Aligning Patients and Their Primary Care Providers (APP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02707146

Recruitment Status : Completed

First Posted : March 14, 2016

Results First Posted : April 30, 2019

Last Update Posted : April 30, 2019

Sponsor:

Collaborator:

Patient-Centered Outcomes Research Institute

Information provided by (Responsible Party):

Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Primary Health Care Quality of Health Care Comorbidity Communication Medical Informatics Applications	Behavioral: Visit Planner Other: Attention Control Pamphlet Device: iPad	Not Applicable

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.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	750 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	Aligning the Visit Priorities of Complex Patients and Their Primary Care Providers
Study Start Date :	March 2016
Actual Primary Completion Date :	July 2017
Actual Study Completion Date :	December 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Behavioral: Visit Planner The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit Device: iPad
Active Comparator: 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	Other: Attention Control Pamphlet Patients in the attention control arm will receive an approved educational handout on health lifestyle

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	30 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707146

Locations

Layout table for location information

United States, California
Oakland Medical Center
Oakland, California, United States, 94610

Sponsors and Collaborators

Kaiser Permanente

Patient-Centered Outcomes Research Institute

Investigators

Layout table for investigator information

Principal Investigator:	Richard W Grant, MD MPH	Division of Research, KPNC

Study Documents (Full-Text)

Documents provided by Kaiser Permanente:

Study Protocol and Statistical Analysis Plan [PDF] July 12, 2018

More Information

Publications of Results:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT02707146
Other Study ID Numbers:	CN-14-2070-H
First Posted:	March 14, 2016 Key Record Dates
Results First Posted:	April 30, 2019
Last Update Posted:	April 30, 2019
Last Verified:	April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

To Top