Trial · NCT02318797

Optimizing Behavioral Health Homes for Adults With Serious Mental Illness

NCT02318797, Not applicable, Completed, University of Pittsburgh; results first posted 2018-02-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Optimizing Behavioral Health Homes for Adults With Serious Mental Illness. Trials, record NCT02318797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02318797

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Optimizing Behavioral Health Homes for Adults With Serious Mental Illness
NCT number: NCT02318797
Status: Completed
Phases: Not applicable
Enrollment: 1,229 participants, actual
Lead sponsor: University of Pittsburgh
Conditions: Chronic Disease, Mental Health, Behavioral Health, Cardiovascular Disease, Diabetes Mellitus Type 2, Substance-related Disorders, Vascular Diseases
Interventions: Patient Self-Directed Care, Provider-Supported Integrated Care
First posted: 2014-12-17
Last updated: 2018-02-22
Results first posted: 2018-02-22

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Patient Activation in Care (PAM, a 13-item Scale)	Baseline and every 6 months over 2 year active intervention period	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.
Primary	Change in Health Status ( SF-12v2™): Physical Health Sub-scale	Baseline and every 6 months over 2 year active intervention period	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.
Primary	Change in Engagement in Primary/Specialty Care	Updated annually using claims data over 2 year active intervention period	The frequency of primary/specialty care visits over two 12-month time periods.
Primary	Change in Health Status ( SF-12v2™): Mental Health Sub-scale	Baseline and every 6 months during the active intervention period	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.
Secondary	Change in Hope (Hope Scale)	Baseline and every 6 months during the active intervention period	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.
Secondary	Change in Quality of Life (QLESQ)	Baseline and every 6 months over 2 year active intervention period	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).
Secondary	Change in Medication Adherence - Diabetes	Updated annually using claims data over 2 year active intervention period	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.
Secondary	Change in Functional Status (Sheehan Disability Scale)	Baseline and every 6 months over 2 year active intervention period	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.
Secondary	Change in Emergent Care Use (Claims Data)	Updated annually using claims data over 2 year active intervention period	Behavioral and physical health claims data will be obtained to determine frequency of emergent service use for participants over 12-month time periods.
Secondary	Change in Lab Monitoring - Overall	Updated annually using claims data over 2 year active intervention period	Frequency of lab tests (glucose, lipids, EKG) in 12 month periods

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Patient Activation in Care (PAM, a 13-item Scale)	Baseline and every 6 months over 2 year active intervention period	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)	units on a scale	MEAN
PRIMARY	Change in Health Status ( SF-12v2™): Physical Health Sub-scale	Baseline and every 6 months over 2 year active intervention period	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)	units on a scale	MEAN
PRIMARY	Change in Engagement in Primary/Specialty Care	Updated annually using claims data over 2 year active intervention period	Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point	Frequency of visits in 12-month periods	MEAN
PRIMARY	Change in Health Status ( SF-12v2™): Mental Health Sub-scale	Baseline and every 6 months during the active intervention period	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)	units on a scale	MEAN
SECONDARY	Change in Hope (Hope Scale)	Baseline and every 6 months during the active intervention period	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)	Units on a scale	MEAN
SECONDARY	Change in Quality of Life (QLESQ)	Baseline and every 6 months over 2 year active intervention period	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)	Units on a scale	MEAN
SECONDARY	Change in Medication Adherence - Diabetes	Updated annually using claims data over 2 year active intervention period	The N for the time point with the greatest # of participants who were prescribed a diabetes medication.	Medication possession ratio	MEAN
SECONDARY	Change in Functional Status (Sheehan Disability Scale)	Baseline and every 6 months over 2 year active intervention period	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)	Units on a scale	MEAN
SECONDARY	Change in Emergent Care Use (Claims Data)	Updated annually using claims data over 2 year active intervention period	\# of individuals with 80% Medicaid eligibility in the 12 months prior to the data collection time point.	frequency of visits in 12-month periods	MEAN
SECONDARY	Change in Lab Monitoring - Overall	Updated annually using claims data over 2 year active intervention period	Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point	frequency of lab tests in 12 mo. period	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group146

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Patient Activation in Care (PAM, a 13-item Scale)	Patient Self-Directed Care	Baseline	56.99	Standard Deviation 15.03	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Provider-Supported Integrated Care	Baseline	56.77	Standard Deviation 14.59	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Patient Self-Directed Care	6-month follow up	56.84	Standard Deviation 14.45	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Provider-Supported Integrated Care	6-month follow up	58.74	Standard Deviation 14.90	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Patient Self-Directed Care	12-month follow up	58.36	Standard Deviation 15.08	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Provider-Supported Integrated Care	12-month follow up	57.46	Standard Deviation 14.89	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Patient Self-Directed Care	18-month follow up	58.90	Standard Deviation 14.98	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Provider-Supported Integrated Care	18-month follow up	57.84	Standard Deviation 15.11	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Patient Self-Directed Care	24-month follow up	57.04	Standard Deviation 15.15	units on a scale
Change in Patient Activation in Care (PAM, a 13-item Scale)	Provider-Supported Integrated Care	24-month follow up	58.61	Standard Deviation 15.64	units on a scale

1 to 10 of 146Source ClinicalTrials.gov

See all 146 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Patient Self-Directed Care	516
Overall Study	STARTED	Provider-Supported Integrated Care	713
Overall Study	COMPLETED	Patient Self-Directed Care	428
Overall Study	COMPLETED	Provider-Supported Integrated Care	611
Overall Study	NOT COMPLETED	Patient Self-Directed Care	88
Overall Study	NOT COMPLETED	Provider-Supported Integrated Care	102

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Death - not associated with study activities	General disorders	Patient Self-Directed Care	3	516	3
serious	Death - not associated with study activities	General disorders	Provider-Supported Integrated Care	6	713	6

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Patient Self-Directed Care	3	516
Total, all-cause mortality	Provider-Supported Integrated Care	6	713
Total, other adverse events	Patient Self-Directed Care	0	516
Total, other adverse events	Provider-Supported Integrated Care	0	713
Total, serious adverse events	Patient Self-Directed Care	3	516
Total, serious adverse events	Provider-Supported Integrated Care	6	713

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Patient Self-Directed Care vs Provider-Supported Integrated Care: deaths from any cause	Trial comparisons
Patient Self-Directed Care vs Provider-Supported Integrated Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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