Optimizing Behavioral Health Homes for Adults With Serious Mental Illness

Cardiovascular Disease Clinical Trial

— PCORI OH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318797
• Other study ID #: PCORI 271
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: February 19, 2018
• Start date: October 2013
• Est. completion date: January 2017

Study information

• Verified date: February 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1229
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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
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

Locations

Country	Name	City	State
United States	Community Care Behavioral Health Organizations	Pittsburgh	Pennsylvania

Sponsors (9)

Lead Sponsor

Collaborator

University of Pittsburgh

Behavioral Health Alliance of Rural Pennsylvania, Columbia Montour Snyder Union Mental Health, Community Care Behavioral Health Organization, U. of Pittsburgh Qualitative, Eval And Stakeholder Engagement Research Services, University of Pittsburgh Comparative Effectiveness Research Center, University of Pittsburgh Graduate School of Public Health, Dept of Biostatistics, UPMC Center for High-Value Health Care, Western Psychiatric Institute and Clinic of UPMC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and every 6 months over 2 year active intervention period
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.	Baseline and every 6 months over 2 year active intervention period
Primary	Change in Engagement in Primary/Specialty Care	The frequency of primary/specialty care visits over two 12-month time periods.	Updated annually using claims data over 2 year active intervention period
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.	Baseline and every 6 months during the active intervention period
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.	Baseline and every 6 months during the active intervention period
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).	Baseline and every 6 months over 2 year active intervention period
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.	Updated annually using claims data over 2 year active intervention period
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.	Baseline and every 6 months over 2 year active intervention period
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.	Updated annually using claims data over 2 year active intervention period
Secondary	Change in Lab Monitoring - Overall	Frequency of lab tests (glucose, lipids, EKG) in 12 month periods	Updated annually using claims data over 2 year active intervention period
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.	Baseline and every 6 months over 2 year active intervention period
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.	Updated annually using claims data over 2 year active intervention period
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.	Updated annually using claims data over 2 year active intervention period
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.	Updated annually using claims data over 2 year active intervention period
Secondary	Change in Lab Monitoring - Glucose	Frequency of glucose lab tests in 12 month periods	Updated annually using claims data over 2 year active intervention period
Secondary	Change in Lab Monitoring - Lipids	Frequency of lipid lab tests in 12 month periods	Updated annually using claims data over 2 year active intervention period
Secondary	Change in Lab Monitoring - EKG	Frequency of EKG tests in 12 month periods	Updated annually using claims data over 2 year active intervention period