Patient-centered CareNCT01520662
Impact of a Wellness Portal on The Delivery of Patient-Centered Preventive Care
A study testing Implementation of a secure web-based patient Wellness Portal in people with Patient-centered Care, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
Building upon our experience with a very sophisticated preventive services prompt and reminder system, the Preventive Services Reminder System (PSRS), the investigators propose to conduct a systematic three-year study with the following aims: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient-centered Care
- What is being tested?
- Implementation of a secure web-based patient Wellness Portal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients must have been seen at least twice by the enrolled clinician in the last twelve months;
- Patients must be six years old or younger or 50 years old and older;
- Patients (or their caretakers) must speak either English or Spanish and must have a basic level of computer skills that include being able to navigate a simple, consumer-oriented web site, use the keyboard and the mouse to interact with the browser, and understand / respond to
Who cannot join
- Not established patient
- Between than 6 years old and 50 years old
- Not fluent in English or Spanish, no basic computer skills or no help available for navigating a web browser
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma HSC Department of Family and Prevetive Medicne
Oklahoma City, Oklahoma, 73104
About this study
Building upon our experience with a very sophisticated preventive services prompt and reminder system, the Preventive Services Reminder System (PSRS), the investigators propose to conduct a systematic three-year study with the following aims:
- To develop, field test, and refine an Internet-based patient Wellness Portal linked to PSRS to facilitate patient-centered, preventive care in primary care practices;
- To determine the impact of the Wellness Portal on the process of patient-centered preventive care by examining the behavior and experiences of both patients and providers and the degree to which recommended services are individualized; and
- To develop model Wellness Portal practices and disseminate the Wellness Portal technology and knowledge derived from Aims 1 and 2 findings.
Read the detailed description
Project Aim 1: Develop, field test, and further refine an Internet-based Wellness Portal for use by patients seen in primary care settings to facilitate patient-centered, preventive care.
Specific Objectives:
- Assemble an Advisory Committee of clinicians, office staff, patients, and national HIT experts and develop a patient Wellness Portal that can be accessed by patients through the Internet and also in the provider's office via computer kiosks;
- Field test the Wellness Portal in two OKPRN practices and collect patient and provider satisfaction data via surveys and personal feedback to improve and refine the Wellness Portal and its integration into the comprehensive care delivery process.
Project Aim 2: Determine the impact of the Wellness Portal on the process of patient-centered preventive care by examining the experience of patients and providers with care and individualization of recommended services.
Specific Objectives:
- Assess the impact of the Wellness Portal on patient-centered care:
- Assess the impact of the Wellness Portal on patient activation and the medical home;
- Understand the impact of Wellness Portal use, the role of activated patients, and the concept of medical home on the provision of patient-centered care;
- Measure the impact of the Wellness Portal on the individualization of preventive services that are recommended and delivered based upon individual risk factors and patient preferences;
- Describe utilization and implementation of the Wellness Portal, capture and analyze documented decisions on opting out from evidence-based recommendations, and assess the impact of the portal on missed opportunities for delivering preventive care.
- Conditions
- Patient-centered Care
- Being tested
- Implementation of a secure web-based patient Wellness Portal
- Keywords
- patient-centered care, wellness, preventive services, primary care, To accomplish Aim 2, we will conduct a nine-month pre-post, randomized controlled trial (RCT) in four primary care, practices. The study will focus on the impact of a patient, Wellness Portal on the quantity and quality of preventive, care patients receive in primary care practices.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a secure web-based patient Wellness PortalOther
Patients in intervention practices will review and update their wellness records, risk factor information, allergy and contraindication profile, and personal preferences through the Wellness Portal before they visit their primary care provider.
| Study group | Role | What they receive |
|---|---|---|
| Wellness Portal Intervention | Experimental | Wellness Portal Intervention: patients have access to the portal in the course of the study. Receives: Other: Implementation of a secure web-based patient Wellness Portal |
| Wellness Portal Control | No intervention | Control patients don't have access to the Wellness Portal in the course of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the impact of the Wellness Portal on the process of patient-centered preventive care by examining the experience of patients and providers with care and individualization of recommended services
Measured: 9 months run per practice / 12 months total
Secondary outcomes (1)
a) Assess the impact of the Wellness Portal on patient-centered care b) Describe utilization and implementation of the Wellness Portal
Measured: 09/01/2007 - 08/31/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startSep 2007
- Primary completionJul 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient-centered 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, James Mold, Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- James W Mold, MD, MPH, Principal investigator, University of Oklahoma HSC Department of Family and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520662
- Sponsor's protocol ID
- Wellness Portal Study
- Other IDs
- 1R18HS017188-01
- Status last verified
- Jan 2012
- First submitted
- 19 Jan 2012
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Wellness Portal on The Delivery of Patient-Centered Preventive Care
- ClinicalTrials.gov ID
- NCT01520662
- Acronym / sponsor ID
- Wellness Portal Study
- Conditions
- Patient-centered Care
- Keywords
- patient-centered care, wellness, preventive services, primary care, To accomplish Aim 2, we will conduct a nine-month pre-post, randomized controlled trial (RCT) in four primary care, practices. The study will focus on the impact of a patient, Wellness Portal on the quantity and quality of preventive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Jan 2012 (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.
Building upon our experience with a very sophisticated preventive services prompt and reminder system, the Preventive Services Reminder System (PSRS), the investigators propose to conduct a systematic three-year study with the following aims:
- To develop, field test, and refine an Internet-based patient Wellness Portal linked to PSRS to facilitate patient-centered, preventive care in primary care practices;
- To determine the impact of the Wellness Portal on the process of patient-centered preventive care by examining the behavior and experiences of both patients and providers and the degree to which recommended services are individualized; and
- To develop model Wellness Portal practices and disseminate the Wellness Portal technology and knowledge derived from Aims 1 and 2 findings.
Detailed description
Project Aim 1: Develop, field test, and further refine an Internet-based Wellness Portal for use by patients seen in primary care settings to facilitate patient-centered, preventive care.
Specific Objectives:
- Assemble an Advisory Committee of clinicians, office staff, patients, and national HIT experts and develop a patient Wellness Portal that can be accessed by patients through the Internet and also in the provider's office via computer kiosks;
- Field test the Wellness Portal in two OKPRN practices and collect patient and provider satisfaction data via surveys and personal feedback to improve and refine the Wellness Portal and its integration into the comprehensive care delivery process.
Project Aim 2: Determine the impact of the Wellness Portal on the process of patient-centered preventive care by examining the experience of patients and providers with care and individualization of recommended services.
Specific Objectives:
- Assess the impact of the Wellness Portal on patient-centered care:
- Assess the impact of the Wellness Portal on patient activation and the medical home;
- Understand the impact of Wellness Portal use, the role of activated patients, and the concept of medical home on the provision of patient-centered care;
- Measure the impact of the Wellness Portal on the individualization of preventive services that are recommended and delivered based upon individual risk factors and patient preferences;
- Describe utilization and implementation of the Wellness Portal, capture and analyze documented decisions on opting out from evidence-based recommendations, and assess the impact of the portal on missed opportunities for delivering preventive care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellness Portal Intervention | Experimental | Other: Implementation of a secure web-based patient Wellness PortalWellness Portal Intervention: patients have access to the portal in the course of the study. |
| Wellness Portal Control | No intervention | –Control patients don't have access to the Wellness Portal in the course of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have been seen at least twice by the enrolled clinician in the last twelve months;
- Patients must be six years old or younger or 50 years old and older;
- Patients (or their caretakers) must speak either English or Spanish and must have a basic level of computer skills that include being able to navigate a simple, consumer-oriented web site, use the keyboard and the mouse to interact with the browser, and understand / respond to
Key exclusion criteria (3 listed)
- Not established patient
- Between than 6 years old and 50 years old
- Not fluent in English or Spanish, no basic computer skills or no help available for navigating a web browser
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 |
|---|---|---|
| Implementation of a secure web-based patient Wellness PortalPatients in intervention practices will review and update their wellness records, risk factor information, allergy and contraindication profile, and personal preferences through the Wellness Portal before they visit their primary care provider. | Other | Wellness Portal Intervention |
Primary outcome
Determine the impact of the Wellness Portal on the process of patient-centered preventive care by examining the experience of patients and providers with care and individualization of recommended services
Time frame: 9 months run per practice / 12 months total
1 secondary outcome
a) Assess the impact of the Wellness Portal on patient-centered care b) Describe utilization and implementation of the Wellness Portal
Time frame: 09/01/2007 - 08/31/2010
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 30 Jan 2012.
- Home Page of the Oklahoma Physicians Resource/Research Network, a primary care practice-based PBRNLink provided by the sponsor.
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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.
James W Mold, MD, MPH principal investigator
University of Oklahoma HSC Department of Family and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of a secure web-based patient Wellness Portal in people with Patient-centered Care, run by Agency for Healthcare Research and Quality (AHRQ) 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 3 inclusion and 3 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 Jan 2012. 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?
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?
Determine the impact of the Wellness Portal on the process of patient-centered preventive care by examining the experience of patients and providers with care and individualization of recommended services (time frame: 9 months run per practice / 12 months total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2012.