Clinical trial NCT06107946: The MuSt-PC: a Pilot Study to Assess Symptom Burden of Co-occuring Symptoms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palliative Care
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2023-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Ability and willingness of patients to complete follow-up assessments
timeFrame: after 2 weeks
Secondary outcomes:
measure: Recruitment of patients; the number of patients that consented and those that declined participation, as well as number of eligible patients.
timeFrame: after 2 weeks
measure: Adherence to advice by patients provided based on the MuSt-PC CDSS
timeFrame: after 2 weeks
measure: Patient impressions of the MuSt-PC CDSS
timeFrame: after 2 weeks
measure: Time until symptom burden decreases after the use of the MuSt-PC CDSS based on the filled out Utrecht Symptom Diaries (days)
timeFrame: after 2 weeks
measure: Feedback about the follow-up assessments within this pilot
timeFrame: after 2 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: LUMC
Study officials:
affiliation: University Medical Center Groningen
name: An KL Reyners, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: