Chronic IllnessNCT02386189
Pilot Study to Improve Care Coordination
A study testing Patient Care Coordination Training in people with Chronic Illness, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is 1) to learn how VA patients can help share their health information between their VA providers and providers outside the VA and 2) if sharing this information is useful to providers and improves care received. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Illness
- What is being tested?
- Patient Care Coordination Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2015to 31 Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Access to a computer with internet, phone, and a printer.
- English speaking
- VA or Non-VA Providers: provide care to a stuy participant
Who cannot join
- Previously shared health data with a provider via their My HealtheVet or local provider patient portal
- No scheduled VA or non-VA appointments
Trial locations and contacts
1 site in 1 country.
United States1 site
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
About this study
Official title: Dual Health Systems Users: Strategies to Implement Optimal Care Coordination
The purpose of this study is 1) to learn how VA patients can help share their health information between their VA providers and providers outside the VA and 2) if sharing this information is useful to providers and improves care received.
Read the 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.
- Conditions
- Chronic Illness
- Being tested
- Patient Care Coordination Training
- Keywords
- Continuity of Patient Care, Health Records, Personal, Veterans, Patient Participation, Chronic Disease
- Medical subject headings
- Chronic Disease, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Care Coordination TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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. |
| Care Coordination | Active comparator | 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. Receives: Behavioral: Patient Care Coordination Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Perceived Continuity of Care From Multiple Providers- Management Continuity
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.
Measured: The time frame is from baseline assessment to 12 months post baseline during which at least one VA and one Community medical visit occurred.
Patient Perceived Continuity of Care From Multiple Clinicians - Informational Continuity
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.
Measured: Baseline to 12-month follow-up
Patient Perceived Continuity of Care From Multiple Clinicians- Role Continuity
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.
Measured: Baseline to 12-month follow-up
Secondary outcomes (4)
Number of Participants With Duplication of Laboratory Tests
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.
Measured: 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.
Proportion of Medication Concordance
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.
Measured: Time frame between two medical visits occuring within the one year study period
Relational Coordination- VA Providers
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.
Measured: 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.
Relational Coordination Community Providers
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study start2 Mar 2015
- Primary completion1 Mar 2017
- Study completion31 Mar 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carolyn L Turvey, PhD MS, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386189
- Sponsor's protocol ID
- SDR 14-392
- Status last verified
- Aug 2019
- First submitted
- 11 Feb 2015
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22966108Manski-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.
PubMed 25361788
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Health Systems Users: Strategies to Implement Optimal Care Coordination
- ClinicalTrials.gov ID
- NCT02386189
- Acronym / sponsor ID
- SDR 14-392
- Conditions
- Chronic Illness
- Keywords
- Continuity of Patient Care, Health Records, Personal, Veterans, Patient Participation, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is 1) to learn how VA patients can help share their health information between their VA providers and providers outside the VA and 2) if sharing this information is useful to providers and improves care received.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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. |
| Care Coordination | Active comparator | Behavioral: Patient Care Coordination TrainingVeterans 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Previously shared health data with a provider via their My HealtheVet or local provider patient portal
- No scheduled VA or non-VA appointments
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 |
|---|---|---|
| Patient Care Coordination TrainingVeterans 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. | Behavioural | Care Coordination |
Primary outcome
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.
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.
Patient Perceived Continuity of Care From Multiple Clinicians - Informational Continuity
Time frame: Baseline to 12-month follow-up
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.
Patient Perceived Continuity of Care From Multiple Clinicians- Role Continuity
Time frame: Baseline to 12-month follow-up
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.
4 secondary outcomes
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.
Proportion of Medication Concordance
Time frame: Time frame between two medical visits occuring within the one year study period
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22966108Haggerty 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.
- Background: PubMed 25361788Manski-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.
- 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.
Carolyn L Turvey, PhD MS principal investigator
Iowa City VA Health Care System, Iowa City, IA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Care Coordination Training in people with Chronic Illness, run by VA Office of Research and Development 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 9 inclusion and 2 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 28 Aug 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 Jul 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?
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.). The study lists 3 primary outcomes in all. 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 NCT02386189, which also lists 2 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 Aug 2019.