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NCT03385512 · ClinicalTrials.gov registry record · NA
OPEN & ASK: Improving Patient-Centered Communication in Primary Care
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 5,565
- Enrollment target
NCT03385512: Completed NA study, sponsored by University of California, San Diego.
NCT03385512 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 5,565 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (297% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03385512, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 5,565 participants
- Enrollment target
Study Summary
This large scale multi-center cluster randomized controlled trial (RCT) is designed to assess the comparative effectiveness of three interventions in diverse ambulatory care settings and patient populations. Findings will help healthcare systems decide which approach to adopt to empower patients and enable providers to engage in patient centered communication. The specific aims are to: 1. Engage with patients and healthcare providers who have used the tools in the pilot study (ClinicalTrials.gov Identifier NCT02522286) at the Sutter Health Palo Alto Medical Foundation (PAMF), as well as new stakeholders at University of California San Diego Health System and Meyers Primary Care Institute at University of Massachusetts and Reliant Medical Group, to further refine and adapt these patient-centered interventions to be integrated into real world primary care clinics. 2. Conduct a large scale cluster RCT with three arms, to evaluate the comparative effectiveness of three interventions: OPEN with in-person SPI training (High Touch), OPEN with online SPI training (High Tech), and ASK. Primary outcomes will include patient perceptions of how well their PCPs have engaged them in patient centered communication. The investigators will also measure patients' confidence in managing their health, intention to follow through with care plans, and downstream behaviors in following through with care plans, use of services such as phone calls, secure messaging, and additional visits. 3. Identify the strategy that has the most potential for sustained impact and replication within and across healthcare systems. The investigators will analyze the fidelity to the intervention protocols, including consistency of delivery as intended and the time/effort involved in implementing the interventions. The investigators will also assess the extent to which the programs become institutionalized. The investigators anticipate that this multi-level healthcare system intervention will result in signi
Primary Outcome
Responses from CollaboRATE, a validated 3-item, patient-reported measure of shared decision making compared between baseline and intervention patients; immediately after the indexed visit and 3 months after the indexed visit with their PCP for intervention patients; and across interventions for variations. The 3 questions, which will be answered on a scale of o "No effort was made" to 9 "Every effort was made" are: 1. How much effort was made to help you understand your health issue? 2. How muc
Interventions
- BEHAVIORAL OPEN High Touch
- BEHAVIORAL OPEN High Tech
- BEHAVIORAL ASK Poster in Exam Rooms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,565 participants |
| Start Date | 2018-01-23 |
| Est. Completion | 2022-09-30 |
| Phase | NA |
What the finished NCT03385512 record still lists
NCT03385512 is an interventional study that assigns participants to a tested intervention. Its 5,565 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (297% higher).
The record links to 0 conditions, and to 3 interventions - of which OPEN High Touch is the first listed.
NCT03385512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03385512 about?
NCT03385512 is a clinical study titled "OPEN & ASK: Improving Patient-Centered Communication in Primary Care". This large scale multi-center cluster randomized controlled trial (RCT) is designed to assess the comparative effectiveness of three interventions in diverse ambulatory care settings and patient populations. Findings will help healthcare systems decide which approach to adopt to empower patients and...
What is the current status of trial NCT03385512?
This trial is currently completed. It is a NA study. The enrollment target is 5,565 participants. The study started on 2018-01-23. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT03385512?
The interventions under investigation include: OPEN High Touch (BEHAVIORAL), OPEN High Tech (BEHAVIORAL), ASK Poster in Exam Rooms (BEHAVIORAL).
Who is sponsoring clinical trial NCT03385512?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03385512's enrollment target sits among peer trials
5,565 24th of 2000 higher than 1,977 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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