跳至主要内容
临床试验/NCT06835439
NCT06835439已完成不适用

Improving Access and Engagement in Spine Pain Rehabilitation - STEPPT Mixed Methods Pilot Study

San Diego State University2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年11月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
2
主要终点
Ethnic Disparity in Rate of Physician Referral to Physical Therapy

研究概览

简要总结

This 6-month pilot study aims to assess the feasibility, acceptability, and estimate effect sizes of the pilot STEPPT intervention for addressing ethnic disparities in physical therapy referrals and adherence between Hispanic and Non-Hispanic White patients with spine pain. Feasibility and acceptability will be assessed based on the extent to which the pilot clinic implements all components of the intervention appropriately, feedback from clinic staff during implementation of the intervention, and feedback from patients during post-intervention interviews. The investigators anticipate that the intervention will be both feasible and acceptable. Feedback from patients and clinic staff will be used to inform intervention modifications for a larger clinical trial. Effect sizes for the pilot STEPPT intervention (intervention) in comparison to standard care (control) will be assessed by evaluating changes in ethnic disparities (Hispanic vs. Non-Hispanic White) in physician referral to physical therapy and patient adherence to physical therapy referral for the treatment of spine pain before and after implementation of the pilot STEPPT intervention. In comparison to standard care, the investigators expect STEPPT to reduce ethnic disparities in referral and adherence outcomes.

详细描述

STEPPT is a health system, quality improvement intervention for Hispanic patients with spine pain including the following components: (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials, and (3) enhanced patient health navigation to educate patients and address barriers to attending physical therapy for Hispanic patients with spine pain. This pilot study aims to test the feasibility and acceptability of a prototype intervention developed using patient feedback, focus groups, and collaboration with Family Health Centers of San Diego (FHCSD) administrators and staff. The primary outcome is change in relative rates of referral and adherence to physical therapy between Hispanic and Non-Hispanic White patients with spine pain before and after implementation of the STEPPT intervention within one pilot clinic in the health system. The study will collect data on physical therapy referrals and adherence from electronic health records (EHR) before (3-month usual care control phase) and after (3-month intervention phase) implementing STEPPT. A process evaluation will be conducted through monthly audits and structured observations of clinic workflow. Ongoing interactions with clinic staff will facilitate implementation of the intervention and solicit suggestions for improving feasibility. Post-intervention interviews with a subset of Hispanic patients will assess acceptability of the intervention. Interviews will focus on patient experiences with education materials and enhanced healthcare navigation

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 years or older.
  • Patients seeking care within the designated Federally Qualified Health System Adult or Adult Walk-in primary care clinic
  • Ethnicity/Race: Participants must identify as either Hispanic or Non-Hispanic White ethnicity/race.
  • Consent: Participants must have signed a broad consent for the use of de-identified health information for research.
  • Spine Pain: Participants must meet one of the following:
  • New Spine Pain Problem: A new ICD code for neck or back pain added to the problem list during a visit with a primary care physician.
  • Existing Spine Pain Diagnosis: An existing ICD code for neck or back pain on the problem list that is associated with a physician referral for any service during the visit related to the neck or back pain problem.

排除标准

  • Non-Musculoskeletal Spine Pain: Participants with spine pain due to a non-musculoskeletal etiology (e.g., infection, cancer, urological disorders, pregnancy) are excluded.
  • Urgent Medical Conditions: Patients requiring urgent medical intervention (e.g., fracture, cauda equina syndrome) are excluded.
  • Patients with a physical therapy referral external to the healthcare system are excluded from the analysis of physical therapy adherence

研究组 & 干预措施

STEPPT Intervention

Experimental

Participants in this arm will receive the pilot STEPPT intervention, which includes (1) education of providers and staff on disparities in referrals and the benefits of physical therapy for spine pain, (2) modifications to the EHR to automate physical therapy referral and delivery of culturally tailored patient education materials, and (3) enhanced patient health navigation to educate patients and address barriers to attending physical therapy for Hispanic patients with spine pain. The goal is to reduce ethnic disparities by improving physical therapy referral and adherence rates for Hispanic patients with spine pain.

干预措施: STEPPT Pilot (Behavioral)

Standard Care (Control)

Active Comparator

Standard care during the 3-month baseline period, prior to implementing the STEPPT intervention, will be the active comparator arm. Ethnic disparities in referral and adherence rates will be compared between the 3-month baseline period and the 3-month intervention period to estimate the effect size of the pilot STEPPT intervention for reducing ethnic disparities in physical therapy referral and adherence outcomes.

干预措施: Standard Care (Control) (Behavioral)

结局指标

主要结局

Ethnic Disparity in Rate of Physician Referral to Physical Therapy

时间窗: 3-month before the intervention and 3 month during intervention period.

Ethnic disparity (Hispanic vs. Non-Hispanic White) in rate of physician referral of patients with spine pain (low back or neck pain) to physical therapy, as documented in the electronic health record (EHR).

Ethnic Disparity in Rate of Patient Adherence to Physical Therapy Referral

时间窗: 3-month before the intervention and 3 month during intervention period.

Ethnic disparity (Hispanic vs. Non-Hispanic White) in rate of attendance of first physical therapy visit after being referred, as documented in the electronic health record (EHR).

次要结局

  • Patient Interviews(Up to 3-months post-intervention)
  • Involvement Rating Score(3-month pilot intervention period.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

招募中
不适用
Door-to-door back to work: can social inclusion of people dependent on social welfare benefits be stimulated by a door-to-door approach?The problems targeted in this study are social exclusion and unemployment with people with children who have been dependent on social welfare benefits for more than three years.
NL-OMON27340Trimbos Institute300
招募中
不适用
Addressing the impact of social inclusion and quality of medical care on the long-term outcome of acute myocardial infarction in a rural setting in eastern Germany. The KAHRB (Kleinräumige Analyse der Herzinfarkte in der Region Stadt Brandenburg mit angrenzenden Gemeinden) cohort studyI21.1I21.0Acute transmural myocardial infarction of inferior wallAcute transmural myocardial infarction of anterior wall
DRKS00024463Städtisches Klinikum Brandenburg Zentrum für Innere Medizin I1,000
已完成
不适用
How socioeconomic inequalities impact pathways of care for coronary artery disease. A qualitative study from the view of multimorbid elderly patientsI25Chronic ischaemic heart disease
DRKS00007839Institut für Medizinische Soziologie, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg48
已完成
Unknown
Initiatives to Reduce Health Disparities Related to Lifestyle-related Diseases through Online Consultations and Media EducatioHypertension, diabetis
JPRN-UMIN000050171Fukushima Medical University600
已完成
不适用
Safety Net Support Use in CaliforniaHouseholds
NCT04485377University of California, Berkeley501