Aligning Patients and Their Primary Care Providers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Aligning the Visit Priorities of Complex Patients and Their Primary Care Providers

Conditions
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Primary Health Care, Quality of Health Care, Comorbidity, Communication, Medical Informatics Applications

Intervention / Treatment
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* Behavioral: Visit Planner
* Other: Attention Control Pamphlet
* Device: iPad


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tablet in the waiting room<br>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 | Behavioral: Visit Planner<br>* The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit<br>Device: iPad<br> <br> |
| Active Comparator: Health Education Handout<br>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 | Other: Attention Control Pamphlet<br>* Patients in the attention control arm will receive an approved educational handout on health lifestyle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |