Clinical trial NCT03428308: Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease
Official title: Detection and Treatment of Selected Somatic Chronic Diseases in Patients With Severe Mental Disease: Development and Testing of a Coordinated Interdisciplinary and Intersectoral Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemia
Cardiac Insufficiency
Diabetes Mellitus, Type 2
Hypertension
Hypercholesterolemia
Severe Mental Disorder
Lead sponsor: Intersectoral Research Unit for Health Services
Sponsor class: OTHER_GOV
Collaborators: name: The City of Copenhagen
name: Mental Health Services in the Capital Region, Denmark
name: Research Unit Of General Practice, Copenhagen
name: Bispebjerg Hospital
First posted: 2018-02-09
Enrollment: 90
Sex: ALL
Minimum age (years): 36
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who meet the inclusion criteria will be identified and invited to participate by their general practitioner. Patients who agree to partcipate will be invited to a screening consultation focusing on selected somatic diseases. Patients who are diagnosed with one or more of the selected somatic diseases will be included in the intervention, which consists of individualized courses of treatment focusing on initiation and maintenance of medical treatment and complying with current clinical guidelines and course programmes. The intervention is planned to run for one year.
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: Identified patients with mental disease
timeFrame: Baseline
measure: Patients attending screening
timeFrame: Baseline
measure: Patients diagnosed with somatic disease
timeFrame: Baseline
measure: Patients with untreated somatic disease
timeFrame: Baseline
measure: Number of follow-up visits
timeFrame: One year
Secondary outcomes:
measure: Appropriateness of medical treatment
timeFrame: One year
measure: Change in HbA1c (blood test)
timeFrame: One year
measure: Change in body weight
timeFrame: One year
measure: Change in blood pressure
timeFrame: One year
measure: Change in blood cholesterol (blood test)
timeFrame: One year
Other outcomes:
measure: Success of inclusion criteria
timeFrame: One year
measure: Success of exclusion criteria
timeFrame: One year
measure: Success of initiatives for recruiting patients
timeFrame: One year
measure: Success of screening and treatment
timeFrame: One year
measure: Individual benefits
timeFrame: One year
measure: Circumstances for success
timeFrame: One year
measure: Success of intersectoral cooperation
timeFrame: One year
Locations:
Study officials:
affiliation: Intersectoral Research Unit for Health Services
name: Ane F Bendix, MD
role: STUDY_DIRECTOR
References: