SchizophreniaPCORI-SDMNCT02507349
Person-Centered Versus Measurement-Based Care in Mental Health
A study testing Person-Centered Care and Measurement-Based Care in people with Schizophrenia and Bipolar Disorder, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depression
- What is being tested?
- Person-Centered Care and Measurement-Based Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,443 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth Psychiatric Research Center
Lebanon, New Hampshire, 03766
UPMC Center for High-Value Health Care
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Amplifying the Patient's Voice: Person-Centered Versus Measurement-Based Approaches 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:
Read more
- 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.
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.
Read the 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:
- 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.
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depression
- Being tested
- Person-Centered Care, Measurement-Based Care
- Keywords
- serious mental illness, mental health services research, measurement-based care, shared decision making, psychiatric medication management, community psychiatry, comparative effectiveness research, mixed methods research
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-Centered CareBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Person-Centered Care |
| 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. Receives: Behavioral: Measurement-Based Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Experience of Medication Treatment (PEMM)
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.
Measured: Baseline and every eight months during the two-year intervention phase
Shared Decision Making Questionnaire (SDM-Q-9)
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.
Measured: Baseline and every eight months during the two-year intervention phase
Secondary outcomes (8)
Hope
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.
Measured: Baseline and every eight months during the two-year intervention phase
Medication Side Effects
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.
Measured: Baseline and every eight months during the two-year intervention phase
Patient Activation Measure (PAM)
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.
Measured: Baseline and every eight months during the two-year intervention phase
Behavior and Symptom Identification Scale (BASIS-24)
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.
Measured: Baseline and every eight months during the two-year intervention phase
Sheehan Disability Scale
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.
Measured: Baseline and every eight months during the two-year intervention phase
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
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.
Measured: Baseline and every eight months during the two-year intervention phase
Engagement in Medication and Evaluation Visit
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.
Measured: Baseline, 8 months, 24 months
Engagement in Psychotherapy Visit
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.
Measured: Baseline, 8 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startAug 2014
- Primary completion31 Oct 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,443 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Kim MacDonald-Wilson, University of Pittsburgh
- Investigators
- Gregory J McHugo, PhD, Principal investigator, Dartmouth Psychiatric Research Center, The Geisel School of Medicine at DartmouthKim MacDonald-Wilson, ScD,CRC,CPRP, Principal investigator, UPMC Center for High-Value Health CarePatricia E Deegan, PhD, Principal investigator, Pat Deegan, PhD & Associates, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507349
- Sponsor's protocol ID
- CDR-1306-02474
- Acronym
- PCORI-SDM
- Status last verified
- Feb 2019
- First submitted
- 30 Jun 2015
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplifying the Patient's Voice: Person-Centered Versus Measurement-Based Approaches in Mental Health
- ClinicalTrials.gov ID
- NCT02507349
- Acronym / sponsor ID
- PCORI-SDM / CDR-1306-02474
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depression
- Keywords
- serious mental illness, mental health services research, measurement-based care, shared decision making, psychiatric medication management, community psychiatry, comparative effectiveness research, mixed methods research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,443 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Dartmouth College, Patient-Centered Outcomes Research Institute
- Study start
- Aug 2014 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Posted 1 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Person-Centered Care | Active comparator | Behavioral: Person-Centered CareDecision 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 | Active comparator | Behavioral: Measurement-Based CareClinic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Person-Centered CareDecision 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. | Behavioural | Person-Centered Care |
| Measurement-Based CareClinic 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. | Behavioural | Measurement-Based Care |
Primary outcome
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.
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.
8 secondary outcomes
Hope
Time frame: Baseline and every eight months during the two-year intervention phase
Medication Side Effects
Time frame: Baseline and every eight months during the two-year intervention phase
Patient Activation Measure (PAM)
Time frame: Baseline and every eight months during the two-year intervention phase
Behavior and Symptom Identification Scale (BASIS-24)
Time frame: Baseline and every eight months during the two-year intervention phase
Sheehan Disability Scale
Time frame: Baseline and every eight months during the two-year intervention phase
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)
Time frame: Baseline and every eight months during the two-year intervention phase
Engagement in Medication and Evaluation Visit
Time frame: Baseline, 8 months, 24 months
Engagement in Psychotherapy Visit
Time frame: Baseline, 8 months, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gregory J McHugo, PhD principal investigator
Dartmouth Psychiatric Research Center, The Geisel School of Medicine at Dartmouth
Kim MacDonald-Wilson, ScD,CRC,CPRP principal investigator
UPMC Center for High-Value Health Care
Patricia E Deegan, PhD principal investigator
Pat Deegan, PhD & Associates, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-Centered Care and Measurement-Based Care in people with Schizophrenia and Bipolar Disorder, run by University of Pittsburgh at 2 sites in United States.
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 5 inclusion and 2 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 1 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Experience of Medication Treatment (PEMM) (time frame: Baseline and every eight months during the two-year intervention phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2019.