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Optimizing Behavioral Health Homes for Adults With Serious Mental Illness

Optimizing Behavioral Health Homes by Focusing on Outcomes That Matter Most for Adults With Serious Mental Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02318797
Acronym
PCORI OH
Enrollment
1229
Registered
2014-12-17
Start date
2013-10-31
Completion date
2017-01-31
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral Health, Cardiovascular Disease, Chronic Disease, Diabetes Mellitus Type 2, Mental Health, Substance-related Disorders, Vascular Diseases

Keywords

Chronic disease, Mental Health, Behavioral Health, Community mental health centers, Intervention studies, Mixed methods, Qualitative research

Brief summary

Adults with serious mental illness (SMI) frequently have unmet medical needs which place them at risk for adverse health outcomes. While there are proven ways to manage and/or prevent serious medical conditions common among this population, information is needed to understand their impact on outcomes that matter most for patients, particularly in community mental health centers (CMHCs) where most adults with SMI receive their care and rural areas where locating and receiving health care services can be challenging. The investigators will test two promising ways for promoting the health, wellness, and recovery of adults with SMI. One way will help patients manage their health and health care through self-management strategies, including the use of a web portal, and peer support (patient self-directed care) and the other through interactions with nurses during clinic visits (provider-supported integrated care). The investigators will compare the two interventions on three primary patient-centered outcomes (i.e. patient activation in care, health status, engagement in primary/specialty care). The investigators hypothesize that: 1. Patient self-directed care will result in improvement in patient activation. 2. Provider-supported integrated care will result in greater improvement in frequency in primary/specialty care visits. 3. Both interventions will result in significant improvements in the three primary outcomes. The investigators will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. The investigators will examine these data to learn if, how, and why the new services improve outcomes over time. This information will help us understand patient and other stakeholder views about the services and, if appropriate, ensure their continued and/or expanded availability.

Detailed description

The combination of high medical need with difficulty accessing quality medical care makes adults with serious mental illness (SMI) one of our nation's most medically vulnerable populations. While evidence-based interventions exist for managing and/or preventing high rates of chronic medical conditions in this population, information is needed to understand their impact on outcomes that matter most for patients, particularly in community mental health centers (CMHCs) where most adults with SMI receive their care and rural areas where availability of and access to health care services is limited. Building on the work of a multi-stakeholder collaboration in rural Pennsylvania, the UPMC Center for High-Value Health Care and our patient, provider, and payer partners will evaluate two promising interventions-patient self-directed care and provider-supported integrated care-for promoting the health, wellness, and recovery of adults with SMI. We will address four questions that patients have identified as important to them: 1. Given my mental and physical conditions, what should I expect will happen to my overall health, wellness, and recovery when I engage in the new services offered by my CMHC? 2. If I choose to participate in these services, what are the potential advantages or disadvantages to me? 3. In what ways can I become more active in managing my own health and health care? 4. Which of the services that my CMHC could make available to me will impact outcomes that I care about and help me make the best decisions about my health and care? Our aims compare the effectiveness of the interventions on patient-centered outcomes and explore the moderating role of patient characteristics and the mediating role of engagement in the interventions. By demonstrating which interventions improve outcomes for whom under what circumstances, we will inform positive patient heath choices and key stakeholder decision making to support these choices, thereby advancing health system improvement efforts to avoid early mortality and comorbidity in this population. We have enrolled 1,229 Medicaid-enrolled adults who have or are at risk for chronic medical conditions and receive care at rural and suburban CMHCs. Using a cluster randomized design with a mixed-methods approach, we randomly assigned 11 CMHCs to one of the two interventions. Quantitative (self-report, claims, process) and qualitative (interviews) data will be gathered across multiple time points from baseline through the end of the two-year intervention. Descriptive and multivariate analyses will be used to examine the impact of the interventions on outcomes over time and explore the roles of moderating and mediating variables. Qualitative results will be used to understand patient and other stakeholder perspectives and promote dissemination and sustainability.

Interventions

BEHAVIORALPatient 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

BEHAVIORALProvider-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

Sponsors

UPMC Center for High-Value Health Care
CollaboratorUNKNOWN
Western Psychiatric Institute and Clinic of UPMC
CollaboratorUNKNOWN
Community Care Behavioral Health Organization
CollaboratorUNKNOWN
Columbia Montour Snyder Union Mental Health
CollaboratorUNKNOWN
Behavioral Health Alliance of Rural Pennsylvania
CollaboratorUNKNOWN
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults age 18 and older * Serious mental illness (schizophrenia, bipolar disorder, major depression) * Receive services at one of the 11 participating community mental health centers * At least one claim for outpatient case management or peer specialist services

Exclusion criteria

* Not willing to provide informed consent * Assessed by clinicians as being too ill to be treated on an outpatient basis * Unable to speak, read, or understand English at the minimum required level

Design outcomes

Primary

MeasureTime frameDescription
Change in Patient Activation in Care (PAM, a 13-item Scale)Baseline and every 6 months over 2 year active intervention periodAssessed 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.
Change in Health Status ( SF-12v2™): Physical Health Sub-scaleBaseline and every 6 months over 2 year active intervention periodHealth 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.
Change in Engagement in Primary/Specialty CareUpdated annually using claims data over 2 year active intervention periodThe frequency of primary/specialty care visits over two 12-month time periods.
Change in Health Status ( SF-12v2™): Mental Health Sub-scaleBaseline and every 6 months during the active intervention periodHealth 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.

Secondary

MeasureTime frameDescription
Change in Emergent Care Use (Claims Data)Updated annually using claims data over 2 year active intervention periodBehavioral and physical health claims data will be obtained to determine frequency of emergent service use for participants over 12-month time periods.
Change in Lab Monitoring - OverallUpdated annually using claims data over 2 year active intervention periodFrequency of lab tests (glucose, lipids, EKG) in 12 month periods
Change in Patient Satisfaction With CareBaseline and every 6 months over 2 year active intervention periodChange 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.
Change in Medication Adherence - AntipsychoticsUpdated annually using claims data over 2 year active intervention periodClaims 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.
Change in Hope (Hope Scale)Baseline and every 6 months during the active intervention periodAssessed 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.
Change in Medication Adherence - AntidepressantsUpdated annually using claims data over 2 year active intervention periodClaims 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.
Change in Lab Monitoring - GlucoseUpdated annually using claims data over 2 year active intervention periodFrequency of glucose lab tests in 12 month periods
Change in Lab Monitoring - LipidsUpdated annually using claims data over 2 year active intervention periodFrequency of lipid lab tests in 12 month periods
Change in Lab Monitoring - EKGUpdated annually using claims data over 2 year active intervention periodFrequency of EKG tests in 12 month periods
Change in Medication Adherence - HypertensionUpdated annually using claims data over 2 year active intervention periodClaims 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.
Change in Quality of Life (QLESQ)Baseline and every 6 months over 2 year active intervention periodPatient 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).
Change in Medication Adherence - DiabetesUpdated annually using claims data over 2 year active intervention periodClaims 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.
Change in Functional Status (Sheehan Disability Scale)Baseline and every 6 months over 2 year active intervention periodFunctional 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
516
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
713
Total1,229

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath36
Overall StudyLost to Follow-up8596

Baseline characteristics

CharacteristicTotalPatient Self-Directed CareProvider-Supported Integrated Care
Age, Continuous43.01 years42.37 years43.47 years
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1223 Participants514 Participants709 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
3 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
93 Participants21 Participants72 Participants
Race (NIH/OMB)
More than one race
26 Participants11 Participants15 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1104 Participants483 Participants621 Participants
Sex: Female, Male
Female
769 Participants341 Participants428 Participants
Sex: Female, Male
Male
460 Participants175 Participants285 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 5166 / 713
other
Total, other adverse events
0 / 5160 / 713
serious
Total, serious adverse events
3 / 5166 / 713

Outcome results

Primary

Change in Engagement in Primary/Specialty Care

The frequency of primary/specialty care visits over two 12-month time periods.

Time frame: Updated annually using claims data over 2 year active intervention period

Population: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Engagement in Primary/Specialty Care24-month follow up11.05 Frequency of visits in 12-month periodsStandard Deviation 8.58
Patient Self-Directed CareChange in Engagement in Primary/Specialty CareBaseline9.87 Frequency of visits in 12-month periodsStandard Deviation 7.93
Patient Self-Directed CareChange in Engagement in Primary/Specialty Care12-month follow up11.33 Frequency of visits in 12-month periodsStandard Deviation 8.46
Provider-Supported Integrated CareChange in Engagement in Primary/Specialty Care12-month follow up11.77 Frequency of visits in 12-month periodsStandard Deviation 7.93
Provider-Supported Integrated CareChange in Engagement in Primary/Specialty CareBaseline8.72 Frequency of visits in 12-month periodsStandard Deviation 6.69
Provider-Supported Integrated CareChange in Engagement in Primary/Specialty Care24-month follow up10.88 Frequency of visits in 12-month periodsStandard Deviation 7.9
Comparison: Treatment by time interaction testp-value: 0.4582Mixed Models Analysis
Comparison: Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)p-value: <0.0001Mixed Models Analysis
Comparison: Test for gender by treatment by time interactionp-value: 0.05Mixed Models Analysis
Comparison: Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)p-value: 0.1792Mixed Models Analysis
Primary

Change in Health Status ( SF-12v2™): Mental Health Sub-scale

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.

Time frame: Baseline and every 6 months during the active intervention period

Population: 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)

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Mental Health Sub-scale6-month follow up37.79 units on a scaleStandard Deviation 11.18
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Mental Health Sub-scale18-month follow up38.52 units on a scaleStandard Deviation 11.15
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Mental Health Sub-scaleBaseline36.59 units on a scaleStandard Deviation 11.91
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Mental Health Sub-scale24-month follow up39.63 units on a scaleStandard Deviation 11.38
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Mental Health Sub-scale12-month follow up39.42 units on a scaleStandard Deviation 10.35
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Mental Health Sub-scale24-month follow up40.56 units on a scaleStandard Deviation 11.92
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Mental Health Sub-scale6-month follow up40.78 units on a scaleStandard Deviation 12.02
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Mental Health Sub-scale12-month follow up39.80 units on a scaleStandard Deviation 11.48
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Mental Health Sub-scale18-month follow up40.63 units on a scaleStandard Deviation 11.4
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Mental Health Sub-scaleBaseline39.57 units on a scaleStandard Deviation 12.13
Comparison: Treatment by time interaction testp-value: 0.2179Mixed Models Analysis
Comparison: Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)p-value: <0.0001Mixed Models Analysis
Comparison: Test for gender by treatment by time interactionp-value: 0.4797Mixed Models Analysis
Comparison: Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)p-value: 0.0014Mixed Models Analysis
Primary

Change in Health Status ( SF-12v2™): Physical Health Sub-scale

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.

Time frame: Baseline and every 6 months over 2 year active intervention period

Population: 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)

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Physical Health Sub-scale6-month follow up41.19 units on a scaleStandard Deviation 11.44
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Physical Health Sub-scale18-month follow up39.71 units on a scaleStandard Deviation 11.8
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Physical Health Sub-scale12-month follow up41.33 units on a scaleStandard Deviation 10.78
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Physical Health Sub-scale24-month follow up40.07 units on a scaleStandard Deviation 12.16
Patient Self-Directed CareChange in Health Status ( SF-12v2™): Physical Health Sub-scaleBaseline42.12 units on a scaleStandard Deviation 11.47
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Physical Health Sub-scale24-month follow up41.96 units on a scaleStandard Deviation 10.99
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Physical Health Sub-scaleBaseline42.47 units on a scaleStandard Deviation 11.05
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Physical Health Sub-scale6-month follow up42.26 units on a scaleStandard Deviation 11
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Physical Health Sub-scale12-month follow up41.19 units on a scaleStandard Deviation 11.32
Provider-Supported Integrated CareChange in Health Status ( SF-12v2™): Physical Health Sub-scale18-month follow up41.28 units on a scaleStandard Deviation 10.99
Comparison: Treatment by time interaction testp-value: 0.4103Mixed Models Analysis
Comparison: Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)p-value: <0.0001Mixed Models Analysis
Comparison: Test for gender by treatment by time interactionp-value: 0.4068Mixed Models Analysis
Comparison: Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)p-value: 0.2656Mixed Models Analysis
Primary

Change in Patient Activation in Care (PAM, a 13-item Scale)

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.

Time frame: Baseline and every 6 months over 2 year active intervention period

Population: 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)

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Patient Activation in Care (PAM, a 13-item Scale)6-month follow up56.84 units on a scaleStandard Deviation 14.45
Patient Self-Directed CareChange in Patient Activation in Care (PAM, a 13-item Scale)18-month follow up58.90 units on a scaleStandard Deviation 14.98
Patient Self-Directed CareChange in Patient Activation in Care (PAM, a 13-item Scale)12-month follow up58.36 units on a scaleStandard Deviation 15.08
Patient Self-Directed CareChange in Patient Activation in Care (PAM, a 13-item Scale)24-month follow up57.04 units on a scaleStandard Deviation 15.15
Patient Self-Directed CareChange in Patient Activation in Care (PAM, a 13-item Scale)Baseline56.99 units on a scaleStandard Deviation 15.03
Provider-Supported Integrated CareChange in Patient Activation in Care (PAM, a 13-item Scale)24-month follow up58.61 units on a scaleStandard Deviation 15.64
Provider-Supported Integrated CareChange in Patient Activation in Care (PAM, a 13-item Scale)Baseline56.77 units on a scaleStandard Deviation 14.59
Provider-Supported Integrated CareChange in Patient Activation in Care (PAM, a 13-item Scale)6-month follow up58.74 units on a scaleStandard Deviation 14.9
Provider-Supported Integrated CareChange in Patient Activation in Care (PAM, a 13-item Scale)12-month follow up57.46 units on a scaleStandard Deviation 14.89
Provider-Supported Integrated CareChange in Patient Activation in Care (PAM, a 13-item Scale)18-month follow up57.84 units on a scaleStandard Deviation 15.11
Comparison: Treatment by time interaction testp-value: <0.0001Mixed Models Analysis
Comparison: Test for gender by treatment by time interactionp-value: 0.0019Mixed Models Analysis
Secondary

Change in Emergent Care Use (Claims Data)

Behavioral and physical health claims data will be obtained to determine frequency of emergent service use for participants over 12-month time periods.

Time frame: Updated annually using claims data over 2 year active intervention period

Population: \# of individuals with 80% Medicaid eligibility in the 12 months prior to the data collection time point.

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Emergent Care Use (Claims Data)Baseline3.83 frequency of visits in 12-month periodsStandard Deviation 5.87
Patient Self-Directed CareChange in Emergent Care Use (Claims Data)12-month follow up3.21 frequency of visits in 12-month periodsStandard Deviation 5.07
Patient Self-Directed CareChange in Emergent Care Use (Claims Data)24-month follow-up2.68 frequency of visits in 12-month periodsStandard Deviation 4.44
Provider-Supported Integrated CareChange in Emergent Care Use (Claims Data)Baseline2.36 frequency of visits in 12-month periodsStandard Deviation 4.32
Provider-Supported Integrated CareChange in Emergent Care Use (Claims Data)12-month follow up2.37 frequency of visits in 12-month periodsStandard Deviation 4.63
Provider-Supported Integrated CareChange in Emergent Care Use (Claims Data)24-month follow-up2.19 frequency of visits in 12-month periodsStandard Deviation 4.08
Comparison: Test for treatment by time interactionp-value: 0.002Mixed Models Analysis
Secondary

Change in Functional Status (Sheehan Disability Scale)

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.

Time frame: Baseline and every 6 months over 2 year active intervention period

Population: 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)

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Functional Status (Sheehan Disability Scale)6 month follow-up12.97 Units on a scaleStandard Deviation 8.87
Patient Self-Directed CareChange in Functional Status (Sheehan Disability Scale)18 month follow-up13.58 Units on a scaleStandard Deviation 8.57
Patient Self-Directed CareChange in Functional Status (Sheehan Disability Scale)12 month follow-up12.71 Units on a scaleStandard Deviation 8.6
Patient Self-Directed CareChange in Functional Status (Sheehan Disability Scale)24 month follow-up13.31 Units on a scaleStandard Deviation 8.69
Patient Self-Directed CareChange in Functional Status (Sheehan Disability Scale)Baseline13.82 Units on a scaleStandard Deviation 9.2
Provider-Supported Integrated CareChange in Functional Status (Sheehan Disability Scale)24 month follow-up11.90 Units on a scaleStandard Deviation 8.58
Provider-Supported Integrated CareChange in Functional Status (Sheehan Disability Scale)Baseline12.71 Units on a scaleStandard Deviation 8.82
Provider-Supported Integrated CareChange in Functional Status (Sheehan Disability Scale)6 month follow-up11.33 Units on a scaleStandard Deviation 8.53
Provider-Supported Integrated CareChange in Functional Status (Sheehan Disability Scale)12 month follow-up12.29 Units on a scaleStandard Deviation 8.62
Provider-Supported Integrated CareChange in Functional Status (Sheehan Disability Scale)18 month follow-up12.20 Units on a scaleStandard Deviation 8.54
Comparison: Treatment by time interaction testp-value: 0.5566Mixed Models Analysis
Comparison: Test for change over time (only calculated if treatment by time interaction non-significant)p-value: <0.0001Mixed Models Analysis
Secondary

Change in Hope (Hope Scale)

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.

Time frame: Baseline and every 6 months during the active intervention period

Population: 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)

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Hope (Hope Scale)6 month follow-up6.24 Units on a scaleStandard Deviation 2.52
Patient Self-Directed CareChange in Hope (Hope Scale)18 month follow-up6.31 Units on a scaleStandard Deviation 2.47
Patient Self-Directed CareChange in Hope (Hope Scale)12 month follow-up6.47 Units on a scaleStandard Deviation 2.47
Patient Self-Directed CareChange in Hope (Hope Scale)24 month follow-up6.35 Units on a scaleStandard Deviation 2.47
Patient Self-Directed CareChange in Hope (Hope Scale)Baseline6.24 Units on a scaleStandard Deviation 2.59
Provider-Supported Integrated CareChange in Hope (Hope Scale)24 month follow-up6.51 Units on a scaleStandard Deviation 2.61
Provider-Supported Integrated CareChange in Hope (Hope Scale)Baseline6.46 Units on a scaleStandard Deviation 2.62
Provider-Supported Integrated CareChange in Hope (Hope Scale)6 month follow-up6.57 Units on a scaleStandard Deviation 2.6
Provider-Supported Integrated CareChange in Hope (Hope Scale)12 month follow-up6.56 Units on a scaleStandard Deviation 2.64
Provider-Supported Integrated CareChange in Hope (Hope Scale)18 month follow-up6.65 Units on a scaleStandard Deviation 2.53
Comparison: Treatment by time interaction testp-value: 0.0058Mixed Models Analysis
Secondary

Change in Lab Monitoring - EKG

Frequency of EKG tests in 12 month periods

Time frame: Updated annually using claims data over 2 year active intervention period

Population: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Lab Monitoring - EKGBaseline0.12 frequency of EKG tests in 12 mo. periodStandard Deviation 0.39
Patient Self-Directed CareChange in Lab Monitoring - EKG12 month follow-up0.13 frequency of EKG tests in 12 mo. periodStandard Deviation 0.43
Patient Self-Directed CareChange in Lab Monitoring - EKG24 month follow-up0.10 frequency of EKG tests in 12 mo. periodStandard Deviation 0.34
Provider-Supported Integrated CareChange in Lab Monitoring - EKGBaseline0.15 frequency of EKG tests in 12 mo. periodStandard Deviation 0.51
Provider-Supported Integrated CareChange in Lab Monitoring - EKG12 month follow-up0.16 frequency of EKG tests in 12 mo. periodStandard Deviation 0.49
Provider-Supported Integrated CareChange in Lab Monitoring - EKG24 month follow-up0.12 frequency of EKG tests in 12 mo. periodStandard Deviation 0.42
Comparison: Test for treatment by time interactionp-value: 0.4715Mixed Models Analysis
Comparison: Test for change over time (only calculated if treatment by time interaction non-significant)p-value: 0.9209Mixed Models Analysis
Secondary

Change in Lab Monitoring - Glucose

Frequency of glucose lab tests in 12 month periods

Time frame: Updated annually using claims data over 2 year active intervention period

Population: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Lab Monitoring - GlucoseBaseline1.55 frequency of lab tests in 12 mo. periodStandard Deviation 2.55
Patient Self-Directed CareChange in Lab Monitoring - Glucose12 month follow-up1.46 frequency of lab tests in 12 mo. periodStandard Deviation 2.69
Patient Self-Directed CareChange in Lab Monitoring - Glucose24 month follow-up1.41 frequency of lab tests in 12 mo. periodStandard Deviation 2.31
Provider-Supported Integrated CareChange in Lab Monitoring - GlucoseBaseline1.21 frequency of lab tests in 12 mo. periodStandard Deviation 2.52
Provider-Supported Integrated CareChange in Lab Monitoring - Glucose12 month follow-up1.33 frequency of lab tests in 12 mo. periodStandard Deviation 2.65
Provider-Supported Integrated CareChange in Lab Monitoring - Glucose24 month follow-up1.16 frequency of lab tests in 12 mo. periodStandard Deviation 2.5
Comparison: Test for treatment by time interactionp-value: <0.0001Mixed Models Analysis
Secondary

Change in Lab Monitoring - Lipids

Frequency of lipid lab tests in 12 month periods

Time frame: Updated annually using claims data over 2 year active intervention period

Population: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Lab Monitoring - LipidsBaseline0.37 frequency of lab tests in 12 mo. periodStandard Deviation 0.74
Patient Self-Directed CareChange in Lab Monitoring - Lipids12 month follow-up0.35 frequency of lab tests in 12 mo. periodStandard Deviation 0.73
Patient Self-Directed CareChange in Lab Monitoring - Lipids24 month follow-up0.40 frequency of lab tests in 12 mo. periodStandard Deviation 0.73
Provider-Supported Integrated CareChange in Lab Monitoring - LipidsBaseline0.41 frequency of lab tests in 12 mo. periodStandard Deviation 0.86
Provider-Supported Integrated CareChange in Lab Monitoring - Lipids12 month follow-up0.46 frequency of lab tests in 12 mo. periodStandard Deviation 0.9
Provider-Supported Integrated CareChange in Lab Monitoring - Lipids24 month follow-up0.46 frequency of lab tests in 12 mo. periodStandard Deviation 1.39
Comparison: Test for treatment by time interactionp-value: 0.0202Mixed Models Analysis
Secondary

Change in Lab Monitoring - Overall

Frequency of lab tests (glucose, lipids, EKG) in 12 month periods

Time frame: Updated annually using claims data over 2 year active intervention period

Population: Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Lab Monitoring - OverallBaseline1.67 frequency of lab tests in 12 mo. periodStandard Deviation 2.64
Patient Self-Directed CareChange in Lab Monitoring - Overall12 month follow-up1.60 frequency of lab tests in 12 mo. periodStandard Deviation 2.79
Patient Self-Directed CareChange in Lab Monitoring - Overall24 month follow-up1.52 frequency of lab tests in 12 mo. periodStandard Deviation 2.36
Provider-Supported Integrated CareChange in Lab Monitoring - OverallBaseline1.37 frequency of lab tests in 12 mo. periodStandard Deviation 2.65
Provider-Supported Integrated CareChange in Lab Monitoring - Overall12 month follow-up1.49 frequency of lab tests in 12 mo. periodStandard Deviation 2.79
Provider-Supported Integrated CareChange in Lab Monitoring - Overall24 month follow-up1.30 frequency of lab tests in 12 mo. periodStandard Deviation 2.7
Comparison: Test for treatment by time interactionp-value: 0.0029Mixed Models Analysis
Secondary

Change in Medication Adherence - Antidepressants

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.

Time frame: Updated annually using claims data over 2 year active intervention period

Population: The N for the time point with the greatest # of participants who were prescribed am antidepressant medication.

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Medication Adherence - Antidepressants6 month follow-up0.79 Medication possession ratioStandard Deviation 0.29
Patient Self-Directed CareChange in Medication Adherence - Antidepressants18 month follow-up0.81 Medication possession ratioStandard Deviation 0.29
Patient Self-Directed CareChange in Medication Adherence - Antidepressants12 month follow-up0.81 Medication possession ratioStandard Deviation 0.27
Patient Self-Directed CareChange in Medication Adherence - Antidepressants24 month follow-up0.83 Medication possession ratioStandard Deviation 0.27
Patient Self-Directed CareChange in Medication Adherence - AntidepressantsBaseline0.79 Medication possession ratioStandard Deviation 0.31
Provider-Supported Integrated CareChange in Medication Adherence - Antidepressants24 month follow-up0.82 Medication possession ratioStandard Deviation 0.26
Provider-Supported Integrated CareChange in Medication Adherence - AntidepressantsBaseline0.84 Medication possession ratioStandard Deviation 0.27
Provider-Supported Integrated CareChange in Medication Adherence - Antidepressants6 month follow-up0.86 Medication possession ratioStandard Deviation 0.24
Provider-Supported Integrated CareChange in Medication Adherence - Antidepressants12 month follow-up0.84 Medication possession ratioStandard Deviation 0.27
Provider-Supported Integrated CareChange in Medication Adherence - Antidepressants18 month follow-up0.82 Medication possession ratioStandard Deviation 0.27
Comparison: Test for treatment by time interactionp-value: 0.1653Mixed Models Analysis
Comparison: Test for change over time (only calculated if treatment by time interaction non-significant)p-value: 0.1772Mixed Models Analysis
Secondary

Change in Medication Adherence - Antipsychotics

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.

Time frame: Updated annually using claims data over 2 year active intervention period

Population: The N for the time point with the greatest # of participants who were prescribed a antipsychotic medication.

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Medication Adherence - Antipsychotics6 month follow-up0.70 Medication possession ratioStandard Deviation 0.32
Patient Self-Directed CareChange in Medication Adherence - Antipsychotics18 month follow-up0.78 Medication possession ratioStandard Deviation 0.26
Patient Self-Directed CareChange in Medication Adherence - Antipsychotics12 month follow-up0.74 Medication possession ratioStandard Deviation 0.32
Patient Self-Directed CareChange in Medication Adherence - Antipsychotics24 month follow-up0.78 Medication possession ratioStandard Deviation 0.28
Patient Self-Directed CareChange in Medication Adherence - AntipsychoticsBaseline0.73 Medication possession ratioStandard Deviation 0.29
Provider-Supported Integrated CareChange in Medication Adherence - Antipsychotics24 month follow-up0.81 Medication possession ratioStandard Deviation 0.27
Provider-Supported Integrated CareChange in Medication Adherence - AntipsychoticsBaseline0.81 Medication possession ratioStandard Deviation 0.26
Provider-Supported Integrated CareChange in Medication Adherence - Antipsychotics6 month follow-up0.80 Medication possession ratioStandard Deviation 0.27
Provider-Supported Integrated CareChange in Medication Adherence - Antipsychotics12 month follow-up0.82 Medication possession ratioStandard Deviation 0.27
Provider-Supported Integrated CareChange in Medication Adherence - Antipsychotics18 month follow-up0.78 Medication possession ratioStandard Deviation 0.28
Comparison: Test for treatment by time interactionp-value: 0.1183Mixed Models Analysis
Comparison: Test for change over time (only calculated if treatment by time interaction non-significant)p-value: 0.0569Mixed Models Analysis
Secondary

Change in Medication Adherence - Diabetes

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.

Time frame: Updated annually using claims data over 2 year active intervention period

Population: The N for the time point with the greatest # of participants who were prescribed a diabetes medication.

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Medication Adherence - DiabetesBaseline0.78 Medication possession ratioStandard Deviation 0.3
Patient Self-Directed CareChange in Medication Adherence - Diabetes18 month follow-up0.86 Medication possession ratioStandard Deviation 0.23
Patient Self-Directed CareChange in Medication Adherence - Diabetes12 month follow-up0.83 Medication possession ratioStandard Deviation 0.27
Patient Self-Directed CareChange in Medication Adherence - Diabetes24 month follow-up0.77 Medication possession ratioStandard Deviation 0.32
Patient Self-Directed CareChange in Medication Adherence - Diabetes6 month follow-up0.86 Medication possession ratioStandard Deviation 0.27
Provider-Supported Integrated CareChange in Medication Adherence - Diabetes24 month follow-up0.91 Medication possession ratioStandard Deviation 0.17
Provider-Supported Integrated CareChange in Medication Adherence - DiabetesBaseline0.89 Medication possession ratioStandard Deviation 0.2
Provider-Supported Integrated CareChange in Medication Adherence - Diabetes6 month follow-up0.91 Medication possession ratioStandard Deviation 0.2
Provider-Supported Integrated CareChange in Medication Adherence - Diabetes12 month follow-up0.91 Medication possession ratioStandard Deviation 0.17
Provider-Supported Integrated CareChange in Medication Adherence - Diabetes18 month follow-up0.88 Medication possession ratioStandard Deviation 0.24
Comparison: Test for treatment by time interactionp-value: 0.0001Mixed Models Analysis
Secondary

Change in Medication Adherence - Hypertension

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.

Time frame: Updated annually using claims data over 2 year active intervention period

Population: The N for the time point with the greatest # of participants who were prescribed a antihypertensive medication.

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Medication Adherence - Hypertension6 month follow-up0.73 Medication possession ratioStandard Deviation 0.31
Patient Self-Directed CareChange in Medication Adherence - Hypertension18 month follow-up0.81 Medication possession ratioStandard Deviation 0.28
Patient Self-Directed CareChange in Medication Adherence - Hypertension12 month follow-up0.76 Medication possession ratioStandard Deviation 0.29
Patient Self-Directed CareChange in Medication Adherence - Hypertension24 month follow-up0.83 Medication possession ratioStandard Deviation 0.3
Patient Self-Directed CareChange in Medication Adherence - HypertensionBaseline0.75 Medication possession ratioStandard Deviation 0.31
Provider-Supported Integrated CareChange in Medication Adherence - Hypertension24 month follow-up0.82 Medication possession ratioStandard Deviation 0.27
Provider-Supported Integrated CareChange in Medication Adherence - HypertensionBaseline0.76 Medication possession ratioStandard Deviation 0.3
Provider-Supported Integrated CareChange in Medication Adherence - Hypertension6 month follow-up0.79 Medication possession ratioStandard Deviation 0.3
Provider-Supported Integrated CareChange in Medication Adherence - Hypertension12 month follow-up0.82 Medication possession ratioStandard Deviation 0.27
Provider-Supported Integrated CareChange in Medication Adherence - Hypertension18 month follow-up0.80 Medication possession ratioStandard Deviation 0.28
Comparison: Test for treatment by time interactionp-value: 0.0745Mixed Models Analysis
Comparison: Test for change over time (only calculated if treatment by time interaction non-significant)p-value: <0.0001Mixed Models Analysis
Secondary

Change in Patient Satisfaction With Care

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.

Time frame: Baseline and every 6 months over 2 year active intervention period

Population: 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)

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Patient Satisfaction With CareBaseline2.99 Units on a scaleStandard Deviation 1.06
Patient Self-Directed CareChange in Patient Satisfaction With Care18 month follow-up3.16 Units on a scaleStandard Deviation 1.03
Patient Self-Directed CareChange in Patient Satisfaction With Care12 month follow-up3.25 Units on a scaleStandard Deviation 0.99
Patient Self-Directed CareChange in Patient Satisfaction With Care24 month follow-up3.17 Units on a scaleStandard Deviation 1.1
Patient Self-Directed CareChange in Patient Satisfaction With Care6 month follow-up3.17 Units on a scaleStandard Deviation 1.04
Provider-Supported Integrated CareChange in Patient Satisfaction With Care24 month follow-up3.37 Units on a scaleStandard Deviation 0.95
Provider-Supported Integrated CareChange in Patient Satisfaction With Care6 month follow-up3.23 Units on a scaleStandard Deviation 0.95
Provider-Supported Integrated CareChange in Patient Satisfaction With CareBaseline3.17 Units on a scaleStandard Deviation 0.96
Provider-Supported Integrated CareChange in Patient Satisfaction With Care12 month follow-up3.31 Units on a scaleStandard Deviation 0.95
Provider-Supported Integrated CareChange in Patient Satisfaction With Care18 month follow-up3.25 Units on a scaleStandard Deviation 0.95
Comparison: Test for treatment by time interactionp-value: 0.0021Mixed Models Analysis
Secondary

Change in Quality of Life (QLESQ)

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).

Time frame: Baseline and every 6 months over 2 year active intervention period

Population: 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)

ArmMeasureGroupValue (MEAN)Dispersion
Patient Self-Directed CareChange in Quality of Life (QLESQ)6 month follow-up42.29 Units on a scaleStandard Deviation 11.32
Patient Self-Directed CareChange in Quality of Life (QLESQ)Baseline42.00 Units on a scaleStandard Deviation 11.6
Patient Self-Directed CareChange in Quality of Life (QLESQ)12 month follow-up44.52 Units on a scaleStandard Deviation 10.36
Patient Self-Directed CareChange in Quality of Life (QLESQ)18 month follow-up43.10 Units on a scaleStandard Deviation 10.75
Patient Self-Directed CareChange in Quality of Life (QLESQ)24 month follow-up43.98 Units on a scaleStandard Deviation 11.65
Provider-Supported Integrated CareChange in Quality of Life (QLESQ)24 month follow-up45.80 Units on a scaleStandard Deviation 12.02
Provider-Supported Integrated CareChange in Quality of Life (QLESQ)18 month follow-up44.88 Units on a scaleStandard Deviation 11.34
Provider-Supported Integrated CareChange in Quality of Life (QLESQ)12 month follow-up44.35 Units on a scaleStandard Deviation 11.42
Provider-Supported Integrated CareChange in Quality of Life (QLESQ)Baseline44.38 Units on a scaleStandard Deviation 11.12
Provider-Supported Integrated CareChange in Quality of Life (QLESQ)6 month follow-up45.76 Units on a scaleStandard Deviation 11.09
Comparison: Treatment by time interaction testp-value: 0.0014Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026