Aligning Patients and Their Primary Care Providers

Communication Clinical Trial

— APP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707146
• Other study ID #: CN-14-2070-H
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication
• Comorbidity
• Medical Informatics Applications
• Primary Health Care
• Quality of Health Care

Intervention

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

Other:
• Attention Control Pamphlet
Patients in the attention control arm will receive an approved educational handout on health lifestyle

Device:
• iPad

Locations

Country	Name	City	State
United States	Oakland Medical Center	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. d — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months
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	Within 1 week of primary care study visit