Clinical trial NCT04314154: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Mental Illness
Rehabilitation
Schizophrenia
Keywords: SMI
Rehabilitation
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2020-03-19
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- unable to understand the content of the questionnaires, or their mental state does not allow them to answer the questionnaires as required

Primary outcomes:
measure: GAF
timeFrame: 0,3, 6 and 9 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Mental health Center
Study officials:
References: