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临床试验/NCT06527196
NCT06527196进行中(未招募)不适用

TEAMS R34 #3: Developing and Testing a Team-Based Implementation Strategy for Depression Screening in a Pediatric Health Care System

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Referral Processing Time

研究概览

简要总结

Pediatric depression is a global concern that has fueled efforts for enhanced detection and treatment engagement. While many health systems have implemented components of depression screening protocols, there is limited evidence of effective follow-up for pediatric depression. Key barriers to prompt service linkage include a shared understanding of individual and team member roles and coordination between clinicians and staff across service areas. This project aims to refine and test a team-based implementation strategy, a team charter, improve implementation of an existing pediatric depression screening protocol in a large pediatric healthcare system. The implementation strategy will target team mechanisms at the organizational-level and provider-level. The team charter is hypothesized to lead to improved, efficient, and effective decision-making to increase the frequency of depression screening and timely service linkage. Findings are expected to yield better understanding of how to optimize team activities and patterns in the pediatric depression screening to treatment cascade. This should also culminate in improved patient engagement and outcomes, which are critical to address the youth mental health crisis.

详细描述

Aim 1: Use mixed methods to refine a team-based implementation strategy to improve implementation of an existing health system universal depression screening protocol (clinical intervention)

Aim 2: Use a two-arm hybrid type 3 implementation-effectiveness pilot trial to assess the initial effectiveness of the team-based implementation strategy on the depression screening protocol.

Aim 3: Use mixed methods to assess team/organizational (intra-organizational alignment, implementation climate) and team member/provider (communication, coordination, psychological safety, shared cognitions) mechanisms of the team-based implementation strategy and a novel application of natural language processing methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •Inclusion criteria for all groups of participants are intentionally broad to ensure valid analyses:
  • •Employed as medical staff and/or a medical or health provider at Rady Children's Hospital San Diego.
  • •Experience providing or supporting care to children and adolescents with mental health care needs.

排除标准

  • •Any individual that does not meet the inclusion criteria will be excluded from study participation.

研究组 & 干预措施

Team-Enhanced Condition

Experimental

The team-enhanced condition will include:

  1. Two initial 1-hour didactic sessions to develop the team charter.
  2. Biweekly check-ins (15-30 minutes) where the research team will review ongoing use of the team charter with participants and explore any necessary revisions.

干预措施: Team-Enhanced Condition (Behavioral)

Standard Condition

Active Comparator

In the comparison condition, staff will continue to use multiple discrete strategies already implemented as apart of the depression screening pathway. These existing strategies include:

  1. Training in the depression screening tool (Patient Health Questionnaire)
  2. Orientation to the clinical pathway (i.e., screening conducted at every urgent care or emergency department visit and every 30 days for all other medical visits)
  3. Expectations for handoff to the next step in the care cascade

干预措施: Standard Condition (Behavioral)

结局指标

主要结局

Referral Processing Time

时间窗: 6 months

Referral processing, will be based on the time (in hours) from screening to referral based on electronic health record (EHR) timestamps. This will be used to help assess workflow efficiency.

Mental Health Service Linkage (Caregiver Report of Successful Mental Health Service Linkage)

时间窗: 3 months, 6 months

Successful mental health service linkage will be assessed by obtaining caregivers' reports of linkage to any mental health service (internal and external of study's chosen pediatric healthy system) following an elevated depression score on the PHQ-9 (10+). Context: The Patient Health Questionnaire asks respondents to answer 9 questions that assess mental health status over the patient's last two weeks. Patients answer each question on a scale ranging from 0 (not at all) up to 3 (nearly every day). Scores are calculated by adding individual values together to produce a cumulative score (can range from 0 to 27). A higher score indicates a higher risk for depression symptomology. For the pediatric health system in this study, a score above 10 warrants referral to a behavioral health professional, as well as educational materials and other service referrals.

Provider Response Based on Patient Health Questionnaire (PHQ-9) Score

时间窗: Baseline, 3 months, 6 months

This measure will be obtained by using the electronic health record (EHR) to determine whether or not providers responded to a patient with an elevated score (10+) on the Patient Health Questionnaire (PHQ-9). This will help researchers assess clinical outcomes of the study intervention (team communication training). Context: The Patient Health Questionnaire asks respondents to answer 9 questions that assess mental health status over the patient's last two weeks. Patients answer each question on a scale ranging from 0 (not at all) up to 3 (nearly every day). Scores are calculated by adding individual values together to produce a cumulative score (can range from 0 to 27). A higher score indicates a higher risk for depression symptomology. For the pediatric health system in this study, a score above 10 warrants referral to a behavioral health professional, as well as educational materials and other service referrals.

Acceptability, Feasibility, and Appropriateness of Intervention Measure

时间窗: 6 months

This 9-item instrument will be administered to participants following completion of the study intervention. The measure was designed to assess the degree to which the intervention is well-received (acceptability), relevant in the given setting (appropriate), and possible and workable (feasibility). The items on the measure (9 total) are each rated on a scale from 1 (completely disagree) to 5 (completely agree). Following completion, individual subscales (3 total) can be obtained by averaging participants' responses for each of the three components (acceptability, appropriateness, and feasibility).

Referral Quality (Provider Report of Successful Mental Health Service Referrals)

时间窗: 6 months

Referral quality is a measure based on providers' reports of whether referral to the a behavioral health service occurred or not. This will be used to assess workflow efficiency.

Time to Mental Health Service Linkage

时间窗: Baseline, 3 months, 6 months

This measure captures time (days) to service linkage for patients that need referrals based on the Patient Health Questionnaire (PHQ-9) score. This data will be obtained from the electronic health record (EHR). This will help researchers assess clinical outcomes of the study intervention (team communication training). Context: The Patient Health Questionnaire asks respondents to answer 9 questions that assess mental health status over the patient's last two weeks. Patients answer each question on a scale ranging from 0 (not at all) up to 3 (nearly every day). Scores are calculated by adding individual values together to produce a cumulative score (can range from 0 to 27). A higher score indicates a higher risk for depression symptomology. For the pediatric health system in this study, a score above 10 warrants referral to a behavioral health professional, as well as educational materials and other service referrals.

次要结局

  • Implementation Climate Measure(Baseline, 3 months, 6 months)
  • Collaboration and Satisfaction About Care Decisions (CSACD)(Baseline, 3 months, 6 months)
  • Card Sorting Activity(Baseline, 3 months, 6 months)
  • Edmonson's Psychological Safety (Interpersonal Risk Taking) Climate Measure(Baseline, 3 months, 6 months)
  • Family Demographics Questionnaire(Baseline, 3 months, 6 months)
  • Implementation Climate Measure(Baseline, 3 months, 6 months)
  • Collaboration and Satisfaction About Care Decisions (CSACD)(Baseline, 3 months, 6 months)
  • Card Sorting Activity(Baseline, 3 months, 6 months)
  • Edmonson's Psychological Safety (Interpersonal Risk Taking) Climate Measure(Baseline, 3 months, 6 months)
  • Family Demographics Questionnaire(Baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole Stadnick

Associate Professor

University of California, San Diego

研究点 (2)

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