Primary Health CareAPPNCT02707146
Aligning Patients and Their Primary Care Providers
A study testing Visit Planner and iPad in people with Primary Health Care and Quality of Health Care, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Primary Health Care, Quality of Health Care, Comorbidity
- What is being tested?
- Visit Planner and iPad
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Excluded by their primary care provider
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aligning the Visit Priorities of Complex 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.
Read the 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.
- Conditions
- Primary Health Care, Quality of Health Care, Comorbidity, Communication, Medical Informatics Applications
- Being tested
- Visit Planner, Attention Control Pamphlet, iPad
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visit PlannerBehavioural
The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit
Attention Control PamphletOther
Patients in the attention control arm will receive an approved educational handout on health lifestyle
iPadDevice
| Study group | Role | What they receive |
|---|---|---|
| Tablet in the waiting room | Experimental | 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 Receives: Behavioral: Visit Planner; Device: iPad |
| Health Education Handout | Active comparator | 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 Receives: Other: Attention Control Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: Within 1 week of primary care study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Richard W Grant, MD MPH, Principal investigator, Division of Research, KPNC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707146
- Sponsor's protocol ID
- CN-14-2070-H
- Acronym
- APP
- Status last verified
- Apr 2019
- First submitted
- 4 Mar 2016
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30858257Kowalski 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.
PubMed 29330237Lyles 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.
PubMed 27627965Ruvalcaba 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.
PubMed 30950803Santo 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.
PubMed 31300571
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aligning the Visit Priorities of Complex Patients and Their Primary Care Providers
- ClinicalTrials.gov ID
- NCT02707146
- Acronym / sponsor ID
- APP / CN-14-2070-H
- Conditions
- Primary Health Care, Quality of Health Care, Comorbidity, Communication, Medical Informatics Applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Posted 30 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet in the waiting room | Experimental | Behavioral: Visit Planner, Device: iPadPatients 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 |
| Health Education Handout | Active comparator | Other: Attention Control PamphletPatients 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (1 listed)
- Excluded by their primary care provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visit PlannerThe Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit | Behavioural | Tablet in the waiting room |
| Attention Control PamphletPatients in the attention control arm will receive an approved educational handout on health lifestyle | Other | Health Education Handout |
| iPad | Device | Tablet in the waiting room |
Primary outcome
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.
1 secondary outcome
Patient-reported Outcomes
Time frame: Within 1 week of primary care study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30858257Grant 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.
- Results publication: PubMed 29330237Kowalski 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.
- Results publication: PubMed 27627965Lyles 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.
- Results publication: PubMed 30950803Ruvalcaba 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.
- Derived from this study: PubMed 31300571Santo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard W Grant, MD MPH principal investigator
Division of Research, KPNC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visit Planner and iPad in people with Primary Health Care and Quality of Health Care, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggregate Measure of Guideline-Based Clinical Care Gaps (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02707146, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.