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Идёт набор NCT06399991

Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi

Без фазы С лечением Anxiety Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Champion strategy, Adapted LOCI leadership and climate alignment strategy plus champion strategy.
Кому может быть актуально
Состояния в реестре: Anxiety, Depression. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Malawi
Следующий шаг
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Официальное название

Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi (ALIGN)

Обзор

The main objective of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health treatment model into multiple medical care settings.

Подробное описание

Task-shared mental health interventions are effective in low- and middle-income countries (LMICs), yet they remain underutilized, and the mental health treatment gap remains substantial. Innovative implementation strategies are needed to successfully integrate evidence-based mental health treatments into medical care in LMICs.

A common component of many implementation efforts is a "champion" strategy which identifies and empowers an on-the-ground staff member as the implementation champion, in charge of focusing their colleagues' efforts on implementation of the evidence-based treatment model. Yet a growing body of research, including our own work in Malawi and elsewhere, highlights that the champion's success is strongly influenced by the strength of support from their line manager and other up-the-chain organization leaders, who are critical in aligning the organization's climate and priorities in support of the implementation effort.

Approaches to influencing leadership engagement to change organizational climate and align priorities has been developed over decades in the field of organizational and industrial psychology but only relatively recently applied to implementation science health research and primarily to implementation in high-income countries. The Leadership and Organizational Change for Implementation (LOCI) is a recently developed multi-level leadership coaching implementation strategy that has demonstrated effectiveness in changing organizational climate, aligning priorities, and enhancing mental health treatment model integration in the US and Norway, but has not been adapted to or tested in low-income country settings. LOCI has significant potential to address the gaps identified in our current research by aligning leadership priorities to support champions in advancing mental health integration.

The overall aim of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health treatment model into multiple medical care settings via a cluster-randomized randomized control trial(RCT).

Leadership alignment strategies are an understudied but essential ingredient for successful mental health integration efforts. This project will make a major contribution to our understanding of the role of leadership alignment in advancing evidence-based mental health integration in LMICs.

Вмешательства

  • Поведенческое Champion strategy
    The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.
  • Поведенческое Adapted LOCI leadership and climate alignment strategy plus champion strategy
    The LOCI strategy involves engaging with district health leadership through data and feedback, leadership development trainings, coaching, and alignment strategy activities to align leadership and climate in support of implementing the evidence-based mental health package. The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.

Первичные конечные точки

  • Proportion of screening-eligible visits at which patients were screened for mental health [Срок оценки: Over the 12 months of the randomized period]
  • Proportion of visits at which patients endorsed suicidal ideation at which a suicide risk assessment was completed [Срок оценки: Over the 12 months of the randomized period]
  • Proportion of patients who were appropriately initiated on mental health treatment [Срок оценки: Over the 12 months of the randomized period]
  • Proportion of follow-up visits at which clinical decisions followed mental health treatment guidelines [Срок оценки: Over the 12 months of the randomized period]
  • Proportion of Counseling sessions meeting Fidelity Threshold [Срок оценки: Over the 12 months of the randomized period]
Вторичные конечные точки (2)
  • Proportion of patients achieving mental health remission [Срок оценки: 3 months after participant enrollment]
  • Proportion of patients achieving chronic condition control [Срок оценки: 6 months after participant enrollment]

Критерии участия

Критерии включения

  • 18 years old or older
  • Patient receiving medical care in participating district who screened positive for elevated common mental disorder symptoms that day or in the preceding month.

Критерии исключения

  • <18 years old
  • Not currently a patient receiving medical care in participating district who screened positive for elevated common mental disorder symptoms that day or in the preceding month.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Malawi · 12 центров
  • Chiradzulu District Hospital — Chiradzulu
  • Dedza District Hospital — Dedza
  • Kasungu District Hospital — Kasungu
  • Machinga District Hospital — Machinga
  • Mangochi District Hospital — Mangochi
  • Mchinji District Hospital — Mchinji
  • Mulanje District Hospital — Mulanje
  • Mzimba South District Hospital — Mzimba
  • … и ещё 4 центра

Идентификаторы

NCT: NCT06399991 · 23-2722 · R01MH133028

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗