Evaluation of Intensive Management Patient Aligned Care Team (ImPACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02932228|
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : May 29, 2019
Last Update Posted : June 12, 2019
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Primary Health Care Health Care Costs||Other: ImPACT||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||583 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluating Innovative Care Models for High-Utilizing Patients|
|Actual Study Start Date :||January 1, 2013|
|Actual Primary Completion Date :||June 1, 2014|
|Actual Study Completion Date :||May 1, 2015|
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.
The ImPACT team offers the following services:
No Intervention: 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.
- 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.
- Hospitalization [ Time Frame: 17 months ]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.
- Emergency Department Utilization [ Time Frame: 17 months ]Number of Emergency Department visits
- Outpatient Utilization [ Time Frame: 17 months ]Number of visits to primary, specialty, and mental health clinics. Number reported is mean primary care visits between ImPACT and PACT.
- Feasibility: Time to Enrollment [ Time Frame: 9 months ]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
- Feasibility: Participation [ Time Frame: 9 months ]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
- Implementation Process [ Time Frame: 9 months ]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.
- Patient Satisfaction [ Time Frame: 9 months ]
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
- Medical care
- Social work services
- Recreational and community services
- 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".
- Health Status (Patient-reported) [ Time Frame: up to 9 months ]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.
- Symptom Burden (Patient-reported) [ Time Frame: up to 9 months ]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.
- Functional Status (Patient-reported) [ Time Frame: 9 months ]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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932228
|Principal Investigator:||Donna M Zulman, MD MS||VA Palo Alto Health Care System, Palo Alto, CA|
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
|First Posted:||October 13, 2016 Key Record Dates|
|Results First Posted:||May 29, 2019|
|Last Update Posted:||June 12, 2019|
|Last Verified:||May 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|