Clinical trial NCT05913726: MDT Conferences for People With Diabetes and Multimorbidity
Official title: Network of Doctors for Multimorbidity and Diabetes - The NOMAD Intervention: Protocol for Feasibility Trial of Multidisciplinary Team Conferences for People With Diabetes and Multimorbidity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Comorbidities and Coexisting Conditions
Keywords: Multidisciplinary team conferences
Feasibility
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Odense
First posted: 2023-06-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of all adult residents in the geographical region of Funen, Denmark, who meet eligibility criteria.

Funen inhabits approximately 500.000.

Brief summary: The goal of this observational study is to test if regular meetings (multidisciplinary team conferences) between several different medical doctors can work well in everyday hospital life. The doctor meetings are meant to discuss patients who have both diabetes and other chronic conditions at the same time.

The main questions it aims to answer are:

* How can the concept of these meetings work in everyday hospital life?
* What are the patients and doctors getting out of the meetings?

Patients with diabetes and concurrent other diseases will be asked:

* if they want their case discussed on the doctor meeting
* to answer a set of questions about their well-being and symptoms before and 6 months after the meeting
* if the research group can store their information for the study

Doctors participating in the meetings are asked to answer questions about what they have learned in the meetings.

Detailed description: Introduction: Many people struggle with several chronic conditions at once. This is known as multimorbidity. The prevalence of multimorbidity is rising. Diabetes is one of the chronic conditions often associated with multimorbidity. The prevalence of diabetes is likewise increasing world-wide.

Having diabetes and multimorbidity can be a great burden for a person as they have to deal with symptoms, treatments, lifestyle changes and checkups. The picture complicates as many healthcare systems have a disease-specific approach rather than a patient-centered approach. This often leads to multiple different outpatient clinic contacts, possibly uncoordinated treatment and fragmented care. One can view the patient as a nomad between departments and sectors, often lacking coherence.

The aim of this study is to feasibility test a complex intervention designed to coordinate care and treatment for people with diabetes and multimorbidity prior to a large-scale randomised trial.

Intervention: To gain a more patient-centered approach, better coordination of care and treatment and possibly increase life quality for people with diabetes and multimorbidity, a working group has set out to develop a complex intervention guided by relevant guidelines. The intervention consists of multidisciplinary team conferences (MDT) performed by medical doctors within the specialities of endocrinology, cardiology, respiratory medicine, nephrology and clinical pharmacology, called Network of dOctors for Multimorbidity and Diabetes - NOMAD. The doctors sit together every two weeks to discuss the treatment, coordinate care and review medications of referred patients with diabetes and minimum one other condition within the collaborating specialities. Patients can be referred from hospital departments or from their general practitioner (GP), in which case, the GP attends the meeting by video conference. Prior to the MDT, a questionnaire concerning health related quality of life is sent out to the patient. The same questionnaire is sent out 6 months after the MDT and followed by a contact to the patient - either physical or by phone by healthcare professional. The doctors review the answers before the MDT and use them as discussion support in the MDT. All doctors attending the MDT have time scheduled prior to MDT to prepare and read about the patients. Especially the clinical pharmacologist has extended preparation time to ensure a thorough review of the patients medications list - which oftentimes consist of more than 15 different prescriptions.

Methods: This is a one-arm mixed-methods feasibility study of a complex intervention. The MDT conferences will be evaluated for feasibility through prospectively collected data. The evaluation will be based on the following process indicators:

1. completion of PRO-questionnaire
2. technical issues before, during or after MDT
3. time schedule in MDT kept or not
4. does MDT conclusion note correspond to MDT referral letter?
5. clinician preparation time

The patients' perspectives will be explored through the questionnaires and also through interviews of a selection of participants - both intervention receivers and providers, contributing to a qualitative process evaluation. The feasibility of using (patient-reported outcome, PRO) a collection of generic, validated questionnaires to measure intervention effect will be assessed. Through a run-time of 17 months, approximately 120 participants are anticipated. Results will be reported narratively and with descriptive statistics. The interviews will be reported in a separate paper.

Ethics: As the study focuses mainly on an organisational level, detailed information on individual level is not required. The scientific ethics committee has been requested for approval, replying that this study is exempt from ethics approval as it collects no human material (ref. number: 20222000 - 150).

The study is registered in list of research/quality-development projects in Region of Southern Denmark (ref. number: 22/56265).

Implications: This study will provide valuable insights into how a complex intervention of MDTs can be implemented in clinical practice, how it is received by end-users and provide decision-makers with useful experience on how to organise such an intervention. Furthermore it will elucidate the use of PRO and laboratory values as effect measures. All of this will lay the grounds for a future randomised trial where efficiency, effectiveness and clinical effect of MDT can be evaluated.

Eligibility criteria: Inclusion Criteria:

* Adult, any type of diabetes, diabetes management by general practitioner or Steno Diabetes Centre Odense, minimum one chronic condition within heart, kidney or lung specialities.

Exclusion Criteria:

* none

Primary outcomes:
measure: Recruitment
timeFrame: Full project period, 17 months.
measure: Completion of PRO-questionnaire
timeFrame: Full project period, 17 months.
measure: Technical difficulties i relation to MDT
timeFrame: Full project period, 17 months.
measure: Time schedule
timeFrame: Full project period, 17 months.
measure: MDT recommendations
timeFrame: Assessed at 6 month follow up.
measure: Clinician preparation time
timeFrame: Full project period, 17 months.
Secondary outcomes:
measure: Laboratory values
timeFrame: Assessed at time point of referral to MDT and 6 months after MDT.
measure: Clinician learning
timeFrame: Full project period, 17 months.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Dept.s of Cardiology and Clinical Research, O.U. Hospital and University of Southern Denmark.
name: Ann-Dorthe O Zwisler, Professor
role: PRINCIPAL_INVESTIGATOR
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