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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
Sponsor:
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Primary Health Care
Health Care Costs
Intervention Other: ImPACT
Enrollment 583
Recruitment Details Recruitment into ImPACT completed by ImPACT staff at VAPAHCS
Pre-assignment Details  
Arm/Group Title ImPACT PACT
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 150 433
Completed 140 405
Not Completed 10 28
Reason Not Completed
Death             8             23
not eligible upon chart review             2             5
Arm/Group Title ImPACT PACT Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 140 405 545
Hide Baseline Analysis Population Description
death rate before starting program, age, chronic conditions, and history of homelessness
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 405 participants 545 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
64
  45.7%
212
  52.3%
276
  50.6%
>=65 years
76
  54.3%
193
  47.7%
269
  49.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 405 participants 545 participants
66.4  (14) 65.7  (13) 66.05  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 405 participants 545 participants
Female
10
   7.1%
40
   9.9%
50
   9.2%
Male
130
  92.9%
365
  90.1%
495
  90.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 140 participants 405 participants 545 participants
140 405 545
1.Primary Outcome
Title VA Health Care Costs
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Program's effect on monthly person level costs
Arm/Group Title ImPACT PACT
Hide Arm/Group Description:
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.
Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Overall Number of Participants Analyzed 140 405
Mean (Standard Deviation)
Unit of Measure: US Dollars
Baseline monthly costs 6139  (2312) 5821  (2217)
Follow-up monthly costs 4850  (1780) 4618  (1741)
2.Secondary Outcome
Title Hospitalization
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ImPACT PACT
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 140 405
Mean (Standard Deviation)
Unit of Measure: Admissions
Baseline 1.3  (1.5) 1.3  (1.5)
Follow-up 0.7  (1.2) 0.7  (1.2)
3.Secondary Outcome
Title Emergency Department Utilization
Hide Description Number of Emergency Department visits
Time Frame 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ImPACT PACT
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 140 405
Mean (Standard Deviation)
Unit of Measure: visits
Baseline 3.4  (3.3) 3.3  (3.3)
Follow-up 2.1  (2.9) 2.1  (2.9)
4.Secondary Outcome
Title Outpatient Utilization
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ImPACT PACT
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 140 405
Mean (Standard Deviation)
Unit of Measure: visits
Baseline 10.9  (7.7) 10.6  (7.8)
Follow up 21.8  (17.4) 7.4  (7.5)
5.Other Pre-specified Outcome
Title Feasibility: Time to Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only conducted on the ImPACT group.
Arm/Group Title ImPACT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 140
Measure Type: Number
Unit of Measure: participants
80
6.Other Pre-specified Outcome
Title Feasibility: Participation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only conducted on the ImPACT group.
Arm/Group Title ImPACT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 140
Mean (Full Range)
Unit of Measure: encounters
2.4
(1 to 4)
7.Other Pre-specified Outcome
Title Implementation Process
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only conducted on the ImPACT group.
Arm/Group Title Providers at VAPAHCS
Hide Arm/Group Description:
Clinicians and leadership at VAPAHCS impacted by implementation of the ImPACT program
Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
15
 100.0%
8.Other Pre-specified Outcome
Title Patient Satisfaction
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The survey was only given to ImPACT enrollees.
Arm/Group Title ImPACT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.16  (.60)
9.Other Pre-specified Outcome
Title Health Status (Patient-reported)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was only conducted on the ImPACT group.
Arm/Group Title ImPACT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 62.7  (17.7)
Follow up 66.8  (18.2)
10.Other Pre-specified Outcome
Title Symptom Burden (Patient-reported)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The survey was only given to ImPACT enrollees.
Arm/Group Title ImPACT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 4.6  (3.3)
Follow up 4.7  (3.2)
11.Other Pre-specified Outcome
Title Functional Status (Patient-reported)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The survey was only given to ImPACT enrollees.
Arm/Group Title ImPACT
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 52
Follow up 56
Time Frame 17months
Adverse Event Reporting Description Adverse events required to be reported to the VA R&D and local IRB committees. A review of adverse events was completed at each annual review of the projects IRB. There were no participants affected by serious adverse events.
 
Arm/Group Title ImPACT PACT
Hide Arm/Group Description 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. 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.
All-Cause Mortality
ImPACT PACT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
ImPACT PACT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/140 (0.00%)   0/405 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ImPACT PACT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/140 (0.00%)   0/405 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Donna Zulman
Organization: VA Palo Alto Health Care System
Phone: 650-493-5000 ext 29113
EMail: Donna.Zulman@va.gov
Other Publications:
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
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02932228    
Other Study ID Numbers: PPO 13-117
First Submitted: October 6, 2016
First Posted: October 13, 2016
Results First Submitted: April 6, 2018
Results First Posted: May 29, 2019
Last Update Posted: June 12, 2019