AsthmaNCT02915068
Feasibility of a Clinician Training Program to Improve Patient-provider Communication in the Presence of Health IT Systems in the Exam Room
A study testing EHR-Physician Asthma Care Education Program in people with Asthma, run by University of Michigan at 1 site in United States.
Trial summary
The investigators propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- EHR-Physician Asthma Care Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 31 Aug 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physicians:
- Licensed physician in practice and board certified in primary care or family medicine
- Treating adults with asthma
- Full-time in a practice at an Integrated Health Associates clinic that has implemented a certified EHR system for at least one year
- Consent to participate
- Will generate a roster of adult asthma patients for inclusion in the study
Show all 13Show fewer
- Patients:
- Treated by the participating physician during the study intake period
- 18 years of age or older
- Have a diagnosis of asthma made by a physician using the National Asthma Education and Prevention Program Guidelines
- Have at least one urgent medical care visit for asthma in the previous year
- Have access to a telephone
- Consent to participate
Who cannot join
- Patients:
- 1. Have other chronic disorders that have pulmonary complications
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated Health Associates ClinSite Research
Ann Arbor, Michigan, 48105
About this study
The investigators propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention. Patients will not know which arm their doctor was randomized to. The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.
Read the detailed description
Failure in clinician-patient communication, lack of clarity regarding clinical treatment priorities, and more recently, ineffective use of health IT systems in exam rooms are associated with deficits in achieving chronic disease management goals, and increased healthcare utilization and costs. Strategies for communicating with patients in exam rooms in the presence of electronic health records (EHR) have been described in the literature. Whether such strategies are reaching clinicians and demonstrating positive health outcomes is unclear. The investigators propose to develop and test the feasibility on patient outcomes of an interactive training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs). They propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The PACE program is based on concepts and skills for strengthening communication and patient-clinician relationships through behavior change principles that are highly applicable to patients with asthma and has potential for specific application to EHR use in clinical practice. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention.Patients will not know which arm their doctor was randomized to.The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.
EHR-PACE developed in this study is expected to have a high degree of relevance for improving the patient-provider communication skills of clinicians who see a wide range of patients in a variety of practice settings that have now integrated EHRs. Given that PACE can achieve dramatic outcomes within only two, 2-hour sessions, EHR-PACE has the potential to become an invaluable training tool to busy clinicians if proven feasible and effective. Ultimately, this work has potential for a high degree of impact.
- Conditions
- Asthma
- Being tested
- EHR-Physician Asthma Care Education Program
- Keywords
- patient-provider communication, Electronic Health Records, Provider education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR-Physician Asthma Care Education ProgramBehavioural
participants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Physicians do not receive focused education and training on patient-centered communication with the EHR |
| EHR-PACE | Experimental | participants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs). Receives: Behavioral: EHR-Physician Asthma Care Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline patient report of physician performance at 3 and 6 months
The patient's report of physician performance will be used as the key measure in this study. They will use a validated instrument previously developed by the research group in the PACE trials, focusing on clinical practices of the clinician, especially, use of National Asthma Education and Prevention Program recommended therapies, communication and counseling behaviors specially related to EHR use.
Measured: baseline, 3 months, 6 months
Secondary outcomes (3)
Change from baseline patient satisfaction at 3 and 6 months
specific facets of satisfaction with care adapted from the widely used Patient Satisfaction Questionnaire, especially as it relates to interactions with clinicians in the presence of EHRs in the exam room
Measured: baseline, 3 months, 6 months
Change from baseline asthma control at 3 and 6 months
the Asthma Control Test (ACT), a valid measure responsive to changes in asthma control over time
Measured: baseline, 3 months, 6 months
Change from baseline asthma-related quality of life at 3 and 6 months
Mini Asthma Quality of Life Questionnaire (Mini-AQLQ), a 15-item validated instrument that assesses physical, emotional, and social well-being of adults with asthma through four domains (activity limitations, symptoms, emotional function, and exposure to environmental stimuli).
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startJun 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Minal Patel, University of Michigan
- Investigators
- Minal R Patel, PhD, MPH, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915068
- Sponsor's protocol ID
- HUM00100232
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Clinician Training Program to Improve Patient-provider Communication in the Presence of Health IT Systems in the Exam Room
- ClinicalTrials.gov ID
- NCT02915068
- Acronym / sponsor ID
- HUM00100232
- Conditions
- Asthma
- Keywords
- patient-provider communication, Electronic Health Records, Provider education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2015
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 26 Sep 2016 (estimated)
- 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.
The investigators propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention. Patients will not know which arm their doctor was randomized to. The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.
Detailed description
Failure in clinician-patient communication, lack of clarity regarding clinical treatment priorities, and more recently, ineffective use of health IT systems in exam rooms are associated with deficits in achieving chronic disease management goals, and increased healthcare utilization and costs. Strategies for communicating with patients in exam rooms in the presence of electronic health records (EHR) have been described in the literature. Whether such strategies are reaching clinicians and demonstrating positive health outcomes is unclear. The investigators propose to develop and test the feasibility on patient outcomes of an interactive training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs). They propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The PACE program is based on concepts and skills for strengthening communication and patient-clinician relationships through behavior change principles that are highly applicable to patients with asthma and has potential for specific application to EHR use in clinical practice. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention.Patients will not know which arm their doctor was randomized to.The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.
EHR-PACE developed in this study is expected to have a high degree of relevance for improving the patient-provider communication skills of clinicians who see a wide range of patients in a variety of practice settings that have now integrated EHRs. Given that PACE can achieve dramatic outcomes within only two, 2-hour sessions, EHR-PACE has the potential to become an invaluable training tool to busy clinicians if proven feasible and effective. Ultimately, this work has potential for a high degree of impact.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Physicians do not receive focused education and training on patient-centered communication with the EHR |
| EHR-PACE | Experimental | Behavioral: EHR-Physician Asthma Care Education Programparticipants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Licensed physician in practice and board certified in primary care or family medicine
- Treating adults with asthma
- Full-time in a practice at an Integrated Health Associates clinic that has implemented a certified EHR system for at least one year
- Consent to participate
- Will generate a roster of adult asthma patients for inclusion in the study
Key exclusion criteria (3 listed)
- 1. Have other chronic disorders that have pulmonary complications
- -
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 |
|---|---|---|
| EHR-Physician Asthma Care Education Programparticipants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs). | Behavioural | EHR-PACE |
Primary outcome
Change from baseline patient report of physician performance at 3 and 6 months
Time frame: baseline, 3 months, 6 months
The patient's report of physician performance will be used as the key measure in this study. They will use a validated instrument previously developed by the research group in the PACE trials, focusing on clinical practices of the clinician, especially, use of National Asthma Education and Prevention Program recommended therapies, communication and counseling behaviors specially related to EHR use.
3 secondary outcomes
Change from baseline patient satisfaction at 3 and 6 months
Time frame: baseline, 3 months, 6 months
Change from baseline asthma control at 3 and 6 months
Time frame: baseline, 3 months, 6 months
Change from baseline asthma-related quality of life at 3 and 6 months
Time frame: baseline, 3 months, 6 months
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 Sep 2017.
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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.
Minal R Patel, PhD, MPH principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-Physician Asthma Care Education Program in people with Asthma, run by University of Michigan at 1 site 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 13 inclusion and 3 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 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline patient report of physician performance at 3 and 6 months (time frame: baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.