An interventional study of OPEN High Touch and OPEN High Tech in Patient Engagement, Physician's Role and Physician-Patient Relations, sponsored by University of California, San Diego. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Health services research
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Among 154 studies in Patient Participation with a site in United States — 27 open to participants now, 31 under way, none of them phase 3. Patient Participation · United States.
Among the 154 studies in Patient Participation with a site in United States, this one is the 10th largest by enrollment of the 139 interventional ones that give a count, is one of 6 that started in 2018, is one of 132 with no phase, and was the 44th registered.
409 studies on the registry are indexed under Patient Participation; 100 are open to participants now.
Browse Patient Participation studies →27 of the 154 studies in Patient Participation with a site in United States are open now. Recruiting first, the newest first:
University of Utah · Sites in United States
Ages 18+ · Women only · Healthy volunteers
William Brandenburg, MD · Sites in United States
Ages 18+ · Healthy volunteers
University of Nebraska · Sites in United States
Ages 15–18
University of Washington · Sites in United States
Ages 14+ · Healthy volunteers
Columbia University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 48 Patient Participation studies recruiting now, 32 (67%) set no upper age limit and 9 (19%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 2002; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 5,565 is above the median of 128 across 322 interventional studies indexed under Patient Participation.
Median enrollment 130 across the 139 interventional studies, 257 across the 15 observational. Of the 114 that completed or were terminated, 42 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 154 have an industry lead sponsor. The 10 most frequent:
University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
University of California, San Diego has 3 studies filed under Patient Participation — fewer than ten, so there is no comparison to draw.
13 of the studies in Patient Participation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
| NCT06246409University of FloridaModernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy | 2026-12 |
| NCT07489105Auburn UniversityForge AHEAD: Feasibility of Yoga to Improve Cognitive Function | 2026-12-31 |
| NCT06581484University of California, San FranciscoImproving Congenital Heart Disease Care | 2026-12-31 |
| NCT06358261Johns Hopkins UniversityStudy of a Diabetes Prevention Patient Activation Clinical Decision Support Tool | 2027-01-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 154 studies in Patient Participation with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
The investigators anticipate that this multi-level healthcare system intervention will result in significant improvement in: patient satisfaction with how PCP has engaged them in the visit, confidence in selfcare; patients' intention to adhere to care plan, and clinical indicators. Furthermore, more effective communication would lower health service utilization after the visit. The investigators further expect that the intervention will affect physicians', medical assistants' and nurses' experience as well as healthcare system leaders' intention to implement in routine practice.
This is a three-arm, multi-site, cluster-randomized controlled trial, comparing three approaches to improve communication between patients and their doctors. Three health systems will participate in the study: UCSD Health, Reliant Medical Group, and Sutter Health.
The study will be carried out in 2 phases.
Phase 1: Phase 1 includes intervention and survey development work to take place prior to the RCT.
OPEN High Touch intervention - The High Touch intervention will be modeled after the Open Communication intervention developed in the pilot (ClinicalTrials.gov Identifier NCT02522286) which contained three components: (a) a one question pre-visit survey delivered through the patient portal of the EHR, asking patients what they most want to discuss with their physician in the upcoming visit; (b) an animated video for patients providing coaching on how to best prepare for their upcoming visits and get the most from the visits; and (c) Standardized Patient Instructor (SPI) providing communication coaching for physicians on how to incorporate what matter most to patients in the visit, with empathy, and clarity.
OPEN High Tech intervention - For the High Tech arm, the patient components of the intervention will be identical to the patient components of the High Touch arm (i.e., the pre-visit survey and patient coaching video). The difference will be in the PCP training: we will replace the in-person SPI with a mobile app with embedded audio and video vignettes demonstrating the communication challenges (e.g., patient with a big list of issues, patients who resist physician recommendations, and patients who disagree with physician) and recommended strategies. A mobile app offers several advantages, including being accessible at a convenient time for busy providers, being easily disseminated, and easily updated. The app will be interactive, posing questions to learners in association with video vignettes and asking learners to answer how they would handle the situation. We will start with the idea of building a set of short mobile modules that mirror the High Touch approach, honing skills on acknowledging patient's agenda, negotiate a joint agenda, invite patient to teachback and incorporate it in the After Visit Summary in the EHR.
ASK intervention - The ASK intervention is intended to activate patients by encouraging them to ask three questions during their primary care visit: (1) What are my options? (2) What are the possible benefits and risks of each option? (3) How likely are each of the benefits and risks to happen to me? These questions will be printed on posters and placed in exam rooms used by providers in clinics randomized to the ASK arm of the trial.
Phase 2: Phase 2 covers the trial recruitment, and three waves of data collection. Prior to the start of the RCT we will collect baseline (T0) data to allow measurement of primary care provider (PCP) performance prior to the trial. Patients participating in the T0 phase will provide only post-visit ratings of their encounters; we will not collect other outcome data or clinical indicators for these patients. For all patients in the intervention phase, we will be collecting information at two time points: 1) immediately post-encounter (T1); and 2) three months post-encounter (T2). We will further sample the top 5% high users of services after the intervention and review their medical records including the indexed visit and subsequent services that had occurred within four weeks after the indexed visit. The chart review will enable us to decipher the reasons for high volume of services after the indexed visit. We will also use existing patient survey data (Press-Ganey and/or NRC) to supplement our data sources.
Analytical approach: We will apply intention to treat analysis, providing descriptive statistics on relevant outcome measures across patients, PCPs, and clinics according to their randomized assignments in the RCT. We will then use generalized estimating equations logistic regression analysis to examine the impact of the assignment into the intervention arms and the outcomes, while controlling for patient and physician covariates.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For patient participants:
For health care team (primary care providers, nurse and medical assistants) participants:
Exclusion Criteria:
For patient participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will experience the OPEN High Touch intervention.
Behavioral: OPEN High Touch
Participants in this arm will experience the OPEN High Tech intervention.
Behavioral: OPEN High Tech
Participants in this arm will experience the ASK intervention.
Behavioral: ASK Poster in Exam Rooms
This arm will contain three components: (a) a pre-visit questionnaire delivered through the patient portal of the EHR, asking patients what they most want to discuss with their physician in the upcoming visit; (b) an animated video for patients providing coaching on how to best prepare for their upcoming visits and get the most from the visits; and (c) Standardized Patient Instructor (SPI) providing communication coaching for physicians on how to incorporate what matter most to patients in the visit, with empathy, and clarity.
The patient components of the intervention will be identical to the patient components of the High Touch arm (i.e., the pre-visit survey and patient coaching video). The difference will be in the PCP training: we will replace the in-person SPI with a mobile app program.
This arm is intended to activate patients by encouraging them to ask three questions during their primary care visit: (1) What are my options? (2) What are the possible benefits and risks of each option? (3) How likely are the benefits and risks of each option to occur to me? This will involve placing posters with these questions in all exam rooms used by providers in clinics randomized to the ASK arm of the trial.
Patient reported experience with care: CollaboRATE
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 much effort was made to listen to the things that matter most to you about your health issues? 3. How much effort was made to include what matters most to you in choosing what to do next?
Time frame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
Patient reported experience with care: Doctor Facilitation subscale of the Perceived Involvement in Care Scale
Responses from this validated 5-item, patient reported measure of their perceptions of how well their physician facilitated their involvement in decision making are compared between baseline and intervention patients; immediately after the indexed visit with their PCP and 3 months after the indexed visit for intervention patients; and across interventions for variations. The 5 questions, which will answered on a scale of 0 "Definitely Disagree" to 9 "Definitely Agree" are: 1. My doctor asked me whether I agree with his/her decisions 2. My doctor gave me a complete explanation for my medical symptoms or treatment 3. My doctor asked me what I believe is causing my medical symptoms 4. My doctor encouraged me to talk about personal concerns related to my medical symptoms 5. My doctor encouraged me to give my opinion about my medical treatment.
Time frame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
Action Plan
The "Patient Instructions" field of the After Visit Summary that patients receive in paper and/or through their online patient portal after the indexed visit with their provider.
Time frame: This will be measured within 7 days of the indexed appointment for intervention patients.
Patient reported confidence to adhere to action plan
Responses from a patient reported measure of their confidence to adhere to their action plan. This will be measured by the question "Overall, how confident are you about your ability to take good care of your health?" using a 5-point Likert scale from 1=not confident at all to 5=Completely confident. This is a question used in the Health Information National Trends Survey (HINTS), a biennial, cross-sectional survey of a nationally-representative sample of American adults, developed and used by the Center for Disease Control and Prevention and National Cancer Institute (https://www.healthypeople.gov/2020/data-source/health-information-national-trends-survey).
Time frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
Patient reported intention to adhere to action plan
Responses from this patient reported measure of intention to adhere to their action plan. We will examine the psychometric property of these measures and expect that they will enable us to form a factor that measures the construct of intention to adhere to care plans. We call this measure INTENTION.
Time frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
Adherence to action plans
A patient reported measure that will be adapted from the Medical Outcomes Study (MOS) general adherence survey instrument with help from our study stakeholders.
Time frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
The Veterans RAND 12-item health survey (VR12)
A 12-item patient reported health status measure.
Time frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
Blood pressure
This will be extracted from the electronic health record and used as a clinical indicator of health outcomes.
Time frame: 12 months after indexed visits for intervention patients.
A1c
This will be extracted from the electronic health record and used as a clinical indicator of health outcomes.
Time frame: 12 months after indexed visits for intervention patients.
LDL
This will be extracted from the electronic health record and used as a clinical indicator of health outcomes.
Time frame: 12 months after indexed visits for intervention patients.
Patient-initiated calls
These will be measured using structured fields in the electronic health record and access log. The investigators will review the charts of the top 5% of telephone callers.
Time frame: 12 months after indexed visits for intervention patients.
E-messages
These will be measured using structured fields in the electronic health record and access log. The investigators will review the charts of the top 5% of e-message senders.
Time frame: 12 months after indexed visits for intervention patients.
Office visits
These will be measured using structured fields in the electronic health record. The investigators will review the charts of the top 5% of office visit generators.
Time frame: 12 months after indexed visits for intervention patients.
Plan to share: Yes — We will make a complete, cleaned, de-identified copy of the final data set used in conducting the final analyses available within 9 months after the completion of the study. Researchers interested in replicating our methods and study findings will have full access to the study protocol, samples of intervention prototypes, analytic methods and codebook. We will deliver our final protocol, prototypes, toolkit, codebook documents, and instructions regarding how other researchers can access our study documents to PCORI.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Within 9 months after the completion of the study.
Access criteria: A Data Use Agreement will be implemented for other researchers interested in using our data for replication of research findings or for additional areas of research. We will request that outside investigators discuss their manuscript ideas with the PI (Dr. Tai-Seale) and Site-PIs (Dr. Cheryl Stults and Dr. Kathy Mazor) before proceeding. Furthermore, we will request that manuscripts using data from our project be approved by the PI and Site-PIs prior to submission for publication. Members of this project team may contribute as co-authors when data from this study are used. We will request that manuscripts, abstracts, presentations, and chapters developed by other investigators credit this study and credit PCORI as the funding source for the data. This process will allow for a central repository and access point for all papers, abstracts, posters, and presentations by any individual or organization using our data.
Ran from Jan 2018 to primary completion in Sep 2022, 56 months.
Of 219 non-industry interventional studies with no phase under Patient Participation, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 56 months is above that.
Counting every sponsor, half of 226 studies reached it within 20 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of California, San Diego →