Chronic DiseaseNCT02292940
Consumer Health IT Tools: Impact on Experience, Access, and Outcomes for Patients With Complex Chronic Conditions
An observational study of Chronic Disease and Patient Outcome Assessment, run by Kaiser Permanente.
Trial summary
Patient use of health IT tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient access to care, change the way healthcare is delivered, and affect patient clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Patient Outcome Assessment, Electronic Health Records
- How many people
- 168,477 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to 31 Aug 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a chronic disease
Who may be able to join
- Patients with chronic conditions
- Patient had at least 10-month membership in 2005
Who cannot join
- Patients less than age 18
About this study
Official title: Consumer Health IT Tools: Impact on Patient Experience, Access, and Health Outcomes for Patients With Complex Chronic Conditions
Patient use of health IT tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient access to care, change the way healthcare is delivered, and affect patient clinical outcomes. This study will examine the impact of implementation and use of consumer health IT tools on patient-reported access to care, utilization of medical care services, and clinical outcomes.
- Keywords
- patient outcome assessment, electronic health records
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Ambulatory Care Sensitive Conditions (ACSC) Hospitalizations. Portal Users vs Those Who Are Not Portal Users
Number of ambulatory care sensitive conditions (ACSC) hospitalizations per 1000 patients per month among those who accessed the portal and those who did not access the portal.
Measured: Data from 2006-2007
Patient Self-report Survey Data
Patient-reported reasons for using the patient portal
Measured: March 2015-April 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2016
- Study completion31 Aug 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.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 168,477 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
- Mary E Reed, DrPh, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292940
- Sponsor's protocol ID
- CN-13-1567-H
- Status last verified
- Mar 2021
- First submitted
- 30 Oct 2014
- Last updated
- 10 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer Health IT Tools: Impact on Patient Experience, Access, and Health Outcomes for Patients With Complex Chronic Conditions
- ClinicalTrials.gov ID
- NCT02292940
- Acronym / sponsor ID
- CN-13-1567-H
- Keywords
- patient outcome assessment, electronic health records
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168,477 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Posted 10 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient use of health IT tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient access to care, change the way healthcare is delivered, and affect patient clinical outcomes. This study will examine the impact of implementation and use of consumer health IT tools on patient-reported access to care, utilization of medical care services, and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a chronic disease
Key inclusion criteria (2 listed)
- Patients with chronic conditions
- Patient had at least 10-month membership in 2005
Key exclusion criteria (1 listed)
- Patients less than age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Ambulatory Care Sensitive Conditions (ACSC) Hospitalizations. Portal Users vs Those Who Are Not Portal Users
Time frame: Data from 2006-2007
Number of ambulatory care sensitive conditions (ACSC) hospitalizations per 1000 patients per month among those who accessed the portal and those who did not access the portal.
Patient Self-report Survey Data
Time frame: March 2015-April 2016
Patient-reported reasons for using the patient portal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mary E Reed, DrPh principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Patient Outcome Assessment, 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?
The sponsor lists 2 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 10 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2021). 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?
Number of Ambulatory Care Sensitive Conditions (ACSC) Hospitalizations. Portal Users vs Those Who Are Not Portal Users (time frame: Data from 2006-2007). The study lists 2 primary outcomes in all. 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 10 Mar 2021.