Primary Health CareImPACTNCT02932228
Evaluation of Intensive Management Patient Aligned Care Team
A study testing ImPACT in people with Primary Health Care and Health Care Costs, run by VA Office of Research and Development.
Trial summary
This evaluation will examine the feasibility, implementation, and effectiveness of a quality improvement intervention-Intensive Management Patient Aligned Care Team (ImPACT)-for high-risk patients. 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?
- ImPACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 May 2015
- 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
- Patient receives care from one of 14 primary care providers (MDs, NPs) who have at least three half-days of clinic per week
- Total VA healthcare costs in the top 5% for VA Palo Alto facility during the 9-month eligibility phase (10/1/11-6/30/12) AND/OR
- Risk for one-year hospitalization in November 2012 in the top 5% (using the VA's Care Assessment Need risk-prediction algorithm)
Who cannot join
- Enrollment in VA's mental health intensive case management program, home-based primary care, or palliative care programs
- Recipient of inpatient care for over half of the 9-month eligibility phase (10/1/11-6/30/12).
- Total VA healthcare costs in the lowest cost decile in the 9-month eligibility phase (10/1/11-6/30/12)
- Risk for one-year hospitalization in November 2012 in the lowest risk quartile (using the VA's Care Assessment Need risk-prediction algorithm).
About this study
Official title: Evaluating Innovative Care Models for High-Utilizing Patients
This evaluation will examine the feasibility, implementation, and effectiveness of a quality improvement intervention-Intensive Management Patient Aligned Care Team (ImPACT)-for high-risk patients.
Read the detailed description
Background: VA's highest-utilizing patients generally have complicated health care needs-including complex and multiple chronic conditions, comorbid mental health conditions, and social stressors-that contribute to high rates of hospitalization, emergency services, and specialty care use. Inspired by emerging intensive primary care models for high-utilizers, VA Palo Alto launched a quality improvement program to augment existing VA primary care (provided by Patient Aligned Care Teams, PACT) with intensive care delivered by a multidisciplinary team. The Intensive management PACT (ImPACT) intervention encompasses a number of evidence-based strategies, including a comprehensive intake process, coordination of specialty care, chronic condition case management, provision of social services, rapid response to deteriorations in health, and facilitation of transitions after high-acuity events.
The ImPACT program was designated as quality improvement (non-research) by the Palo Alto VA. A retrospective evaluation using deidentified data was approved by the Stanford University IRB.
Objectives: The objectives of this evaluation are to assess ImPACT's feasibility, implementation, and effectiveness, and lay the groundwork for future larger-scale efforts and evaluations within the VA system.
Methods: We will partner with the implementation team of VA Palo Alto's ImPACT clinic to conduct a Hybrid Type 1 evaluation of the program's feasibility, implementation, and effectiveness. Specifically, the evaluation will aim to:
- Evaluate the feasibility and implementation of the pilot ImPACT intervention. Using semi-structured interviews with ImPACT and PACT team members and leadership, we will evaluate the success of intervention delivery, including patient identification, recruitment, and retention; provision and uptake of planned services; and monitoring of patient participation and key outcomes.
- Evaluate ImPACT's effect on utilization and costs of care. We will use a difference-in-differences approach, wherein we compare changes in VA health care costs (total, as well as inpatient, outpatient, and fee-basis) and utilization (including hospitalizations, emergency department visits, and specialty care) among ImPACT patients and high-utilizing patients who are receiving usual PACT care.
- Examine the association between ImPACT participation and patient-centered outcomes. Using data from surveys administered in the ImPACT clinic, we will assess patient satisfaction with the ImPACT intervention and overall care, as well as changes in patient-reported outcomes, including health status, symptom burden, and function.
- Conditions
- Primary Health Care, Health Care Costs
- Being tested
- ImPACT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImPACTOther
The ImPACT team offers the following services:
- An intensive intake process, including a home visit if deemed appropriate
- Frequent contact (in-person, telephone, or secure messaging) tailored to a patient's needs
- After-hours access to on-call team member in order to avoid unnecessary emergency care
- Optimization of chronic condition management using evidence-based protocols
- Navigation of transitions between hospital and home
- Coordination of specialty care, including contact with specialists when indicated
- Rapid response to signs of health status deterioration or other stressful events
- Assess patient goals, advance directives, Physician Orders for Life-Sustaining Treatment
| Study group | Role | What they receive |
|---|---|---|
| ImPACT | Experimental | Patients in ImPACT receive intensive outpatient care from the ImPACT team. The ImPACT team augments existing PACT primary care with intensive services delivered by a multidisciplinary team (including a physician, nurse practitioner, social worker, recreational therapist, and program coordinator). ImPACT program elements include a comprehensive patient assessment, identification and tracking of patients' goals and priorities, care management for medical and social service needs, co-attendance at specialty care appointments, and coordination of care with VA and non-VA providers, including during and after hospitalization. Receives: Other: ImPACT |
| PACT | No intervention | Patients in PACT receive usual VA primary care through the VA's Patient Centered Medical Home. VA primary care is delivered by PACT teamlets that comprise a primary care provider, nurse, clinical associate, and administrative associate who are supported by social work, pharmacy, and behavioral health services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VA Health Care Costs
Estimated programs effect on cost among all patients, and correspond to the change in monthly costs among patients in impact minus the change in costs for patients in PACT.
Measured: 17 months
Secondary outcomes (3)
Hospitalization
Admission rates and length of stay of acute medical/surgical, acute mental health, extended medical, and extended mental health inpatient care. Outcome reported is mean(SD) number of hospital admissions using intent to treat analysis between both groups.
Measured: 17 months
Emergency Department Utilization
Number of Emergency Department visits
Measured: 17 months
Outpatient Utilization
Number of visits to primary, specialty, and mental health clinics. Number reported is mean primary care visits between ImPACT and PACT.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start1 Jan 2013
- Primary completion1 Jun 2014
- Study completion1 May 2015
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 (11)Papers the sponsor has linked to this study.
- Other trials for Primary Health CareStudies 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
- None (open label)
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Palo Alto Health Care System, Veteran Affairs Office of Patient Care Services
- Responsible party
- Sponsor
- Investigators
- Donna M Zulman, MD MS, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932228
- Sponsor's protocol ID
- PPO 13-117
- Acronym
- ImPACT
- Status last verified
- May 2019
- First submitted
- 6 Oct 2016
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zulman DM, Jenchura EC, Cohen DM, Lewis ET, Houston TK, Asch SM. How Can eHealth Technology Address Challenges Related to Multimorbidity? Perspectives from Patients with Multiple Chronic Conditions. J Gen Intern Med. 2015 Aug;30(8):1063-70. doi: 10.1007/s11606-015-3222-9. Epub 2015 Feb 18.
PubMed 25691239Zulman DM, Pal Chee C, Wagner TH, Yoon J, Cohen DM, Holmes TH, Ritchie C, Asch SM. Multimorbidity and healthcare utilisation among high-cost patients in the US Veterans Affairs Health Care System. BMJ Open. 2015 Apr 16;5(4):e007771. doi: 10.1136/bmjopen-2015-007771.
PubMed 25882486Gidwani R, Zulman D. Association Between Acute Medical Exacerbations and Consuming or Producing Web-Based Health Information: Analysis From Pew Survey Data. J Med Internet Res. 2015 Jun 23;17(6):e145. doi: 10.2196/jmir.3801.
PubMed 26104000Breland JY, Greenbaum MA, Zulman DM, Rosen CS. The effect of medical comorbidities on male and female Veterans' use of psychotherapy for PTSD. Med Care. 2015 Apr;53(4 Suppl 1):S120-7. doi: 10.1097/MLR.0000000000000284.
PubMed 25767965Hunter G, Yoon J, Blonigen DM, Asch SM, Zulman DM. Health Care Utilization Patterns Among High-Cost VA Patients With Mental Health Conditions. Psychiatr Serv. 2015 Sep;66(9):952-8. doi: 10.1176/appi.ps.201400286. Epub 2015 May 1.
PubMed 25930040Breland JY, Chee CP, Zulman DM. Racial Differences in Chronic Conditions and Sociodemographic Characteristics Among High-Utilizing Veterans. J Racial Ethn Health Disparities. 2015 Jun;2(2):167-75. doi: 10.1007/s40615-014-0060-0. Epub 2014 Nov 8.
PubMed 26863335Hummel DL, Hill C, Shaw JG, Slightam C, Zulman DM. Nurse practitioner-led intensive outpatient team: Effects on end-of-life care. The Journal for Nurse Practitioners. 2017 Mar 14; 13(5):e245-e248
Zulman DM, Ezeji-Okoye SC, Shaw JG, Hummel DL, Holloway KS, Smither SF, Breland JY, Chardos JF, Kirsh S, Kahn JS, Asch SM. Partnered research in healthcare delivery redesign for high-need, high-cost patients: development and feasibility of an Intensive Management Patient-Aligned Care Team (ImPACT). J Gen Intern Med. 2014 Dec;29 Suppl 4(Suppl 4):861-9. doi: 10.1007/s11606-014-3022-7.
PubMed 25355084Breland JY, Asch SM, Slightam C, Wong A, Zulman DM. Key ingredients for implementing intensive outpatient programs within patient-centered medical homes: A literature review and qualitative analysis. Healthc (Amst). 2016 Mar;4(1):22-9. doi: 10.1016/j.hjdsi.2015.12.005. Epub 2015 Dec 29.
PubMed 27001095Zulman DM, Pal Chee C, Ezeji-Okoye SC, Shaw JG, Holmes TH, Kahn JS, Asch SM. Effect of an Intensive Outpatient Program to Augment Primary Care for High-Need Veterans Affairs Patients: A Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 1;177(2):166-175. doi: 10.1001/jamainternmed.2016.8021.
PubMed 28027338Wu FM, Slightam CA, Wong AC, Asch SM, Zulman DM. Intensive Outpatient Program Effects on High-need Patients' Access, Continuity, Coordination, and Engagement. Med Care. 2018 Jan;56(1):19-24. doi: 10.1097/MLR.0000000000000833.
PubMed 29087980
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Innovative Care Models for High-Utilizing Patients
- ClinicalTrials.gov ID
- NCT02932228
- Acronym / sponsor ID
- ImPACT / PPO 13-117
- Conditions
- Primary Health Care, Health Care Costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Palo Alto Health Care System, Veteran Affairs Office of Patient Care Services
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Posted 29 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This evaluation will examine the feasibility, implementation, and effectiveness of a quality improvement intervention-Intensive Management Patient Aligned Care Team (ImPACT)-for high-risk patients.
Detailed description
Background: VA's highest-utilizing patients generally have complicated health care needs-including complex and multiple chronic conditions, comorbid mental health conditions, and social stressors-that contribute to high rates of hospitalization, emergency services, and specialty care use. Inspired by emerging intensive primary care models for high-utilizers, VA Palo Alto launched a quality improvement program to augment existing VA primary care (provided by Patient Aligned Care Teams, PACT) with intensive care delivered by a multidisciplinary team. The Intensive management PACT (ImPACT) intervention encompasses a number of evidence-based strategies, including a comprehensive intake process, coordination of specialty care, chronic condition case management, provision of social services, rapid response to deteriorations in health, and facilitation of transitions after high-acuity events.
The ImPACT program was designated as quality improvement (non-research) by the Palo Alto VA. A retrospective evaluation using deidentified data was approved by the Stanford University IRB.
Objectives: The objectives of this evaluation are to assess ImPACT's feasibility, implementation, and effectiveness, and lay the groundwork for future larger-scale efforts and evaluations within the VA system.
Methods: We will partner with the implementation team of VA Palo Alto's ImPACT clinic to conduct a Hybrid Type 1 evaluation of the program's feasibility, implementation, and effectiveness. Specifically, the evaluation will aim to:
- Evaluate the feasibility and implementation of the pilot ImPACT intervention. Using semi-structured interviews with ImPACT and PACT team members and leadership, we will evaluate the success of intervention delivery, including patient identification, recruitment, and retention; provision and uptake of planned services; and monitoring of patient participation and key outcomes.
- Evaluate ImPACT's effect on utilization and costs of care. We will use a difference-in-differences approach, wherein we compare changes in VA health care costs (total, as well as inpatient, outpatient, and fee-basis) and utilization (including hospitalizations, emergency department visits, and specialty care) among ImPACT patients and high-utilizing patients who are receiving usual PACT care.
- Examine the association between ImPACT participation and patient-centered outcomes. Using data from surveys administered in the ImPACT clinic, we will assess patient satisfaction with the ImPACT intervention and overall care, as well as changes in patient-reported outcomes, including health status, symptom burden, and function.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ImPACT | Experimental | Other: ImPACTPatients in ImPACT receive intensive outpatient care from the ImPACT team. The ImPACT team augments existing PACT primary care with intensive services delivered by a multidisciplinary team (including a physician, nurse practitioner, social worker, recreational therapist, and program coordinator). ImPACT program elements include a comprehensive patient assessment, identification and tracking of patients' goals and priorities, care management for medical and social service needs, co-attendance at specialty care appointments, and coordination of care with VA and non-VA providers, including during and after hospitalization. |
| PACT | No intervention | –Patients in PACT receive usual VA primary care through the VA's Patient Centered Medical Home. VA primary care is delivered by PACT teamlets that comprise a primary care provider, nurse, clinical associate, and administrative associate who are supported by social work, pharmacy, and behavioral health services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient receives care from one of 14 primary care providers (MDs, NPs) who have at least three half-days of clinic per week
- Total VA healthcare costs in the top 5% for VA Palo Alto facility during the 9-month eligibility phase (10/1/11-6/30/12) AND/OR
- Risk for one-year hospitalization in November 2012 in the top 5% (using the VA's Care Assessment Need risk-prediction algorithm)
Key exclusion criteria (4 listed)
- Enrollment in VA's mental health intensive case management program, home-based primary care, or palliative care programs
- Recipient of inpatient care for over half of the 9-month eligibility phase (10/1/11-6/30/12).
- Total VA healthcare costs in the lowest cost decile in the 9-month eligibility phase (10/1/11-6/30/12)
- Risk for one-year hospitalization in November 2012 in the lowest risk quartile (using the VA's Care Assessment Need risk-prediction algorithm).
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 |
|---|---|---|
| ImPACTThe ImPACT team offers the following services: * An intensive intake process, including a home visit if deemed appropriate * Frequent contact (in-person, telephone, or secure messaging) tailored to a patient's needs * After-hours access to on-call team member in order to avoid unnecessary emergency care * Optimization of chronic condition management using evidence-based protocols * Navigation of transitions between hospital and home * Coordination of specialty care, including contact with specialists when indicated * Rapid response to signs of health status deterioration or other stressful events * Assess patient goals, advance directives, Physician Orders for Life-Sustaining Treatment | Other | ImPACT |
Primary outcome
VA Health Care Costs
Time frame: 17 months
Estimated programs effect on cost among all patients, and correspond to the change in monthly costs among patients in impact minus the change in costs for patients in PACT.
3 secondary outcomes
Hospitalization
Time frame: 17 months
Emergency Department Utilization
Time frame: 17 months
Outpatient Utilization
Time frame: 17 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25691239Zulman DM, Jenchura EC, Cohen DM, Lewis ET, Houston TK, Asch SM. How Can eHealth Technology Address Challenges Related to Multimorbidity? Perspectives from Patients with Multiple Chronic Conditions. J Gen Intern Med. 2015 Aug;30(8):1063-70. doi: 10.1007/s11606-015-3222-9. Epub 2015 Feb 18.
- Background: PubMed 25882486Zulman DM, Pal Chee C, Wagner TH, Yoon J, Cohen DM, Holmes TH, Ritchie C, Asch SM. Multimorbidity and healthcare utilisation among high-cost patients in the US Veterans Affairs Health Care System. BMJ Open. 2015 Apr 16;5(4):e007771. doi: 10.1136/bmjopen-2015-007771.
- Background: PubMed 26104000Gidwani R, Zulman D. Association Between Acute Medical Exacerbations and Consuming or Producing Web-Based Health Information: Analysis From Pew Survey Data. J Med Internet Res. 2015 Jun 23;17(6):e145. doi: 10.2196/jmir.3801.
- Background: PubMed 25767965Breland JY, Greenbaum MA, Zulman DM, Rosen CS. The effect of medical comorbidities on male and female Veterans' use of psychotherapy for PTSD. Med Care. 2015 Apr;53(4 Suppl 1):S120-7. doi: 10.1097/MLR.0000000000000284.
- Background: PubMed 25930040Hunter G, Yoon J, Blonigen DM, Asch SM, Zulman DM. Health Care Utilization Patterns Among High-Cost VA Patients With Mental Health Conditions. Psychiatr Serv. 2015 Sep;66(9):952-8. doi: 10.1176/appi.ps.201400286. Epub 2015 May 1.
- Background: PubMed 26863335Breland JY, Chee CP, Zulman DM. Racial Differences in Chronic Conditions and Sociodemographic Characteristics Among High-Utilizing Veterans. J Racial Ethn Health Disparities. 2015 Jun;2(2):167-75. doi: 10.1007/s40615-014-0060-0. Epub 2014 Nov 8.
- BackgroundHummel DL, Hill C, Shaw JG, Slightam C, Zulman DM. Nurse practitioner-led intensive outpatient team: Effects on end-of-life care. The Journal for Nurse Practitioners. 2017 Mar 14; 13(5):e245-e248
- Results publication: PubMed 25355084Zulman DM, Ezeji-Okoye SC, Shaw JG, Hummel DL, Holloway KS, Smither SF, Breland JY, Chardos JF, Kirsh S, Kahn JS, Asch SM. Partnered research in healthcare delivery redesign for high-need, high-cost patients: development and feasibility of an Intensive Management Patient-Aligned Care Team (ImPACT). J Gen Intern Med. 2014 Dec;29 Suppl 4(Suppl 4):861-9. doi: 10.1007/s11606-014-3022-7.
- Results publication: PubMed 27001095Breland JY, Asch SM, Slightam C, Wong A, Zulman DM. Key ingredients for implementing intensive outpatient programs within patient-centered medical homes: A literature review and qualitative analysis. Healthc (Amst). 2016 Mar;4(1):22-9. doi: 10.1016/j.hjdsi.2015.12.005. Epub 2015 Dec 29.
- Results publication: PubMed 28027338Zulman DM, Pal Chee C, Ezeji-Okoye SC, Shaw JG, Holmes TH, Kahn JS, Asch SM. Effect of an Intensive Outpatient Program to Augment Primary Care for High-Need Veterans Affairs Patients: A Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 1;177(2):166-175. doi: 10.1001/jamainternmed.2016.8021.
- Results publication: PubMed 29087980Wu FM, Slightam CA, Wong AC, Asch SM, Zulman DM. Intensive Outpatient Program Effects on High-need Patients' Access, Continuity, Coordination, and Engagement. Med Care. 2018 Jan;56(1):19-24. doi: 10.1097/MLR.0000000000000833.
- 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.
Donna M Zulman, MD MS principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
Questions about this trial
What is this clinical trial studying?
A study testing ImPACT in people with Primary Health Care and Health Care Costs, run by VA Office of Research and Development.
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 4 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 12 Jun 2019. 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 29 May 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?
VA Health Care Costs (time frame: 17 months). 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 NCT02932228, which also lists 11 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 12 Jun 2019.