Diabete Type 2NCT04619836
Cost-effectiveness of the Care Pathways
An observational study of Diabete Type 2 and Substance Abuse, run by Tampere University Hospital at 1 site in Finland.
Trial summary
In this study we research patient segmentation made by Suuntima-service and it´s impacts to Quality of care, Service use and Costs of care among Type 2 Diabetes patients and Substance Abuse patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabete Type 2, Substance Abuse
- How many people
- 2,500 participants
- Where
- 1 siteFinland
- Study dates
- 26 Jun 2020to Dec 2035
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: and
Who may be able to join
- every diabetes type 2 patiets, who visit health to center diabetes nurse and substance abuse client who visit health and socialcenter, and whose services and self management are planned by Suuntima segmentation customership srategies
Who cannot join
- under 18 years, over 90 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cost-effectiveness of the Care Pathways - Effects of Patient Segmentation to Quality and Costs of Type 2 Diabetes and Substance Abuse Care and Services
In this study we research patient segmentation made by Suuntima-service and it´s impacts to Quality of care, Service use and Costs of care among Type 2 Diabetes patients and Substance Abuse patients.
With this Suuntima-servise based segmentation we assume to find appropriate services and Self-Management to allocate Type 2 Diabetes and Substance Abuse patients. We plan their care pathways by Suuntiman-service customership strategies (Self-acting, community, co-operation, network).
Read the detailed description
The study recruits 270 adult-type diabetics and 200 clients of substance abuse services for each of the four client segments (self-employment, community, cooperation, network client) and the comparison group.
Based on previous evaluations and studies of the Suuntima service, it is assumed that there will be 60% self-acting customers, 20% community customers, 10% co-operation customers, 10% network customers, therefore patients must be recruited sample. Thus, a total of about 1,350 to 1,500 patients are recruited for adult-type diabetes patients, and 1,000 to 1,200 clients for substance abuse services until sufficient representation is obtained for each clientele.
Every adult patients with type 2 diabetes who are admitted to the caregiver's preparatory diabetic nurse appointment for the annual diabetes control will be asked to participate in the study until the number of patients required for the study has been accumulated. With regard to the substance abuse process, all clients who come to the substance abuse nurse's office are asked to participate in the study.
Nursing staff review the information document with the subjects in an understandable way and the subjects are given the opportunity to ask questions about the study. If they choose to participate in the study, they will be asked to comply with consent to participate in the study.A Suuntima is made for the research subject and the customership and the type of use of the services, ie the servicepath, are defined. At the beginning, the research patients fill in a 15D questionnaire measuring the quality of life and a service experience meter (NPS, Net Promoter Score) and answer questions about height, weight, smoking habbits and how they manages in their everyday life. Clients of substance abuse services answer also questions about substance use. To monitor the quality and effectiveness of treatment, clinical variables are collected from the patient information system according to the recommendation of the National Diabetes Treatment Quality Register (Glucose hemoglobin, LDL cholesterol, albumin-creatinine ratio). Similarly, the necessary clinical parameters (serum glutamyltransferase (GT), serum low-carbohydrate transferrin (CDT), and drug screen) are collected from clients of substance abuse to monitor the quality and effectiveness of treatment.
In addition, the study collects information on the use of the health and social services and costs in general, as well as on the use and costs of services related to diabetes or substance abuse are collected from the patient information systems of both the health centers and Tampere Univercity hospital information systems of municipal social services. Laboratory data are collected from Fimlab's information systems with the permission of the registrar, and cost data for specialist care are collected from Tays' Mynla system.
Follow-up data will be collected after one and two years in connection with diabetes monitoring, in which case the above-mentioned data collection will be repeated. For substance abuse clients, monitoring is performed at 6 months and 12 months. In addition, the follow-up visit examines with a questionnaire whether the customer path has been realized as planned during the follow-up period.
In the autumn of 2020, the health care professionals participating in the study will be interviewed about the implementation of customer paths during the year. Interviews are recorded, transcribed. Participation in the interview is voluntary and your information will be collected without any unique identifiers. The information is processed in such a way that no individual interviewee can be directly identified from them.
At the same time, similar information is collected at the reference health centers agreed in Pirkanmaa for adult-type diabetic patients and substance abuse patients, whose services are not planned according to the Suuntima service customership carepathways.
- Conditions
- Diabete Type 2, Substance Abuse
- Keywords
- patient segmentation, effectiveness, cost-effectiveness, quality of life, quality of care
- Medical subject headings
- Diabetes Mellitus, Type 2, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| segmentation type 2 diabetes patitents | Those type 2 diabetes patients, who have segmenteted for four groups to organinize cervices and self care | |
| Non-segmentation type 2 diabetes patients | Those type 2 diabetes patiets who have not segementated | |
| Segmentation substance abuse clients | Those type substance abuse clients, who have segmenteted for four groups to organinize cervices and self care | |
| Non-segmentation substance abuse clients | Those type substance abuse clients, who have not segmenteted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire (Prom)
change in quality of life measured by 15D- questionnaire
Measured: 2 years
Net promoter score questionnaire (NPS)
effects to NPS questionnaire
Measured: 2 years
Effects to health and social services use
volume of services will be collected from national patient register
Measured: 2 years
Effects to health and social services use
costs of services will be collected from national patient register
Measured: 2 years
Effects to quality of care with laboratory mesurements
glucose hemoglobin (B-HbA1c)
Measured: 2 years
Effects to quality of care with laboratory mesurements
plasma low density lipoprotein cholesterol level (f-P-Kol-LDL-cholesterol)
Measured: 2 years
Effects to quality of care with laboratory mesurements
Urine albumin/creatinine ratio (U-Alb/Krea)
Measured: 2 years
Effects to quality of care with laboratory mesurements
seerum Gamma Glutamyl Transferase (GGT)
Measured: 2 years
Effects to quality of care with laboratory mesurements
carbohydrate deficient transferrin (CDT)
Measured: 2 years
Effects to quality of care with laboratory mesurements
Urine drugtest
Measured: 2 years
Effects to quality of care with physiological mesurements
Weight in kilograms
Measured: 2 years
Effects to quality of care with physiological mesurements
Height in meters
Measured: 2 years
Effects to quality of care with questionnaire
smoking habits questionnaire
Measured: 2 years
Secondary outcomes (1)
How to guide patients
interview to nurses, qualitative data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start26 Jun 2020
- Primary completion31 Dec 2022 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Sari Mäkinen, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619836
- Sponsor's protocol ID
- R19134
- Status last verified
- Oct 2021
- First submitted
- 26 Jun 2020
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No