Optimizing Behavioral Health Homes for Adults With Serious Mental Illness

NCT02318797 | Completed Results DMC

• 1 other identifier: PCORI 271
• Study Type: interventional
• Target: 1,229
• Locations: 1 country
• Sites: 1

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. 1.Patient self-directed care will result in improvement in patient activation.
2. 2.Provider-supported integrated care will result in greater improvement in frequency in primary/specialty care visits.
3. 3.Both interventions will result in significant improvements in the three primary outcomes.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (13)

• Change in Hope (Hope Scale)

  Baseline and every 6 months during the active intervention period

• Change in Quality of Life (QLESQ)

  Baseline and every 6 months over 2 year active intervention period

• Change in Medication Adherence - Diabetes

  Updated annually using claims data over 2 year active intervention period

• Change in Functional Status (Sheehan Disability Scale)

  Baseline and every 6 months over 2 year active intervention period

• Change in Emergent Care Use (Claims Data)

  Updated annually using claims data over 2 year active intervention period

Study Arms (2)

Patient Self-Directed Care

ACTIVE COMPARATOR

See intervention description

Behavioral: Patient Self-Directed Care

Provider-Supported Integrated Care

ACTIVE COMPARATOR

See intervention description

Behavioral: Provider-Supported Integrated Care

Interventions

Patient Self-Directed Care BEHAVIORAL

Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs

Patient Self-Directed Care

Provider-Supported Integrated Care BEHAVIORAL

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

Provider-Supported Integrated Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• UPMC Center for High-Value Health Care: collaborator
• Western Psychiatric Institute and Clinic of UPMC: collaborator
• Community Care Behavioral Health Organization: collaborator
• Columbia Montour Snyder Union Mental Health: collaborator
• Behavioral Health Alliance of Rural Pennsylvania: collaborator

Study Sites (1)

Community Care Behavioral Health Organizations

Pittsburgh, Pennsylvania, 15229, United States

Location

MeSH Terms

Conditions

Chronic Disease; Psychological Well-Being; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Substance-Related Disorders; Vascular Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Charles Reynolds, MD
• Organization: University of Pittsburgh Department of Psychiatry

reynoldscf@upmc.edu

412-246-6414

Study Officials

• Charles F. Reynolds, MD

  University of Pittsburgh; UPMC Center for High-Value Health Care

  PRINCIPAL INVESTIGATOR

• James M. Schuster, MD, MBA

  Community Care Behavioral Health; UPMC Center for High-Value Health Care

  PRINCIPAL INVESTIGATOR

• Tracy A. Carney, AAS

  Recovery Central Clubhouse, Columbia Montour Snyder Union Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 17, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 22, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-02

Locations

US (1)