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

Palliative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06107946
• Other study ID #: 11087
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: An KL Reyners, MD, PhD
• Phone: +50 361 2821
• Email: a.k.l.reyners[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Palliative Care

Intervention

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).

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen
Netherlands	LUMC	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adherence to advice by patients provided based on the MuSt-PC CDSS	% of patients	after 2 weeks
Secondary	Patient impressions of the MuSt-PC CDSS	10 questions with a 4-point Likert scale	after 2 weeks
Secondary	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
Secondary	Feedback about the follow-up assessments within this pilot	open questions	after 2 weeks