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N/A N=2,443 Randomized Single-blind Treatment

Person-Centered Versus Measurement-Based Care in Mental Health

Schizophrenia · Bipolar Disorder · Major Depression

Enrolled (actual)
2,443
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Patient Experience of Medication Treatment (PEMM) — 3.009; 3.007; 2.6; 3.09 Units on a scale — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Person-Centered Care (Behavioral); Measurement-Based Care (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pittsburgh
Primary completion
Oct 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Experience of Medication Treatment (PEMM)
3.009; 3.007; 2.6; 3.09; 3.056; 3.068 <0.0001 sig
PRIMARY
Shared Decision Making Questionnaire (SDM-Q-9)
74.082; 73.69; 72; 83.703; 75.946; 76.12 0.6243
SECONDARY
Hope
6.008; 6.003; 6.5; 4; 6.078; 5.984 0.4677
SECONDARY
Medication Side Effects
3.935; 3.849; 3.75; 4.333; 3.527; 3.878 0.8733
SECONDARY
Patient Activation Measure (PAM)
62.707; 62.467; 47.75; 60.467; 63.979; 60.908 0.2328
SECONDARY
Behavior and Symptom Identification Scale (BASIS-24)
1.496; 1.483; 1.418; 2.03; 1.291; 1.449 0.0033 sig
SECONDARY
Sheehan Disability Scale
10.514; 10.826; 13.5; 19; 9.536; 10.737 0.1649
SECONDARY
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
54.922; 53.51; 52.38; 37.5; 57.756; 52.902 0.0080 sig
SECONDARY
Engagement in Medication and Evaluation Visit
6.356; 6.785; 5.977; 6.851; 5.517; 5.691 <0.0001 sig
SECONDARY
Engagement in Psychotherapy Visit
8.706; 9.679; 7.825; 9.369; 7.224; 6.864 0.0003 sig

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02507349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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