Primary Health Care, Quality of Health Care, Comorbidity, Communication, Medical Informatics Applications
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVisit Planner
The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit
OTHERAttention Control Pamphlet
Patients in the attention control arm will receive an approved educational handout on health lifestyle
DEVICEiPad
Sponsors
Patient-Centered Outcomes Research Institute
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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: * 1\) relatively new to their provider (0-3 visits in past 18 months) or if associated with their provider for \> 18 months, * 2\) have evidence for medical complexity (4 or more prescribed medicines, in a chronic disease management program, or recently admitted to hospital or emergency department)
Exclusion criteria
* Excluded by their primary care provider
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aggregate Measure of Guideline-Based Clinical Care Gaps | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Outcomes | Within 1 week of primary care study visit | Telephone survey will be conducted within 1 week of visit using validated questionnaire items that assess patient-provider communication and patient satisfaction with care |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 359 |
| 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 | 391 |
| Total | 750 |
Baseline characteristics
| Characteristic | Tablet in the Waiting Room | Health Education Handout | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 164 Participants | 179 Participants | 343 Participants |
| Age, Categorical Between 18 and 65 years | 195 Participants | 212 Participants | 407 Participants |
| Age, Continuous | 60.3 years STANDARD_DEVIATION 12.1 | 61.2 years STANDARD_DEVIATION 11.7 | 60.8 years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Race/ethnicity African-American | 115 Participants | 97 Participants | 212 Participants |
| Race/Ethnicity, Customized Race/ethnicity Asian | 20 Participants | 34 Participants | 54 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 69 Participants | 98 Participants | 167 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other (>1 race/ethnicity) | 14 Participants | 15 Participants | 29 Participants |
| Race/Ethnicity, Customized Race/ethnicity White | 141 Participants | 147 Participants | 288 Participants |
| Region of Enrollment United States | 359 participants | 391 participants | 750 participants |
| Sex: Female, Male Female | 235 Participants | 251 Participants | 486 Participants |
| Sex: Female, Male Male | 124 Participants | 140 Participants | 264 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 359 | 0 / 391 |
| other Total, other adverse events | 0 / 359 | 0 / 391 |
| serious Total, serious adverse events | 0 / 359 | 0 / 391 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tablet in the Waiting Room | Aggregate Measure of Guideline-Based Clinical Care Gaps | 184 Participants |
| Health Education Handout | Aggregate Measure of Guideline-Based Clinical Care Gaps | 210 Participants |
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
Time frame: Within 1 week of primary care study visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tablet in the Waiting Room | Patient-reported Outcomes | Prepare list of questions? | 198 Participants |
| Tablet in the Waiting Room | Patient-reported Outcomes | Tell your doctor your top concerns at beginning o | 304 Participants |
| Health Education Handout | Patient-reported Outcomes | Prepare list of questions? | 160 Participants |
| Health Education Handout | Patient-reported Outcomes | Tell your doctor your top concerns at beginning o | 297 Participants |
Chi-squared