Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 643
- 试验地点
- 7
- 主要终点
- Proportion of individuals with CF receiving annual palliative care screening
研究概览
简要总结
Five Cystic Fibrosis (CF) centers, key stakeholders, and a palliative care institute have collaborated to create a novel primary palliative care intervention for patients with CF, "Improving Life with CF: A Primary Palliative Care Partnership," and established the infrastructure and support necessary for a follow-on implementation study. This intervention provides a framework for a nationally generalizable model to improve best practices in generalist-level palliative care in CF.
Objectives:
Aim 1: Implement a primary palliative care intervention comprising screening-and-triage workflows, best practice treatment guides for high frequency problems, patient/family and provider education, and a quality improvement (QI) toolkit.
Aim 2: Evaluate feasibility, uptake, and preliminary outcomes during a multisite pragmatic, implementation trial of the intervention at 5 diverse Cystic Fibrosis (CF) Centers.
Subaim 2.1: Evaluate feasibility and uptake as measured by rates of screening and treatment delivery.
Hypothesis 1: Related to feasibility and uptake of the intervention:
- > 80% of individuals with CF of all ages will receive an annual palliative care screening.
- > 25% of individuals with CF will receive a palliative care screening prompted by hospitalization, new diagnosis of CF-Related Diabetes, need for transplantation, or another disease- or treatment-specific trigger.
Hypothesis 2: Related to provider education:
a) > 80% will access >1 training(s) (on-demand webinars or in-service by trained site educators).
Subaim 2.2: Evaluate data on preliminary outcomes for individuals with CF by comparing ratings on patient- and caregiver-reported outcome measures (e.g., Integrated Palliative Care Outcome Scale, Cystic Fibrosis Questionnaire-Revised, Memorial Symptom Assessment Scale-Cystic Fibrosis, and Brief Assessment Scale for Caregivers) during the trial to baseline ratings and exploring covariates of change (age, race/ethnicity, gender, disease severity, CFTR modifier treatment, psychological distress, and varied indicators reflecting intervention implementation).
详细描述
Introduction:
Palliative care is an interdisciplinary model of care intended to mitigate the suffering and illness burden experienced by patients with serious illnesses, and their families, from the time of diagnosis forward. The illness burden experienced by patients with CF and their caregivers is characterized by problems in many domains (e.g., physical symptoms, emotional distress, caregiver burden, and need for goal-setting). Interventions to address the goals of palliative care must be undertaken throughout the course of the illness by CF professionals-an approach known as generalist-level or primary palliative care. At present, there are no standardized, generalizable models of primary palliative care for CF.
New CF Foundation guidelines recommend that CF Centers screen all adults and children from the time of diagnosis, along with caregivers of individuals with CF of all ages, for unmet palliative care needs annually and after "triggers" such as hospitalization or other major events (Kavalieratos D et al. J Palliat Med. 2020 Sep 16. Epub ahead of print). The goal is to identify high frequency problems, such as symptom distress and the need for advance care planning (ACP).
The proposed intervention will involve a multi-site implementation trial of a new care model that applies the CF Foundation Palliative Care Guidelines (Kavalieratos D et al., 2020) at five CF Centers across the country. We will collect longitudinal data from patients and family caregivers on palliative care outcomes and also evaluate uptake of the care model.
Research conduct:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (age > 12 years) who are treated at the participating CF Centers will be eligible for participation in the study if the following inclusion/exclusion criteria are met:
- •Have a diagnosis of CF.
- •Receive treatment at one of the participating CF Care Centers in the study.
- •Age ≥ 12 years.
- •For patients age 12-17 years, willingness and ability to provide implied informed consent by a parent or legal guardian for the patient's participation in the study, with child's implied assent, AND willingness and ability to provide consent by the parent or legal guardian for the parent's or guardian's participation in the caregiver assessment, for proxy completion of selected study measures.
- •For patients age >18 years, willingness and ability to provide implied informed consent for participation in the study.
- •Willingness to complete questionnaires two times.
- •English or Spanish as the primary language.
- •In order to ensure generalizability of the intervention, participants will not be excluded from the study for any of the following reasons:
- •Extent of CF disease severity or lung/liver transplant status.
- •Current use of CFTR modulators or other medical, psychological, or complementary therapies.
- •Concomitant participation in another clinical research study.
- •Lack of a participating caregiver for patients age > 18 years.
- •Caregivers (age > 18 years) will be eligible for participation if the following inclusion/exclusion criteria are met:
- •Are an identified caregiver of a patient with CF of any age, who receives treatment at one of the participating CF Care Centers in the study.
- •For patients age < 18 years, the caregiver will be a parent or legal guardian.
- •For patients age ≥ 18 years, the caregiver will be chosen by the patient (e.g., parent, spouse, partner, other relative or friend).
- •Willingness and ability to provide implied informed consent.
- •Willingness to complete questionnaires two times.
- •English or Spanish as the primary language.
- •The CF patient(s) (age > 12) for whom the caregiver provides CF care may accept or decline participation.
排除标准
- •Any subjects who are deemed unable to participate will be excluded, including those with evidence of cognitive impairment severe enough to prevent implied informed consent or completing the survey instruments, or at the PI's discretion.
结局指标
主要结局
Proportion of individuals with CF receiving annual palliative care screening
时间窗: 2 years
Evaluate uptake of annual palliative care needs assessment process across 5 CF centers
次要结局
- Patient Health Questionnaire-8 (PHQ-8)(2 years)
- PROMIS® Parent Proxy Depression-Short Form (PDSF)(2 years)
- Cystic Fibrosis Questionnaire-Revised (CFQ-R)(2 years)
- Generalized Anxiety Disorder-7 item Scale (GAD-7)(2 years)
- PROMIS® Parent Proxy Anxiety-Short Form (PASF)(2 years)
- PROMIS® Global Health-Short Form (PGHSF)(2 years)
- Brief Assessment Scale for Caregivers (BASC)(2 years)
- Integrated Palliative Care Outcome Scale (IPOS)(2 years)
- Use of primary palliative care provider education materials(2 years)
- Memorial Symptom Assessment Scale-Cystic Fibrosis (MSAS-CF)(2 years)
- PROMIS® Parent Proxy Pain Interference-Short Form 8a (PPISF)(2 years)
- Proportion of individuals with CF receiving triggered palliative care screening(2 years)
- Perceived Stress Scale (PSS)(2 years)
研究者
Anna M. Georgiopoulos, M.D.
Principal Investigator
Massachusetts General Hospital