MDT Conferences for People With Diabetes and Multimorbidity

Diabetes Mellitus Clinical Trial

— NOMAD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913726
• Other study ID #: Steno-MDT3
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Odense University Hospital
• Contact: Stine J Bugge, MD
• Phone: 004552652330
• Email: stine.jorstad.bugge[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comorbidities and Coexisting Conditions
• Diabetes Mellitus

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Steno Diabetes Center Odense

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

Andersen JD, Jensen MH, Vestergaard P, Jensen V, Hejlesen O, Hangaard S. The multidisciplinary team in diagnosing and treatment of patients with diabetes and comorbidities: A scoping review. J Multimorb Comorb. 2023 Mar 20;13:26335565231165966. doi: 10.1177/26335565231165966. eCollection 2023 Jan-Dec. — View Citation

Fortin M, Lapointe L, Hudon C, Vanasse A, Ntetu AL, Maltais D. Multimorbidity and quality of life in primary care: a systematic review. Health Qual Life Outcomes. 2004 Sep 20;2:51. doi: 10.1186/1477-7525-2-51. — View Citation

Henriksen DP, Ennis ZN, Panou V, Hangaard J, Jensen PB, Johansson SL, Nagarajah S, Poulsen MK, Rothmann MJ, Schousboe K, Bugge SJ, Jessen LB, Schneider IR, Olsen Zwisler AD, Hojlund K, Damkier P. Physician-led in-hospital multidisciplinary team conferences with multiple medical specialities present - A scoping review. J Multimorb Comorb. 2022 Dec 7;12:26335565221141745. doi: 10.1177/26335565221141745. eCollection 2022 Jan-Dec. — View Citation

Menotti A, Mulder I, Nissinen A, Giampaoli S, Feskens EJ, Kromhout D. Prevalence of morbidity and multimorbidity in elderly male populations and their impact on 10-year all-cause mortality: The FINE study (Finland, Italy, Netherlands, Elderly). J Clin Epidemiol. 2001 Jul;54(7):680-6. doi: 10.1016/s0895-4356(00)00368-1. — View Citation

O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, Yardley L, Hoddinott P. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. doi: 10.1136/bmjopen-2019-029954. — View Citation

Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10. — View Citation

Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061. — View Citation

Uijen AA, van de Lisdonk EH. Multimorbidity in primary care: prevalence and trend over the last 20 years. Eur J Gen Pract. 2008;14 Suppl 1:28-32. doi: 10.1080/13814780802436093. — View Citation

Williams JS, Egede LE. The Association Between Multimorbidity and Quality of Life, Health Status and Functional Disability. Am J Med Sci. 2016 Jul;352(1):45-52. doi: 10.1016/j.amjms.2016.03.004. Epub 2016 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Number of patients referred to MDT. Reported as total number of referred patients throughout the project period and as mean/median per MDT.	Full project period, 17 months.
Primary	Completion of PRO-questionnaire	How many participants completed the PRO-questionnaire. Reported as absolute number and percentage of total number of participants.	Full project period, 17 months.
Primary	Technical difficulties i relation to MDT	How many times did technical difficulties occur i relation to MDT. Technical difficulties defined as 1) problem with sending/receiving referral letter, 2) managing PRO-questionnaire completion, 3) problems with video, sound or connection during MDT or 4) problems with contacting participant for followup. Reported as absolute numbers and percentage of all MDTs.	Full project period, 17 months.
Primary	Time schedule	Was time schedule kept on MDT? Simple count of how often time schedule of 30 minutes per patient case was NOT kept. Reported as absolute number and percentage of total number of patient cases.	Full project period, 17 months.
Primary	MDT recommendations	How often are MDT recommendations initiated? Assessed at 6 month follow up by examining electronic patient records and conversation with participant. Reported as simple count of how many times recommendations are followed/initiated and percentage of recommendations followed out of total MDT recommendations.	Assessed at 6 month follow up.
Primary	Clinician preparation time	How many minutes does each clinician take to prepare an MDT case discussion? Assessed by survey completed by clinicians at end of each MDT case discussion. Reported as means and medians in whole minutes.	Full project period, 17 months.
Secondary	Laboratory values	A simple count of how many participants who have relevant laboratory values (HbA1C, LDL, creatinine) less than 90 days old at time point of referral and time point of 6 months follow up. Reported as absolute numbers and percentages.	Assessed at time point of referral to MDT and 6 months after MDT.
Secondary	Clinician learning	To which degree did the clinician find the MDT case discussion educational/enlightening/useful for personal development? Assessed by completion of mini-survey by each clinician at the end of each MDT case discussion. Survey consists of visual analogue scale 0-100 mm. 0 indicating "not educational at all" and 100 indicating "most educational, as much as possible". Clinician learning is reported as means and medians on this scale.	Full project period, 17 months.

External Links

•   Invisible numbers: the true extent of noncommunicable diseases and what to do about them. Geneva: World Health Organization; 2022. Licence: CC BY-NC-SA 3.0 IGO.
•   World Health Organization. Multimorbidity. Geneva. ; 2016. ISBN 978-92-4-151165-0