- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06527196
TEAMS R34 #3: Team-Based Implementation Strategy for Pediatric Depression Screening
TEAMS R34 #3: Developing and Testing a Team-Based Implementation Strategy for Depression Screening in a Pediatric Health Care System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92123
- UC San Diego: IN STEP Children's Mental Health Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Any individual that does not meet the inclusion criteria will be excluded from study participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Standard Condition
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:
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Providers in the standard condition will be asked to continue practices and response to depression screening as currently implemented by the hospital system.
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Experimental: Team-Enhanced Condition
The team-enhanced condition will include:
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Participants in the experimental arm (team-enhanced condition) will be asked to participate in the creation and use of a team charter.
This will occur over a period of six months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acceptability, Feasibility, and Appropriateness of Intervention Measure
Time Frame: 6 months
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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).
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6 months
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Referral Processing Time
Time Frame: 6 months
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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.
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6 months
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Provider Response Based on Patient Health Questionnaire (PHQ-9) Score
Time Frame: Baseline, 3 months, 6 months
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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. |
Baseline, 3 months, 6 months
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Mental Health Service Linkage (Caregiver Report of Successful Mental Health Service Linkage)
Time Frame: 3 months, 6 months
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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. |
3 months, 6 months
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Referral Quality (Provider Report of Successful Mental Health Service Referrals)
Time Frame: 6 months
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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.
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6 months
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Time to Mental Health Service Linkage
Time Frame: Baseline, 3 months, 6 months
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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. |
Baseline, 3 months, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Implementation Climate Measure
Time Frame: Baseline, 3 months, 6 months
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Implementation climate will be measured with the Implementation Climate Measure.
Implementation climate refers to the belief amongst users of an innovation within an organization that utilizing said innovation is rewarded, supported and expected.
This instrument consists of 6 items that assess implementation with two questions per climate dimension (expected, supported, and rewarded).
The instrument is based on a Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Scores are averaged across multiple items to give an overall score or subscale score for implementation climate.
Generally, a higher score indicates a more positive perception of implementation climate in an organization.
This instrument will be administered to participants through study completion.
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Baseline, 3 months, 6 months
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Collaboration and Satisfaction About Care Decisions (CSACD)
Time Frame: Baseline, 3 months, 6 months
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The CSACD instrument (6 items total) will be used to assess communication and coordination.
For each question, participants respond based on a 7-point likert-type scale where 1= strongly disagree and 7 = strongly agree. 2 individual subscales (3 questions each) can be obtained by averaging responses for the items related to collaboration and the items related to satisfaction.
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Baseline, 3 months, 6 months
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Edmonson's Psychological Safety (Interpersonal Risk Taking) Climate Measure
Time Frame: Baseline, 3 months, 6 months
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Psychological safety, which refers to an individual's understanding that the workplace, (specifically the policies/procedures) cultivates a safe arena for interpersonal risk taking, will be measured using Edmonson's Psychological Safety Climate Measure.
Participants respond to 7 items total with answer choices from 0 (doesn't apply at all) up to 4 (entirely applies).
Scale scores are then determined by averaging responses to each item.
Generally, a higher score indicates a stronger perception of psychological safety within the team.
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Baseline, 3 months, 6 months
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Family Demographics Questionnaire
Time Frame: Baseline, 3 months, 6 months
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Child demographics will be obtained using a Family Demographics Questionnaire and the electronic health record (EHR).
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Baseline, 3 months, 6 months
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Card Sorting Activity
Time Frame: Baseline, 3 months, 6 months
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Card sorting is a research assessment to elicit individual mental models about a participant's understanding of a situation, event, or process. Within team contexts, card sorting can be used to interrogate the extent to which team members have aligned thinking about key elements of a situation, event or process, i.e., team mental models. In open card sorts participants are given a set of main concepts and told to sort them into different categories. Each makes a specific label for each category. In closed card sorts, participants are also given a set of key concepts, but participants are instead given pre-existing categories to sort concepts into. Each participant from the Aim 2 trial will complete the card-sorting task following team charter development to assess team mental models of member roles, responsibilities, and goals across depression care cascade team members. |
Baseline, 3 months, 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicole A Stadnick, PhD, MPH, UCSD Associate Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 810627
- P50MH126231 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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