- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02386189
Pilot Study to Improve Care Coordination
Dual Health Systems Users: Strategies to Implement Optimal Care Coordination
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent studies estimate that 43 to 75% of Veterans also receive care from non-VA providers (dual use). Dual use is a concern because splitting care between two or more health systems and multiple providers may result in poor coordination of services and a loss of continuity -ultimately putting the patient at increased risk for poor outcomes. Addressing dual use in Veterans is an issue of care coordination. One component of care coordination is information sharing, which often relies on the patient to share information between systems/providers. Veterans registered in My HealtheVet with premium account status have access to download and print a VA health summary (VA CCD). This health summary can be shared with non-VA providers to inform them about recent VA care. This pilot randomized controlled trial will compare usual care to an intervention which aims to improve care coordination for dual use Veterans by educating them about the use of information technology to share health information and informing their providers about the extent and nature of care from other health care systems.
Methods: Dual use Veterans with at least one chronic health condition and both an upcoming VA and non-VA appointments within the study time frame will be eligible to participate. Veterans will be randomized to the intervention or usual care. Veterans in the intervention group will be trained on use of My HealtheVet and their community patient portal (if applicable) to access summary health information to share with providers. In addition, he/she will create a document that lists all members of their health care team. All participants will be asked to take a provider evaluation packet each provider visit (VA and non-VA). After the visit, a phone call will be scheduled with the Veteran to ask about the appointment and medical records from the appointment will be obtained. Outcomes: The main outcomes will be related to patient perceived continuity of care, provider relational coordination survey, medication concordance, and medical laboratory test duplication. Pre and post scores on the patient activation measures will also be explored.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
VA Patient
- Receives health care from VA and non-VA provider
- Diagnosed with a chronic health condition
- Prescribed 5 or more medications
- Upcoming VA and non-VA appointments within the study time frame
- Registered or willing to become registered with My HealtheVet
- Access to a computer with internet, phone, and a printer.
- English speaking
VA or Non-VA Providers: provide care to a stuy participant
Exclusion Criteria:
- Previously shared health data with a provider via their My HealtheVet or local provider patient portal
- No scheduled VA or non-VA appointments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Usual Care
Veterans randomized to usual care will not receive any training on using their patient portal(s) to access and share information.
They will be contacted via phone and/or secure messaging to remind him/her to take the VA or non-VA provider packet to their appointment.
At the conclusion of the study, Veterans assigned to usual care will be provided the training information on the VA health summary for their own reference.
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Active Comparator: Care Coordination
Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments.
He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers.
A VA and non-VA provider visit will be evaluated.
|
Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments.
He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers.
A VA and non-VA provider visit will be evaluated.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Perceived Continuity of Care From Multiple Providers- Management Continuity
Time Frame: The time frame is from baseline assessment to 12 months post baseline during which at least one VA and one Community medical visit occurred.
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Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title.
Management continuity refers to the patient being able to identify one provider who is the main coordinator and assures all the links within the health care team.
The possible range on this measure was between 5 and 40 and the analysis was conducted on the pre-post difference on Management Continuity, subtracting the baseline score from the post-intervention score.
More positive score indicated greater perceived management continuity and greater improvement in perceived management continuity.
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The time frame is from baseline assessment to 12 months post baseline during which at least one VA and one Community medical visit occurred.
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Patient Perceived Continuity of Care From Multiple Clinicians - Informational Continuity
Time Frame: Baseline to 12-month follow-up
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Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title.
Informational Continuity refers to whether patients experienced communication failures between providers.
The possible range on this measure was between 12 and 36.
The analysis was conducted on the pre-post difference on Informational Continuity, subtracting the baseline score from the post-intervention score.
For this measure a lower score and a decline between post intervention and baseline scores (or a negative value) indicates more positive outcomes.
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Baseline to 12-month follow-up
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Patient Perceived Continuity of Care From Multiple Clinicians- Role Continuity
Time Frame: Baseline to 12-month follow-up
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Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title.
Role Continuity refers to the role of all clinicians being clear to the patient and to the providers on the treatment team.
The possible range on this measure was between 6 and 30, and the analysis was conducted on the pre-post difference on this measure.
More positive score indicated greater perceived role clarity and, when comparing pre and post score, a more positive score indicated greater improvement in perceived role clarity.
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Baseline to 12-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Duplication of Laboratory Tests
Time Frame: Baseline assessment to 12 months post-baseline, where a laboratory duplication is only counted if the medical visits occurred within three months of each other.
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Participants had at least one VA medical visit and one community medical visit.
Medical records were obtained from both visits and compared.
Patients were considered to have a laboratory duplication if the same labs were drawn at both visits and the two visits occurred within three months of each other.
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Baseline assessment to 12 months post-baseline, where a laboratory duplication is only counted if the medical visits occurred within three months of each other.
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Proportion of Medication Concordance
Time Frame: Time frame between two medical visits occuring within the one year study period
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All participants had at least one VA medical visit and one community medical visit.
Medical records were obtained from both visits.
Medication lists were obtained from both visits.
A medication concordance metric (proportion) was calculated where the denominator was the total number of unique medications identified on both the VA medication list and the community provider medication list.
The numerator was the total number of medications (including dose and frequency) that were concordant between the medication lists.
This comparison did not include over the counter medications.
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Time frame between two medical visits occuring within the one year study period
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Relational Coordination- VA Providers
Time Frame: Providers completed the coordination measure at the time of the medical visit which could occur at any point in the 12 month follow-up period.
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Relational Coordination was assessed using Gittell's 7-item measure as described Relational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey.
This was assessed by providers seeing patients enrolled in this study, and this outcome is based on VA providers assessment of Relational Coordination.
The scale total score could range from 7 to 35 with higher scores indicating greater relational coordination.
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Providers completed the coordination measure at the time of the medical visit which could occur at any point in the 12 month follow-up period.
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Relational Coordination Community Providers
Time Frame: Providers completed the coordination measure at the time of the medical visit which could occur at any point in the 12 month follow-up period.
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Relational Coordination was assessed using Gittell's 7-item measure as described iRelational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey.
The scale total score could range from 7 to 35 with higher scores indicating greater relational coordination.
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Providers completed the coordination measure at the time of the medical visit which could occur at any point in the 12 month follow-up period.
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Collaborators and Investigators
Investigators
- Principal Investigator: Carolyn L Turvey, PhD MS, Iowa City VA Health Care System, Iowa City, IA
Publications and helpful links
General Publications
- Haggerty JL, Roberge D, Freeman GK, Beaulieu C, Breton M. Validation of a generic measure of continuity of care: when patients encounter several clinicians. Ann Fam Med. 2012 Sep-Oct;10(5):443-51. doi: 10.1370/afm.1378.
- Manski-Nankervis JA, Blackberry I, Young D, O'Neal D, Patterson E, Furler J. Relational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey. BMC Health Serv Res. 2014 Nov 1;14:515. doi: 10.1186/s12913-014-0515-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDR 14-392
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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