Clinical trial NCT02507349: Person-Centered Versus Measurement-Based Care in Mental Health
Official title: Amplifying the Patient's Voice: Person-Centered Versus Measurement-Based Approaches in Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Major Depression
Keywords: serious mental illness
mental health services research
measurement-based care
shared decision making
psychiatric medication management
community psychiatry
comparative effectiveness research
mixed methods research
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: Patient-Centered Outcomes Research Institute
First posted: 2015-07-23
Enrollment: 2443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fifteen minutes is the typical length of an outpatient medication management appointment for people with serious mental health conditions. These brief interactions with prescribers are frequently provider-driven with insufficient time focused on the patient's needs and personal recovery. Shared decision making is a strategy that could improve this interaction. This study examines how technology can be used in the care process to amplify the voice of the patient, support shared decisions, and improve treatment outcomes.

Investigators will compare the effectiveness of Measurement-Based vs. Person-Centered Care on two primary patient-centered outcomes: the patient experience of care with medication treatment and the level of shared decision making. Investigators hypothesize that:

1. Person-Centered Care will result in greater improvement in patient experience of care with medication treatment than Measurement-Based Care.
2. Person-Centered Care will result in a greater level of shared decision making during the medication visit than Measurement-Based Care.

The study team 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. Investigators are especially interested to learn if and how these two approaches are perceived to change medication treatment, if patients are more satisfied and empowered in their care, and why and how providers perceive and adopt changes to their clinical care.

Detailed description: An important attribute of patient-centered care is the active engagement of patients in making health care decisions. Despite advances in health care to support shared decision making, the patient experience of mental health care remains provider-driven. For individuals with serious mental illness (SMI), important decisions involve the choice of medications and how best to use medications to support individualized, person-centered recovery goals. By comparing the effectiveness of two approaches for promoting shared decision making around medication treatment on outcomes that matter most to individuals with SMI, the proposed study will advance ongoing and much-needed efforts to evolve toward a more personalized, recovery-oriented system of mental health care.

Building on the work of a multi-stakeholder collaboration, investigators will compare two interventions, Person-Centered Care and Measurement-Based Care, both focused on patient-prescriber interactions around medication treatment. The investigators' study will address three questions that patients have identified as important to them:

1. Are there ways I can be more involved in my care that will result in better outcomes?
2. How likely am I to benefit from improved communication with my prescriber?
3. How will shared decision making support my personal recovery and overall wellness?

Study aims will compare the effectiveness of measurement-based vs. person-centered care on the patient experience of care and on shared decision making. Investigators hypothesize that:

1. Person-Centered Care will result in greater improvement in patient experience of care with medication treatment than Measurement-Based Care.
2. Person-Centered Care will result in a greater level of shared decision making during the medication visit than Measurement-Based Care.

In addition, investigators will compare the effectiveness of the two approaches on seven secondary patient-centered outcomes, and examine differences in outcomes within the two approaches for subgroups of patients based on their: (1) current status regarding psychiatric medication, (2) engagement with the interventions, and (3) illness severity.

The target population is 2,460+ Medicaid-enrolled adults with SMI who receive medication treatment at one of 15 community mental health centers (CMHC). Using a prospective cluster-randomized design with a mixed-methods approach, investigators will randomly assign CMHCs to one of the two interventions. Quantitative (self-report, claims, process) and qualitative (interviews) data will be gathered at multiple time points across the two-year intervention period (baseline, 8 months, 16 months, and 24 months). Multi-level longitudinal analyses will examine the impact of the interventions on outcomes and explore the role of moderating variables. Qualitative data will be used to understand patient and stakeholder perspectives and to promote dissemination and sustainability.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 and older
* Non-SMI (anxiety, post-traumatic stress disorder, depression, dysthymia, depression NOS) or SMI (schizophrenia, bipolar disorder, major depression)
* Receiving services at one of the 15 participating community mental health centers
* At least three claims for medication management services in past 12 months
* Insured by Community Care Behavioral Health Organization

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient Experience of Medication Treatment (PEMM)
timeFrame: Baseline and every eight months during the two-year intervention phase
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: Baseline and every eight months during the two-year intervention phase
Secondary outcomes:
measure: Hope
timeFrame: Baseline and every eight months during the two-year intervention phase
measure: Medication Side Effects
timeFrame: Baseline and every eight months during the two-year intervention phase
measure: Patient Activation Measure (PAM)
timeFrame: Baseline and every eight months during the two-year intervention phase
measure: Behavior and Symptom Identification Scale (BASIS-24)
timeFrame: Baseline and every eight months during the two-year intervention phase
measure: Sheehan Disability Scale
timeFrame: Baseline and every eight months during the two-year intervention phase
measure: Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
timeFrame: Baseline and every eight months during the two-year intervention phase
measure: Engagement in Medication and Evaluation Visit
timeFrame: Baseline, 8 months, 24 months
measure: Engagement in Psychotherapy Visit
timeFrame: Baseline, 8 months, 24 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Psychiatric Research Center
state: New Hampshire
city: Pittsburgh
country: United States
facility: UPMC Center for High-Value Health Care
state: Pennsylvania
Study officials:
affiliation: Dartmouth Psychiatric Research Center, The Geisel School of Medicine at Dartmouth
name: Gregory J McHugo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPMC Center for High-Value Health Care
name: Kim MacDonald-Wilson, ScD,CRC,CPRP
role: PRINCIPAL_INVESTIGATOR
affiliation: Pat Deegan, PhD & Associates, LLC
name: Patricia E Deegan, PhD
role: PRINCIPAL_INVESTIGATOR
References: