Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Positive and Negative Symptoms of Schizophrenia (PANSS) scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors are masked to study arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Facilitators of the implementation strategy:
- •At least 18 years of age
- •Confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or psychiatric clinical officer
- •Completion of the YouBelongHOME (YBH) program
- •Provision of informed consent,
- •Fluency in the local language (Luganda)
- •Good functioning with respect to performance of daily chores,engagement with family members, comprehension and community participation as assessed by the YBH team
- •A supportive family member.
- •Primary care providers:
- •Provides primary care in health facility of Kampala/Wakiso District
- •Selected by facility in-charge
- •Community health workers
- •Provides community based health service in health facility where primary care providers are trained (from Kampala/Wakiso district)
- •Selected by facility in-charge
- •Patients (Primary beneficiaries)
- •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;
- •Ability of the patient or responsible surrogate to consent to study enrolment and procedures;
- •Persons eligible for outpatient management of psychosis
- •Family members a. Family member or caregiver of the patients above.
排除标准
- •Facilitators of the implementation strategy:
- •a. Inability to provide informed consent.
- •Primary care providers:
- •Community health workers:
- •Persons diagnosed with psychosis requiring inpatient management/services; and
- •Persons for whom consent for participation in the study cannot be obtained.
- •Patients found to be severely ill beyond the capacity of the health facility to treat.
- •Family members a. Family members who doesn't provide consent for participation
研究组 & 干预措施
Treatment as usual
Training primary care workers in diagnosis and treatment; training community health workers in detection and referral.
干预措施: Primary care health worker training (Other)
Treatment as usual
Training primary care workers in diagnosis and treatment; training community health workers in detection and referral.
干预措施: Community Health Workers Training (Other)
Strengthening care in collaboration with people with lived experience of psychosis in Uganda
Trainings done in collaboration with people with lived experience of psychosis; as well as additional home visits conducted by people with lived experience of psychosis.
干预措施: Primary care health worker training (Other)
Strengthening care in collaboration with people with lived experience of psychosis in Uganda
Trainings done in collaboration with people with lived experience of psychosis; as well as additional home visits conducted by people with lived experience of psychosis.
干预措施: Community Health Workers Training (Other)
Strengthening care in collaboration with people with lived experience of psychosis in Uganda
Trainings done in collaboration with people with lived experience of psychosis; as well as additional home visits conducted by people with lived experience of psychosis.
干预措施: Home visits (Other)
结局指标
主要结局
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
时间窗: 8 months post enrollment
Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse
次要结局
- Discrimination and Stigma Scale-Brief version(8 months post enrollment)
- World Health Organization Quality of Life-Brief Scale(8 months post enrollment)
- Service user collaboration checklist(8 months post enrollment)
- EuroQuality of Life 5-Dimension 5-Level(8 months post enrollment)
- Social Inclusion Scale(8 months post enrollment)
- Hospitalization Record(8 months post enrollment)
- Client Service Receipt Inventory(8 months post enrollment)
- Family Interview Schedule-Impact on Caregivers(8 months post enrollment)
- Community Health Workers: Social Distance Scale(immediately after training)
- Community Health Workers: Assessment tool(monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check)
- Primary care workers: Mental health Gap Action Program Knowledge(final supervision: 8 months post training)
- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5(3 months post patient enrollment)
- Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis(final supervision - 8 months post training)
- Community Health Workers: Village health team referral(monthly throughout the study period (average of 8 months), starts immediately after training)
- Community Health Workers: Village health team referral with psychosis(monthly throughout the study period (average of 8 months), starts immediately after training)
- Primary care workers: Social Distance Scale(final supervision: 8 months post training)
- Health Facility Record(final supervision - 8 months post training)
研究者
Brandon A Kohrt, MD, PhD
Professor
George Washington University