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

• 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

Participant Flow

Recruitment Details	Recruitment into ImPACT completed by ImPACT staff at VAPAHCS
Pre-assignment Details

Arm/Group Title	ImPACT	PACT
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

Baseline Characteristics

Arm/Group Title		ImPACT	PACT	Total
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
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

Outcome Measures

1. Primary Outcome

Title	VA Health Care Costs
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

Outcome Measure Data

Analysis Population Description

Program's effect on monthly person level costs

Arm/Group Title	ImPACT	PACT
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ImPACT	PACT
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
Description	Number of Emergency Department visits
Time Frame	17 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ImPACT	PACT
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ImPACT	PACT
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
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

Outcome Measure Data

Analysis Population Description

This analysis was only conducted on the ImPACT group.

Arm/Group Title	ImPACT
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
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

Outcome Measure Data

Analysis Population Description

This analysis was only conducted on the ImPACT group.

Arm/Group Title	ImPACT
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
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

Outcome Measure Data

Analysis Population Description

This analysis was only conducted on the ImPACT group.

Arm/Group Title	Providers at VAPAHCS
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
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; 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".
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

The survey was only given to ImPACT enrollees.

Arm/Group Title	ImPACT
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)
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

Outcome Measure Data

Analysis Population Description

This analysis was only conducted on the ImPACT group.

Arm/Group Title	ImPACT
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)
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

Outcome Measure Data

Analysis Population Description

The survey was only given to ImPACT enrollees.

Arm/Group Title	ImPACT
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)
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

Outcome Measure Data

Analysis Population Description

The survey was only given to ImPACT enrollees.

Arm/Group Title	ImPACT
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

Adverse Events

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
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	--/--	--/--
Serious Adverse Events
	ImPACT	PACT
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/140 (0.00%)	0/405 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr Donna Zulman
• Organization: VA Palo Alto Health Care System
• Phone: 650-493-5000 ext 29113
• EMail: Donna.Zulman@va.gov

Publications of Results:

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.

Other 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

• 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