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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05133726
Other study ID # Pro00111459
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1132
Est. completion date September 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Text4Support
Daily supportive text messages
Peer support
Meeting with peers who have lived experiences with similar diagnoses but are in recovery

Locations

Country Name City State
Canada Foothills Hospital Calgary
Canada Alberta Hospital Edmonton Alberta
Canada Grey Nuns Hospital Edmonton Alberta
Canada Misericordia Community Hospital Edmonton Alberta
Canada Royal Alexander Hospital Edmonton Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada Northern Lights Regional Health Centre Fort McMurray Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Alberta Alberta Innovates Health Solutions

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. Erratum In: JMIR Res Protoc. 2021 Nov 8;10(11):e34515. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in the Reach of the Text4Support We will monitor and evaluate changes in the proportion of target population who receive the supportive text messages baseline, 24 weeks, 52 weeks
Other Change in the fidelity of the intervention We will monitor and evaluate changes in the adherence of peer support workers to the implementation guidelines/protocols baseline, 24 weeks, 52 weeks
Other Sustainability of the intervention We will evaluate the proportion of implementation sites who continue implementing the intervention after the active phase of the project 52 weeks
Other Acceptability of the intervention Using satisfaction surveys, we will evaluate the proportion of participants who found the intervention acceptable 52 weeks
Primary Change in 30 day readmission rate Readmission to acute psychiatric care within 30 days of discharge baseline, 24 weeks, 52 weeks
Secondary Change in Clinical Outcomes in Routine Evaluation 10 (CORE-10) scores The CORE-10 is a short 10 item easy-to-use assessment measure for common presentations of psychological distress, designed to be used for screening as well as over the course of treatment to track progress. The measure is a shortened version of the 34 item CORE Outcome Measure tool, both of which ask respondents to self-report symptoms over the past week. baseline, 24 weeks, 52 weeks
Secondary Change in EuroQol- 5 Dimension (EQ-5D)scores EQ-5D is an instrument which evaluates the generic quality of life baseline, 24 weeks, 52 weeks
Secondary Change in Patient Health Questionnaire (PHQ-9) scores The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: n The PHQ-9 incorporates the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. baseline, 24 weeks, 52 weeks
Secondary Change in Recovery Assessment Scale (RAS)scores The RAS is a 20-item measure developed as an outcome measure for program evaluations. Based on a process model of recovery, the RAS attempts to assess aspects of recovery with a special focus on hope and self-determination. baseline, 24 weeks, 52 weeks
Secondary Change in Brief Resilience Scale scores The Brief Resilience Scale was created to assess the perceived ability to bounce back or recover from stress. The scale was developed to assess a unitary construct of resilience, including both positively and negatively worded items. The possible score range is from 1 (low resilience) to 5 (high resilience). baseline, 24 weeks, 52 weeks
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