Primary Health CareNCT03100526
Patient Aligned Care Team (PACT) Intensive Management (PIM) Project
A study testing PACT Intensive Management in people with Primary Health Care and Health Care Costs, run by Veteran Affairs Office of Patient Care Services.
Trial summary
Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while the patient is still in the ambulatory care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Health Care, Health Care Costs
- What is being tested?
- PACT Intensive Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,210 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- selected for intensive management
Who cannot join
- enrolled in other intensive case management at VA
About this study
Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while the patient is still in the ambulatory care setting.
Goal:
Read more
- Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
- Improve Veteran and staff satisfaction
Objectives:
- Maintain the patient in the home setting as much as possible
- Secure appropriate home environment to facilitate health and well-being
- Utilize comprehensive team-based care
- Engage appropriate Veteran Health Administration (VHA) programs to provide interdisciplinary, coordinated, and timely management of complex medical issues
- Conditions
- Primary Health Care, Health Care Costs
- Being tested
- PACT Intensive Management
- Keywords
- High-Risk Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACT Intensive ManagementBehavioural
Also called PIM
Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while they are still in the ambulatory care setting.
Goal:
- Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
- Improve Veteran and staff satisfaction
Objectives:
- Maintain the patient in the home setting as much as possible
- Secure appropriate home environment to facilitate health and well-being
- Utilize comprehensive team-based care
- Engage appropriate VHA programs to provide interdisciplinary, coordinated, and timely management of complex medical issues
| Study group | Role | What they receive |
|---|---|---|
| Intervention--PACT Intensive Management | Experimental | The intervention is the PACT Intensive Management Program (PIM) which provides intensive interdisciplinary care planning, care coordination, patient self-management support, and tailored goal setting based on patient needs and preferences, and additional care management services. Receives: Behavioral: PACT Intensive Management |
| Usual care | No intervention | High-Risk patients receiving care in PACT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VA health care cost
Total costs of VA care, including inpatient, outpatient, pharmacy and fee-basis services.
Measured: 2 years (two 1-year points)
Secondary outcomes (3)
Healthcare Utilization
VA central repository administrative data will be analyzed to calculate utilization of hospital, emergency and outpatient primary and specialty care. This information will be electronically abstracted through the VA central repository administrative data center
Measured: 2 years (two 1-year points)
Total Medicare Cost
Data will be extracted from VHA's Corporate Data Warehouse to capture patient Medicare cost. Medicare claims data to measure total patient inpatient and outpatient cost for services reimbursed by Medicare. Inpatient cost will be measured as cost for total acute hospitalizations, and subcategories: medical, surgical, psychiatric, rehabilitation, hospice and ambulatory care-sensitive conditions. Outpatient cost will be measured as the cost for combined visits in VHA and elsewhere reimbursed by Medicare in 9 categories: primary care, specialty care, mental health, surgical, home health, nursing home, diagnostic, rehabilitation and ED.
Measured: 2 years (two 1-year points)
Total Medicare Utilization
Data will be extracted from VHA's Corporate Data Warehouse to capture patient utilization. Medicare claims data to measure total patient inpatient and outpatient utilization for services reimbursed by Medicare. Inpatient utilization will be measured as counts of total acute hospitalizations, and subcategories: medical, surgical, psychiatric, rehabilitation, hospice and ambulatory care-sensitive conditions. Outpatient utilization will be measured as the number of combined visits in VHA and elsewhere reimbursed by Medicare in 9 categories: primary care, specialty care, mental health, surgical, home health, nursing home, diagnostic, rehabilitation and ED.
Measured: 2 years (two 1-year points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startNov 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Health 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veteran Affairs Office of Patient Care Services
- Sponsor type
- US federal agency
- Collaborators
- VA Office of Research and Development, VA Palo Alto Health Care System, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Lisa Rubenstein, MD, Principal investigator, VAGLAHS- WLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100526
- Sponsor's protocol ID
- PIM Evaluation
- Status last verified
- May 2020
- First submitted
- 10 Feb 2017
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoon J, Chang E, Rubenstein LV, Park A, Zulman DM, Stockdale S, Ong MK, Atkins D, Schectman G, Asch SM. Impact of Primary Care Intensive Management on High-Risk Veterans' Costs and Utilization: A Randomized Quality Improvement Trial. Ann Intern Med. 2018 Jun 19;168(12):846-854. doi: 10.7326/M17-3039. Epub 2018 Jun 5.
PubMed 29868706Chang ET, Zulman DM, Asch SM, Stockdale SE, Yoon J, Ong MK, Lee M, Simon A, Atkins D, Schectman G, Kirsh SR, Rubenstein LV; PIM Executive Committee and Demonstration Sites. An operations-partnered evaluation of care redesign for high-risk patients in the Veterans Health Administration (VHA): Study protocol for the PACT Intensive Management (PIM) randomized quality improvement evaluation. Contemp Clin Trials. 2018 Jun;69:65-75. doi: 10.1016/j.cct.2018.04.008. Epub 2018 Apr 23.
PubMed 29698772
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Aligned Care Team (PACT) Intensive Management (PIM) Project
- ClinicalTrials.gov ID
- NCT03100526
- Acronym / sponsor ID
- PIM Evaluation
- Conditions
- Primary Health Care, Health Care Costs
- Keywords
- High-Risk Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,210 participants (actual)
- Lead sponsor
- Veteran Affairs Office of Patient Care ServicesUS federal agency
- Collaborators
- VA Office of Research and Development, VA Palo Alto Health Care System, US Department of Veterans Affairs
- Study start
- Nov 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while the patient is still in the ambulatory care setting.
Goal:
- Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
- Improve Veteran and staff satisfaction
Objectives:
- Maintain the patient in the home setting as much as possible
- Secure appropriate home environment to facilitate health and well-being
- Utilize comprehensive team-based care
- Engage appropriate Veteran Health Administration (VHA) programs to provide interdisciplinary, coordinated, and timely management of complex medical issues
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention--PACT Intensive Management | Experimental | Behavioral: PACT Intensive ManagementThe intervention is the PACT Intensive Management Program (PIM) which provides intensive interdisciplinary care planning, care coordination, patient self-management support, and tailored goal setting based on patient needs and preferences, and additional care management services. |
| Usual care | No intervention | –High-Risk patients receiving care in PACT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- selected for intensive management
Key exclusion criteria (1 listed)
- enrolled in other intensive case management at VA
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 |
|---|---|---|
| PACT Intensive ManagementAlso: PIMPurpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while they are still in the ambulatory care setting. Goal: * Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients * Improve Veteran and staff satisfaction Objectives: * Maintain the patient in the home setting as much as possible * Secure appropriate home environment to facilitate health and well-being * Utilize comprehensive team-based care * Engage appropriate VHA programs to provide interdisciplinary, coordinated, and timely management of complex medical issues | Behavioural | Intervention--PACT Intensive Management |
Primary outcome
VA health care cost
Time frame: 2 years (two 1-year points)
Total costs of VA care, including inpatient, outpatient, pharmacy and fee-basis services.
3 secondary outcomes
Healthcare Utilization
Time frame: 2 years (two 1-year points)
Total Medicare Cost
Time frame: 2 years (two 1-year points)
Total Medicare Utilization
Time frame: 2 years (two 1-year points)
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 11 May 2020.
- Derived from this study: PubMed 29868706Yoon J, Chang E, Rubenstein LV, Park A, Zulman DM, Stockdale S, Ong MK, Atkins D, Schectman G, Asch SM. Impact of Primary Care Intensive Management on High-Risk Veterans' Costs and Utilization: A Randomized Quality Improvement Trial. Ann Intern Med. 2018 Jun 19;168(12):846-854. doi: 10.7326/M17-3039. Epub 2018 Jun 5.
- Derived from this study: PubMed 29698772Chang ET, Zulman DM, Asch SM, Stockdale SE, Yoon J, Ong MK, Lee M, Simon A, Atkins D, Schectman G, Kirsh SR, Rubenstein LV; PIM Executive Committee and Demonstration Sites. An operations-partnered evaluation of care redesign for high-risk patients in the Veterans Health Administration (VHA): Study protocol for the PACT Intensive Management (PIM) randomized quality improvement evaluation. Contemp Clin Trials. 2018 Jun;69:65-75. doi: 10.1016/j.cct.2018.04.008. Epub 2018 Apr 23.
- 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.
Lisa Rubenstein, MD principal investigator
VAGLAHS- WLA
Questions about this trial
What is this clinical trial studying?
A study testing PACT Intensive Management in people with Primary Health Care and Health Care Costs, run by Veteran Affairs Office of Patient Care Services.
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 1 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 11 May 2020. 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?
VA health care cost (time frame: 2 years (two 1-year points)). 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 NCT03100526, 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 11 May 2020; AzTrials last refreshed its copy on 2 Nov 2026.