Cost-effectiveness of the Care Pathways

Sponsor
Tampere University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04619836
Collaborator
Tampere University (Other)
2,500
1
185.2
13.5

Study Details

Study Description

Brief 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.

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).

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jun 26, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 1, 2035

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life questionnaire (Prom) [2 years]

      change in quality of life measured by 15D- questionnaire

    2. Net promoter score questionnaire (NPS) [2 years]

      effects to NPS questionnaire

    3. Effects to health and social services use [2 years]

      volume of services will be collected from national patient register

    4. Effects to health and social services use [2 years]

      costs of services will be collected from national patient register

    5. Effects to quality of care with laboratory mesurements [2 years]

      glucose hemoglobin (B-HbA1c)

    6. Effects to quality of care with laboratory mesurements [2 years]

      plasma low density lipoprotein cholesterol level (f-P-Kol-LDL-cholesterol)

    7. Effects to quality of care with laboratory mesurements [2 years]

      Urine albumin/creatinine ratio (U-Alb/Krea)

    8. Effects to quality of care with laboratory mesurements [2 years]

      seerum Gamma Glutamyl Transferase (GGT)

    9. Effects to quality of care with laboratory mesurements [2 years]

      carbohydrate deficient transferrin (CDT)

    10. Effects to quality of care with laboratory mesurements [2 years]

      Urine drugtest

    11. Effects to quality of care with physiological mesurements [2 years]

      Weight in kilograms

    12. Effects to quality of care with physiological mesurements [2 years]

      Height in meters

    13. Effects to quality of care with questionnaire [2 years]

      smoking habits questionnaire

    Secondary Outcome Measures

    1. How to guide patients [1 year]

      interview to nurses, qualitative data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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
    Exclusion Criteria:
    • under 18 years, over 90 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tampere university hospital Tampere Finland 33521

    Sponsors and Collaborators

    • Tampere University Hospital
    • Tampere University

    Investigators

    • Principal Investigator: Sari Mäkinen, Tampere University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tampere University Hospital
    ClinicalTrials.gov Identifier:
    NCT04619836
    Other Study ID Numbers:
    • R19134
    First Posted:
    Nov 6, 2020
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tampere University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2021