Clinical trial NCT05863572: Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
Official title: Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: YouBelong Uganda
name: Butabika National Referral Hospital
First posted: 2023-05-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Facilitators of the implementation strategy:

   1. At least 18 years of age
   2. Confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or psychiatric clinical officer
   3. Completion of the YouBelongHOME (YBH) program
   4. Provision of informed consent,
   5. Fluency in the local language (Luganda)
   6. Good functioning with respect to performance of daily chores,engagement with family members, comprehension and community participation as assessed by the YBH team
   7. A supportive family member.
2. Primary care providers:

   1. Provides primary care in health facility of Kampala/Wakiso District
   2. Selected by facility in-charge
3. Community health workers

   1. Provides community based health service in health facility where primary care providers are trained (from Kampala/Wakiso district)
   2. Selected by facility in-charge
4. Patients (Primary beneficiaries)

   1. Persons diagnosed with psychosis at a primary health care facility in Kampala/Wakiso District; For this study, a diagnosis of psychosis will include the following diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):schizophrenia spectrum and other psychotic disorders \[brief psychotic disorder, schizophreniform disorder, schizoaffective disorder, schizophrenia, and organic psychosis (i.e., psychosis secondary to a medical condition such as HIV or an alcohol- or substance-use disorder)\];bipolar affective disorder and related disorders;
   2. Ability of the patient or responsible surrogate to consent to study enrolment and procedures;
   3. Persons eligible for outpatient management of psychosis
5. Family members a. Family member or caregiver of the patients above.

Exclusion Criteria:

1. Facilitators of the implementation strategy:

   a. Inability to provide informed consent.
2. Primary care providers:

   None
3. Community health workers:

   None
4. Patients

   1. Persons diagnosed with psychosis requiring inpatient management/services; and
   2. Persons for whom consent for participation in the study cannot be obtained.
   3. Patients found to be severely ill beyond the capacity of the health facility to treat.
5. Family members a. Family members who doesn't provide consent for participation

Primary outcomes:
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) scale
timeFrame: baseline - immediately after enrollment
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) scale
timeFrame: 4 months post enrollment
measure: Positive and Negative Symptoms of Schizophrenia (PANSS) scale
timeFrame: 8 months post enrollment
Secondary outcomes:
measure: World Health Organization Quality of Life-Brief Scale
timeFrame: immediately after enrollment
measure: World Health Organization Quality of Life-Brief Scale
timeFrame: 4 months post enrollment
measure: World Health Organization Quality of Life-Brief Scale
timeFrame: 8 months post enrollment
measure: Service user collaboration checklist
timeFrame: immediately after enrollment
measure: Service user collaboration checklist
timeFrame: 4 months post enrollment
measure: Service user collaboration checklist
timeFrame: 8 months post enrollment
measure: EuroQuality of Life 5-Dimension 5-Level
timeFrame: immediately after enrollment
measure: EuroQuality of Life 5-Dimension 5-Level
timeFrame: 4 months post enrollment
measure: EuroQuality of Life 5-Dimension 5-Level
timeFrame: 8 months post enrollment
measure: Discrimination and Stigma Scale-Brief version
timeFrame: immediately after enrollment
measure: Discrimination and Stigma Scale-Brief version
timeFrame: 4 months post enrollment
measure: Discrimination and Stigma Scale-Brief version
timeFrame: 8 months post enrollment
measure: Social Inclusion Scale
timeFrame: immediately after enrollment
measure: Social Inclusion Scale
timeFrame: 4 months post enrollment
measure: Social Inclusion Scale
timeFrame: 8 months post enrollment
measure: Hospitalization Record
timeFrame: immediately after enrollment
measure: Hospitalization Record
timeFrame: 4 months post-enrollment
measure: Hospitalization Record
timeFrame: 8 months post enrollment
measure: Client Service Receipt Inventory
timeFrame: immediately after enrollment
measure: Client Service Receipt Inventory
timeFrame: 4 months post enrollment
measure: Client Service Receipt Inventory
timeFrame: 8 months post enrollment
measure: Family Interview Schedule-Impact on Caregivers
timeFrame: immediately after enrollment
measure: Family Interview Schedule-Impact on Caregivers
timeFrame: 4 months post enrollment
measure: Family Interview Schedule-Impact on Caregivers
timeFrame: 8 months post enrollment
measure: Community Health Workers: Social Distance Scale
timeFrame: pre training
measure: Community Health Workers: Social Distance Scale
timeFrame: immediately after training
measure: Community Health Workers: Assessment tool
timeFrame: monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check
measure: Community Health Workers: Village health team referral
timeFrame: monthly throughout the study period (average of 8 months), starts immediately after training
measure: Community Health Workers: Village health team referral with psychosis
timeFrame: monthly throughout the study period (average of 8 months), starts immediately after training
measure: Primary care workers: Social Distance Scale
timeFrame: pre training
measure: Primary care workers: Social Distance Scale
timeFrame: immediately after training
measure: Primary care workers: Social Distance Scale
timeFrame: final supervision: 8 months post training
measure: Primary care workers: Mental health Gap Action Program Knowledge
timeFrame: pre training
measure: Primary care workers: Mental health Gap Action Program Knowledge
timeFrame: immediately after training
measure: Primary care workers: Mental health Gap Action Program Knowledge
timeFrame: final supervision: 8 months post training
measure: Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
timeFrame: pre training
measure: Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
timeFrame: immediately after training
measure: Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis
timeFrame: final supervision - 8 months post training
measure: Health Facility Record
timeFrame: pre training
measure: Health Facility Record
timeFrame: immediately after training
measure: Health Facility Record
timeFrame: final supervision - 8 months post training
measure: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5
timeFrame: 3 months post patient enrollment
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: YouBelong Uganda
Study officials:
affiliation: George Washington University
name: Brandon Kohrt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: YouBelong Uganda
name: Byamah Mutamba, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: