Patient EngagementNCT03385512
OPEN & ASK: Improving Patient-Centered Communication in Primary Care
A study testing OPEN High Touch, OPEN High Tech and ASK Poster in Exam Rooms in people with Patient Engagement and Physician's Role, run by University of California, San Diego at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Engagement, Physician's Role, Physician-Patient Relations
- What is being tested?
- OPEN High Touch, OPEN High Tech and ASK Poster in Exam Rooms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,565 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jan 2018to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patient participants:
- Adults 18 years and older,
- Have an activated account to the patient portal of the electronic health record
- Able to read/write in English or Spanish
- Have an appointment with their PCP, who has volunteered to be participate in the study, during the data collection period
- Willing and able to provide informed consent and complete brief questionnaires online.
Show all 9Show fewer
- For health care team (primary care providers, nurse and medical assistants) participants:
- Employed at one of the participating study clinics
- Willing and able to provide informed consent and complete brief questionnaires online.
Who cannot join
- For patient participants:
- People who don't speak English or Spanish
- People who do not have an active My Chart/My Health Online account.
- Younger than 18 years old.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Palo Alto Medical Foundation Research Institute
Mountain View, California, 94040
University of California San Diego Health System
San Diego, California, 92093
Meyers Primary Care Institute at University of Massachusetts Medical School/Reliant Medical Group
Worcester, Massachusetts, 01605
About this study
Official title: Improving Patient-Centered Communication in Primary Care: A Cluster Randomized Controlled Trial of the Comparative Effectiveness of Three Interventions
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:
- 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.
- 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.
- 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 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.
Read the detailed description
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.
- Being tested
- OPEN High Touch, OPEN High Tech, ASK Poster in Exam Rooms
- Keywords
- Virtual standardized patient coaching, Standardized patient instructor coaching, Patient centered communication
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPEN High TouchBehavioural
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.
OPEN High TechBehavioural
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.
ASK Poster in Exam RoomsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| OPEN High Touch | Experimental | Participants in this arm will experience the OPEN High Touch intervention. Receives: Behavioral: OPEN High Touch |
| OPEN High Tech | Experimental | Participants in this arm will experience the OPEN High Tech intervention. Receives: Behavioral: OPEN High Tech |
| ASK Poster | Experimental | Participants in this arm will experience the ASK intervention. Receives: Behavioral: ASK Poster in Exam Rooms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- How much effort was made to help you understand your health issue?
- 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?
Measured: 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:
- My doctor asked me whether I agree with his/her decisions
- My doctor gave me a complete explanation for my medical symptoms or treatment
- My doctor asked me what I believe is causing my medical symptoms
- My doctor encouraged me to talk about personal concerns related to my medical symptoms
- My doctor encouraged me to give my opinion about my medical treatment.
Measured: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after indexed visits for intervention patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start23 Jan 2018
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient and health care team participants and the clinics in which they practice will be randomly assigned to one of three groups for the duration of their participation in the study: 1) OPEN High Tech, 2) OPEN High Touch and 3) ASK. Unit of randomization is clinic. Physicians will be clustered in clinics and patients clustered within physicians.
- Masking
- None (open label)
- Enrolment
- 5,565 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Reliant Medical Group, University of Massachusetts, Worcester, Palo Alto Medical Foundation, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Ming Tai-Seale, PhD, MPH, University of California, San Diego
- Investigators
- Ming Tai-Seale, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385512
- Sponsor's protocol ID
- IHS-1608-35689
- Status last verified
- Nov 2022
- First submitted
- 20 Dec 2017
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Tai-Seale M, Elwyn G, Wilson CJ, Stults C, Dillon EC, Li M, Chuang J, Meehan A, Frosch DL. Enhancing Shared Decision Making Through Carefully Designed Interventions That Target Patient And Provider Behavior. Health Aff (Millwood). 2016 Apr;35(4):605-12. doi: 10.1377/hlthaff.2015.1398.
PubMed 27044959Tai-Seale M, Sullivan G, Cheney A, Thomas K, Frosch D. The Language of Engagement: "Aha!" Moments from Engaging Patients and Community Partners in Two Pilot Projects of the Patient-Centered Outcomes Research Institute. Perm J. 2016 Spring;20(2):89-92. doi: 10.7812/TPP/15-123. Epub 2016 Feb 22.
PubMed 26909777Dillon EC, Stults CD, Wilson C, Chuang J, Meehan A, Li M, Elwyn G, Frosch DL, Yu E, Tai-Seale M. An evaluation of two interventions to enhance patient-physician communication using the observer OPTION5 measure of shared decision making. Patient Educ Couns. 2017 Oct;100(10):1910-1917. doi: 10.1016/j.pec.2017.04.020. Epub 2017 May 1.
PubMed 28532861Tai-Seale M, Cheung M, Vaida F, Ruo B, Walker A, Rosen RL, Hogarth M, Fisher KA, Singh S, Yood RA, Garber L, Saphirak C, Li M, Chan AS, Yu EE, Kallenberg G, Longhurst CA, Millen M, Stults CD, Mazor KM. Patient-Clinician Communication Interventions Across Multiple Primary Care Sites: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2024 Dec 6;5(12):e244436. doi: 10.1001/jamahealthforum.2024.4436.
PubMed 39671203Stults CD, Mazor KM, Cheung M, Ruo B, Li M, Walker A, Saphirak C, Vaida F, Singh S, Fisher KA, Rosen R, Yood R, Garber L, Longhurst C, Kallenberg G, Yu E, Chan A, Millen M, Tai-Seale M. Patients' Perspectives on Plans Generated During Primary Care Visits and Self-Reported Adherence at 3 Months: Data From a Randomized Trial. J Particip Med. 2024 Mar 14;16:e50242. doi: 10.2196/50242.
PubMed 38483458Tai-Seale M, Rosen R, Ruo B, Hogarth M, Longhurst CA, Lander L, Walker AL, Stults CD, Chan A, Mazor K, Garber L, Millen M. Implementation of Patient Engagement Tools in Electronic Health Records to Enhance Patient-Centered Communication: Protocol for Feasibility Evaluation and Preliminary Results. JMIR Res Protoc. 2021 Aug 26;10(8):e30431. doi: 10.2196/30431.
PubMed 34435960
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient-Centered Communication in Primary Care: A Cluster Randomized Controlled Trial of the Comparative Effectiveness of Three Interventions
- ClinicalTrials.gov ID
- NCT03385512
- Acronym / sponsor ID
- IHS-1608-35689
- Keywords
- Virtual standardized patient coaching, Standardized patient instructor coaching, Patient centered communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,565 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Reliant Medical Group, University of Massachusetts, Worcester, Palo Alto Medical Foundation, Patient-Centered Outcomes Research Institute
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patient and health care team participants and the clinics in which they practice will be randomly assigned to one of three groups for the duration of their participation in the study: 1) OPEN High Tech, 2) OPEN High Touch and 3) ASK. Unit of randomization is clinic. Physicians will be clustered in clinics and patients clustered within physicians.
| Arm | Type | Receives |
|---|---|---|
| OPEN High Touch | Experimental | Behavioral: OPEN High TouchParticipants in this arm will experience the OPEN High Touch intervention. |
| OPEN High Tech | Experimental | Behavioral: OPEN High TechParticipants in this arm will experience the OPEN High Tech intervention. |
| ASK Poster | Experimental | Behavioral: ASK Poster in Exam RoomsParticipants in this arm will experience the ASK intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults 18 years and older,
- Have an activated account to the patient portal of the electronic health record
- Able to read/write in English or Spanish
- Have an appointment with their PCP, who has volunteered to be participate in the study, during the data collection period
- Willing and able to provide informed consent and complete brief questionnaires online.
Key exclusion criteria (4 listed)
- People who don't speak English or Spanish
- People who do not have an active My Chart/My Health Online account.
- Younger than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPEN High TouchThis 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. | Behavioural | OPEN High Touch |
| OPEN High TechThe 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. | Behavioural | OPEN High Tech |
| ASK Poster in Exam RoomsThis 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. | Behavioural | ASK Poster |
Primary outcome
Patient reported experience with care: CollaboRATE
Time frame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
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?
Patient reported experience with care: Doctor Facilitation subscale of the Perceived Involvement in Care Scale
Time frame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.
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.
11 secondary outcomes
Action Plan
Time frame: This will be measured within 7 days of the indexed appointment for intervention patients.
Patient reported confidence to adhere to action plan
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
Time frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
Adherence to action plans
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)
Time frame: This will be measured within 7 days and again 3 months after the indexed visits for intervention patients.
Blood pressure
Time frame: 12 months after indexed visits for intervention patients.
A1c
Time frame: 12 months after indexed visits for intervention patients.
LDL
Time frame: 12 months after indexed visits for intervention patients.
Patient-initiated calls
Time frame: 12 months after indexed visits for intervention patients.
E-messages
Time frame: 12 months after indexed visits for intervention patients.
Office visits
Time frame: 12 months after indexed visits for intervention patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 27044959Tai-Seale M, Elwyn G, Wilson CJ, Stults C, Dillon EC, Li M, Chuang J, Meehan A, Frosch DL. Enhancing Shared Decision Making Through Carefully Designed Interventions That Target Patient And Provider Behavior. Health Aff (Millwood). 2016 Apr;35(4):605-12. doi: 10.1377/hlthaff.2015.1398.
- Background: PubMed 26909777Tai-Seale M, Sullivan G, Cheney A, Thomas K, Frosch D. The Language of Engagement: "Aha!" Moments from Engaging Patients and Community Partners in Two Pilot Projects of the Patient-Centered Outcomes Research Institute. Perm J. 2016 Spring;20(2):89-92. doi: 10.7812/TPP/15-123. Epub 2016 Feb 22.
- Background: PubMed 28532861Dillon EC, Stults CD, Wilson C, Chuang J, Meehan A, Li M, Elwyn G, Frosch DL, Yu E, Tai-Seale M. An evaluation of two interventions to enhance patient-physician communication using the observer OPTION5 measure of shared decision making. Patient Educ Couns. 2017 Oct;100(10):1910-1917. doi: 10.1016/j.pec.2017.04.020. Epub 2017 May 1.
- Derived from this study: PubMed 39671203Tai-Seale M, Cheung M, Vaida F, Ruo B, Walker A, Rosen RL, Hogarth M, Fisher KA, Singh S, Yood RA, Garber L, Saphirak C, Li M, Chan AS, Yu EE, Kallenberg G, Longhurst CA, Millen M, Stults CD, Mazor KM. Patient-Clinician Communication Interventions Across Multiple Primary Care Sites: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2024 Dec 6;5(12):e244436. doi: 10.1001/jamahealthforum.2024.4436.
- Derived from this study: PubMed 38483458Stults CD, Mazor KM, Cheung M, Ruo B, Li M, Walker A, Saphirak C, Vaida F, Singh S, Fisher KA, Rosen R, Yood R, Garber L, Longhurst C, Kallenberg G, Yu E, Chan A, Millen M, Tai-Seale M. Patients' Perspectives on Plans Generated During Primary Care Visits and Self-Reported Adherence at 3 Months: Data From a Randomized Trial. J Particip Med. 2024 Mar 14;16:e50242. doi: 10.2196/50242.
- Derived from this study: PubMed 34435960Tai-Seale M, Rosen R, Ruo B, Hogarth M, Longhurst CA, Lander L, Walker AL, Stults CD, Chan A, Mazor K, Garber L, Millen M. Implementation of Patient Engagement Tools in Electronic Health Records to Enhance Patient-Centered Communication: Protocol for Feasibility Evaluation and Preliminary Results. JMIR Res Protoc. 2021 Aug 26;10(8):e30431. doi: 10.2196/30431.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Tai-Seale, PhD, MPH principal investigator
University of California, San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPEN High Touch, OPEN High Tech and ASK Poster in Exam Rooms in people with Patient Engagement and Physician's Role, run by University of California, San Diego at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported experience with care: CollaboRATE (time frame: Within 7 days of a regularly scheduled appointment (the indexed visit) and 3 months after the indexed visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385512, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.