Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity (INSPIRE): Tailored Digital Tools, Telehealth Coaching, and Primary Care Coordination
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 586
- 试验地点
- 4
- 主要终点
- Change from Baseline in Pain Intensity and Interference on the 11-point Pain, Enjoyment of Life, and General Activity Scale (PEG)
研究概览
简要总结
INSPIRE creates a trilingual mobile app and telehealth coaching program to promote non-pharmacologic strategies for pain management with Black, Chinese, and Latinx communities in the San Francisco Bay Area. Years 1-2 will develop the app and test it with a brief single arm pilot starting in Nov 2023. A full two arm randomized controlled trial (RCT) will being in early 2025 with changes in PEG scores as the primary outcome. Secondary outcomes include Helping to End Addiction Longterm (HEAL) common data elements.
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
- Single (Outcomes Assessor)
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
- •age 18 or older
- •speak English, Spanish, or Cantonese
- •have a UCSF Health or SFHN medical provider (any type)
- •be willing to use a smartphone (iOS or Android - either their own or one provided by the study)
- •have chronic, non-malignant pain for at least 3 months
- •be willing to participate in a 12 month patient-centered chronic pain management study where they will be randomized into one of two comparison arms
排除标准
- •Severe mental illness or other condition preventing informed consent
研究组 & 干预措施
Intervention
The INSPIRE chronic pain management system has three primary components: 1) a patient facing smartphone app that collects and interprets a comprehensive intake and patient reported outcomes (PROs), provides health education, and a tailored, modular self-management program that includes cognitive-behavioral therapy (CBT), physical therapy (PT), and mindfulness-based interventions (MBI), 2) a weekly telehealth visit with a pain coach that uses the PRO data and module engagement measures to guide the visit, and 3) enhanced primary care coordination achieved through pain coaching notes and alerts integrated into the electronic health record (EHR).
干预措施: CBT, Mindfulness, and Movement (Behavioral)
Control
Control participants will receive educational materials about chronic pain and full workbook with non-pharmacologic strategies.
结局指标
主要结局
Change from Baseline in Pain Intensity and Interference on the 11-point Pain, Enjoyment of Life, and General Activity Scale (PEG)
时间窗: Baseline, 3mo, 6mo, 12mo
The PEG Pain Screening Tool is a validated, self-reported 3-question survey assessing pain severity, the extent to which pain interferes with enjoyment of life, and the extent to which pain interferes with general activity. Possible scores for each question range from 0 (no pain, no interference) to 10 (worst possible pain, worst possible interference). The average of scores from the three questions yields the PEG score. Change = (PEG score at time point - PEG score at baseline)
次要结局
- Change from Baseline in Self-reported Depressive Symptoms on the 4-point Patient Health Questionnaire - 9 (PHQ-9)(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Physical Functioning on the 5-point PROMIS Physical Function Short Form 6b(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Sleep Disturbance and Sleep Duration on the 5-point PROMIS Sleep Disturbance Short Form 6a(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Self-reported Psychological Inflexibility on the 7-point Psychological Inflexibility in Pain Scale(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Fear and Anxiety about Pain on the 5-point Pain Catastrophizing Scale Short Form 6(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Self-reported Alcohol Use Disorder Symptoms on the 5-point Alcohol Use Disorder Identification Test (AUDIT)(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Self-reported Anxiety Symptoms on the 4-point General Anxiety Scale (GAD-7)(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Drug Abuse Screening Test (DAST) Score(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Internalized Stigma of Mental Illness on the 4-point Internalized Stigma of Mental Illness Inventory (ISMI)(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Overall Satisfaction with Treatment on the 7-point Patient Global Impression of Change (PGIC)(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Self-reported Social Isolation on the 5-point PROMIS Social Isolation Short Form 8a(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Clinician Self-reported Attitudes, Beliefs, and Perspectives about Mental Illness on the 5-point Opening Minds Survey for Health Care Providers(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Patient Self-reported Trust of their Healthcare Provider(s) on the 5-point PROMIS Healthcare Relationship Trust (HCR) Scale(Baseline, 3mo, 6mo, 12mo)
- Change from Baseline in Self-reported Pain Self-Efficacy on the 7-point Pain Self-Efficacy Questionnaire - Two Item Short Form (PSEQ-2)(Baseline, 3mo, 6mo, 12mo)