Person-Centered Versus Measurement-Based Care in Mental Health

NCT02507349 | Completed Results DMC

• 1 other identifier: CDR-1306-02474
• Study Type: interventional
• Target: 2,443
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (2)

• Patient Experience of Medication Treatment (PEMM)

  The PEMM is a 12-item self-report measure of mental health patient experience of medication management with prescribers .Response options for 11 questions range from 0=Never to 4=Always, and the response options for the final question range from 0=Very Dissatisfied to 4=Very Satisfied. Overall possible range was 0 to 4. PEMM scores for each time point reflect the mean score of all measures collected within that time frame.

  Baseline and every eight months during the two-year intervention phase

• Shared Decision Making Questionnaire (SDM-Q-9)

  The SDM-Q-9 is a 9-item self-report measure of the degree of shared decision making in clinical encounters. There are 6 possible responses ranging from: Completely Disagree (0) to Completely Agree (5). Raw score ranges from 0 to 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of shared decision making in clinical encounters. SDM-Q-9 scores for each time point reflect the mean score of all measures collected within that time frame.

  Baseline and every eight months during the two-year intervention phase

Secondary Outcomes (8)

• Hope

  Baseline and every eight months during the two-year intervention phase

• Medication Side Effects

  Baseline and every eight months during the two-year intervention phase

• Patient Activation Measure (PAM)

  Baseline and every eight months during the two-year intervention phase

• Behavior and Symptom Identification Scale (BASIS-24)

  Baseline and every eight months during the two-year intervention phase

• Sheehan Disability Scale

  Baseline and every eight months during the two-year intervention phase

Study Arms (2)

Person-Centered Care

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.

Behavioral: Person-Centered Care

Measurement-Based Care

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.

Behavioral: Measurement-Based Care

Interventions

Person-Centered Care BEHAVIORAL

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

Measurement-Based Care BEHAVIORAL

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

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
• 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

You may not qualify if:

• 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
• Dartmouth College: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Dartmouth Psychiatric Research Center

Lebanon, New Hampshire, 03766, United States

Location

UPMC Center for High-Value Health Care

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major

Interventions

Patient-Centered Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

The PEMM was developed for this study. For unavoidable reasons, site randomization was not maintained. Data collection timepoints were expanded.

Results Point of Contact

• Title: Kelly Williams, Program Administrator
• Organization: UPMC Center for High-Value Health Care

Williamsk17@upmc.edu

412-454-1198

Study Officials

• Gregory J McHugo, PhD

  Dartmouth Psychiatric Research Center, The Geisel School of Medicine at Dartmouth

  PRINCIPAL INVESTIGATOR

• Kim MacDonald-Wilson, ScD,CRC,CPRP

  UPMC Center for High-Value Health Care

  PRINCIPAL INVESTIGATOR

• Patricia E Deegan, PhD

  Pat Deegan, PhD & Associates, LLC

  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: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Director

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 23, 2015
• Study Start: August 1, 2014
• Primary Completion: October 31, 2016
• Study Completion: March 31, 2017
• Last Updated: February 26, 2019
• Results First Posted: February 1, 2019

Record last verified: 2019-02

Locations

US (2)