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Evaluation of Intensive Management Patient Aligned Care Team

Evaluating Innovative Care Models for High-Utilizing Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02932228
Acronym
ImPACT
Enrollment
583
Registered
2016-10-13
Start date
2013-01-01
Completion date
2015-05-01
Last updated
2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Health Care, Health Care Costs

Brief 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.

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: 1. 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. 2. 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. 3. 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.

Interventions

OTHERImPACT

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

Sponsors

VA Palo Alto Health Care System
CollaboratorFED
Veteran Affairs Office of Patient Care Services
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
VA Health Care Costs17 monthsEstimated 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.

Secondary

MeasureTime frameDescription
Hospitalization17 monthsAdmission 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.
Emergency Department Utilization17 monthsNumber of Emergency Department visits
Outpatient Utilization17 monthsNumber of visits to primary, specialty, and mental health clinics. Number reported is mean primary care visits between ImPACT and PACT.

Other

MeasureTime frameDescription
Health Status (Patient-reported)up to 9 monthsWe will assess patient-reported health status through a patient survey administered at time of enrollment and 4-9 months after enrollment. Outcome measure includes mean patient activation scores between baseline and follow up survey periods. Activation is measured on a scale from 0-100, with higher numbers corresponding to higher levels of patient activation.
Feasibility: Time to Enrollment9 monthsTo evaluate ImPACT's feasibility, we will assess time to enrollment for invited participants. Number is reported is number of participants still enrolled in ImPACT program after 9 months
Functional Status (Patient-reported)9 monthsWe will assess changes in patient-reported functional status through a patient survey administered at time of enrollment and 4-9 months after enrollment. The outcome measure includes percentage of patients(from 0-100%) who indicated having some difficulty, much difficulty, or inability to perform tasks due to functional limitations. A higher score indicates more functional limitations
Symptom Burden (Patient-reported)up to 9 monthsWe will assess changes in patient-reported symptom burden, including pain through a patient survey administered at time of enrollment and 4-9 months after enrollment. Outcome measure below is the mean number of participants who rate their pain in the last weeks on a 10 point scale where 0=None and 10=severe pain, a higher value indicates worse symptom burden.
Feasibility: Participation9 monthsWe will evaluate proportion of patients who participate in ImPACT and the frequency of their contact with ImPACT team members. Outcome measure is the average number of patient-ImPACT provider in person contacts per month from 2/2013-6/2014
Implementation Process9 monthsInterviews with ImPACT team members, PACT providers, and VA facility leadership will be used to understand the ImPACT program implementation process. Outcome measure is number of participants enrolled and completed interviews.
Patient Satisfaction9 monthsWe will assess patient satisfaction with the ImPACT intervention and changes in satisfaction with overall care. The Patient Satisfaction Questionnaires ask: Please describe your satisfaction with ImPACT Clinical Services 1. Medical care 2. Social work services 3. Recreational and community services 4. After-hours services The 4 items were combined to create a mean overall satisfaction with ImPACT care score, which ranges from 1-4, 4 indicating better satisfaction with the program. The scale is measured on a 4 point scale with 1 meaning strongly disagree and 4 meaning strongly agree.

Participant flow

Recruitment details

Recruitment into ImPACT completed by ImPACT staff at VAPAHCS

Participants by arm

ArmCount
ImPACT
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.
140
PACT
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.
405
Total545

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath823
Overall Studynot eligible upon chart review25

Baseline characteristics

CharacteristicPACTImPACTTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
193 Participants76 Participants269 Participants
Age, Categorical
Between 18 and 65 years
212 Participants64 Participants276 Participants
Age, Continuous65.7 years
STANDARD_DEVIATION 13
66.4 years
STANDARD_DEVIATION 14
66.05 years
STANDARD_DEVIATION 13.5
Region of Enrollment
United States
405 Participants140 Participants545 Participants
Sex: Female, Male
Female
40 Participants10 Participants50 Participants
Sex: Female, Male
Male
365 Participants130 Participants495 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1400 / 405
serious
Total, serious adverse events
0 / 1400 / 405

Outcome results

Primary

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.

Time frame: 17 months

Population: Program's effect on monthly person level costs

ArmMeasureGroupValue (MEAN)Dispersion
ImPACTVA Health Care CostsBaseline monthly costs6139 US DollarsStandard Deviation 2312
ImPACTVA Health Care CostsFollow-up monthly costs4850 US DollarsStandard Deviation 1780
PACTVA Health Care CostsBaseline monthly costs5821 US DollarsStandard Deviation 2217
PACTVA Health Care CostsFollow-up monthly costs4618 US DollarsStandard Deviation 1741
Secondary

Emergency Department Utilization

Number of Emergency Department visits

Time frame: 17 months

ArmMeasureGroupValue (MEAN)Dispersion
ImPACTEmergency Department UtilizationBaseline3.4 visitsStandard Deviation 3.3
ImPACTEmergency Department UtilizationFollow-up2.1 visitsStandard Deviation 2.9
PACTEmergency Department UtilizationBaseline3.3 visitsStandard Deviation 3.3
PACTEmergency Department UtilizationFollow-up2.1 visitsStandard Deviation 2.9
Secondary

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.

Time frame: 17 months

ArmMeasureGroupValue (MEAN)Dispersion
ImPACTHospitalizationBaseline1.3 AdmissionsStandard Deviation 1.5
ImPACTHospitalizationFollow-up0.7 AdmissionsStandard Deviation 1.2
PACTHospitalizationBaseline1.3 AdmissionsStandard Deviation 1.5
PACTHospitalizationFollow-up0.7 AdmissionsStandard Deviation 1.2
Secondary

Outpatient Utilization

Number of visits to primary, specialty, and mental health clinics. Number reported is mean primary care visits between ImPACT and PACT.

Time frame: 17 months

ArmMeasureGroupValue (MEAN)Dispersion
ImPACTOutpatient UtilizationBaseline10.9 visitsStandard Deviation 7.7
ImPACTOutpatient UtilizationFollow up21.8 visitsStandard Deviation 17.4
PACTOutpatient UtilizationBaseline10.6 visitsStandard Deviation 7.8
PACTOutpatient UtilizationFollow up7.4 visitsStandard Deviation 7.5
Other Pre-specified

Feasibility: Participation

We will evaluate proportion of patients who participate in ImPACT and the frequency of their contact with ImPACT team members. Outcome measure is the average number of patient-ImPACT provider in person contacts per month from 2/2013-6/2014

Time frame: 9 months

Population: This analysis was only conducted on the ImPACT group.

ArmMeasureValue (MEAN)
ImPACTFeasibility: Participation2.4 encounters
Other Pre-specified

Feasibility: Time to Enrollment

To evaluate ImPACT's feasibility, we will assess time to enrollment for invited participants. Number is reported is number of participants still enrolled in ImPACT program after 9 months

Time frame: 9 months

Population: This analysis was only conducted on the ImPACT group.

ArmMeasureValue (NUMBER)
ImPACTFeasibility: Time to Enrollment80 participants
Other Pre-specified

Functional Status (Patient-reported)

We will assess changes in patient-reported functional status through a patient survey administered at time of enrollment and 4-9 months after enrollment. The outcome measure includes percentage of patients(from 0-100%) who indicated having some difficulty, much difficulty, or inability to perform tasks due to functional limitations. A higher score indicates more functional limitations

Time frame: 9 months

Population: The survey was only given to ImPACT enrollees.

ArmMeasureGroupValue (NUMBER)
ImPACTFunctional Status (Patient-reported)Baseline52 percentage of participants
ImPACTFunctional Status (Patient-reported)Follow up56 percentage of participants
Other Pre-specified

Health Status (Patient-reported)

We will assess patient-reported health status through a patient survey administered at time of enrollment and 4-9 months after enrollment. Outcome measure includes mean patient activation scores between baseline and follow up survey periods. Activation is measured on a scale from 0-100, with higher numbers corresponding to higher levels of patient activation.

Time frame: up to 9 months

Population: This analysis was only conducted on the ImPACT group.

ArmMeasureGroupValue (MEAN)Dispersion
ImPACTHealth Status (Patient-reported)Baseline62.7 units on a scaleStandard Deviation 17.7
ImPACTHealth Status (Patient-reported)Follow up66.8 units on a scaleStandard Deviation 18.2
Other Pre-specified

Implementation Process

Interviews with ImPACT team members, PACT providers, and VA facility leadership will be used to understand the ImPACT program implementation process. Outcome measure is number of participants enrolled and completed interviews.

Time frame: 9 months

Population: This analysis was only conducted on the ImPACT group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ImPACTImplementation Process15 Participants
Other Pre-specified

Patient Satisfaction

We will assess patient satisfaction with the ImPACT intervention and changes in satisfaction with overall care. The Patient Satisfaction Questionnaires ask: Please describe your satisfaction with ImPACT Clinical Services 1. Medical care 2. Social work services 3. Recreational and community services 4. After-hours services The 4 items were combined to create a mean overall satisfaction with ImPACT care score, which ranges from 1-4, 4 indicating better satisfaction with the program. The scale is measured on a 4 point scale with 1 meaning strongly disagree and 4 meaning strongly agree.

Time frame: 9 months

Population: The survey was only given to ImPACT enrollees.

ArmMeasureValue (MEAN)Dispersion
ImPACTPatient Satisfaction3.16 units on a scaleStandard Deviation 0.6
Other Pre-specified

Symptom Burden (Patient-reported)

We will assess changes in patient-reported symptom burden, including pain through a patient survey administered at time of enrollment and 4-9 months after enrollment. Outcome measure below is the mean number of participants who rate their pain in the last weeks on a 10 point scale where 0=None and 10=severe pain, a higher value indicates worse symptom burden.

Time frame: up to 9 months

Population: The survey was only given to ImPACT enrollees.

ArmMeasureGroupValue (MEAN)Dispersion
ImPACTSymptom Burden (Patient-reported)Baseline4.6 Units on a scaleStandard Deviation 3.3
ImPACTSymptom Burden (Patient-reported)Follow up4.7 Units on a scaleStandard Deviation 3.2

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026