Overview

This trial is active, not recruiting.

Conditions schizophrenia, bipolar disorder, major depression
Treatments person-centered care, measurement-based care
Sponsor UPMC
Collaborator Dartmouth-Hitchcock Medical Center
Start date August 2014
End date December 2016
Trial size 2405 participants
Trial identifier NCT02507349, CDR-1306-02474

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.
person-centered care
Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.
(Active Comparator)
Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.
measurement-based care
Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.

Primary Outcomes

Measure
Patient Experience of Medication Treatment (PEMM)
time frame: Baseline and every eight months during the two-year intervention phase
Shared Decision Making Questionnaire (SDM-Q-9)
time frame: Baseline and every eight months during the two-year intervention phase

Secondary Outcomes

Measure
Hope
time frame: Baseline and every eight months during the two-year intervention phase
Medication Side Effects
time frame: Baseline and every eight months during the two-year intervention phase
Patient Activation Measure (PAM)
time frame: Baseline and every eight months during the two-year intervention phase
Behavior and Symptom Identification Scale (BASIS-24)
time frame: Baseline and every eight months during the two-year intervention phase
Sheehan Disability Scale
time frame: Baseline and every eight months during the two-year intervention phase
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
time frame: Baseline and every eight months during the two-year intervention phase

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adults age 18 and older - Serious mental illness (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

Additional Information

Official title Amplifying the Patient's Voice: Person-Centered Versus Measurement-Based Approaches in Mental Health
Principal investigator Gregory J McHugo, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by UPMC.