Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda

Psychosis Clinical Trial

— SCAPE-U  

Official title:

Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863572
• Other study ID #: HS2327ES
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: George Washington University
• Contact: Brandon A Kohrt, MD, PhD
• Phone: 2027412860
• Email: bkohrt[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Other:
• Primary care health worker training
Training primary care workers to detect and treat psychosis.
• Community Health Workers Training
training community health workers in detection and referral
• Home visits
home visits conducted by people with lived experience of psychosis

Locations

Country	Name	City	State
Uganda	YouBelong Uganda	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
George Washington University	Butabika National Referral Hospital, YouBelong Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Symptoms of Schizophrenia (PANSS) scale	Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse	baseline - immediately after enrollment
Primary	Positive and Negative Symptoms of Schizophrenia (PANSS) scale	Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse	4 months post enrollment
Primary	Positive and Negative Symptoms of Schizophrenia (PANSS) scale	Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse	8 months post enrollment
Secondary	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	immediately after enrollment
Secondary	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	4 months post enrollment
Secondary	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	8 months post enrollment
Secondary	Service user collaboration checklist	Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience	immediately after enrollment
Secondary	Service user collaboration checklist	Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience	4 months post enrollment
Secondary	Service user collaboration checklist	Benefits and challenges of service users' collaboration, minimum = 12, maximum = 48, higher number refers to strong collaboration experience	8 months post enrollment
Secondary	EuroQuality of Life 5-Dimension 5-Level	Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse	immediately after enrollment
Secondary	EuroQuality of Life 5-Dimension 5-Level	Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse	4 months post enrollment
Secondary	EuroQuality of Life 5-Dimension 5-Level	Quality of Life (for health economics analyses), minimum = 5, maximum=25, higher score is worse	8 months post enrollment
Secondary	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	immediately after enrollment
Secondary	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	4 months post enrollment
Secondary	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	8 months post enrollment
Secondary	Social Inclusion Scale	Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion	immediately after enrollment
Secondary	Social Inclusion Scale	Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion	4 months post enrollment
Secondary	Social Inclusion Scale	Social Inclusion of service users, minimum = 10, maximum = 50, Higher score refers to better experience of social inclusion	8 months post enrollment
Secondary	Hospitalization Record	no minimum or maximum, score is total number of days patient was hospitalized during study period	immediately after enrollment
Secondary	Hospitalization Record	no minimum or maximum, score is total number of days patient was hospitalized during study period	4 months post-enrollment
Secondary	Hospitalization Record	no minimum or maximum, score is total number of days patient was hospitalized during study period	8 months post enrollment
Secondary	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	immediately after enrollment
Secondary	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	4 months post enrollment
Secondary	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	8 months post enrollment
Secondary	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	immediately after enrollment
Secondary	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	4 months post enrollment
Secondary	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	8 months post enrollment
Secondary	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	pre training
Secondary	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	immediately after training
Secondary	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	monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check
Secondary	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	monthly throughout the study period (average of 8 months), starts immediately after training
Secondary	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	monthly throughout the study period (average of 8 months), starts immediately after training
Secondary	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	pre training
Secondary	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	immediately after training
Secondary	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	final supervision: 8 months post training
Secondary	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	pre training
Secondary	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	immediately after training
Secondary	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	final supervision: 8 months post training
Secondary	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	pre training
Secondary	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	immediately after training
Secondary	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	final supervision - 8 months post training
Secondary	Health Facility Record	no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants	pre training
Secondary	Health Facility Record	no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants	immediately after training
Secondary	Health Facility Record	no minimum or maximum, score is the total number of patient diagnosed with psychosis : clinical records reviewed by Research Assistants	final supervision - 8 months post training
Secondary	Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5	Accuracy of patient diagnosis by study mental health specialist	3 months post patient enrollment