yours.
   * There are 2 days in the week we should not worry about, yesterday and tomorrow. That leaves today. Live for today.
   * Stumbling blocks can become stepping stones to a better life. You can turn adversities into opportunities. Don't be discouraged by today's problems.
   * Letting go of resentment is a gift you give yourself. It will ease your journey immeasurably. Make peace with everyone, and happiness will be yours.

With respect to content, analysis of Alberta service data suggests that diagnostic clusters for patients discharged from acute into community for follow-up falls into six major categories: mood disorders, anxiety disorders, schizophrenia and other psychotic disorders, substance use disorders, adjustment disorders and personality disorders. Thus, text message content will focus on two dimensions. First, general content that is indicated regardless of symptomatology will be presented, including messages of self-care, social support, hope, affirmation, and recovery. Second, specific content will be provided that focuses on management of symptoms related to the specific conditions described above (e.g., activity scheduling in depression). As a component of scalability and inclusiveness, text message content can also be customized based on end user characteristics. Specifically, the investigators will explore content that is sensitive to needs based on age group, cultural identity, gender identification, and non-English language communication. This serves to enhance access for diverse groups, many of whom may be marginalized or underserved. In addition, patients identified to be most at-risk of readmission to hospital will be offered peer support, which also takes into account age and gender of both the patient and PSWs. Options for matching patients and PSWs by cultural identity and sexual orientation will be explored as the project is scaled up and the pool of PSWs increases. Consequently, recruitment of PSWs will take into account diversity in age, gender, cultural identity and sexual orientation.

Study aim This study is designed to address gaps in care/support available at the community level for psychiatric patients discharged from hospital and referred to community mental health services for follow-up. The investigators aim to reduce the psychological treatment and support gap for AMH patients who have been discharged from acute care and are scheduled to receive mental health and psychiatric treatment from AMH services after a long wait. Our pilot test (unpublished) of these interventions provide evidence that psychiatric readmissions, and emergency department visits can be reduced by 10-25% if implemented at scale in Alberta, thus resulting in cost-savings for individuals and the province.

Methods and analysis This study will both evaluate the effectiveness of this intervention as well as implementation context and outcomes. The Consolidated Framework for Implementation Research (CFIR) will provide an overarching guidance to design, implementation, and evaluation by examining outer/inner contexts, intervention characteristics, and stakeholders involved as well as the process of implementation.

Further, using the Reach-Effectiveness-Adoption-Implementation- Maintenance (RE-AIM) framework, the investigators will: examine the reach of the interventions, i.e., text and peer support; evaluate their effectiveness; gauge support for their adoption; evaluate fidelity in implementation; and document the maintenance (sustainability) of implementation post-trail.

Study design A pragmatic stepped-wedge cluster-randomized approach will be applied, providing Text4Support and Peer Support Service (PSS) to 10,800 patients recruited across 11 acute care sites and day hospitals across Alberta as the clustered unit of randomization. The design reconciles constraints under which policy makers and service managers operate with need for rigorous scientific evaluations. In a stepped-wedge study, the design is extended so every cluster provides pre-post observations, and switches from control to intervention exposure but not at the same time-point.

This design has been successfully used to implement complex programs and change management involving large-scale programs in many countries. The study also adheres to the various checklists from the EQUATOR network.

Eligibility criteria: Inclusion Criteria:

* Patients who are 18 or 65 years of age
* Able to provide informed written consent have been diagnosed with mental health condition, and are ready for discharge.
* Patients should have a mobile device capable of receiving text messages

Exclusion Criteria:

* Patients will be ineligible if they do not meet the above inclusion criteria,
* If they have an addiction disorder but not a mental health diagnosis
* Are not capable of reading text messages from a mobile device or if they know they 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: Change in 30 day readmission rate
timeFrame: baseline, 24 weeks, 52 weeks
Secondary outcomes:
measure: Change in Clinical Outcomes in Routine Evaluation 10 (CORE-10) scores
timeFrame: baseline, 24 weeks, 52 weeks
measure: Change in EuroQol- 5 Dimension (EQ-5D)scores
timeFrame: baseline, 24 weeks, 52 weeks
measure: Change in Patient Health Questionnaire (PHQ-9) scores
timeFrame: baseline, 24 weeks, 52 weeks
measure: Change in Recovery Assessment Scale (RAS)scores
timeFrame: baseline, 24 weeks, 52 weeks
measure: Change in Brief Resilience Scale scores
timeFrame: baseline, 24 weeks, 52 weeks
Other outcomes:
measure: Change in the Reach of the Text4Support
timeFrame: baseline, 24 weeks, 52 weeks
measure: Change in the fidelity of the intervention
timeFrame: baseline, 24 weeks, 52 weeks
measure: Sustainability of the intervention
timeFrame: 52 weeks
measure: Acceptability of the intervention
timeFrame: 52 weeks
Locations:
city: Edmonton
country: Canada
facility: Royal Alexander 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
city: Fort McMurray
country: Canada
facility: Northern Lights Regional Health Centre
state: Alberta
city: Calgary
country: Canada
facility: Foothills Hospital
Study officials:
affiliation: University of Alberta
name: Vincent Agyapong, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adu MK, Shalaby R, Eboreime E, Sapara A, Nkire N, Chawla R, Chima C, Achor M, Osiogo F, Chue P, Greenshaw AJ, Agyapong VI. Text Messaging Versus Email Messaging to Support Patients With Major Depressive Disorder: Protocol for a Randomized Hybrid Type II Effectiveness-Implementation Trial. JMIR Res Protoc. 2021 Oct 13;10(10):e29495. doi: 10.2196/29495.
citation: Agyapong VIO, Juhas M, Ohinmaa A, Omeje J, Mrklas K, Suen VYM, Dursun SM, Greenshaw AJ. Randomized controlled pilot trial of supportive text messages for patients with depression. BMC Psychiatry. 2017 Aug 2;17(1):286. doi: 10.1186/s12888-017-1448-2.
citation: Shalaby RAH, Agyapong VIO. Peer Support in Mental Health: Literature Review. JMIR Ment Health. 2020 Jun 9;7(6):e15572. doi: 10.2196/15572.
citation: Agyapong VI, Mrklas K, Juhas M, Omeje J, Ohinmaa A, Dursun SM, Greenshaw AJ. Cross-sectional survey evaluating Text4Mood: mobile health program to reduce psychological treatment gap in mental healthcare in Alberta through daily supportive text messages. BMC Psychiatry. 2016 Nov 8;16(1):378. doi: 10.1186/s12888-016-1104-2.
citation: Agyapong VI, Ahern S, McLoughlin DM, Farren CK. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. J Affect Disord. 2012 Dec 10;141(2-3):168-76. doi: 10.1016/j.jad.2012.02.040. Epub 2012 Mar 29.
citation: Eboreime E, Shalaby R, Mao W, Owusu E, Vuong W, Surood S, Bales K, MacMaster FP, McNeil D, Rittenbach K, Ohinmaa A, Bremault-Phillips S, Hilario C, Greiner R, Knox M, Chafe J, Coulombe J, Xin-Min L, McLean C, Rathwell R, Snaterse M, Spurvey P, Taylor VH, McLean S, Urichuk L, Tzeggai B, McCabe C, Grauwiler D, Jordan S, Brown E, Fors L, Savard T, Grunau M, Kelton F, Stauffer S, Cao B, Chue P, Abba-Aji A, Silverstone P, Nwachukwu I, Greenshaw A, Agyapong VIO. Reducing readmission rates for individuals discharged from acute psychiatric care in Alberta using peer and text message support: Protocol for an innovative supportive program. BMC Health Serv Res. 2022 Mar 12;22(1):332. doi: 10.1186/s12913-022-07510-8.