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OpenTrials
Completed

NCT Number: NCT02707146

Aligning Patients and Their Primary Care Providers

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oakland Medical Center

Oakland, California, 94610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visit Planner

Behavioral

The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit

Attention Control Pamphlet

Other

Patients in the attention control arm will receive an approved educational handout on health lifestyle

iPad

Device

Primary outcomes

  1. Aggregate Measure of Guideline-Based Clinical Care Gaps

    Time frame: 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 outcomes

  1. Patient-reported Outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: APP

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 14, 2016
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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