Viewing Study NCT05133726



Ignite Creation Date: 2024-05-06 @ 4:54 PM
Last Modification Date: 2024-10-26 @ 2:18 PM
Study NCT ID: NCT05133726
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-04-17
First Post: 2021-10-21

Brief Title: Peer and Text Message Support to Reduce Readmission Rates for Patients Discharged from Acute Psychiatric Care
Sponsor: University of Alberta
Organization: University of Alberta

Study Overview

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
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 AMH 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 84-119 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 140 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 callstextszoom 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 httpsapplicationresiliencenhopecom 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 AMH 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 Albertas North Zone which improved the psychological treatment gap and was effective scalable ie 10000 recipients within 6 months and the Text4Hope program launched in Alberta during the COVID 19 pandemic which was also effective and scalable 48000 subscribers within 3 months Text4Support provides Cognitive Behavioral Therapy CBT-based and diagnosis-specific ie 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 Dont be discouraged by todays 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 eg 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 caresupport 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 outerinner 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 ie 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 10800 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None