跳至主要内容
临床试验/NCT02507349
NCT02507349已完成不适用

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

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 2,443 人开始时间: 2014年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,443
试验地点
4
主要终点
Shared Decision Making Questionnaire (SDM-Q-9)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Person-Centered Care (Behavioral)

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.

干预措施: Measurement-Based Care (Behavioral)

结局指标

主要结局

Shared Decision Making Questionnaire (SDM-Q-9)

时间窗: 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.

Patient Experience of Medication Treatment (PEMM)

时间窗: 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.

次要结局

  • Behavior and Symptom Identification Scale (BASIS-24)(Baseline and every eight months during the two-year intervention phase)
  • Engagement in Psychotherapy Visit(Baseline, 8 months, 24 months)
  • Hope(Baseline and every eight months during the two-year intervention phase)
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)(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)
  • Sheehan Disability Scale(Baseline and every eight months during the two-year intervention phase)
  • Engagement in Medication and Evaluation Visit(Baseline, 8 months, 24 months)
  • Medication Side Effects(Baseline and every eight months during the two-year intervention phase)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kim MacDonald-Wilson

Senior Director

University of Pittsburgh

研究点 (4)

Loading locations...

相似试验