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Person-Centered Versus Measurement-Based Care in Mental Health (PCORI-SDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02507349
Recruitment Status : Completed
First Posted : July 23, 2015
Results First Posted : February 1, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Dartmouth College
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kim MacDonald-Wilson, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Major Depression Behavioral: Person-Centered Care Behavioral: Measurement-Based Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amplifying the Patient's Voice: Person-Centered Versus Measurement-Based Approaches in Mental Health
Actual Study Start Date : August 2014
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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: 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.
Behavioral: 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 Outcome Measures :
  1. Patient Experience of Medication Treatment (PEMM) [ Time Frame: Baseline and every eight months during the two-year intervention phase ]
    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.

  2. Shared Decision Making Questionnaire (SDM-Q-9) [ Time Frame: Baseline and every eight months during the two-year intervention phase ]
    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.


Secondary Outcome Measures :
  1. Hope [ Time Frame: Baseline and every eight months during the two-year intervention phase ]
    Patient hopefulness will be assessed using a single question: "Overall, how hopeful does the patient feel about his/her life?" Responses are on a scale of 1 through 10 with 1=No Hope and 10=Filled with Hope. Hopefulness scores for each time point reflect the mean score of all measures collected within that time frame.

  2. Medication Side Effects [ Time Frame: Baseline and every eight months during the two-year intervention phase ]
    Medication side effects will be assessed using a single question: "How much is the patient troubled by medication side effects?" Responses are on a scale of 1 through 10 with 1=Not Bothered at all by side effects and 10=Very Bothered by side effects. Medication side effect scores for each time point reflect the mean score of all measures collected within that time frame.

  3. Patient Activation Measure (PAM) [ Time Frame: Baseline and every eight months during the two-year intervention phase ]
    PAM is a 13-item scale that assesses the knowledge, skills, and confidence of patients essential to managing their own health and health care. Response options are: Strongly Disagree, Disagree, Agree, and Strongly Agree. 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. Overall possible range was 0 to 91.6. PAM scores for each time point reflect the mean score of all measures collected within that time frame.

  4. Behavior and Symptom Identification Scale (BASIS-24) [ Time Frame: Baseline and every eight months during the two-year intervention phase ]
    The BASIS-24 identifies a wide range of symptoms and problems that occur across the psychiatric diagnostic spectrum. There are 5 ordered responses either ranging from No Difficulty to Extreme Difficulty or from None of the Time to All of the Time. Each of 24 questions is scored on a 5 point scale (from 0 to 4 where 0 is the lowest severity and 4 is the highest). The overall BASIS-24 score is a weighted sum that is computed by multiplying the rating for each question by its weight and totaling the weighted ratings for each question. Overall possible range was 0 to 3.99. BASIS-24 scores for each time point reflect the mean score of all measures collected within that time frame.

  5. Sheehan Disability Scale [ Time Frame: Baseline and every eight months during the two-year intervention phase ]
    The Sheehan Disability Scale measures the extent to which three major sectors in the person's life are impaired by psychiatric symptoms (work/school, social/leisure life, and family/home life). The 3 items are summed together to form a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Sheehan Disability Scale scores for each time point reflect the mean score of all measures collected within that time frame.

  6. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF) [ Time Frame: Baseline and every eight months during the two-year intervention phase ]
    Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a 16-item, self-report questionnaire for assessing quality of life in multiple domains (e.g., physical health, mood, leisure time activities, social relationships, and overall). Response items are on a 5-point scale ranging from Very Poor to Very Good. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. The raw total score was transformed into a percentage maximum possible score using the following formula. The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. Overall possible range was 0-100. QLESQ-SF scores for each time point reflect the mean score of all measures collected within that time frame.

  7. Engagement in Medication and Evaluation Visit [ Time Frame: Baseline, 8 months, 24 months ]
    Count of the number of medication checks and evaluation visits for each study participant for the 12 month period prior to and including the anchor date of the time point.

  8. Engagement in Psychotherapy Visit [ Time Frame: Baseline, 8 months, 24 months ]
    Count of the number of psychotherapy visits for each study participant for the 12 month period prior to and including the anchor date of the time point.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507349


Locations
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United States, New Hampshire
Dartmouth Psychiatric Research Center
Lebanon, New Hampshire, United States, 03766
United States, Pennsylvania
UPMC Center for High-Value Health Care
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
University of Pittsburgh
Dartmouth College
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: 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

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Responsible Party: Kim MacDonald-Wilson, Senior Director, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02507349     History of Changes
Other Study ID Numbers: CDR-1306-02474
First Posted: July 23, 2015    Key Record Dates
Results First Posted: February 1, 2019
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Kim MacDonald-Wilson, University of Pittsburgh:
serious mental illness
mental health services research
measurement-based care
shared decision making
psychiatric medication management
community psychiatry
comparative effectiveness research
mixed methods research
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders