Increasing Social Connection Through Crisis Caring Contacts: A Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 974
- 试验地点
- 6
- 主要终点
- UCLA Loneliness Scale, Version 3
研究概览
简要总结
The main purpose is to learn if sending messages from the VA (called "Caring Contacts") reduces loneliness and improves mental health. The investigators want to understand if these messages are effective in Veterans aged 60 and above who have missed appointments at the VA even though they have health problems. Participants will receive up to 10 postcards mailed in envelopes from a fellow Veteran (Peer Specialist) from their local VA, and will be asked to fill out four surveys. The investigators are recruiting 920 Veterans aged 50 years and older who have felt isolated and have missed appointments at the VA to join this study.
详细描述
Lack of social connection is a common and powerful predictor of suicidal ideation, suicide attempts, functional decline, and death, even after adjustment for sociodemographic and clinical variables. Loneliness, specifically, is associated with a 26% increased likelihood of all-cause mortality. The urgency of addressing these problems is only amplified by the COVID-19 pandemic, which for some time may further increase loneliness, suicide, and other causes of mortality. Due to their risk for loneliness and negative health outcomes, a group of particular concern is older adults and patients with medical or psychiatric comorbidity who have poor treatment engagement.
Caring Contacts is an intervention that can address loneliness and treatment disengagement. It involves periodically sending brief messages to at-risk individuals with nondemanding expressions of care and concern. It is one of just two non-pharmacologic interventions to have evidence in randomized controlled trials (RCTs) for reducing rates of suicide. However, Caring Contacts has only been evaluated in a relatively narrowly indicated population of patients with acute psychiatric issues.
Major gaps in the understanding of Caring Contacts include whether it reduces loneliness, whether it can diminish causes of mortality besides suicide, and whether it is effective older Veterans and patients with treatment disengagement. The overarching objective of this project is to evaluate "Crisis Caring Contacts" (CCC), an adaptation of Caring Contacts tailored to Veterans at risk for lack of social connection and lapses in treatment amidst the COVID-19 pandemic and its aftermath.
Primary aims for this study are: 1) Among older Veterans with poor treatment engagement, evaluate the effectiveness of Crisis Caring Contacts in decreasing loneliness, compared to enhanced usual care; 2) Evaluate the effect of Crisis Caring Contacts on other important outcomes, including treatment engagement and suicidal ideation; 3) Explore potential moderators of treatment response to Crisis Caring Contacts; and 4) Explore the effect of Crisis Caring Contacts on all-cause mortality, suicide attempts, and drug overdoses.
Impact: This project will advance scientific understanding of key gaps related to the mechanisms and outcomes of Caring Contacts, while also evaluating a timely, pragmatic, low-cost, and scalable intervention for Veterans affected by lack of social connection and treatment engagement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Following recommendations for blinding in behavioral interventions, participants will be blinded by limiting details about the study hypotheses and differences between the study arms. Furthermore, research staff involved in outcome assessment and study biostatisticians involved in data analysis will be blinded to study arms.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 50 years and above
- •have at least four VA appointments in the prior 6-18 months in primary care or mental health
- •have at least two comorbidities contained in the Elixhauser Index
- •a) zero completed appointments in the past 6 months and zero appointments scheduled, or b) in the 90th percentile or higher in terms of no-shows or appointments canceled by patient in the prior 12 months
排除标准
- •no valid mailing address
- •no valid phone number
- •inclusion in an existing Caring Contacts program
- •diagnosis of neurocognitive disorder or other significant cognitive impairment indicative of inadequate decision-making capacity
结局指标
主要结局
UCLA Loneliness Scale, Version 3
时间窗: 12-month follow-up
This scale has a score range from 20 -80, with higher scores representing greater degrees of loneliness.
Count of mental health or primary care visits over 12 months
时间窗: The 12-month period from the date of randomization to 12-month follow-up
Treatment engagement will be assessed by counting VA outpatient visits to mental health or primary care during the 12 months after randomization. More visits will represent greater treatment engagement.
次要结局
- PROMIS Short Form v2.0 - Emotional Support 4a(12-month follow-up)
- Trust in Public Healthcare System, Institutional Trust Subscale (adapted for VA)(12-month follow-up)
- Depressive Symptom Index Suicidality Subscale (DSI-SS)(12-month follow-up)
- Suicide Ideation Scale (SIS)(12-month follow-up)