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NCT Number: NCT02507349

Person-Centered Versus Measurement-Based Care in Mental Health

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.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Psychiatric Research Center, Lebanon, New Hampshire, United States

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About this study

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:

  • Are there ways I can be more involved in my care that will result in better outcomes?
  • How likely am I to benefit from improved communication with my prescriber?
  • 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:

  • Person-Centered Care will result in greater improvement in patient experience of care with medication treatment than Measurement-Based Care.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Dartmouth College
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Amplifying the Patient's Voice: Person-Centered Versus Measurement-Based Approaches in Mental Health

Acronym: PCORI-SDM

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 23, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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