Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease
Primary Purpose
Ischemia, Cardiac Insufficiency, Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Screening
Treatment
Sponsored by
About this trial
This is an interventional screening trial for Ischemia
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Individualized treatment of detected somatic disease(s)
Arm Description
Outcomes
Primary Outcome Measures
Identified patients with mental disease
Proportion of individuals identified with the selected mental diseases from the general practitioner's total population
Patients attending screening
Proportion of individuals who attend screening out of the total population of individuals who indicate via telephone their wish to participate
Patients diagnosed with somatic disease
Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases
Patients with untreated somatic disease
Proportion of screened individuals in whom untreated somatic disease is identified
Number of follow-up visits
Number of follow-up visits for participants in whom medical treatment of somatic disease has been initiated is compared with number of visits in general practice the year before the intervention
Secondary Outcome Measures
Appropriateness of medical treatment
Whether the patients' medical treatment is appropriate is assessed using the Medication Appropriateness Index (MAI)
Change in HbA1c (blood test)
Assessment of change in HbA1c since baseline for the participants for whom medical treatment has been initiated
Change in body weight
Assessment of change in body weight (kilograms) since baseline for the participants for whom medical treatment has been initiated
Change in blood pressure
Assessment of change in blood pressure (mmHg) since baseline for the participants for whom medical treatment has been initiated
Change in blood cholesterol (blood test)
Assessment of change in blood cholesterol since baseline for the participants for whom medical treatment has been initiated
Full Information
NCT ID
NCT03428308
First Posted
January 26, 2018
Last Updated
February 8, 2018
Sponsor
Intersectoral Research Unit for Health Services
Collaborators
The City of Copenhagen, Mental Health Centre Copenhagen, Research Unit Of General Practice, Copenhagen, Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03428308
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intersectoral Research Unit for Health Services
Collaborators
The City of Copenhagen, Mental Health Centre Copenhagen, Research Unit Of General Practice, Copenhagen, Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Evaluation of the effect of the intervention
Evaluation of the implementation process
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia, Cardiac Insufficiency, Diabetes Mellitus, Type 2, Hypertension, Hypercholesterolemia, Severe Mental Disorder
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individualized treatment of detected somatic disease(s)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
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
Intervention Name(s)
Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identified patients with mental disease
Description
Proportion of individuals identified with the selected mental diseases from the general practitioner's total population
Time Frame
Baseline
Title
Patients attending screening
Description
Proportion of individuals who attend screening out of the total population of individuals who indicate via telephone their wish to participate
Time Frame
Baseline
Title
Patients diagnosed with somatic disease
Description
Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases
Time Frame
Baseline
Title
Patients with untreated somatic disease
Description
Proportion of screened individuals in whom untreated somatic disease is identified
Time Frame
Baseline
Title
Number of follow-up visits
Description
Number of follow-up visits for participants in whom medical treatment of somatic disease has been initiated is compared with number of visits in general practice the year before the intervention
Time Frame
One year
Secondary Outcome Measure Information:
Title
Appropriateness of medical treatment
Description
Whether the patients' medical treatment is appropriate is assessed using the Medication Appropriateness Index (MAI)
Time Frame
One year
Title
Change in HbA1c (blood test)
Description
Assessment of change in HbA1c since baseline for the participants for whom medical treatment has been initiated
Time Frame
One year
Title
Change in body weight
Description
Assessment of change in body weight (kilograms) since baseline for the participants for whom medical treatment has been initiated
Time Frame
One year
Title
Change in blood pressure
Description
Assessment of change in blood pressure (mmHg) since baseline for the participants for whom medical treatment has been initiated
Time Frame
One year
Title
Change in blood cholesterol (blood test)
Description
Assessment of change in blood cholesterol since baseline for the participants for whom medical treatment has been initiated
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Success of inclusion criteria
Description
Qualitative interviews with clinicians will be done to assess the success of the inclusion criteria.
Time Frame
One year
Title
Success of exclusion criteria
Description
Qualitative interviews with clinicians will be done to assess the success of the exclusion criteria.
Time Frame
One year
Title
Success of initiatives for recruiting patients
Description
Qualitative interviews with clinicians and municipal contact/support persons will be done to assess the success of the process in incentivizing participants to attend screening and subsequent follow-up visits.
Data registration sheets on attendance and telephonic contact with participants will be evaluated.
Time Frame
One year
Title
Success of screening and treatment
Description
Qualitative interviews with clinicians and municipal contact/support persons will be done to assess the success of the process in screening and treating the target individuals in general practice
Time Frame
One year
Title
Individual benefits
Description
Qualitative interviews with clinicians, municipal contact/support persons and participants will be done to assess which individuals benefited from the intervention and which did not.
Time Frame
One year
Title
Circumstances for success
Description
Qualitative interviews with clinicians, municipal contact/support persons and participants will be done to assess the circumstances under which the intervention succeeded.
Time Frame
One year
Title
Success of intersectoral cooperation
Description
Qualitative interviews with clinicians, municipal contact/support persons, psychiatrists, clinical pharmacologists and participants will be done to assess how the intersectoral cooperation functioned.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Marie Lyngsø, PhD
Phone
+4531145637
Email
annemarie.lyngsoe@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Julie C Grew, PhD
Phone
+4526285755
Email
julie.grew@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ane F Bendix, MD
Organizational Affiliation
Intersectoral Research Unit for Health Services
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease
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