Evaluation of Intensive Management Patient Aligned Care Team (ImPACT)

• ClinicalTrials.gov Identifier: NCT02932228
• Recruitment Status: Completed
• First Posted: October 13, 2016
• Results First Posted: May 29, 2019
• Last Update Posted: June 12, 2019
• Sponsor: VA Office of Research and Development
• Collaborators: VA Palo Alto Health Care System; Veteran Affairs Office of Patient Care Services
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: October 6, 2016
• First Posted Date: October 13, 2016
• Results First Submitted Date: April 6, 2018
• Results First Posted Date: May 29, 2019
• Last Update Posted Date: June 12, 2019
• Actual Study Start Date: January 1, 2013
• Actual Primary Completion Date: June 1, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 30, 2019)

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.

Original Primary Outcome Measures (submitted: October 11, 2016)

VA health care costs [ Time Frame: 17 months after ImPACT program initiation ]

Total costs of VA care, including inpatient, outpatient, and fee-basis care

Current Secondary Outcome Measures (submitted: February 12, 2019)

• 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.

Original Secondary Outcome Measures (submitted: October 11, 2016)

• Hospitalization [ Time Frame: 17 months after ImPACT program initiation ]
  Admission rates and length of stay of acute medical/surgical, acute mental health, extended medical, and extended mental health inpatient care
• Emergency Department Utilization [ Time Frame: 17 months after ImPACT program initiation ]
  Number of Emergency Department visits
• Outpatient Utilization [ Time Frame: 17 months after ImPACT program initiation ]
  Number of visits to primary, specialty, and mental health clinics

Current Other Pre-specified Outcome Measures (submitted: February 12, 2019)

• 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

  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".
• 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

Original Other Pre-specified Outcome Measures (submitted: October 11, 2016)

• Feasibility: Time to Enrollment [ Time Frame: 9 months after ImPACT program initiation ]
  To evaluate ImPACT's feasibility, we will assess time to enrollment for invited participants.
• Feasibility: Participation [ Time Frame: 9 months after ImPACT program initiation ]
  We will evaluate proportion of patients who participate in ImPACT and the frequency of their contact with ImPACT team members
• 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
• Patient satisfaction [ Time Frame: up to 9 months ]
  We will assess patient satisfaction with the ImPACT intervention and changes in satisfaction with overall care (Patient Satisfaction Questionnaire subscales)
• 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
• Symptom burden (patient-reported) [ Time Frame: up to 9 months ]
  We will assess changes in patient-reported symptom burden, including fatigue, pain, sleep problems, and stress, through a patient survey administered at time of enrollment and 4-9 months after enrollment
• Functional status (patient-reported) [ Time Frame: up to 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

Descriptive Information

• Brief Title: Evaluation of Intensive Management Patient Aligned Care Team
• Official Title: Evaluating Innovative Care Models for High-Utilizing Patients
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Primary Health Care
• Health Care Costs

Intervention

Other: ImPACT

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 Arms

• Experimental: 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.
  Intervention: Other: ImPACT
• 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.

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.
• Zulman 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.
• Gidwani 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.
• Breland 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.
• Hunter 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.
• Breland 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.
• Hummel 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.
• Breland 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.
• Zulman 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.
• Wu 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 11, 2016): 583
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 1, 2015
• Actual Primary Completion Date: June 1, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT02932228
• Other Study ID Numbers: PPO 13-117
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Donna Zulman, VA Palo Alto Health Care System, Physician Investigator
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: VA Palo Alto Health Care System

Collaborators

• VA Palo Alto Health Care System
• Veteran Affairs Office of Patient Care Services

Investigators

• Principal Investigator: Donna M Zulman, MD MS; VA Palo Alto Health Care System, Palo Alto, CA

• PRS Account: VA Office of Research and Development
• Verification Date: May 2019