Severe Mental IllnessPROM-PREMNCT04314154
Using Clinical Process Indicators, Patient Reported Outcome Measures (PROMs), and Patient Reported Experience Measures (PREMs) to Improve the Quality and Continuity of Care for Psychiatric Patients
An observational study of Severe Mental Illness and Rehabilitation, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The objective of the proposed study is to take a further step in this direction by developing, implementing and monitoring a routine systematic evaluation of clinical process and outcome indicators, patient reported experience (PREMs) and patient reported outcomes (PROMs) to study the quality and continuity of care… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Mental Illness, Rehabilitation, Schizophrenia
- What is being tested?
- Monitoring PROM @ PREM data on participating patients
- How many people
- 125 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Apr 2020to 15 Apr 2022
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 125 patients (ages 18-55) suffering from SMI (Severe Mental Ilness) admitted to SHALVATA mental health center and their clinicians will be recruited to participate in a prospective longitudinal assessment.
Who may be able to join
- Patients admitted to hospitalization in each of the participating departments
- suffer from SMI (schizophrenia, bipolar disorder of any kind, major effective disorder, anxiety disorders in need of hospitalization, severe personality disorder required for hospitalization)
- Speaking and reading and writing in fluent Hebrew
- Sign a trial consent form
Who cannot join
- unable to understand the content of the questionnaires, or their mental state does not allow them to answer the questionnaires as required
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the proposed study is to take a further step in this direction by developing, implementing and monitoring a routine systematic evaluation of clinical process and outcome indicators, patient reported experience (PREMs) and patient reported outcomes (PROMs) to study the quality and continuity of care over time.
Read the detailed description
Background: Monitoring quality of care in the context of psychiatric hospitalization is crucial. The Israeli National quality, Service and Safety Administration project has signified a major step in this direction enhancing the measuring and monitoring the quality of care.
Purpose: The objective of the proposed study is to take a further step in this direction by developing, implementing and monitoring a routine systematic evaluation of clinical process and outcome indicators, patient reported experience (PREMs) and patient reported outcomes (PROMs) to study the quality and continuity of care over time.
Hypotheses: We hypothesize that 1) adherence to indicators will be associated with better PREMs, PROMs and clinician ratings 2) PROMs and clinician ratings will be positively related and 3) PREMs and PROMs will be positively related.
Method: 125 patients (ages 18-55) admitted to SHALVATA mental health center and their clinicians will be recruited to participate in a prospective longitudinal assessment. Each will include PREMs, PROMs clinician rated outcomes and assessment of the degree to which clinical indicators (reflected processes of clinical guidelines) were carried out. The assessments will take place at admission, discharge and every 3 months for up for 9 months. The design is a repeated measures design with evaluating the interaction effect between assessed levels of indicators ("between subject effect") and level of change in the PREMs, PROMs clinician along the research trajectory ("within subject effect").
Importance of the study: The mental health reform, implemented cross-nationally since 2015 emphasizes client centred and continuity of care and seeks to increase the quality, availability and accessibility of mental health services in Israel. Most of the discussion to date has been on the later issues of access and availability and much less on quality and continuity of care which requires standardized routine longitudinal assessment of process indicators and patients reported experience and outcome. The proposed study represents a pioneer effort to collect systematic data which can help evaluate the quality and impact of services over time. Findings can be useful to guide policy about the feasibility and impact of process indicators and their relation to PROMs and PREMs over time.
- Conditions
- Severe Mental Illness, Rehabilitation, Schizophrenia
- Being tested
- Monitoring PROM @ PREM data on participating patients
- Keywords
- SMI, Rehabilitation
- Medical subject headings
- Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring PROM @ PREM data on participating patientsOther
125 patients (ages 18-55) admitted to SHALVATA mental health center and their clinicians will be recruited to participate in a prospective longitudinal assessment. Each will include PREMs, PROMs clinician rated outcomes and assessment of the degree to which clinical indicators (reflected processes of clinical guidelines) were carried out. The assessments will take place at admission, discharge and every 3 months for up for 9 months. The design is a repeated measures design with evaluating the interaction effect between assessed levels of indicators ("between subject effect") and level of change in the PREMs, PROMs clinician along the research trajectory ("within subject effect").
| Study group | Role | What they receive |
|---|---|---|
| Study group | Group of all patients hospitalized in the SMHC and due participate in rehabilitative procedures Receives: Other: Monitoring PROM @ PREM data on participating patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAF
The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100. An improvement will be regarded if the GAF will increase in 10% from start point (time=0 months) to end point (time=9 months). Assessments will be made also on 3 and 6 months in order to examine graduality in improvement.
Measured: 0,3, 6 and 9 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start15 Apr 2020 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Haifa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314154
- Sponsor's protocol ID
- 0001-20-SHA
- Acronym
- PROM-PREM
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Clinical Process Indicators, Patient Reported Outcome Measures (PROMs), and Patient Reported Experience Measures (PREMs) to Improve the Quality and Continuity of Care for Psychiatric Patients
- ClinicalTrials.gov ID
- NCT04314154
- Acronym / sponsor ID
- PROM-PREM / 0001-20-SHA
- Conditions
- Severe Mental Illness, Rehabilitation, Schizophrenia
- Keywords
- SMI, Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Collaborators
- University of Haifa
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 19 Mar 2020 (actual)
- 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 objective of the proposed study is to take a further step in this direction by developing, implementing and monitoring a routine systematic evaluation of clinical process and outcome indicators, patient reported experience (PREMs) and patient reported outcomes (PROMs) to study the quality and continuity of care over time.
Detailed description
Background: Monitoring quality of care in the context of psychiatric hospitalization is crucial. The Israeli National quality, Service and Safety Administration project has signified a major step in this direction enhancing the measuring and monitoring the quality of care.
Purpose: The objective of the proposed study is to take a further step in this direction by developing, implementing and monitoring a routine systematic evaluation of clinical process and outcome indicators, patient reported experience (PREMs) and patient reported outcomes (PROMs) to study the quality and continuity of care over time.
Hypotheses: We hypothesize that 1) adherence to indicators will be associated with better PREMs, PROMs and clinician ratings 2) PROMs and clinician ratings will be positively related and 3) PREMs and PROMs will be positively related.
Method: 125 patients (ages 18-55) admitted to SHALVATA mental health center and their clinicians will be recruited to participate in a prospective longitudinal assessment. Each will include PREMs, PROMs clinician rated outcomes and assessment of the degree to which clinical indicators (reflected processes of clinical guidelines) were carried out. The assessments will take place at admission, discharge and every 3 months for up for 9 months. The design is a repeated measures design with evaluating the interaction effect between assessed levels of indicators ("between subject effect") and level of change in the PREMs, PROMs clinician along the research trajectory ("within subject effect").
Importance of the study: The mental health reform, implemented cross-nationally since 2015 emphasizes client centred and continuity of care and seeks to increase the quality, availability and accessibility of mental health services in Israel. Most of the discussion to date has been on the later issues of access and availability and much less on quality and continuity of care which requires standardized routine longitudinal assessment of process indicators and patients reported experience and outcome. The proposed study represents a pioneer effort to collect systematic data which can help evaluate the quality and impact of services over time. Findings can be useful to guide policy about the feasibility and impact of process indicators and their relation to PROMs and PREMs over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Monitoring PROM @ PREM data on participating patientsGroup of all patients hospitalized in the SMHC and due participate in rehabilitative procedures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 125 patients (ages 18-55) suffering from SMI (Severe Mental Ilness) admitted to SHALVATA mental health center and their clinicians will be recruited to participate in a prospective longitudinal assessment.
Key inclusion criteria (4 listed)
- Patients admitted to hospitalization in each of the participating departments
- suffer from SMI (schizophrenia, bipolar disorder of any kind, major effective disorder, anxiety disorders in need of hospitalization, severe personality disorder required for hospitalization)
- Speaking and reading and writing in fluent Hebrew
- Sign a trial consent form
Key exclusion criteria (1 listed)
- unable to understand the content of the questionnaires, or their mental state does not allow them to answer the questionnaires as required
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 |
|---|---|---|
| Monitoring PROM @ PREM data on participating patients125 patients (ages 18-55) admitted to SHALVATA mental health center and their clinicians will be recruited to participate in a prospective longitudinal assessment. Each will include PREMs, PROMs clinician rated outcomes and assessment of the degree to which clinical indicators (reflected processes of clinical guidelines) were carried out. The assessments will take place at admission, discharge and every 3 months for up for 9 months. The design is a repeated measures design with evaluating the interaction effect between assessed levels of indicators ("between subject effect") and level of change in the PREMs, PROMs clinician along the research trajectory ("within subject effect"). | Other | Study group |
Primary outcome
GAF
Time frame: 0,3, 6 and 9 months after enrollment
The Global Assessment of Functioning, or GAF, scale is used to rate how serious a mental illness may be. It measures how much a person's symptoms affect his or her day-to-day life on a scale of 0 to 100. An improvement will be regarded if the GAF will increase in 10% from start point (time=0 months) to end point (time=9 months). Assessments will be made also on 3 and 6 months in order to examine graduality in improvement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mental Illness and Rehabilitation, run by Shalvata Mental Health Center at 1 site in Israel.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shlomo Mendlovic, MD (972-9-7478532 ext. 532, mendlovic@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAF (time frame: 0,3, 6 and 9 months after enrollment). 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 19 Mar 2020.