Mental DisordersRQP-MHNCT01226329
The Right Question Project-Mental Health: An Intervention to Increase Engagement and Retention in Mental Health Care
A study testing Right Question Project - Mental Health (RQP-MH) and Pamphlet in people with Mental Disorders, run by Massachusetts General Hospital at 13 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Right Question Project - Mental Health (RQP-MH) and Pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 724 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jul 2008to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02215
El Futuro Clinic, Carrboro site
Carrboro, North Carolina, 27510
El Futuro Clinic, Durham site
Durham, North Carolina, 27701
Martha Eliot Health Center
Jamaica Plain, Massachusetts, 02130
Cambridge Health Alliance (Malden Family Medicine Center)
Malden, Massachusetts, 02148
Community-University Health Care Center
Minneapolis, Minnesota, 55404
University Behavioral Healthcare
New Brunswick, New Jersey, 08901
Columbia University Medical Center, Outpatient Psychiatry Program
New York, New York, 10032
Hamm Memorial Psychiatric Clinic
Saint Paul, Minnesota, 55102
West Side Community Health Services - La Clinica
Saint Paul, Minnesota, 55107
Cambridge Health Alliance (Central Street Health Center)
Somerville, Massachusetts, 02143
Edward M Kennedy Health Center (Great Brook Valley Health Center)
Worcester, Massachusetts, 01605
Puerto Rico1 site
Clinica de Salud Mental de la Comunidad Universidad Carlos Albizu
San Juan, 00901
About this study
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.
Read the 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.
- Conditions
- Mental Disorders
- Being tested
- Right Question Project - Mental Health (RQP-MH), Pamphlet
- Keywords
- Minority Groups, Decision Making, Patient Participation, Mental Health Services, retention, attendance, patient activation, Hispanic Americans, patient-provider communication
- Medical subject headings
- Mental Disorders, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Question Project - Mental Health (RQP-MH)Behavioural
Also called Patient Activation and Self-Management (PASM) intervention
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."
PamphletBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RQP-MH | Experimental | 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. Receives: Behavioral: Right Question Project - Mental Health (RQP-MH) |
| Comparison Group | Active comparator | Participants in this arm will receive a pamphlet in either Spanish or English called "Managing Your Mental Health Care." Receives: Behavioral: Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 30days, 90days
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.
Measured: Baseline, 30days, 90days
Engagement in mental health care
Scheduling and keeping mental health treatment appointments over a six month period after finishing the final research interview.
Measured: Six months following last 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)
Measured: Six months following last research interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJul 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Margarita Alegria, PhD, Massachusetts General Hospital
- Investigators
- Margarita Alegria, PhD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226329
- Sponsor's protocol ID
- CHA-IRB00329/07/08
- Other IDs
- P60MD002261-03
- Acronym
- RQP-MH
- Status last verified
- Jun 2016
- First submitted
- 16 Sep 2010
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24647680
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Right Question Project-Mental Health: An Intervention to Increase Engagement and Retention in Mental Health Care
- ClinicalTrials.gov ID
- NCT01226329
- Acronym / sponsor ID
- RQP-MH / CHA-IRB00329/07/08
- Conditions
- Mental Disorders
- Keywords
- Minority Groups, Decision Making, Patient Participation, Mental Health Services, retention, attendance, patient activation, Hispanic Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jul 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RQP-MH | Experimental | Behavioral: Right Question Project - Mental Health (RQP-MH)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. |
| Comparison Group | Active comparator | Behavioral: PamphletParticipants in this arm will receive a pamphlet in either Spanish or English called "Managing Your Mental Health Care." |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Question Project - Mental Health (RQP-MH)Also: Patient Activation and Self-Management (PASM) interventionThe 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." | Behavioural | RQP-MH |
| PamphletParticipants 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. | Behavioural | Comparison Group |
Primary outcome
Patient Activation
Time frame: Baseline, 30days, 90days
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
Time frame: Baseline, 30days, 90days
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
Time frame: Six months following last research interview
Scheduling and keeping mental health treatment appointments over a six month period after finishing the final research interview.
Retention in mental health treatment
Time frame: Six months following last research interview
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Derived from this study: PubMed 24647680Alegria 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.
- Center for Multicultural Mental Health ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita Alegria, PhD principal investigator
Cambridge Health Alliance
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Question Project - Mental Health (RQP-MH) and Pamphlet in people with Mental Disorders, run by Massachusetts General Hospital at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation (time frame: Baseline, 30days, 90days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.