Trial Outcomes & Findings for Evaluation of Intensive Management Patient Aligned Care Team (NCT NCT02932228)

NCT ID: NCT02932228

Last Updated: 2019-06-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 583 participants
• Primary outcome timeframe: 17 months
• Results posted on: 2019-06-12

Participant Flow

Recruitment into ImPACT completed by ImPACT staff at VAPAHCS

Participant milestones

Measure	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.	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.
Overall Study STARTED	150	433
Overall Study COMPLETED	140	405
Overall Study NOT COMPLETED	10	28

Reasons for withdrawal

Measure	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.	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.
Overall Study Death	8	23
Overall Study not eligible upon chart review	2	5

Baseline Characteristics

Evaluation of Intensive Management Patient Aligned Care Team

Baseline characteristics by cohort

Measure	ImPACT n=140 Participants 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.	PACT n=405 Participants 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 n=545 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants	212 Participants n=7 Participants	276 Participants n=5 Participants
Age, Categorical >=65 years	76 Participants n=5 Participants	193 Participants n=7 Participants	269 Participants n=5 Participants
Age, Continuous	66.4 years STANDARD_DEVIATION 14 • n=5 Participants	65.7 years STANDARD_DEVIATION 13 • n=7 Participants	66.05 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	40 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants	365 Participants n=7 Participants	495 Participants n=5 Participants
Region of Enrollment United States	140 Participants n=5 Participants	405 Participants n=7 Participants	545 Participants n=5 Participants

PRIMARY outcome

Timeframe: 17 months

Population: Program's effect on monthly person level 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.

Outcome measures

Measure	ImPACT n=140 Participants 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.	PACT n=405 Participants Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
VA Health Care Costs Baseline monthly costs	6139 US Dollars Standard Deviation 2312	5821 US Dollars Standard Deviation 2217
VA Health Care Costs Follow-up monthly costs	4850 US Dollars Standard Deviation 1780	4618 US Dollars Standard Deviation 1741

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ImPACT n=140 Participants 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.	PACT n=405 Participants Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Hospitalization Baseline	1.3 Admissions Standard Deviation 1.5	1.3 Admissions Standard Deviation 1.5
Hospitalization Follow-up	0.7 Admissions Standard Deviation 1.2	0.7 Admissions Standard Deviation 1.2

SECONDARY outcome

Timeframe: 17 months

Number of Emergency Department visits

Outcome measures

Measure	ImPACT n=140 Participants 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.	PACT n=405 Participants Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Emergency Department Utilization Follow-up	2.1 visits Standard Deviation 2.9	2.1 visits Standard Deviation 2.9
Emergency Department Utilization Baseline	3.4 visits Standard Deviation 3.3	3.3 visits Standard Deviation 3.3

SECONDARY outcome

Timeframe: 17 months

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

Outcome measures

Measure	ImPACT n=140 Participants 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.	PACT n=405 Participants Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Outpatient Utilization Baseline	10.9 visits Standard Deviation 7.7	10.6 visits Standard Deviation 7.8
Outpatient Utilization Follow up	21.8 visits Standard Deviation 17.4	7.4 visits Standard Deviation 7.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

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

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

Outcome measures

Measure	ImPACT n=140 Participants 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.	PACT Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Feasibility: Time to Enrollment	80 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

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

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

Outcome measures

Measure	ImPACT n=140 Participants 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.	PACT Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Feasibility: Participation	2.4 encounters Interval 1.0 to 4.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

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

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.

Outcome measures

Measure	ImPACT n=15 Participants 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.	PACT Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Implementation Process	15 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Population: The survey was only given to ImPACT enrollees.

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".

Outcome measures

Measure	ImPACT n=50 Participants 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.	PACT Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Patient Satisfaction	3.16 units on a scale Standard Deviation .60	—

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 9 months

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

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.

Outcome measures

Measure	ImPACT n=51 Participants 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.	PACT Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Health Status (Patient-reported) Baseline	62.7 units on a scale Standard Deviation 17.7	—
Health Status (Patient-reported) Follow up	66.8 units on a scale Standard Deviation 18.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 9 months

Population: The survey was only given to ImPACT enrollees.

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.

Outcome measures

Measure	ImPACT n=42 Participants 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.	PACT Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Symptom Burden (Patient-reported) Follow up	4.7 Units on a scale Standard Deviation 3.2	—
Symptom Burden (Patient-reported) Baseline	4.6 Units on a scale Standard Deviation 3.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Population: The survey was only given to ImPACT enrollees.

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

Outcome measures

Measure	ImPACT n=52 Participants 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.	PACT Patients in PACT receive usual VA primary care through the VA's patient centered medical home.
Functional Status (Patient-reported) Baseline	52 percentage of participants	—
Functional Status (Patient-reported) Follow up	56 percentage of participants	—

Adverse Events

ImPACT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PACT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Donna Zulman

VA Palo Alto Health Care System

Phone: 650-493-5000

Email: Donna.Zulman@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place