Trial Outcomes & Findings for Optimizing Behavioral Health Homes for Adults With Serious Mental Illness (NCT NCT02318797)
NCT ID: NCT02318797
Last Updated: 2018-02-22
Results Overview
Assessed using the PAM, a 13-item scale that renders a total activation score. This measure gauges the knowledge, skills, and confidence of patients essential to managing their own health and health care. It divides into progressively higher levels of activation: starting to take a role, building knowledge and confidences, taking action, and maintaining behaviors. The raw score scale for the PAM ranges from 13 to 52. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome.
COMPLETED
NA
1229 participants
Baseline and every 6 months over 2 year active intervention period
2018-02-22
Participant Flow
Participant milestones
| Measure |
Provider-Supported Integrated Care
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
Patient Self-Directed Care
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
|---|---|---|
|
Overall Study
STARTED
|
713
|
516
|
|
Overall Study
COMPLETED
|
611
|
428
|
|
Overall Study
NOT COMPLETED
|
102
|
88
|
Reasons for withdrawal
| Measure |
Provider-Supported Integrated Care
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
Patient Self-Directed Care
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
|---|---|---|
|
Overall Study
Death
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
96
|
85
|
Baseline Characteristics
Optimizing Behavioral Health Homes for Adults With Serious Mental Illness
Baseline characteristics by cohort
| Measure |
Patient Self-Directed Care
n=516 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=713 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
Total
n=1229 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.37 years
n=93 Participants
|
43.47 years
n=4 Participants
|
43.01 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
341 Participants
n=93 Participants
|
428 Participants
n=4 Participants
|
769 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=93 Participants
|
285 Participants
n=4 Participants
|
460 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
514 Participants
n=93 Participants
|
709 Participants
n=4 Participants
|
1223 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
483 Participants
n=93 Participants
|
621 Participants
n=4 Participants
|
1104 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 6 months over 2 year active intervention periodPopulation: Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)
Assessed using the PAM, a 13-item scale that renders a total activation score. This measure gauges the knowledge, skills, and confidence of patients essential to managing their own health and health care. It divides into progressively higher levels of activation: starting to take a role, building knowledge and confidences, taking action, and maintaining behaviors. The raw score scale for the PAM ranges from 13 to 52. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome.
Outcome measures
| Measure |
Patient Self-Directed Care
n=438 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=615 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Patient Activation in Care (PAM, a 13-item Scale)
6-month follow up
|
56.84 units on a scale
Standard Deviation 14.45
|
58.74 units on a scale
Standard Deviation 14.90
|
|
Change in Patient Activation in Care (PAM, a 13-item Scale)
Baseline
|
56.99 units on a scale
Standard Deviation 15.03
|
56.77 units on a scale
Standard Deviation 14.59
|
|
Change in Patient Activation in Care (PAM, a 13-item Scale)
12-month follow up
|
58.36 units on a scale
Standard Deviation 15.08
|
57.46 units on a scale
Standard Deviation 14.89
|
|
Change in Patient Activation in Care (PAM, a 13-item Scale)
18-month follow up
|
58.90 units on a scale
Standard Deviation 14.98
|
57.84 units on a scale
Standard Deviation 15.11
|
|
Change in Patient Activation in Care (PAM, a 13-item Scale)
24-month follow up
|
57.04 units on a scale
Standard Deviation 15.15
|
58.61 units on a scale
Standard Deviation 15.64
|
PRIMARY outcome
Timeframe: Baseline and every 6 months over 2 year active intervention periodPopulation: Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)
Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The physical health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains. Scores range from 0-100 and better physical health is indicated by a higher score.
Outcome measures
| Measure |
Patient Self-Directed Care
n=511 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=705 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Health Status ( SF-12v2™): Physical Health Sub-scale
18-month follow up
|
39.71 units on a scale
Standard Deviation 11.80
|
41.28 units on a scale
Standard Deviation 10.99
|
|
Change in Health Status ( SF-12v2™): Physical Health Sub-scale
Baseline
|
42.12 units on a scale
Standard Deviation 11.47
|
42.47 units on a scale
Standard Deviation 11.05
|
|
Change in Health Status ( SF-12v2™): Physical Health Sub-scale
6-month follow up
|
41.19 units on a scale
Standard Deviation 11.44
|
42.26 units on a scale
Standard Deviation 11.00
|
|
Change in Health Status ( SF-12v2™): Physical Health Sub-scale
12-month follow up
|
41.33 units on a scale
Standard Deviation 10.78
|
41.19 units on a scale
Standard Deviation 11.32
|
|
Change in Health Status ( SF-12v2™): Physical Health Sub-scale
24-month follow up
|
40.07 units on a scale
Standard Deviation 12.16
|
41.96 units on a scale
Standard Deviation 10.99
|
PRIMARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point
The frequency of primary/specialty care visits over two 12-month time periods.
Outcome measures
| Measure |
Patient Self-Directed Care
n=449 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=648 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Engagement in Primary/Specialty Care
Baseline
|
9.87 Frequency of visits in 12-month periods
Standard Deviation 7.93
|
8.72 Frequency of visits in 12-month periods
Standard Deviation 6.69
|
|
Change in Engagement in Primary/Specialty Care
12-month follow up
|
11.33 Frequency of visits in 12-month periods
Standard Deviation 8.46
|
11.77 Frequency of visits in 12-month periods
Standard Deviation 7.93
|
|
Change in Engagement in Primary/Specialty Care
24-month follow up
|
11.05 Frequency of visits in 12-month periods
Standard Deviation 8.58
|
10.88 Frequency of visits in 12-month periods
Standard Deviation 7.90
|
PRIMARY outcome
Timeframe: Baseline and every 6 months during the active intervention periodPopulation: Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)
Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The mental health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains (reverse of the weighting used for the physical health component summary score). Scores range from 0-100 and better mental health is indicated by a higher score.
Outcome measures
| Measure |
Patient Self-Directed Care
n=510 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=703 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Health Status ( SF-12v2™): Mental Health Sub-scale
Baseline
|
36.59 units on a scale
Standard Deviation 11.91
|
39.57 units on a scale
Standard Deviation 12.13
|
|
Change in Health Status ( SF-12v2™): Mental Health Sub-scale
6-month follow up
|
37.79 units on a scale
Standard Deviation 11.18
|
40.78 units on a scale
Standard Deviation 12.02
|
|
Change in Health Status ( SF-12v2™): Mental Health Sub-scale
12-month follow up
|
39.42 units on a scale
Standard Deviation 10.35
|
39.80 units on a scale
Standard Deviation 11.48
|
|
Change in Health Status ( SF-12v2™): Mental Health Sub-scale
18-month follow up
|
38.52 units on a scale
Standard Deviation 11.15
|
40.63 units on a scale
Standard Deviation 11.40
|
|
Change in Health Status ( SF-12v2™): Mental Health Sub-scale
24-month follow up
|
39.63 units on a scale
Standard Deviation 11.38
|
40.56 units on a scale
Standard Deviation 11.92
|
SECONDARY outcome
Timeframe: Baseline and every 6 months during the active intervention periodPopulation: Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)
Assessed using the Hope Scale, an instrument designed to measure hope that has been previously used in health services research. Twelve items are rated on a four-point response scale ranging from "definitely false" to "definitely true" and summed to produce a total score. The hope scale ranges from 1 to 10, with 1 being no hope and 10 being filled with hope.
Outcome measures
| Measure |
Patient Self-Directed Care
n=510 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=710 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Hope (Hope Scale)
Baseline
|
6.24 Units on a scale
Standard Deviation 2.59
|
6.46 Units on a scale
Standard Deviation 2.62
|
|
Change in Hope (Hope Scale)
6 month follow-up
|
6.24 Units on a scale
Standard Deviation 2.52
|
6.57 Units on a scale
Standard Deviation 2.60
|
|
Change in Hope (Hope Scale)
12 month follow-up
|
6.47 Units on a scale
Standard Deviation 2.47
|
6.56 Units on a scale
Standard Deviation 2.64
|
|
Change in Hope (Hope Scale)
18 month follow-up
|
6.31 Units on a scale
Standard Deviation 2.47
|
6.65 Units on a scale
Standard Deviation 2.53
|
|
Change in Hope (Hope Scale)
24 month follow-up
|
6.35 Units on a scale
Standard Deviation 2.47
|
6.51 Units on a scale
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Baseline and every 6 months over 2 year active intervention periodPopulation: Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)
Patient quality of life is measured using the QLESQ (Quality of Life Enjoyment and Satisfaction Questionnaire) in which participants respond on a scale of 1 (very poor) to 5 (very good) their level of satisfaction with a variety of social and physical domains. The total raw score ranges from 14 to 70 or 0-100%. Only the first 14 items yield the raw total score as the last two items are standalone. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score). The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. The information below reflects raw scores (rather than percentages).
Outcome measures
| Measure |
Patient Self-Directed Care
n=426 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=638 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Quality of Life (QLESQ)
12 month follow-up
|
44.52 Units on a scale
Standard Deviation 10.36
|
44.35 Units on a scale
Standard Deviation 11.42
|
|
Change in Quality of Life (QLESQ)
18 month follow-up
|
43.10 Units on a scale
Standard Deviation 10.75
|
44.88 Units on a scale
Standard Deviation 11.34
|
|
Change in Quality of Life (QLESQ)
24 month follow-up
|
43.98 Units on a scale
Standard Deviation 11.65
|
45.80 Units on a scale
Standard Deviation 12.02
|
|
Change in Quality of Life (QLESQ)
Baseline
|
42.00 Units on a scale
Standard Deviation 11.60
|
44.38 Units on a scale
Standard Deviation 11.12
|
|
Change in Quality of Life (QLESQ)
6 month follow-up
|
42.29 Units on a scale
Standard Deviation 11.32
|
45.76 Units on a scale
Standard Deviation 11.09
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: The N for the time point with the greatest # of participants who were prescribed a diabetes medication.
Claims data used to calculate diabetes medication possession ratio (MPO) for participants diagnosed with diabetes in 6 month time periods. If the (first\_fill - last\_end\_Date) \> 180 then MPR = (total days supply - (first\_fill - last\_end\_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.
Outcome measures
| Measure |
Patient Self-Directed Care
n=47 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=58 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Medication Adherence - Diabetes
6 month follow-up
|
0.86 Medication possession ratio
Standard Deviation 0.27
|
0.91 Medication possession ratio
Standard Deviation 0.20
|
|
Change in Medication Adherence - Diabetes
12 month follow-up
|
0.83 Medication possession ratio
Standard Deviation 0.27
|
0.91 Medication possession ratio
Standard Deviation 0.17
|
|
Change in Medication Adherence - Diabetes
18 month follow-up
|
0.86 Medication possession ratio
Standard Deviation 0.23
|
0.88 Medication possession ratio
Standard Deviation 0.24
|
|
Change in Medication Adherence - Diabetes
24 month follow-up
|
0.77 Medication possession ratio
Standard Deviation 0.32
|
0.91 Medication possession ratio
Standard Deviation 0.17
|
|
Change in Medication Adherence - Diabetes
Baseline
|
0.78 Medication possession ratio
Standard Deviation 0.30
|
0.89 Medication possession ratio
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Baseline and every 6 months over 2 year active intervention periodPopulation: Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)
Functional status is measured using the Sheehan Disability Scale which assesses functional impairment in three domains including: work/school, social and family life. Respondents rate the extent to which work/school, social life and home life or family responsibilities are impaired by symptoms. The three items from the Sheehan Disability Scale are summed together into a single measure of global functional impairment. This measure ranges from 0 to 30, with 0 being unimpaired and 30 being highly impaired.
Outcome measures
| Measure |
Patient Self-Directed Care
n=473 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=686 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Functional Status (Sheehan Disability Scale)
Baseline
|
13.82 Units on a scale
Standard Deviation 9.20
|
12.71 Units on a scale
Standard Deviation 8.82
|
|
Change in Functional Status (Sheehan Disability Scale)
6 month follow-up
|
12.97 Units on a scale
Standard Deviation 8.87
|
11.33 Units on a scale
Standard Deviation 8.53
|
|
Change in Functional Status (Sheehan Disability Scale)
12 month follow-up
|
12.71 Units on a scale
Standard Deviation 8.60
|
12.29 Units on a scale
Standard Deviation 8.62
|
|
Change in Functional Status (Sheehan Disability Scale)
18 month follow-up
|
13.58 Units on a scale
Standard Deviation 8.57
|
12.20 Units on a scale
Standard Deviation 8.54
|
|
Change in Functional Status (Sheehan Disability Scale)
24 month follow-up
|
13.31 Units on a scale
Standard Deviation 8.69
|
11.90 Units on a scale
Standard Deviation 8.58
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: \# of individuals with 80% Medicaid eligibility in the 12 months prior to the data collection time point.
Behavioral and physical health claims data will be obtained to determine frequency of emergent service use for participants over 12-month time periods.
Outcome measures
| Measure |
Patient Self-Directed Care
n=449 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=648 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Emergent Care Use (Claims Data)
Baseline
|
3.83 frequency of visits in 12-month periods
Standard Deviation 5.87
|
2.36 frequency of visits in 12-month periods
Standard Deviation 4.32
|
|
Change in Emergent Care Use (Claims Data)
12-month follow up
|
3.21 frequency of visits in 12-month periods
Standard Deviation 5.07
|
2.37 frequency of visits in 12-month periods
Standard Deviation 4.63
|
|
Change in Emergent Care Use (Claims Data)
24-month follow-up
|
2.68 frequency of visits in 12-month periods
Standard Deviation 4.44
|
2.19 frequency of visits in 12-month periods
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point
Frequency of lab tests (glucose, lipids, EKG) in 12 month periods
Outcome measures
| Measure |
Patient Self-Directed Care
n=449 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=648 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Lab Monitoring - Overall
24 month follow-up
|
1.52 frequency of lab tests in 12 mo. period
Standard Deviation 2.36
|
1.30 frequency of lab tests in 12 mo. period
Standard Deviation 2.70
|
|
Change in Lab Monitoring - Overall
Baseline
|
1.67 frequency of lab tests in 12 mo. period
Standard Deviation 2.64
|
1.37 frequency of lab tests in 12 mo. period
Standard Deviation 2.65
|
|
Change in Lab Monitoring - Overall
12 month follow-up
|
1.60 frequency of lab tests in 12 mo. period
Standard Deviation 2.79
|
1.49 frequency of lab tests in 12 mo. period
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Baseline and every 6 months over 2 year active intervention periodPopulation: Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)
Change in patient satisfaction with care was assessed using the Patient Assessment of Care for Chronic Conditions (PACIC). Each item of the PACIC is on a 1 to 5 scale. The total score is the average of all 20 item scores. Higher scores represent increased frequency of structured chronic care.
Outcome measures
| Measure |
Patient Self-Directed Care
n=444 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=647 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Patient Satisfaction With Care
12 month follow-up
|
3.25 Units on a scale
Standard Deviation 0.99
|
3.31 Units on a scale
Standard Deviation 0.95
|
|
Change in Patient Satisfaction With Care
Baseline
|
2.99 Units on a scale
Standard Deviation 1.06
|
3.17 Units on a scale
Standard Deviation 0.96
|
|
Change in Patient Satisfaction With Care
6 month follow-up
|
3.17 Units on a scale
Standard Deviation 1.04
|
3.23 Units on a scale
Standard Deviation 0.95
|
|
Change in Patient Satisfaction With Care
18 month follow-up
|
3.16 Units on a scale
Standard Deviation 1.03
|
3.25 Units on a scale
Standard Deviation 0.95
|
|
Change in Patient Satisfaction With Care
24 month follow-up
|
3.17 Units on a scale
Standard Deviation 1.10
|
3.37 Units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: The N for the time point with the greatest # of participants who were prescribed a antipsychotic medication.
Claims data used to calculate antipsychotic medication possession ratio (MPR) for participants in 6 month time periods. If the (first\_fill - last\_end\_Date) \> 180 then MPR = (total days supply - (first\_fill - last\_end\_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.
Outcome measures
| Measure |
Patient Self-Directed Care
n=151 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=198 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Medication Adherence - Antipsychotics
Baseline
|
0.73 Medication possession ratio
Standard Deviation 0.29
|
0.81 Medication possession ratio
Standard Deviation 0.26
|
|
Change in Medication Adherence - Antipsychotics
6 month follow-up
|
0.70 Medication possession ratio
Standard Deviation 0.32
|
0.80 Medication possession ratio
Standard Deviation 0.27
|
|
Change in Medication Adherence - Antipsychotics
12 month follow-up
|
0.74 Medication possession ratio
Standard Deviation 0.32
|
0.82 Medication possession ratio
Standard Deviation 0.27
|
|
Change in Medication Adherence - Antipsychotics
18 month follow-up
|
0.78 Medication possession ratio
Standard Deviation 0.26
|
0.78 Medication possession ratio
Standard Deviation 0.28
|
|
Change in Medication Adherence - Antipsychotics
24 month follow-up
|
0.78 Medication possession ratio
Standard Deviation 0.28
|
0.81 Medication possession ratio
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: The N for the time point with the greatest # of participants who were prescribed a antihypertensive medication.
Claims data used to calculate antihypertensive medication possession ratio (MPR) for participants in 6 month time periods. If the (first\_fill - last\_end\_Date) \> 180 then MPR = (total days supply - (first\_fill - last\_end\_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.
Outcome measures
| Measure |
Patient Self-Directed Care
n=98 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=126 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Medication Adherence - Hypertension
Baseline
|
0.75 Medication possession ratio
Standard Deviation 0.31
|
0.76 Medication possession ratio
Standard Deviation 0.30
|
|
Change in Medication Adherence - Hypertension
6 month follow-up
|
0.73 Medication possession ratio
Standard Deviation 0.31
|
0.79 Medication possession ratio
Standard Deviation 0.30
|
|
Change in Medication Adherence - Hypertension
12 month follow-up
|
0.76 Medication possession ratio
Standard Deviation 0.29
|
0.82 Medication possession ratio
Standard Deviation 0.27
|
|
Change in Medication Adherence - Hypertension
18 month follow-up
|
0.81 Medication possession ratio
Standard Deviation 0.28
|
0.80 Medication possession ratio
Standard Deviation 0.28
|
|
Change in Medication Adherence - Hypertension
24 month follow-up
|
0.83 Medication possession ratio
Standard Deviation 0.30
|
0.82 Medication possession ratio
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: The N for the time point with the greatest # of participants who were prescribed am antidepressant medication.
Claims data used to calculate antidepressant medication possession ratio (MPR) for participants in 6 month time periods. If the (first\_fill - last\_end\_Date) \> 180 then MPR = (total days supply - (first\_fill - last\_end\_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.
Outcome measures
| Measure |
Patient Self-Directed Care
n=188 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=231 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Medication Adherence - Antidepressants
24 month follow-up
|
0.83 Medication possession ratio
Standard Deviation 0.27
|
0.82 Medication possession ratio
Standard Deviation 0.26
|
|
Change in Medication Adherence - Antidepressants
Baseline
|
0.79 Medication possession ratio
Standard Deviation 0.31
|
0.84 Medication possession ratio
Standard Deviation 0.27
|
|
Change in Medication Adherence - Antidepressants
6 month follow-up
|
0.79 Medication possession ratio
Standard Deviation 0.29
|
0.86 Medication possession ratio
Standard Deviation 0.24
|
|
Change in Medication Adherence - Antidepressants
12 month follow-up
|
0.81 Medication possession ratio
Standard Deviation 0.27
|
0.84 Medication possession ratio
Standard Deviation 0.27
|
|
Change in Medication Adherence - Antidepressants
18 month follow-up
|
0.81 Medication possession ratio
Standard Deviation 0.29
|
0.82 Medication possession ratio
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point
Frequency of glucose lab tests in 12 month periods
Outcome measures
| Measure |
Patient Self-Directed Care
n=449 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=648 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Lab Monitoring - Glucose
Baseline
|
1.55 frequency of lab tests in 12 mo. period
Standard Deviation 2.55
|
1.21 frequency of lab tests in 12 mo. period
Standard Deviation 2.52
|
|
Change in Lab Monitoring - Glucose
12 month follow-up
|
1.46 frequency of lab tests in 12 mo. period
Standard Deviation 2.69
|
1.33 frequency of lab tests in 12 mo. period
Standard Deviation 2.65
|
|
Change in Lab Monitoring - Glucose
24 month follow-up
|
1.41 frequency of lab tests in 12 mo. period
Standard Deviation 2.31
|
1.16 frequency of lab tests in 12 mo. period
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point
Frequency of lipid lab tests in 12 month periods
Outcome measures
| Measure |
Patient Self-Directed Care
n=449 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=648 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Lab Monitoring - Lipids
Baseline
|
0.37 frequency of lab tests in 12 mo. period
Standard Deviation 0.74
|
0.41 frequency of lab tests in 12 mo. period
Standard Deviation 0.86
|
|
Change in Lab Monitoring - Lipids
12 month follow-up
|
0.35 frequency of lab tests in 12 mo. period
Standard Deviation 0.73
|
0.46 frequency of lab tests in 12 mo. period
Standard Deviation 0.90
|
|
Change in Lab Monitoring - Lipids
24 month follow-up
|
0.40 frequency of lab tests in 12 mo. period
Standard Deviation 0.73
|
0.46 frequency of lab tests in 12 mo. period
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Updated annually using claims data over 2 year active intervention periodPopulation: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point
Frequency of EKG tests in 12 month periods
Outcome measures
| Measure |
Patient Self-Directed Care
n=449 Participants
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=648 Participants
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
Change in Lab Monitoring - EKG
Baseline
|
0.12 frequency of EKG tests in 12 mo. period
Standard Deviation 0.39
|
0.15 frequency of EKG tests in 12 mo. period
Standard Deviation 0.51
|
|
Change in Lab Monitoring - EKG
12 month follow-up
|
0.13 frequency of EKG tests in 12 mo. period
Standard Deviation 0.43
|
0.16 frequency of EKG tests in 12 mo. period
Standard Deviation 0.49
|
|
Change in Lab Monitoring - EKG
24 month follow-up
|
0.10 frequency of EKG tests in 12 mo. period
Standard Deviation 0.34
|
0.12 frequency of EKG tests in 12 mo. period
Standard Deviation 0.42
|
Adverse Events
Patient Self-Directed Care
Provider-Supported Integrated Care
Serious adverse events
| Measure |
Patient Self-Directed Care
n=516 participants at risk
See intervention description
Patient Self-Directed Care: Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
|
Provider-Supported Integrated Care
n=713 participants at risk
See intervention description
Provider-Supported Integrated Care: Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
|
|---|---|---|
|
General disorders
Death - not associated with study activities
|
0.58%
3/516 • Number of events 3 • Over the entire 2 year implementation and data collection period: October 2013 - January 2016
|
0.84%
6/713 • Number of events 6 • Over the entire 2 year implementation and data collection period: October 2013 - January 2016
|
Other adverse events
Adverse event data not reported
Additional Information
Charles Reynolds, MD
University of Pittsburgh Department of Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place