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

NCT04314154 | Unknown

• 1 other identifier: 0001-20-SHA
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Mental Illness; Rehabilitation; Schizophrenia

Keywords

SMI; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study group

Group of all patients hospitalized in the SMHC and due participate in rehabilitative procedures

Other: Monitoring PROM @ PREM data on participating patients

Interventions

Monitoring PROM @ PREM data on participating patients OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shalvata Mental Health Center: lead
• University of Haifa: collaborator

Study Sites (1)

Shalvata Mental health Center

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Mental Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Central Study Contacts

Shlomo Mendlovic, MD

CONTACT

972-9-7478532; mendlovic@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 19, 2020
• Study Start: April 15, 2020
• Primary Completion: January 31, 2022
• Study Completion: April 15, 2022
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)