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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This project focuses on improving the patient-provider primary care visit interaction by addressing the need to align patient and provider priorities in a way that incorporates patients' goals and preferences while supporting the clinical work of their providers.
The aim of this clinical trial is to enroll new and/or complex patients and their physicians in a 12-month randomized study. At each scheduled primary care visit during the trial period, Intervention Patients will be provided with a waiting room Tablet loaded with the "Visit Planner" intervention tool designed to support prioritization and discussion of top health care concerns. Control Patients will be given a written educational handout to review. Patient-centered outcomes will be obtained at baseline and after visits using validated survey instruments. Clinical outcomes focus on differences in quality of care. If successful, this approach to aligning patient and provider visit priorities can potentially be disseminated and adapted to a wide variety of different care settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablet in the waiting room | Experimental | Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet |
|
| Health Education Handout | Active Comparator | Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visit Planner | Behavioral | The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aggregate Measure of Guideline-Based Clinical Care Gaps | All patients enrolled in the study will have one or more guideline-based care gaps at baseline. Care gaps are defined as: overdue for cancer screening (mammography, colorectal cancer), overdue for chronic disease monitoring (blood pressure, HbA1c), above goal for chronic disease (SBP > 140, HbA1c > 8%), or medication related (not prescribed a statin if clinically indicated, not prescribed medicine for osteoporosis if indicated, < 80% adherence to medication for diabetes, hypertension, or hyperlipidemia), or current smoker. The investigators will assess % of patients resolving baseline clinical care gaps after 12 months. The aggregate outcome will be defined as yes/no resolution of baseline care gap. The study arms will be compared using an aggregate measure of these guideline-based clinical care gaps. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Outcomes | Telephone survey will be conducted within 1 week of visit using validated questionnaire items that assess patient-provider communication and patient satisfaction with care | Within 1 week of primary care study visit |
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Inclusion Criteria:
Kaiser Permanente member with an assigned primary care provider, with at least one quality care gap at baseline (overdue screening tests, elevated risk factor levels, sub-optimal adherence to chronically prescribed medicines, current smoker)
Patients must be either:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W Grant, MD MPH | Division of Research, KPNC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland Medical Center | Oakland | California | 94610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30858257 | Result | Grant RW, Lyles C, Uratsu CS, Vo MT, Bayliss EA, Heisler M. Visit Planning Using a Waiting Room Health IT Tool: The Aligning Patients and Providers Randomized Controlled Trial. Ann Fam Med. 2019 Mar;17(2):141-149. doi: 10.1370/afm.2352. | |
| 29330237 | Result | Kowalski CP, McQuillan DB, Chawla N, Lyles C, Altschuler A, Uratsu CS, Bayliss EA, Heisler M, Grant RW. 'The Hand on the Doorknob': Visit Agenda Setting by Complex Patients and Their Primary Care Physicians. J Am Board Fam Med. 2018 Jan-Feb;31(1):29-37. doi: 10.3122/jabfm.2018.01.170167. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tablet in the Waiting Room | Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit iPad |
| FG001 | Health Education Handout | Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tablet in the Waiting Room | Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit iPad |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aggregate Measure of Guideline-Based Clinical Care Gaps | All patients enrolled in the study will have one or more guideline-based care gaps at baseline. Care gaps are defined as: overdue for cancer screening (mammography, colorectal cancer), overdue for chronic disease monitoring (blood pressure, HbA1c), above goal for chronic disease (SBP > 140, HbA1c > 8%), or medication related (not prescribed a statin if clinically indicated, not prescribed medicine for osteoporosis if indicated, < 80% adherence to medication for diabetes, hypertension, or hyperlipidemia), or current smoker. The investigators will assess % of patients resolving baseline clinical care gaps after 12 months. The aggregate outcome will be defined as yes/no resolution of baseline care gap. The study arms will be compared using an aggregate measure of these guideline-based clinical care gaps. | Posted | Count of Participants | Participants | 12 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tablet in the Waiting Room | Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit iPad |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Grant | Division of Research, Kaiser Permanente Northern California | 510-891-5993 | Richard.W.Grant@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2018 | Feb 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Attention Control Pamphlet | Other | Patients in the attention control arm will receive an approved educational handout on health lifestyle |
|
| iPad | Device |
|
| 27627965 | Result | Lyles CR, Altschuler A, Chawla N, Kowalski C, McQuillan D, Bayliss E, Heisler M, Grant RW. User-Centered Design of a Tablet Waiting Room Tool for Complex Patients to Prioritize Discussion Topics for Primary Care Visits. JMIR Mhealth Uhealth. 2016 Sep 14;4(3):e108. doi: 10.2196/mhealth.6187. |
| 30950803 | Result | Ruvalcaba D, Nagao Peck H, Lyles C, Uratsu CS, Escobar PR, Grant RW. Translating/Creating a Culturally Responsive Spanish-Language Mobile App for Visit Preparation: Case Study of "Trans-Creation". JMIR Mhealth Uhealth. 2019 Apr 5;7(4):e12457. doi: 10.2196/12457. |
| 31300571 | Derived | Santo EC, Vo MT, Uratsu CS, Grant RW. Patient-Defined Visit Priorities in Primary Care: Psychosocial Versus Medically-Related Concerns. J Am Board Fam Med. 2019 Jul-Aug;32(4):513-520. doi: 10.3122/jabfm.2019.04.180380. |
| Health Education Handout |
Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet
Visit Planner: The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit
iPad
| OG001 | Health Education Handout | Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle |
|
|
| Secondary | Patient-reported Outcomes | Telephone survey will be conducted within 1 week of visit using validated questionnaire items that assess patient-provider communication and patient satisfaction with care | Posted | Count of Participants | Participants | Within 1 week of primary care study visit |
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| 0 |
| 359 |
| 0 |
| 359 |
| 0 |
| 359 |
| EG001 | Health Education Handout | Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review Attention Control Pamphlet: Patients in the attention control arm will receive an approved educational handout on health lifestyle | 0 | 391 | 0 | 391 | 0 | 391 |
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