Trial Outcomes & Findings for PACT for Individuals With Serious Mental Illness (NCT NCT01668355)

NCT ID: NCT01668355

Last Updated: 2020-02-28

Results Overview

Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 331 participants
• Primary outcome timeframe: 15 months
• Results posted on: 2020-02-28

Participant Flow

Participant milestones

Measure	SMI-PACT Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.	Usual Care Usual Primary Care
Overall Study STARTED	164	167
Overall Study COMPLETED	155	165
Overall Study NOT COMPLETED	9	2

Reasons for withdrawal

Measure	SMI-PACT Patient Aligned Care Team (PACT) medical home to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model designed to coordinate and address physical health needs of people with serious mental illness.	Usual Care Usual Primary Care
Overall Study Death	3	1
Overall Study Withdrawal by Subject	6	1

Baseline Characteristics

PACT for Individuals With Serious Mental Illness

Baseline characteristics by cohort

Measure	SMI-PACT n=164 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model to coordinate and address physical health needs.	Usual Care n=167 Participants Usual Primary Care	Total n=331 Participants Total of all reporting groups
Age, Continuous	58.7 years STANDARD_DEVIATION 10.4 • n=5 Participants	54.5 years STANDARD_DEVIATION 13.9 • n=7 Participants	56.6 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	31 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants	136 Participants n=7 Participants	286 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=5 Participants	127 Participants n=7 Participants	265 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	21 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	74 Participants n=5 Participants	37 Participants n=7 Participants	111 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	94 Participants n=7 Participants	153 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.

Outcome measures

Measure	SMI-PACT n=164 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.	Usual Care n=166 Participants Usual Primary Care
Provision of Appropriate Preventive and Medical Treatments Screened for Body Mass Index	144 Participants	117 Participants
Provision of Appropriate Preventive and Medical Treatments Screened for Blood Pressure	146 Participants	131 Participants
Provision of Appropriate Preventive and Medical Treatments Screened for Lipids	88 Participants	41 Participants
Provision of Appropriate Preventive and Medical Treatments Screened for Glucose or Hemoglobin A1c	119 Participants	85 Participants

PRIMARY outcome

Timeframe: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.

Outcome measures

Measure	SMI-PACT n=129 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.	Usual Care n=133 Participants Usual Primary Care
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health	38.9 score on a scale Standard Deviation 11.0	37.2 score on a scale Standard Deviation 11.6

PRIMARY outcome

Timeframe: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.

Outcome measures

Measure	SMI-PACT n=129 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.	Usual Care n=133 Participants Usual Primary Care
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health	42.3 score on a scale Standard Deviation 12.3	37.6 score on a scale Standard Deviation 12.8

PRIMARY outcome

Timeframe: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.

Outcome measures

Measure	SMI-PACT n=152 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.	Usual Care n=155 Participants Usual Primary Care
Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)	68 score on a scale Standard Deviation 24.2	66.7 score on a scale Standard Deviation 25.1

PRIMARY outcome

Timeframe: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.

Outcome measures

Measure	SMI-PACT n=134 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.	Usual Care n=130 Participants Usual Primary Care
Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)	2.7 score on a scale Standard Deviation 1.0	2.9 score on a scale Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.

Outcome measures

Measure	SMI-PACT n=164 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.	Usual Care n=165 Participants Usual Primary Care
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis	0.88 score on a scale Standard Deviation 0.79	0.65 score on a scale Standard Deviation 0.71

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.

Outcome measures

Measure	SMI-PACT n=164 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.	Usual Care n=165 Participants Usual Primary Care
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning	1.63 score on a scale Standard Deviation 0.68	1.71 score on a scale Standard Deviation 0.72

OTHER_PRE_SPECIFIED outcome

Timeframe: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.

Outcome measures

Measure	SMI-PACT n=162 Participants Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Patient Aligned Care Team (PACT): An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.	Usual Care n=165 Participants Usual Primary Care
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning	2.42 score on a scale Standard Deviation 0.89	2.39 score on a scale Standard Deviation 0.89

Adverse Events

SMI-PACT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alexander Young

VA

Phone: 310-794-7219

Email: alexander.young@va.gov

Results disclosure agreements

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