The MuSt-PC: a Pilot Study to Assess Symptom Burden of Co-occuring Symptoms

The MuSt-PC: A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs - Pilot Study to Assess the Efficacy of a Clinical Decision Support System

In this pilot study, physicians and nurse practitioners working in different care settings will use MuSt-PC, for adult patients with any life-limiting iilness, for whom the Surprise question is answered negatively: if the HCP answers "no" to the question "Would I be surprised if this patiënt died in the next 12 months?''. In total, at least 20 eligible patients will be recruited and asked to perform all study assessments.

Study Overview

• Status: Not yet recruiting
• Conditions: Palliative Care
• Intervention / Treatment: Other: USD questionnaire

Detailed Description

In this pilot study, physicians and nurse practitioners working in different care settings will use MuSt-PC, for adult patients with any life-limiting iilness, for whom the Surprise question is answered negatively: if the HCP answers "no" to the question "Would I be surprised if this patiënt died in the next 12 months?''. In total, at least 20 eligible patients will be recruited and asked to perform all study assessments.

After a baseline screening assessment, all eligible patients with at least 2 simultaneously occurring symptoms with a numeric rating score £4 on the 11 point scale on the Utrecht Symptom Diary, will be asked to fiil out the Utrecht Symptom Diary during two weeks.

In the first week twice daily (morning and evening), in the second week once daily (evening).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: An KL Reyners, MD, PhD; Phone Number: +50 361 2821; Email: a.k.l.reyners@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
    • Contact: An KL Reyners, MD, PhD; Phone Number: +31 50 361 2821; Email: a.k.l.reyners@umcg.nl
    • Principal Investigator: An KL Reyners, MD, PhD
  • Leiden, Netherlands
    • LUMC
    • Contact: Yvette M van der Linden, MD, PhD; Phone Number: 071 5263057; Email: ymvanderlinden@lumc.nl
    • Principal Investigator: Yvette M van der Linden, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients identified as in a palliative care trajectory (based on a negative answer to the surprise question "Would I be surprised if this patiënt died in the next 12 months?")
• All primary diseases (cancer, non-cancer (e.g. COPD, haart failure, frailty)
• Patients should have at least two symptoms on the Utrecht Symptom Diary with a numeric rating score of 4 or higher
• Life expectancy of at least 4 weeks
• Able to fill out Dutch questionnaires
• Informed consent

Exclusion Criteria:

• Patients who are unable or unwilling to self-assess their symptoms at baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: symptom assessment; Patients will have assessed symptom burden using the Dutch validated ESAS (called USD), build in the MuSt-PC tool. Thereafter, they will record symptom burden in a diary during 2 weeks.	Other: USD questionnaire; After a baseline screening symptom assessment, all eligible patients with at least 2 simultaneously occurring symptoms with a numeric rating score ≥4 on the 11 point scale on the Utrecht Symptom Diary, will be asked to fill out the Utrecht Symptom Diary during two weeks. In the first week twice daily (morning and evening), in the second week once daily (evening).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability and willingness of patients to complete follow-up assessments	the percentage of patients who completed all questionnaires during follow-up	after 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment of patients; the number of patients that consented and those that declined participation, as well as number of eligible patients.	% of patients	after 2 weeks
Adherence to advice by patients provided based on the MuSt-PC CDSS	% of patients	after 2 weeks
Patient impressions of the MuSt-PC CDSS	10 questions with a 4-point Likert scale	after 2 weeks
Time until symptom burden decreases after the use of the MuSt-PC CDSS based on the filled out Utrecht Symptom Diaries (days)	in days	after 2 weeks
Feedback about the follow-up assessments within this pilot	open questions	after 2 weeks

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Leiden University Medical Center
• Investigators: Principal Investigator: An KL Reyners, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 11087 (DAIDS ES Registry Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No