CommunicationNCT03766841
Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research
A study testing Facilitated Enrollment in people with Communication, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
To assess whether the routine collection of patient-contextual data improves patient activation and communication, and can mitigate racial disparities in communication and engagement, we are inviting patients who have upcoming appointments at the participating health system to participate in a communication study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Facilitated Enrollment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Nov 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
- aged 18 or older
- able to speak and understand English,
- a patient at a selected Froedtert \& Medical College of Wisconson primary care or internal medicine clinic (i.e., General Internal Medicine On Campus of Milwaukee Regional Medical Center, Sargeant Health Center, or Tosa Health Center (Plank Road Clinic) with an upcoming (> 4 weeks away) appointment and at least 1 previous appointment with the same provider in the previous 12 months.
- Patients with cognitive impairment (e.g. dementia) are eligible to participate through the use of proxies who would ordinarily accompany them to appointments and complete forms or post-visit surveys on their behalf.
Who cannot join
- Minors and non-English speaking patients are not eligible to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
To assess whether the routine collection of patient-contextual data improves patient activation and communication, and can mitigate racial disparities in communication and engagement, we are inviting patients who have upcoming appointments at the participating health system to participate in a communication study. Patients will be randomized to having guided (facilitated) enrollment in a tool that collects patient contextual data, or to usual care. All patients are invited directly by the health system to use the tool. Statistical methods will be used to determine the impact of the tool's use on outcomes of interest, as well as the impact on completion by the use of the facilitated enrollment. The study will particularly focus on assessing the impact of patient-contextual data and communication on heath disparities.
- Conditions
- Communication
- Being tested
- Facilitated Enrollment
- Keywords
- consumer informatics, communication, patient engagement
- Medical subject headings
- Communication, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated EnrollmentBehavioural
Research coordinator will assist patients in account creation and usage of the tool.
| Study group | Role | What they receive |
|---|---|---|
| Facilitated Enrollment | Experimental | Patients will be aided in the account creation and usage of a consumer informatics tool to collect and report patient-contextual data within the electronic health record Receives: Behavioral: Facilitated Enrollment |
| Usual Care | No intervention | Patients will be invited to use the patient contextual data tool as per usual care, but will not receive additional assistance in account creation and usage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome.
Use of Communication Assessment Tool (CAT), a 14-item instrument that reports patient-views of clinician communication Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007;67: 333-342.
Measured: Post Visit ( 1 week)
Secondary outcomes (1)
Change in the composite score of the patient activation measure, a validated instrument to assess a patient's engagement and activation in their health issues.
Short form developed by J Hibbard et al on patient activation Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40: 1918-1930.
Measured: Pre/Post Visit (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Apr 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Crotty, Medical College of Wisconsin
- Investigators
- Bradley H Crotty, MD MPH, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766841
- Sponsor's protocol ID
- PRO00031177
- Status last verified
- Feb 2020
- First submitted
- 29 Nov 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Holt JM, Cusatis R, Winn A, Asan O, Spanbauer C, Williams JS, Flynn KE, Somai M, Talsma A, Laud P, Makoul G, Crotty BH. Impact of Pre-visit Contextual Data Collection on Patient-Physician Communication and Patient Activation: a Randomized Trial. J Gen Intern Med. 2021 Nov;36(11):3321-3329. doi: 10.1007/s11606-020-06583-7. Epub 2021 Feb 9.
PubMed 33559067Holt JM, Winn A, Cusatis R, Talsma A, Crotty BH. Racial Disparities in Patient Activation: The Role of Economic Diversity. West J Nurs Res. 2021 Jun;43(6):517-529. doi: 10.1177/0193945920963130. Epub 2020 Oct 5.
PubMed 33012264Holt JM, Cusatis R, Winn A, Asan O, Spanbauer C, Williams JS, Flynn KE, Somai M, Laud P, Crotty BH. The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 23;9(9):e20309. doi: 10.2196/20309.
PubMed 32965223
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research
- ClinicalTrials.gov ID
- NCT03766841
- Acronym / sponsor ID
- PRO00031177
- Conditions
- Communication
- Keywords
- consumer informatics, communication, patient engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 6 Dec 2018 (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.
To assess whether the routine collection of patient-contextual data improves patient activation and communication, and can mitigate racial disparities in communication and engagement, we are inviting patients who have upcoming appointments at the participating health system to participate in a communication study. Patients will be randomized to having guided (facilitated) enrollment in a tool that collects patient contextual data, or to usual care. All patients are invited directly by the health system to use the tool. Statistical methods will be used to determine the impact of the tool's use on outcomes of interest, as well as the impact on completion by the use of the facilitated enrollment. The study will particularly focus on assessing the impact of patient-contextual data and communication on heath disparities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facilitated Enrollment | Experimental | Behavioral: Facilitated EnrollmentPatients will be aided in the account creation and usage of a consumer informatics tool to collect and report patient-contextual data within the electronic health record |
| Usual Care | No intervention | –Patients will be invited to use the patient contextual data tool as per usual care, but will not receive additional assistance in account creation and usage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 or older
- able to speak and understand English,
- a patient at a selected Froedtert \& Medical College of Wisconson primary care or internal medicine clinic (i.e., General Internal Medicine On Campus of Milwaukee Regional Medical Center, Sargeant Health Center, or Tosa Health Center (Plank Road Clinic) with an upcoming (> 4 weeks away) appointment and at least 1 previous appointment with the same provider in the previous 12 months.
- Patients with cognitive impairment (e.g. dementia) are eligible to participate through the use of proxies who would ordinarily accompany them to appointments and complete forms or post-visit surveys on their behalf.
Key exclusion criteria (1 listed)
- Minors and non-English speaking patients are not eligible to participate
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 |
|---|---|---|
| Facilitated EnrollmentResearch coordinator will assist patients in account creation and usage of the tool. | Behavioural | Facilitated Enrollment |
Primary outcome
Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome.
Time frame: Post Visit ( 1 week)
Use of Communication Assessment Tool (CAT), a 14-item instrument that reports patient-views of clinician communication Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007;67: 333-342.
1 secondary outcome
Change in the composite score of the patient activation measure, a validated instrument to assess a patient's engagement and activation in their health issues.
Time frame: Pre/Post Visit (1 week)
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 5 Feb 2020.
- Derived from this study: PubMed 33559067Holt JM, Cusatis R, Winn A, Asan O, Spanbauer C, Williams JS, Flynn KE, Somai M, Talsma A, Laud P, Makoul G, Crotty BH. Impact of Pre-visit Contextual Data Collection on Patient-Physician Communication and Patient Activation: a Randomized Trial. J Gen Intern Med. 2021 Nov;36(11):3321-3329. doi: 10.1007/s11606-020-06583-7. Epub 2021 Feb 9.
- Derived from this study: PubMed 33012264Holt JM, Winn A, Cusatis R, Talsma A, Crotty BH. Racial Disparities in Patient Activation: The Role of Economic Diversity. West J Nurs Res. 2021 Jun;43(6):517-529. doi: 10.1177/0193945920963130. Epub 2020 Oct 5.
- Derived from this study: PubMed 32965223Holt JM, Cusatis R, Winn A, Asan O, Spanbauer C, Williams JS, Flynn KE, Somai M, Laud P, Crotty BH. The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 23;9(9):e20309. doi: 10.2196/20309.
- Individual participant dataSharing planned: Undecided
Related trials for Communication
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
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.
Bradley H Crotty, MD MPH principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Enrollment in people with Communication, run by Medical College of Wisconsin 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 4 inclusion and 1 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 5 Feb 2020. 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?
Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome. (time frame: Post Visit ( 1 week)). 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 NCT03766841, which also lists 3 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 5 Feb 2020.