search
Back to results

The Right Question Project-Mental Health: An Intervention to Increase Engagement and Retention in Mental Health Care (RQP-MH)

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Right Question Project - Mental Health (RQP-MH)
Pamphlet
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders focused on measuring Minority Groups, Decision Making, Patient Participation, Mental Health Services, retention, attendance, patient activation, Hispanic Americans, patient-provider communication

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • between ages of 18 and 70 (patients above age 65 will be administered the Mini-Cog, a cognitive impairment screener)
  • speak English and/or Spanish
  • currently receiving outpatient mental health care

Exclusion Criteria:

  • suicidal ideation or attempt within the past four weeks
  • lacks capacity to consent (adapted from Zayas, Cabassa, & Perez, 2005)
  • only receiving services that are strictly case-management

Sites / Locations

  • Beth Israel Deaconness Medical Center
  • Martha Eliot Health Center
  • Cambridge Health Alliance (Malden Family Medicine Center)
  • Cambridge Health Alliance (Central Street Health Center)
  • Edward M Kennedy Health Center (Great Brook Valley Health Center)
  • Community-University Health Care Center
  • Hamm Memorial Psychiatric Clinic
  • West Side Community Health Services - La Clinica
  • University Behavioral Healthcare
  • Columbia University Medical Center, Outpatient Psychiatry Program
  • El Futuro Clinic, Carrboro site
  • El Futuro Clinic, Durham site
  • Clinica de Salud Mental de la Comunidad Universidad Carlos Albizu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RQP-MH

Comparison Group

Arm Description

Participants in the intervention arm will receive three Patient Activation and Self-Management education sessions, plus a fourth booster session if they show difficulty mastering the content of the first three trainings.

Participants in this arm will receive a pamphlet in either Spanish or English called "Managing Your Mental Health Care."

Outcomes

Primary Outcome Measures

Patient Activation
Activation is defined as a behavior change approach that includes an individual's acquisition of knowledge, skills and beliefs to take thoughtful action on one's own behalf and actively participate in questions and decisions about one's health and health care treatment.
Patient Self-Management
Self-management focuses on patients gaining knowledge and self-efficacy to better manage their mental health condition and developing awareness of the factors that hinder or enhance their mental health outcomes.
Engagement in mental health care
Scheduling and keeping mental health treatment appointments over a six month period after finishing the final research interview.
Retention in mental health treatment
Attending four or more treatment sessions during the six month period after the final research interview (or completed treatment as designated in the medical record)

Secondary Outcome Measures

Full Information

First Posted
September 16, 2010
Last Updated
June 2, 2016
Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT01226329
Brief Title
The Right Question Project-Mental Health: An Intervention to Increase Engagement and Retention in Mental Health Care
Acronym
RQP-MH
Official Title
The Right Question Project-Mental Health: An Intervention to Increase Engagement and Retention in Mental Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Right Question Project-Mental Health (RQP-MH) is a three-session health education intervention that teaches clients to participate effectively in mental health care. The methodology teaches clients to identify important issues of their illness or treatment, formulate questions, and devise plans to communicate and act in effective ways that address factors impacting their mental health care, with the expectation that this behavior will increase patient-provider communication and improve the therapeutic alliance between patient and provider. The investigators hypothesize that participants receiving the intervention will be more likely to engage and remain in mental health care, and that they will report higher activation and self-management scores as compared to control patients.
Detailed Description
The intervention is one of two Cambridge Health Alliance (CHA) projects from the University of Puerto Rico-Cambridge Health Alliance Research Center of Excellence (UPR-CHA RCE). The overall goal of the project is to evaluate an intervention that teaches patients a set of skills needed to facilitate a more active patient role in the mental health encounter, emphasizing the patient's decision-making process during mental health treatment. The project also aims to support collaborative provider-patient relationships in order to increase engagement and retention and, consequently, reduce service disparities. The intervention has been pilot-tested in the Right Question Project-Mental Health I (RQP-MH I) study (Alegría, 2008), conducted as part of the UPR-CHA EXPORT Center from September 2004 through February 2006. The first aim of the current project is to conduct a multi-site randomized controlled trial to test the Patient Activation and Self-Management (PASM) intervention, also called RQP-MH II, in predominantly Latino mental health clinics. The investigators will assess the intervention's impact on engagement and retention in mental health care. The second aim is to explore the racial/ethnic differences in the effect of the RQP-MH II intervention for Latinos as compared to non-Latino whites, as little is known about the impact of patient race/ethnicity on the effectiveness of patient activation interventions. The fourth aim is to explore the role of patient-provider communication and therapeutic alliance as mediators of the relationship between patient activation and engagement and retention in care. It is expected that increased patient-provider communication and a stronger therapeutic alliance will result from increased participation in the decision-making process. These potential changes in the process of care are expected to consequently increase patient engagement (keeping scheduled appointments) and retention (reduction of premature unilateral termination) in mental health care. Data shows that patients may not readily state their concerns in their medical visits (Roter et al., 1997; Korsch, Gozzi & Francis, 1968) and usually refrain from engaging in information-seeking (Beisdecker & Beisdecker, 1990). Minority patients are even less likely than their white counterparts to have a collaborative relationship with providers (Cooper-Patrick et al., 1999). This is a problematic situation particularly for minority patients, such as Latinos, who cherish maintaining a warm personal connection with their providers (American Medical Association, 1994) and may worry that bringing up questions or asking for explanations might jeopardize the relationship. Minority patients may not be as informed about diagnosis, prognosis, and medication side effects (Schaafsma, Raynor & de Jong-van den Berg, 2003) and consequently feel disappointed that they do not receive needed information (Levinson et al., 1993). They may therefore be less compliant with treatment (Kalichman et al., 1999), and more likely to drop out of care (Takeuchi et al., 1992). Minority patients may have a less comprehensive understanding of mental health care compared to White patients (Miranda and Cooper, 2004). As a result, they are at a greater risk of assuming that the provider's decisions reflect their best interest (Flynn et al., 2004). This is exemplary of Latinos who hold traditional role expectations that oppose active involvement in the clinical encounter and prefer to delegate decisions about their care to their providers (Levinson et al., 2005; Xu, Borders & Arif, 2003). To contend with difficulties in communication, most interventions focus on provider training (Post, Cegala & Miser, 2002), with less attention on teaching patients how to effectively express their concerns and questions to their providers (Andersen & Sharpe, 1991; Roter, 1977). Yet results from assessments of self-management of chronic conditions (Hall, Roter & Katz, 1988; Stewart et al., 1993) indicate that greater patient activation and self-management in treatment can augment satisfaction with care (Blanchard et al., 1990), improve the health care process (Rosenberg, Lussier & Beaudoin, 1997; Epstein et al., 1993), ensure the receipt of guideline concordant treatments (Clever et al., 2006), and potentially enhance health outcomes (Kaplan, Greenfield & Ware, 1989). Most studies of patient activation and self-management in the field of mental health care have not been conducted with minority populations of low literacy nor in a language other than English. Most have not included mixed-methods (qualitative and quantitative) to evaluate the effectiveness of the intervention, and have not obtained cost information that can help evaluate whether changes in patient activation and self-management, or in treatment engagement and retention, could potentially produce savings in treatment or health care outcomes. The proposed project is expected to fill this gap, assessing the effects of a patient activation and self-management intervention using a mixed-methods approach, with three data collection periods. The investigators hypothesize that patients participating in the patient activation and self-management intervention will be significantly more likely to engage and remain in mental health care, and will report significantly higher activation and self-management scores as compared to control patients. Given the relationship of patient participation and health outcomes, increasing Latino patient's participation in decision-making a as mechanism to eliminate service disparities is the goal of the proposed intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Minority Groups, Decision Making, Patient Participation, Mental Health Services, retention, attendance, patient activation, Hispanic Americans, patient-provider communication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
724 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RQP-MH
Arm Type
Experimental
Arm Description
Participants in the intervention arm will receive three Patient Activation and Self-Management education sessions, plus a fourth booster session if they show difficulty mastering the content of the first three trainings.
Arm Title
Comparison Group
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive a pamphlet in either Spanish or English called "Managing Your Mental Health Care."
Intervention Type
Behavioral
Intervention Name(s)
Right Question Project - Mental Health (RQP-MH)
Other Intervention Name(s)
Patient Activation and Self-Management (PASM) intervention
Intervention Description
The RQP-MH trainings each take approximately 45 minutes to complete and are delivered approximately three weeks apart. The manualized intervention uses a Question Formulation Technique (QFT) and a Framework for Active Decision-Making (FADM). The QFT consists of asking patients to generate and revise questions to obtain more informative answers from their providers. The FADM teaches participants to identify questions that will help them consider their role in a decision, the process of decision-making, and the reasons behind a decision. All intervention sessions will be taught by a bachelors-level "Care Manager."
Intervention Type
Behavioral
Intervention Name(s)
Pamphlet
Intervention Description
Participants in this group receive a handout called "Managing Your Mental Health" (available in Spanish and English) that provides tips on how to manage mental health through the proper maintenance of physical health and stress.
Primary Outcome Measure Information:
Title
Patient Activation
Description
Activation is defined as a behavior change approach that includes an individual's acquisition of knowledge, skills and beliefs to take thoughtful action on one's own behalf and actively participate in questions and decisions about one's health and health care treatment.
Time Frame
Baseline, 30days, 90days
Title
Patient Self-Management
Description
Self-management focuses on patients gaining knowledge and self-efficacy to better manage their mental health condition and developing awareness of the factors that hinder or enhance their mental health outcomes.
Time Frame
Baseline, 30days, 90days
Title
Engagement in mental health care
Description
Scheduling and keeping mental health treatment appointments over a six month period after finishing the final research interview.
Time Frame
Six months following last research interview
Title
Retention in mental health treatment
Description
Attending four or more treatment sessions during the six month period after the final research interview (or completed treatment as designated in the medical record)
Time Frame
Six months following last research interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: between ages of 18 and 70 (patients above age 65 will be administered the Mini-Cog, a cognitive impairment screener) speak English and/or Spanish currently receiving outpatient mental health care Exclusion Criteria: suicidal ideation or attempt within the past four weeks lacks capacity to consent (adapted from Zayas, Cabassa, & Perez, 2005) only receiving services that are strictly case-management
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Alegria, PhD
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Martha Eliot Health Center
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Cambridge Health Alliance (Malden Family Medicine Center)
City
Malden
State/Province
Massachusetts
ZIP/Postal Code
02148
Country
United States
Facility Name
Cambridge Health Alliance (Central Street Health Center)
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02143
Country
United States
Facility Name
Edward M Kennedy Health Center (Great Brook Valley Health Center)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Community-University Health Care Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Hamm Memorial Psychiatric Clinic
City
St Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
West Side Community Health Services - La Clinica
City
St Paul
State/Province
Minnesota
ZIP/Postal Code
55107
Country
United States
Facility Name
University Behavioral Healthcare
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Columbia University Medical Center, Outpatient Psychiatry Program
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
El Futuro Clinic, Carrboro site
City
Carrboro
State/Province
North Carolina
ZIP/Postal Code
27510
Country
United States
Facility Name
El Futuro Clinic, Durham site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
Clinica de Salud Mental de la Comunidad Universidad Carlos Albizu
City
San Juan
ZIP/Postal Code
00901
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24647680
Citation
Alegria M, Carson N, Flores M, Li X, Shi P, Lessios AS, Polo A, Allen M, Fierro M, Interian A, Jimenez A, La Roche M, Lee C, Lewis-Fernandez R, Livas-Stein G, Safar L, Schuman C, Storey J, Shrout PE. Activation, self-management, engagement, and retention in behavioral health care: a randomized clinical trial of the DECIDE intervention. JAMA Psychiatry. 2014 May;71(5):557-65. doi: 10.1001/jamapsychiatry.2013.4519.
Results Reference
derived
Links:
URL
http://www.multiculturalmentalhealth.org
Description
Center for Multicultural Mental Health Research

Learn more about this trial

The Right Question Project-Mental Health: An Intervention to Increase Engagement and Retention in Mental Health Care

We'll reach out to this number within 24 hrs