Diabetes Mellitus, Type 2PVPNCT02375932
Pre-Visit Prioritization for Complex Patients With Diabetes
A study testing Pre-Visit Tool in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente.
Trial summary
Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient and provider priorities during primary care visits represents a barrier to effective primary care. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Pre-Visit Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary care physicians (PCPs) at Kaiser Permanente Northern California with potentially eligible patients (type 2 diabetes and HbA1c > 8.0%) wil be recruited and consented to participate in this study. PCPs will review lists of potentially eligible patients of theirs (defined below). Patients approved by PCP's allocated to the intervention arm will be sent a secure message on the PCPs behalf asking them to review the Pre-Visit Prioritization Questionnaire to identify top priorities for discussion at the next scheduled visit.
Patient Inclusion Criteria:
- Current adult member (> 21 years old)
- Diagnosis of type 2 diabetes with most recent HbA1c > 8.0%
- English as primary language
- Registered on kp.org.
Patient Exclusion Criteria:
- Excluded by PCP, and/or: terminal illness, in hospice care or reside in a long-term care facility, severe mental illness (e.g. schizophrenia or personality disorder), currently or recently pregnant, and/or significant dementia
About this study
Official title: Pre-Visit Prioritization for Complex Primary Care Patients With Diabetes
Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient and provider priorities during primary care visits represents a barrier to effective primary care. The investigators propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the electronic health record (EHR) that will enable complex patients to easily define care priorities for their upcoming visit.
Read the detailed description
Patients with type 2 diabetes are increasingly living with multiple concurrent conditions and complicated medical regimens. For these patients, diabetes management decisions and treatment goals must be addressed within the larger context of other competing health concerns. In parallel, clinical advances have led to a substantial increase in the number of tasks that primary care providers must perform during each visit. These twin trends present a formidable challenge to effective diabetes primary care. We hypothesize that among complex patients not meeting diabetes management goals, a web-based health IT tool to help patients explicitly prioritize all health issues (both related and unrelated to diabetes) and then submit these priorities directly into the electronic health record (EHR) for a scheduled visit with their primary care provider will result in more effective diabetes management over time. To test this hypothesis, we propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the EHR that will enable complex patients to easily define care priorities for their upcoming visit.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Pre-Visit Tool, Usual Care Control
- Keywords
- Electronic Medical Records, Primary Health Care, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Visit ToolBehavioural
Patients receive a secure electronic message from their primary providers asking them to prepare for their visit by reviewing important areas of care and identifying their top priorities for discussion at a scheduled visit
Usual Care ControlBehavioural
Patients continue to receive usual care from their primary care provider
| Study group | Role | What they receive |
|---|---|---|
| Pre-Visit Tool | Experimental | Patients whose primary care physicians are allocated to the intervention arm will receive a secure electronic message shortly after scheduling an appointment with their provider asking them to complete a pre-visit prioritization survey using the kp.org patient portal Receives: Behavioral: Pre-Visit Tool |
| Usual Care Control | Active comparator | Patients whose primary care physicians are allocated to the control arm will continue with usual care Receives: Behavioral: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)
We will compare HbA1c control (% patients < 7.0% and mean HbA1c levels) between intervention and control arms
Measured: 1 year after enrollment
Secondary outcomes (1)
Patient assessment of visit communication (measures of communication quality using validated instruments)
We will call a subset of patients in the intervention and control arms after attending a visit with their PCP to assess measures of communication quality using validated instruments
Measured: Shortly after visit with PCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion21 Oct 2016
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard W Grant, MD MPH, Principal investigator, Division of Research, Kaiser Permanente Northern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375932
- Sponsor's protocol ID
- CN-13-1579
- Other IDs
- R01DK099108
- Acronym
- PVP
- Status last verified
- Mar 2019
- First submitted
- 24 Feb 2015
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Grant RW, Adams AS, Bayliss EA, Heisler M. Establishing visit priorities for complex patients: A summary of the literature and conceptual model to guide innovative interventions. Healthc (Amst). 2013 Dec;1(3-4):117-122. doi: 10.1016/j.hjdsi.2013.07.008.
PubMed 24944911Grant RW, Uratsu CS, Estacio KR, Altschuler A, Kim E, Fireman B, Adams AS, Schmittdiel JA, Heisler M. Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system. Contemp Clin Trials. 2016 Mar;47:196-201. doi: 10.1016/j.cct.2016.01.012. Epub 2016 Jan 26.
PubMed 26820612Zamudio CD, Sanchez G, Altschuler A, Grant RW. Influence of Language and Culture in the Primary Care of Spanish-Speaking Latino Adults with Poorly Controlled Diabetes: A Qualitative Study. Ethn Dis. 2017 Dec 7;27(4):379-386. doi: 10.18865/ed.27.4.379. eCollection 2017 Fall.
PubMed 29225438Grant RW, Altschuler A, Uratsu CS, Sanchez G, Schmittdiel JA, Adams AS, Heisler M. Primary care visit preparation and communication for patients with poorly controlled diabetes: A qualitative study of patients and physicians. Prim Care Diabetes. 2017 Apr;11(2):148-153. doi: 10.1016/j.pcd.2016.11.003. Epub 2016 Dec 1.
PubMed 27916628Vo MT, Uratsu CS, Estacio KR, Altschuler A, Kim E, Alexeeff SE, Adams AS, Schmittdiel JA, Heisler M, Grant RW. Prompting Patients with Poorly Controlled Diabetes to Identify Visit Priorities Before Primary Care Visits: a Pragmatic Cluster Randomized Trial. J Gen Intern Med. 2019 Jun;34(6):831-838. doi: 10.1007/s11606-018-4756-4. Epub 2019 Feb 11.
PubMed 30746642
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Visit Prioritization for Complex Primary Care Patients With Diabetes
- ClinicalTrials.gov ID
- NCT02375932
- Acronym / sponsor ID
- PVP / CN-13-1579
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Electronic Medical Records, Primary Health Care, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2015
- Primary completion
- 21 Oct 2016 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient and provider priorities during primary care visits represents a barrier to effective primary care. The investigators propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the electronic health record (EHR) that will enable complex patients to easily define care priorities for their upcoming visit.
Detailed description
Patients with type 2 diabetes are increasingly living with multiple concurrent conditions and complicated medical regimens. For these patients, diabetes management decisions and treatment goals must be addressed within the larger context of other competing health concerns. In parallel, clinical advances have led to a substantial increase in the number of tasks that primary care providers must perform during each visit. These twin trends present a formidable challenge to effective diabetes primary care. We hypothesize that among complex patients not meeting diabetes management goals, a web-based health IT tool to help patients explicitly prioritize all health issues (both related and unrelated to diabetes) and then submit these priorities directly into the electronic health record (EHR) for a scheduled visit with their primary care provider will result in more effective diabetes management over time. To test this hypothesis, we propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the EHR that will enable complex patients to easily define care priorities for their upcoming visit.
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 |
|---|---|---|
| Pre-Visit Tool | Experimental | Behavioral: Pre-Visit ToolPatients whose primary care physicians are allocated to the intervention arm will receive a secure electronic message shortly after scheduling an appointment with their provider asking them to complete a pre-visit prioritization survey using the kp.org patient portal |
| Usual Care Control | Active comparator | Behavioral: Usual Care ControlPatients whose primary care physicians are allocated to the control arm will continue with usual care |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Pre-Visit ToolPatients receive a secure electronic message from their primary providers asking them to prepare for their visit by reviewing important areas of care and identifying their top priorities for discussion at a scheduled visit | Behavioural | Pre-Visit Tool |
| Usual Care ControlPatients continue to receive usual care from their primary care provider | Behavioural | Usual Care Control |
Primary outcome
Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)
Time frame: 1 year after enrollment
We will compare HbA1c control (% patients < 7.0% and mean HbA1c levels) between intervention and control arms
1 secondary outcome
Patient assessment of visit communication (measures of communication quality using validated instruments)
Time frame: Shortly after visit with PCP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Background: PubMed 24944911Grant RW, Adams AS, Bayliss EA, Heisler M. Establishing visit priorities for complex patients: A summary of the literature and conceptual model to guide innovative interventions. Healthc (Amst). 2013 Dec;1(3-4):117-122. doi: 10.1016/j.hjdsi.2013.07.008.
- Results publication: PubMed 26820612Grant RW, Uratsu CS, Estacio KR, Altschuler A, Kim E, Fireman B, Adams AS, Schmittdiel JA, Heisler M. Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system. Contemp Clin Trials. 2016 Mar;47:196-201. doi: 10.1016/j.cct.2016.01.012. Epub 2016 Jan 26.
- Results publication: PubMed 29225438Zamudio CD, Sanchez G, Altschuler A, Grant RW. Influence of Language and Culture in the Primary Care of Spanish-Speaking Latino Adults with Poorly Controlled Diabetes: A Qualitative Study. Ethn Dis. 2017 Dec 7;27(4):379-386. doi: 10.18865/ed.27.4.379. eCollection 2017 Fall.
- Results publication: PubMed 27916628Grant RW, Altschuler A, Uratsu CS, Sanchez G, Schmittdiel JA, Adams AS, Heisler M. Primary care visit preparation and communication for patients with poorly controlled diabetes: A qualitative study of patients and physicians. Prim Care Diabetes. 2017 Apr;11(2):148-153. doi: 10.1016/j.pcd.2016.11.003. Epub 2016 Dec 1.
- Derived from this study: PubMed 30746642Vo MT, Uratsu CS, Estacio KR, Altschuler A, Kim E, Alexeeff SE, Adams AS, Schmittdiel JA, Heisler M, Grant RW. Prompting Patients with Poorly Controlled Diabetes to Identify Visit Priorities Before Primary Care Visits: a Pragmatic Cluster Randomized Trial. J Gen Intern Med. 2019 Jun;34(6):831-838. doi: 10.1007/s11606-018-4756-4. Epub 2019 Feb 11.
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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, Kaiser Permanente Northern California
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Visit Tool in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels) (time frame: 1 year after enrollment). 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 NCT02375932, 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 28 Mar 2019.