Background: Mental health services are most effective and equitable when designed, delivered, and evaluated in collaboration with people with lived experience of mental health conditions. Unfortunately, people with lived experience are rarely involved in health systems strengthening or are limited to specific components (e.g., peer helpers) rather than multi-tiered collaboration in the continuum of health services (e.g., ranging from home- to community- to clinic-based services). Moreover, programs that do involve people with lived experience, typically involve people with a history of a substance use conditions or common mental disorders. In contrast, the collaboration of people with lived experience of psychosis is especially rare. A pilot cluster randomized controlled trial will be conducted in urban and peri-urban areas around Kampala, Uganda, to evaluate the benefits of an implementation strategy for mental health services with engagement of people with lived experience of psychosis throughout the home-to-community-to-clinic care continuum, this is a hybrid type-III implementation-effectiveness pilot focusing on the differences in implementation strategy. This implementation strategy, entitled "Strengthening CAre in collaboration with People with lived Experience of psychosis in Uganda", will include training people with lived experience of psychosis using PhotoVoice and other methods to participate at three levels: in-home services, community engagement, and primary health care facilities. The investigators will compare a standard task-sharing implementation arm using training by mental health specialists with an experimental implementation arm that includes collaboration with people with lived experience. The primary objective is to evaluate the feasibility and acceptability of this strategy in the context of assuring safety and wellbeing of people with lived experience of psychosis who collaborate in health systems strengthening. By collaborating on health systems strengthening across these multiple levels, we foresee a more in-depth contribution that can lead to rethinking how best to design and deliver care for people with lived experience of psychosis. Successful completion of this pilot will be the foundation for a fully powered trial to evaluate the benefits of multi-level collaboration with people with lived experience of psychosis.
The aim of the current study is to conduct a pilot cluster randomized controlled trial to determine feasibility and acceptability of people with lived experience of psychosis collaborating in training primary care and community health care workers and co-delivering services in the home. This pilot study will consist of two trial arms: - Training- As- Usual vs the experimental arm. It will be implemented across three-tiers - in primary health care, community, and home settings. The pilot will also determine the parameters needed for appropriate design and implementation of a fully-power future cluster randomized controlled trial. Objective 1 - To assess the feasibility and acceptability of the implementation strategy from the perspective of people with lived experience of psychosis, family members and primary and community care providers. Objective 2 - To demonstrate proof-of-concept for the benefit of the implementation strategy for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members. Objective 3 - To evaluate changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, accuracy of diagnosis and fidelity to treatment guidelines in actual care settings as well as trial procedures. Objective 4: To evaluate costing, recruitment and retention, and data collection procedures and protocols to determine the optimal design for a future fully powered cluster Randomized Controlled Trial. Objective 5: To establish and demonstrate ethics and safety in collaborating with service users.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Training primary care workers to detect and treat psychosis.
training community health workers in detection and referral
home visits conducted by people with lived experience of psychosis
YouBelong Uganda
Kampala, Uganda
RECRUITINGPositive and Negative Symptoms of Schizophrenia (PANSS) scale
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
Time frame: baseline - immediately after enrollment
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
Time frame: 4 months post enrollment
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
Time frame: 8 months post enrollment
World Health Organization Quality of Life-Brief Scale
Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life
Time frame: immediately after enrollment
World Health Organization Quality of Life-Brief Scale
Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life
Time frame: 4 months post enrollment
World Health Organization Quality of Life-Brief Scale
Brief quality of life scale, minimum = 0, maximum = 100, Higher score refers to better quality of life
Time frame: 8 months post enrollment
Service user collaboration checklist
Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience
Time frame: immediately after enrollment
Service user collaboration checklist
Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience
Time frame: 4 months post enrollment
Service user collaboration checklist
Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience
Time frame: 8 months post enrollment
EuroQuality of Life 5-Dimension 5-Level
Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse
Time frame: immediately after enrollment
EuroQuality of Life 5-Dimension 5-Level
Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse
Time frame: 4 months post enrollment
EuroQuality of Life 5-Dimension 5-Level
Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse
Time frame: 8 months post enrollment
Discrimination and Stigma Scale-Brief version
Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma
Time frame: immediately after enrollment
Discrimination and Stigma Scale-Brief version
Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma
Time frame: 4 months post enrollment
Discrimination and Stigma Scale-Brief version
Stigma experienced by persons living with mental illness, minimum = 0, maximum = 33, Higher score refers to higher experience of stigma
Time frame: 8 months post enrollment
Social Inclusion Scale
Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion
Time frame: immediately after enrollment
Social Inclusion Scale
Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion
Time frame: 4 months post enrollment
Social Inclusion Scale
Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion
Time frame: 8 months post enrollment
Hospitalization Record
no minimum or maximum, score is total number of days patient was hospitalized during study period
Time frame: immediately after enrollment
Hospitalization Record
no minimum or maximum, score is total number of days patient was hospitalized during study period
Time frame: 4 months post-enrollment
Hospitalization Record
no minimum or maximum, score is total number of days patient was hospitalized during study period
Time frame: 8 months post enrollment
Client Service Receipt Inventory
Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare
Time frame: immediately after enrollment
Client Service Receipt Inventory
Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare
Time frame: 4 months post enrollment
Client Service Receipt Inventory
Costs of care to patients, there is no maximum or minimum score, the outcome is total cost for patient to get healthcare
Time frame: 8 months post enrollment
Family Interview Schedule-Impact on Caregivers
Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families
Time frame: immediately after enrollment
Family Interview Schedule-Impact on Caregivers
Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families
Time frame: 4 months post enrollment
Family Interview Schedule-Impact on Caregivers
Impact on family members and caregivers of people with mental illness, minimum = 0, maximum = 48, higher score means higher burden on the families
Time frame: 8 months post enrollment
Community Health Workers: Social Distance Scale
Attitudes of community health workers towards people with psychosis, 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Time frame: pre training
Community Health Workers: Social Distance Scale
Attitudes of community health workers towards people with psychosis, 12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Time frame: immediately after training
Community Health Workers: Assessment tool
Accuracy of detection, no score - will check if their detection matches with the gold standard - Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5
Time frame: monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check
Community Health Workers: Village health team referral
no maximum or minimum, outcome is the number of patients referred by community health workers to the health post
Time frame: monthly throughout the study period (average of 8 months), starts immediately after training
Community Health Workers: Village health team referral with psychosis
no maximum or minimum, outcome is the number of patients diagnosed with psychosis by PCP and referred by community health workers to the health post
Time frame: monthly throughout the study period (average of 8 months), starts immediately after training
Primary care workers: Social Distance Scale
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Time frame: pre training
Primary care workers: Social Distance Scale
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Time frame: immediately after training
Primary care workers: Social Distance Scale
12-item scale of willingness to interact with persons with mental illness, minimum = 0, maximum = 72, higher score is worse outcome
Time frame: final supervision: 8 months post training
Primary care workers: Mental health Gap Action Program Knowledge
Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome
Time frame: pre training
Primary care workers: Mental health Gap Action Program Knowledge
Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome
Time frame: immediately after training
Primary care workers: Mental health Gap Action Program Knowledge
Multiple-choice assessment from mental health Gap Action Programme training materials; minimum = 0, maximum = 100, higher is better outcome
Time frame: final supervision: 8 months post training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Time frame: pre training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Time frame: immediately after training
Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
Observed structured clinical evaluation using a standardized role play, minimum score = 0, maximum = 100, higher scores are better
Time frame: final supervision - 8 months post training
Health Facility Record
no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants
Time frame: pre training
Health Facility Record
no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants
Time frame: immediately after training
Health Facility Record
no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants
Time frame: final supervision - 8 months post training
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5
Accuracy of patient diagnosis by study mental health specialist
Time frame: 3 months post patient enrollment
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