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

Schizophrenia Clinical Trial

— PROM-PREM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04314154
• Other study ID #: 0001-20-SHA
• Status: Not yet recruiting
• Start date: April 15, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: March 2020
• Source: Shalvata Mental Health Center
• Contact: Shlomo Mendlovic, MD
• Phone: 972-9-7478532
• Email: mendlovic[@]clalit.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical 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 over time.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: April 15, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Rehabilitation
• Schizophrenia
• Severe Mental Illness

Intervention

Other:
• Monitoring PROM @ PREM data on participating patients
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").

Locations

Country	Name	City	State
Israel	Shalvata Mental health Center	Hod Hasharon

Sponsors (2)

Lead Sponsor	Collaborator
Shalvata Mental Health Center	University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0,3, 6 and 9 months after enrollment