Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease

NCT ID: NCT03428308

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-12-31

Brief Summary

In Denmark, around 2 % of the population live with severe mental disease. People with severe mental disease live 15-20 years less than the general population. The majority of the years of life lost are a consequence of the excess mortality due to somatic disease. The high prevalence of somatic disease among people with severe mental disease can be largely attributed to physical inactivity, unhealthy diet and side effects from psychopharmacological drugs. Apart from the impacts of unhealthy lifestyle and medication side effects, research suggests that individuals with severe mental disease do not receive the same treatment for their somatic diseases as do the rest of the population. The inequality in diagnostics and treatment can be attributed to stigmatization from healthcare providers and patients' lacking awareness of symptoms and reluctance to seek medical care. Further, the increasing specialization within both somatic and psychiatric care has led to a division between these two treatment systems (8,9). Patients with severe mental disease who simultaneously have one or more somatic diseases need their treatment to be coordinated; such treatment should span general practice, the municipality and the psychiatric and somatic hospital. Accordingly, the following elements are necessary to create effective and coordinated treatment trajectories: detailed preparation, qualitative process evaluation as an integrated part of the courses of treatment, and involvement of all stakeholders from the start.

The overall aim of the project is to optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol, in individuals with schizophrenia, schizoaffective disorder or bipolar disorder; to initiate medical treatment; and to ensure treatment compliance among patients.

Accordingly, the project has the following objectives:

• To develop an intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder that can optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol
• To test whether the developed intervention can optimize the detection of cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol in individuals with schizophrenia, schizoaffective disorder or bipolar disorder

The project's hypotheses are that an interdisciplinary and intersectoral intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder can

• optimize detection of cardiovascular diseases (ischaemia and cardiac insufficiency), diabetes, hypertension and high cholesterol by systematic screening in general practice
• lead to initiation and maintenance of relevant medical treatment. Moreover, we hypothesize that the complete intervention in a long-term perspective will lead to decreased mortality within the target group.

Detailed Description

Design, materials and methods:

The project is divided in two phases. In Phase 1 the project's intervention is developed; in Phase 2 the intervention is tested. Phase 2 will be conducted as a feasibility study.

Recruitment:

Based on experience from previous studies, we know the target group can be difficult to recruit and maintain in a course of treatment. We expect that 10-15 patients belonging to each provider-number will meet the project's inclusion criteria. To obtain sufficient patients for the project, we aim to include 20 general practitioners (individual provider-numbers). Accordingly, it is realistic to assume that around 75 patients undergo screening in general practice.

Recruitment of general practitioners will be done by sending written information about project participation and an invitation to participate. Only general practitioners who have one or several practice nurse(s) will be invited. The written invitation will be followed by a telephone call to all invitees to identify those practitioners wishing to participate.

Intervention:

Phase 1: Development of intervention:

The aim of Phase 1 is to design an intervention based on the experiences and perspectives of the involved stakeholders regarding how to optimize detection and treatment of somatic disease among persons with severe mental disease. The project rests on the fundamental idea that it is crucial to involve all relevant stakeholders as early as in the development phase if the intervention is to be effective and feasible to implement in practice. This phase includes 1) meetings with key stakeholders in the field, 2) observations and interviews within the Mental Health Centre Copenhagen and Copenhagen Municipality, 3) multiple project meetings involving all sectors in the project as well as on-going monitoring by the project group.

Phase 2: Testing of the intervention:

The intervention is divided in two parts: a screening intervention and a treatment intervention. The testing of the interventions is conducted as a feasibility study.

Evaluation:

The evaluation is twofold:

1. Evaluation of the effect of the intervention

2. Evaluation of the implementation process

Conditions

Ischemia; Cardiac Insufficiency; Diabetes Mellitus, Type 2; Hypertension; Hypercholesterolemia; Severe Mental Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Individualized treatment of detected somatic disease(s)

Group Type: EXPERIMENTAL

Screening

Intervention Type: OTHER

Each individual general practitioner reviews his/her record system and detects patients who meet the inclusion criteria. Patients who meet these criteria will be invited to participate in the project.

Treatment

Intervention Type: OTHER

Patients who are diagnosed with one or more of the selected somatic diseases receive an individualized course of treatment in general practice, primarily focusing on initiation and maintenance of medical treatment, and complying with current clinical guidelines and course programmes. Treatment goals are set in active co-operation with the patient and his/her family and with supervision and support from the Mental Health Centre Copenhagen, clinical pharmacologists and relevant staff from the municipality in terms of contact/support persons.

Interventions

Screening

Each individual general practitioner reviews his/her record system and detects patients who meet the inclusion criteria. Patients who meet these criteria will be invited to participate in the project.

Intervention Type: OTHER

Treatment

Patients who are diagnosed with one or more of the selected somatic diseases receive an individualized course of treatment in general practice, primarily focusing on initiation and maintenance of medical treatment, and complying with current clinical guidelines and course programmes. Treatment goals are set in active co-operation with the patient and his/her family and with supervision and support from the Mental Health Centre Copenhagen, clinical pharmacologists and relevant staff from the municipality in terms of contact/support persons.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients who appear in their individual general practitioner's record system with one of the following diagnoses:

• Schizophrenia (ICPC code p72)
• Psychosis-schizoaffective disorder without specification (ICPC code p72)
• Bipolar disorder (ICPC code p73)

Exclusion Criteria

• Persons who live in one of the Municipality of Copenhagen's social-psychiatric residences
• Persons with life-threatening disease
• Persons who do not understand and/or speak the Danish language
• Persons with acute suicidal ideation
• Persons with a severe current abuse incompatible with participation
• Persons who are assessed as being a threat to staff

• Minimum Eligible Age: 36 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The City of Copenhagen

UNKNOWN

Sponsor Role: collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: collaborator

Research Unit Of General Practice, Copenhagen

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

Intersectoral Research Unit for Health Services

OTHER_GOV

Sponsor Role: lead

Responsible Party

Anne Marie Lyngsø

Senior researcher, project manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ane F Bendix, MD

Role: STUDY_DIRECTOR

Intersectoral Research Unit for Health Services

Central Contacts

Anne Marie Lyngsø, PhD

Role: CONTACT

annemarie.lyngsoe@regionh.dk

+4531145637

Julie C Grew, PhD

Role: CONTACT

julie.grew@regionh.dk

+4526285755

Other Identifiers

CSU-2017-002

Identifier Type: -

Identifier Source: org_study_id