Resident Communication Skills Rated by PatientsIMCOMMNCT05057780
Measuring the Impact of an Interactive Communication Skills Curriculum on Internal Medicine Residents
A study testing Communication Skills Curriculum in people with Resident Communication Skills Rated by Patients, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study seeks to assess whether a novel method of teaching communication skills is effective in improving the communication skills of internal medicine residents. Effective communication is widely accepted as an essential skill in both clinical practice and post-graduate training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resident Communication Skills Rated by Patients
- What is being tested?
- Communication Skills Curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 1 May 2019
- 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
- PATIENTS:
- Appointment scheduled with a resident participant at one of eight primary care clinics in our health system
- had completed an appointment with a resident participant within 2 months of the resident completing their communication course
- 18 years of age or older
- proficient in English
- RESIDENTS:
Show all 9Show fewer
- PGY2 and PGY3 Internal Medicine residents at Cleveland Clinic
- Scheduled to receive required educational curriculum on communication
- Scheduled to see patients at one of the eight primary care clinics in our health system
Who cannot join
- PATIENTS:
- No appointment scheduled with a resident participant at one of eight primary care clinics in our health system
- had not completed an appointment with a resident participant within 2 months of the resident completing their communication course
- Less than 18 years of age
- Not proficient in English
- RESIDENTS:
Show all 9Show fewer
- Not PGY2 and PGY3 Internal Medicine residents at Cleveland Clinic
- Not scheduled to receive required educational curriculum on communication
- Not scheduled to see patients at one of the eight primary care clinics in our health system
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Main Campus Hospital
Cleveland, Ohio, 44195
About this study
Official title: Measuring the Impact of an Interactive Communication Skills Curriculum on Internal Medicine Residents: A Cluster Randomized Educational Study
This study seeks to assess whether a novel method of teaching communication skills is effective in improving the communication skills of internal medicine residents. Effective communication is widely accepted as an essential skill in both clinical practice and post-graduate training. While the body of research on effective communication is maturing, training that incorporates this new data lags behind. Methodological difficulties inherent to the study of communication training programs further complicates the effort to create effective, evidence-based training programs for the next generation of practitioners. Cleveland Clinic has taught its internally developed relationship-centered communication model, the R.E.D.E. Model, to over 7000 providers in less than 5 years. While teaching this course, common communication themes emerged as areas where providers often "get stuck". This proposal details a cluster randomized educational study of a novel communication training curriculum that addresses 3 of the common communication themes that emerged and how those themes occur in multiple, different communication challenges. The curriculum will be delivered to 2nd and 3rd year internal medicine residents over three, 1-hr long training sessions. The investigators' primary aim is to test whether residents trained to identify and communicate through these themes will receive better scores on communication from patients seen in their general internal medicine clinic. The investigators will also assess the effect of this training on patient compliance and on management of common chronic diseases such as hypertension, depression, and diabetes. Lastly, the investigators will measure the effect of the training course on resident self-perceived burnout and empathy.
Read the detailed description
This trial employed a cluster-randomized design. The residency program randomly divides the residents into 5 groups when they arrive as interns. These groups receive lectures together for all three years of residency and have similar schedules. The investigators used this predetermined structure to randomize the residents' communication course for this study. Two of the five groups were selected using a random number generator to receive the control course and three of the five groups received the intervention course. Although participation in the research study was voluntary, attending the assigned communication course was a mandatory educational activity for the residents.
Control (standard) Course:
The control course consisted of three hour-long didactic lectures on delivering bad news, discussing prognosis, and talking to patients about pain. The majority of time in these lectures was spent on didactic material. Little, if any, time was spent practicing skills or on interactive skill building. The three parts of the course were delivered over a 4-month period.
Intervention Course:
The intervention course also consisted of three hour-long sessions on communication delivered over a 4-month period. It differed from the control course in subject matter and pedagogy. Subject matter focused on specific skills used in communication: reflective listening, responding to emotion, and providing information within a broad range of communication scenarios. In terms of pedagogy, the intervention course was interactive with a focus on skills practice, communication drills, and improvisation to engage learners. The sessions consisted of fifteen minutes of lecture and 45 minutes of skills practice.
Faculty, senior residents, and fellows at the Center for Excellence in Healthcare Communication (CEHC) facilitated the control and intervention courses.33 Instructors at the CEHC taught facilitators best practices in adult learning theory, small and large group facilitation, and effective communication skills. Two trained facilitators led each course. The same facilitators taught the control and intervention courses.
PARTICIPANTS
Resident Participants:
Residents were recruited from Cleveland Clinic's Internal Medicine Residency program from November 2017 through April 2018. A total of 120 residents were eligible to participate in the study as they were post-graduate (PGY) 2 and 3 residents scheduled to receive mandatory educational curriculum on communication. Residents were invited to participate in the study first by an e-mail and again in person immediately prior to the start of the course. Residents received an information sheet about the study which explained that both the residents and their patients would be surveyed. Residents who completed the baseline surveys were considered enrolled, and their patients were sampled as detailed below. Residents were given a $10 gift card in compensation for their time and effort. While participation in the study was optional, all residents received either the intervention or control course as part of their mandatory educational curriculum. Participating residents provided basic demographic data and information about previous communication training. They also completed the Jefferson Scale of Empathy (JSE) and Maslach Burnout Inventory (MBI), validated tools that measure empathy and burnout respectively.
Patient Participants:
Patients who had an appointment scheduled with an enrolled resident in their primary care clinic were identified through the electronic medical record (EMR). Patients with appointments scheduled at all eight clinics in our health care system were eligible to participate in the study to ensure demographic representation. Eligible patients were age 18 or older, had completed an appointment with a resident in the trial within 2 months of the resident finishing the course, and were proficient in English.
Patients were recruited by mail within two weeks of their appointment and were compensated with a $10 gift card. Survey packets contained a survey invitation cover letter, the study information sheet, the survey, and a stamped return envelope. The cover letter identified the resident the patient saw and the location of their medical appointment, to clarify which medical provider to assess in the survey. The survey consisted of the Communication Assessment Tool, the Patient Activation Measure (PAM13), and demographic questions. Three attempts were made to contact non-responders.
MEASURES
Primary Outcome - Communication Assessment Tool:
The primary outcome was a validated measure of communication, the Communication Assessment Tool (CAT). The CAT is a fifteen item survey measuring physician communication as perceived by patients. Each item is rated from 1 "Poor" to 5 "Excellent". The first fourteen items measure specific aspects of communication, and the last item measures the quality of communication overall. Because surveys such as this are subject to a ceiling effect, scores were also analyzed as the percent of questions that received the maximum score - also known as a "top box" score.
Secondary Outcomes:
In addition, the investigators evaluated whether better communication shaped patient health outcomes. Before and after the patient's clinic appointment, the investigators examined the patient's EMR and extracted information about depression, blood pressure, and admittance history. Depression was evaluated using PHQ-9 scores recorded in the EMR, a common measure of depression with well documented internal consistency and construct validity. The PHQ-9 consists of nine questions, each scored from 0 to 3 for a total score of 0 to 27, with higher scores indicating more severe depression. Scores between 5 and 10 suggest mild depression, 10-14 suggest moderate depression, and 15-27 suggest severe depression. Missed appointments ("no-shows") and cancelled appointments were recorded as the frequency per month. Hospitalizations were recorded as the frequency of hospitalization for 1, 3 and 6 months after the patient's appointment with the internal medicine resident.
Finally, patients also completed the 13-item Patient Activation Measure (PAM13), a standardized measure to assess patients' knowledge, skill, and confidence to manage their own health. Scores range from 0 (low activation) to 100 (high activation). The PAM13 was included in the patient survey.
STATISTICAL ANALYSES Summary statistics were performed for baseline characteristics both at the resident and patient levels. Frequencies with proportions were used for categorical data and means with standard deviations for continuous data. To examine the associations between intervention and control groups, the investigators used chi-square tests for categorical data, and t-tests for continuous data. At the patient level, the investigators then assessed the primary outcome, the CAT score, using multivariable logistic regression, and adjusted for gender, age, race, income, PAM-13 scores, physician's emotional exhaustion as reported on the MBI, JSE score, and year of residency. Results of models were summarized as odds ratios together with 95% Wald Confidence Intervals. All tests were 2-sided and a p<0.05 was considered statistically significant. The investigators used SAS 9.4 for all statistical analyses.
- Being tested
- Communication Skills Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Skills CurriculumOther
Our novel intervention adapted curricula around effective skills used to navigate common communication challenges in clinical practice. These skills were selected after determining patterns from multiple communication sessions delivered to over 6,000 healthcare providers. Our main goal was to enhance communication with patients by helping residents gain confidence and competence using these under-utilized communication skills, regardless of the communication challenge. Over the course of three, 1-hour long sessions on communication in the 2017-2018 academic year, internal medicine residents learned three of these highly effective and often under-utilized skills; reflective listening, responding to emotion and reframing, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Curriculum | Experimental | The intervention course consisted of 3 hour-long sessions on communication delivered over a 4-month period. It differed from the control course in subject matter and pedagogy. Subject matter focused on specific skills used in communication: reflective listening, responding to emotion, and providing information within a broad range of communication scenarios. In terms of pedagogy, the intervention course was interactive with a focus on skills practice, communication drills, and improvisation to engage learners. The sessions consisted of fifteen minutes of lecture and 45 minutes of skills practice. Receives: Other: Communication Skills Curriculum |
| Control (Standard) Curriculum | Active comparator | The control course consisted of three hour-long didactic lectures on delivering bad news, discussing prognosis, and talking to patients about pain. The majority of time in these lectures was spent on didactic material. Little, if any, time was spent practicing skills or on interactive skill building. The three parts of the course were delivered over a 4-month period. Receives: Other: Communication Skills Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Assessment Tool (CAT)
The CAT is a fifteen item survey measuring physician communication as perceived by patients. Each item is rated from 1 "Poor" to 5 "Excellent". The first fourteen items measure specific aspects of communication, and the last item measures the quality of communication overall. Because surveys such as this are subject to a ceiling effect, scores were also analyzed as the percent of questions that received the maximum score - also known as a "top box" score.
Measured: 2-12 weeks after primary care appointment
Secondary outcomes (1)
Patient Activation Measure (PAM13)
PAM is a 13-item measure measure to assess patients' knowledge, skill, and confidence to manage their own health. Scores range from 0 (low activation) to 100 (high activation).
Measured: 2-12 weeks after primary care appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start20 Nov 2017
- Primary completion9 Oct 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resident Communication Skills Rated by PatientsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susannah Rose, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057780
- Sponsor's protocol ID
- 17-1454
- Acronym
- IMCOMM
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of an Interactive Communication Skills Curriculum on Internal Medicine Residents: A Cluster Randomized Educational Study
- ClinicalTrials.gov ID
- NCT05057780
- Acronym / sponsor ID
- IMCOMM / 17-1454
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 27 Sep 2021 (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 study seeks to assess whether a novel method of teaching communication skills is effective in improving the communication skills of internal medicine residents. Effective communication is widely accepted as an essential skill in both clinical practice and post-graduate training. While the body of research on effective communication is maturing, training that incorporates this new data lags behind. Methodological difficulties inherent to the study of communication training programs further complicates the effort to create effective, evidence-based training programs for the next generation of practitioners. Cleveland Clinic has taught its internally developed relationship-centered communication model, the R.E.D.E. Model, to over 7000 providers in less than 5 years. While teaching this course, common communication themes emerged as areas where providers often "get stuck". This proposal details a cluster randomized educational study of a novel communication training curriculum that addresses 3 of the common communication themes that emerged and how those themes occur in multiple, different communication challenges. The curriculum will be delivered to 2nd and 3rd year internal medicine residents over three, 1-hr long training sessions. The investigators' primary aim is to test whether residents trained to identify and communicate through these themes will receive better scores on communication from patients seen in their general internal medicine clinic. The investigators will also assess the effect of this training on patient compliance and on management of common chronic diseases such as hypertension, depression, and diabetes. Lastly, the investigators will measure the effect of the training course on resident self-perceived burnout and empathy.
Detailed description
This trial employed a cluster-randomized design. The residency program randomly divides the residents into 5 groups when they arrive as interns. These groups receive lectures together for all three years of residency and have similar schedules. The investigators used this predetermined structure to randomize the residents' communication course for this study. Two of the five groups were selected using a random number generator to receive the control course and three of the five groups received the intervention course. Although participation in the research study was voluntary, attending the assigned communication course was a mandatory educational activity for the residents.
Control (standard) Course:
The control course consisted of three hour-long didactic lectures on delivering bad news, discussing prognosis, and talking to patients about pain. The majority of time in these lectures was spent on didactic material. Little, if any, time was spent practicing skills or on interactive skill building. The three parts of the course were delivered over a 4-month period.
Intervention Course:
The intervention course also consisted of three hour-long sessions on communication delivered over a 4-month period. It differed from the control course in subject matter and pedagogy. Subject matter focused on specific skills used in communication: reflective listening, responding to emotion, and providing information within a broad range of communication scenarios. In terms of pedagogy, the intervention course was interactive with a focus on skills practice, communication drills, and improvisation to engage learners. The sessions consisted of fifteen minutes of lecture and 45 minutes of skills practice.
Faculty, senior residents, and fellows at the Center for Excellence in Healthcare Communication (CEHC) facilitated the control and intervention courses.33 Instructors at the CEHC taught facilitators best practices in adult learning theory, small and large group facilitation, and effective communication skills. Two trained facilitators led each course. The same facilitators taught the control and intervention courses.
PARTICIPANTS
Resident Participants:
Residents were recruited from Cleveland Clinic's Internal Medicine Residency program from November 2017 through April 2018. A total of 120 residents were eligible to participate in the study as they were post-graduate (PGY) 2 and 3 residents scheduled to receive mandatory educational curriculum on communication. Residents were invited to participate in the study first by an e-mail and again in person immediately prior to the start of the course. Residents received an information sheet about the study which explained that both the residents and their patients would be surveyed. Residents who completed the baseline surveys were considered enrolled, and their patients were sampled as detailed below. Residents were given a $10 gift card in compensation for their time and effort. While participation in the study was optional, all residents received either the intervention or control course as part of their mandatory educational curriculum. Participating residents provided basic demographic data and information about previous communication training. They also completed the Jefferson Scale of Empathy (JSE) and Maslach Burnout Inventory (MBI), validated tools that measure empathy and burnout respectively.
Patient Participants:
Patients who had an appointment scheduled with an enrolled resident in their primary care clinic were identified through the electronic medical record (EMR). Patients with appointments scheduled at all eight clinics in our health care system were eligible to participate in the study to ensure demographic representation. Eligible patients were age 18 or older, had completed an appointment with a resident in the trial within 2 months of the resident finishing the course, and were proficient in English.
Patients were recruited by mail within two weeks of their appointment and were compensated with a $10 gift card. Survey packets contained a survey invitation cover letter, the study information sheet, the survey, and a stamped return envelope. The cover letter identified the resident the patient saw and the location of their medical appointment, to clarify which medical provider to assess in the survey. The survey consisted of the Communication Assessment Tool, the Patient Activation Measure (PAM13), and demographic questions. Three attempts were made to contact non-responders.
MEASURES
Primary Outcome - Communication Assessment Tool:
The primary outcome was a validated measure of communication, the Communication Assessment Tool (CAT). The CAT is a fifteen item survey measuring physician communication as perceived by patients. Each item is rated from 1 "Poor" to 5 "Excellent". The first fourteen items measure specific aspects of communication, and the last item measures the quality of communication overall. Because surveys such as this are subject to a ceiling effect, scores were also analyzed as the percent of questions that received the maximum score - also known as a "top box" score.
Secondary Outcomes:
In addition, the investigators evaluated whether better communication shaped patient health outcomes. Before and after the patient's clinic appointment, the investigators examined the patient's EMR and extracted information about depression, blood pressure, and admittance history. Depression was evaluated using PHQ-9 scores recorded in the EMR, a common measure of depression with well documented internal consistency and construct validity. The PHQ-9 consists of nine questions, each scored from 0 to 3 for a total score of 0 to 27, with higher scores indicating more severe depression. Scores between 5 and 10 suggest mild depression, 10-14 suggest moderate depression, and 15-27 suggest severe depression. Missed appointments ("no-shows") and cancelled appointments were recorded as the frequency per month. Hospitalizations were recorded as the frequency of hospitalization for 1, 3 and 6 months after the patient's appointment with the internal medicine resident.
Finally, patients also completed the 13-item Patient Activation Measure (PAM13), a standardized measure to assess patients' knowledge, skill, and confidence to manage their own health. Scores range from 0 (low activation) to 100 (high activation). The PAM13 was included in the patient survey.
STATISTICAL ANALYSES Summary statistics were performed for baseline characteristics both at the resident and patient levels. Frequencies with proportions were used for categorical data and means with standard deviations for continuous data. To examine the associations between intervention and control groups, the investigators used chi-square tests for categorical data, and t-tests for continuous data. At the patient level, the investigators then assessed the primary outcome, the CAT score, using multivariable logistic regression, and adjusted for gender, age, race, income, PAM-13 scores, physician's emotional exhaustion as reported on the MBI, JSE score, and year of residency. Results of models were summarized as odds ratios together with 95% Wald Confidence Intervals. All tests were 2-sided and a p<0.05 was considered statistically significant. The investigators used SAS 9.4 for all statistical analyses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Curriculum | Experimental | Other: Communication Skills CurriculumThe intervention course consisted of 3 hour-long sessions on communication delivered over a 4-month period. It differed from the control course in subject matter and pedagogy. Subject matter focused on specific skills used in communication: reflective listening, responding to emotion, and providing information within a broad range of communication scenarios. In terms of pedagogy, the intervention course was interactive with a focus on skills practice, communication drills, and improvisation to engage learners. The sessions consisted of fifteen minutes of lecture and 45 minutes of skills practice. |
| Control (Standard) Curriculum | Active comparator | Other: Communication Skills CurriculumThe control course consisted of three hour-long didactic lectures on delivering bad news, discussing prognosis, and talking to patients about pain. The majority of time in these lectures was spent on didactic material. Little, if any, time was spent practicing skills or on interactive skill building. The three parts of the course were delivered over a 4-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Appointment scheduled with a resident participant at one of eight primary care clinics in our health system
- had completed an appointment with a resident participant within 2 months of the resident completing their communication course
- 18 years of age or older
- proficient in English
- PGY2 and PGY3 Internal Medicine residents at Cleveland Clinic
Key exclusion criteria (9 listed)
- No appointment scheduled with a resident participant at one of eight primary care clinics in our health system
- had not completed an appointment with a resident participant within 2 months of the resident completing their communication course
- Less than 18 years of age
- Not proficient in English
- Not PGY2 and PGY3 Internal Medicine residents at Cleveland Clinic
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 |
|---|---|---|
| Communication Skills CurriculumOur novel intervention adapted curricula around effective skills used to navigate common communication challenges in clinical practice. These skills were selected after determining patterns from multiple communication sessions delivered to over 6,000 healthcare providers. Our main goal was to enhance communication with patients by helping residents gain confidence and competence using these under-utilized communication skills, regardless of the communication challenge. Over the course of three, 1-hour long sessions on communication in the 2017-2018 academic year, internal medicine residents learned three of these highly effective and often under-utilized skills; reflective listening, responding to emotion and reframing, respectively. | Other | Control (Standard) Curriculum, Intervention Curriculum |
Primary outcome
Communication Assessment Tool (CAT)
Time frame: 2-12 weeks after primary care appointment
The CAT is a fifteen item survey measuring physician communication as perceived by patients. Each item is rated from 1 "Poor" to 5 "Excellent". The first fourteen items measure specific aspects of communication, and the last item measures the quality of communication overall. Because surveys such as this are subject to a ceiling effect, scores were also analyzed as the percent of questions that received the maximum score - also known as a "top box" score.
1 secondary outcome
Patient Activation Measure (PAM13)
Time frame: 2-12 weeks after primary care appointment
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 2 Oct 2023.
- Individual participant dataSharing planned: No
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.
Susannah Rose, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Skills Curriculum in people with Resident Communication Skills Rated by Patients, run by The Cleveland Clinic 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 9 inclusion and 9 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 2 Oct 2023. 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?
Communication Assessment Tool (CAT) (time frame: 2-12 weeks after primary care appointment). 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 2 Oct 2023.