Medication Review in Patients With Schizophrenia and Diabetes

Schizophrenia Clinical Trial

Official title:

The Effects of a Medication Review on Patients With Coexisting Schizophrenia and Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05243160
• Other study ID #: PRURegionZealand18
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2022
• Source: Psychiatric Research Unit, Region Zealand, Denmark
• Contact: Gesche Jürgens, MD
• Phone: + 45 93 56 60 38
• Email: gju[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the potential beneficial effects of a medication review by a clinical pharmacologist on patients with coexisting schizophrenia and diabetes. The study is an intervention study in which an intervention group is assigned to the medication review whereas a control group is not. Both groups are tested using a thorough test battery at baseline and 6 months after inclusion.

Furthermore a qualitative data assessment will be undertaken using interviews and surveys in order to show any obstacles in implementing the intervention. This is relevant as medication reviews, performed by clinical pharmacologists as well as pharmacists, are not always implemented by the primary physician.

Description:

The effects of a medication review on patients with coexisting schizophrenia and diabetes:

Introduction:

Severe mental illness (SMI) is associated with an increased risk of diabetes (DM) and metabolic complications. The risk of type-2 diabetes is increased 2-3 fold in patients with SMI compared to the average population. This may lead to polypharmacy hence adverse drug interactions as well as adverse side effects emphasizing the need for a thorough medication review. Medication reviews by pharmacists is widely used and implemented in clinical practice. However, to the investigators knowledge studies on medication reviews by medical doctors specialized in the field of clinical pharmacology let alone on this patient cohort is scarce. Hence, this study seeks to investigate the effects of a medication review by a clinical pharmacologist on patients with coexisting schizophrenia and diabetes.

Quality control:

The study protocol will be send for approval by the Danish National Committee on Health Research Ethics. Regarding data managing the study is send to Region Zealand's list of ongoing projects thereby ensuring responsible data managing in accordance with the current legislation.

Randomization:

The investigators aim to enroll approximatively 50 patients suffering from both schizophrenia and diabetes (all types) in this study. Patients are drafted from the fusion clinic in Slagelse Denmark. The fusion clinic is a novel collaboration between endocrinologists and psychiatrists based in Slagelse Hospital department of psychiatry caring for patients with mental illness and diabetes. The clinic seeks to unite endocrinologists and psychiatrists in order to provide the best possible care for patients with coexisting mental illness and diabetes. Patients enrolled at the fusion clinic is invited to participate in this study and after having read and accepted the terms as well as the conditions of the study patients will be randomized to an intervention group as well as a control group. Using block-randomization patients will be distributed in blocks (3:3) thereby preventing any carry-over effect. Treatment arm allocation is hidden from the investigator thereby improving the quality of the data.

Data management:

Data will be accessible for co-authors as well as co-investigators participating in this study. Data will be entered into the RedCap module and written consent forms will be uploaded to this platform. Written files will be stored for 5 years at a safe location according to current legislation.

Intervention:

At baseline all participants recruited will undergo the following ratings: PANSS-6 (positive and negative syndrome scale), "UKU side effects rating scale" a danish acronym for the "Task force for clinical investigations- rating scale" a rating scale for measuring side effects associated with psychopharmacological treatment, MARS (medication adherence rating scale), CGI (clinical global impression scale) and SF-12 (short form survey). Furthermore, data on medicinal load, potential drug-interactions, as well as potential side effects will be obtained at baseline. The intervention group will then be subject to a medication review by a clinical pharmacologist at the beginning of the trial whereas the control group will not. 6 months after the inclusion date both groups will be subject to the same test battery thereby showing any potential differences between the two groups.

Furthermore a qualitative data assessment of the intervention will be included in this study by having surveys send to all participants as well as their primary physician regarding the perceived experience of the intervention. To fully encompass this a selection of the clinicians will be interviewed thereby making room for a thorough qualitative data analysis. The qualitative assessment will help to illuminate potential obstacles or barriers in implementing the medication review in real clinical practice.

Recruitment:

All patients will have to accept a written consent form thereby agreeing to participate in this study. By giving consent, the participant gives the examiner access to the patient record hence health data regarding the participant. Patients are at any time able to withdraw their consent throughout the study without effecting their ongoing treatment.

Ethics:

At the end of the study trial all patients will be offered the medication review thereby ensuring that all patients benefit from this additional expert assessment. The trial does not interfere with the usual treatment and there seems to be no additional risks for the patients participating in this study.

Funding:

The study is funded by the Steno diabetes center region Zealand Denmark and contains enough funding for 1 year of research. The research group is in the process of applying for funding for a 3- year research employment (ph.d.).

Perspective:

The investigators speculate as to whether a medication review by a clinical pharmacologist can improve not only the medicinal load, reduce side effects, minimize adverse drug interactions, reduce financial burden by reducing the medicinal load but also effect the psychometrics e.g. PANSS-6, SF-12 exc. If the intervention proves useful the medication review is easily implemented in the Danish clinical practice and is therefore of relevance for the clinicians.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patients drafted must have diabetes (unspecified) and severe mental illness in this case schizophrenia. Patients are drafted from the "fusion clinic" in Slagelse Denmark which is a collaboration between endocrinologists and psychiatrists in the joint treatment of patients with diabetes and mental illness.

• Only adult patients

Exclusion Criteria:

• none of the above

• Pediatric patients

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Metabolic Syndrome
• Schizophrenia

Intervention

Other:
• medication review
The intervention consist of a medication review by a clinical pharmacologist.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Psychiatric Research Unit, Region Zealand, Denmark	Region Zealand, Steno Diabetes Center Sjaelland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medicinal load	Total amount of pharmaceuticals prescribed	6 months
Primary	PANSS-6 (positive and negative syndrome scale)	Changes in the PANSS-6 scale during study period. Scores ranges from 7-42 with increasing score as illustrating the severity of symptoms	6 months
Secondary	Hb1Ac	Changes Hb1Ac during the study period	6 months
Secondary	UKU side effect rating scale ("UKU" is a danish acronym for the "Task force for clinical investigations")	Measuring side effects related to psychopharmacological treatment. Score ranges from 0 to 54 as the maximum score. High scores corresponding to an increased burden of side effects	6 months
Secondary	SF-12 (short form survey)	Changes in the SF-12 scale during study period. Score ranges from 0 to 100 with 100 as maximum. High scores illustrating a percieved sense of good health.	6 months
Secondary	MARS (medication adherence rating scale).	Measuring adherence to pharmacological treatment. Score ranges from 0 to 10 with 10 as maximum value. Increased score illustrating poor adherence to the pharmacological treatment.	6 months
Secondary	CGI (Clinical Global impression scale)	Clinical Global impression scale: Score ranges from 1-7 with increasing score illustrating poor clinical status: Higher scores corresponding to the severity of the illness.	6 months
Secondary	Adverse interactions	Amount of potential drug interactions	6 months