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Abstract

Introduction

Electronic patient-reported outcome measures (e-PROMs) offer advantages in palliative cancer care, including rapid completion, improved data quality and direct storage, improving clinical decision-making. The electronic Integrated Palliative Care Outcome Scale (e-IPOS) in this context enables thorough self-assessment by patients, enhancing symptom management and self-reflection of their current situation.

Aim

To evaluate the feasibility of implementing the e-IPOS in home palliative cancer care.

Outcomes

The primary outcomes included the enrollment consent rate, study retention rate, e-IPOS completion rate and response completeness, and the number of clinical assessments and interventions performed during home visits. The secondary outcomes were the number of unscheduled visits and patients’ perceived quality of life.

Design

A two-group quasiexperimental clinical pilot study. The control group received standard palliative care, the intervention group received standard care along with weekly e-IPOS completion during home visits. Both groups were enrolled for 4 weeks.

Setting/participants

Adults with advanced cancer from the home palliative care unit of the Istituto Nazionale dei Tumori of Milan.

Results

Twenty-three patients were enrolled (74.19%), and 20 completed the study (drop-out: 13.04%). 82.5% of the expected e-IPOS responses were received, of which 96.9% were fully complete. In the intervention group, the Wilcoxon test showed an increase in identified needs and documented interventions (P < .05) and a decrease in unscheduled visits (P < .05).

Conclusion

It is feasible to recruit people via home palliative care for an e-IPOS implementation study. Future fully powered studies should investigate the feasibility and assess patients’ perceptions of its use to better understand its clinical benefits.

Keywords

palliative care patient-reported outcome electronic health record terminal care self-assessment neoplasms

Introduction

Patient-reported outcomes (PROs) are descriptions of the patient’s health status provided by the patient themselves without interpretation by a clinician or others.^1-4 Patient-reported outcome measures (PROMs) are instruments, often in the form of questionnaires, used to collect information about PROs and evaluate aspects of the patient’s experience, such as symptom burden, functional status, and psychological and emotional well-being.⁵ Giving patients a voice to involve them in their care highlights the importance of PROMs in assisting healthcare professionals in decision-making.^6-8 The use of PROMs has enabled clinicians to identify and address patients’ hidden and unmet needs, allowing patients to become aware of their health condition and their physical, psychological, and social needs.^8-10

PROMs are used in oncology throughout all disease stages, from diagnosis to the terminal phases, and their clinical application is increasingly growing in the context of oncological palliative care.^11-13 This growth in the use of PROMs aligns with the fundamental principles of palliative care, which adopts a holistic perspective of the patient by considering the physical, mental, social, spiritual, and economic dimensions.^14,15 In this context, the use of PROMs has been linked to the prompt monitoring and management of symptoms, such as pain, nausea, fatigue, depression, and nutritional issues, that typically affect advanced-stage cancer patients.^15,16 In palliative cancer care, PROMs are essential for providing truly individualized and high-quality patient-centered care.¹⁷

Electronic PROMs (e-PROMs) are favored over paper forms due to their cost-effectiveness, faster completion time, improved data quality, and higher response rates, resulting in reduced administration time and reduced missing data.^15,18,19 Moreover, the electronic format allows for the direct and systematic storage of collected data in medical records, which can assist healthcare providers and patients in making clinical decisions that positively influence patient well-being.^18,20,21

One PROM used in the palliative care context is the Integrated Palliative Care Outcome Scale (IPOS). This questionnaire has been tested in various inpatient and home care environments as a standardized tool to assess the current and evolving palliative needs of patients²² and is also used in an electronic format.²³ Burner-Fritsch et al’s study stated that engaging with the e-IPOS during the palliative phase necessitates a thorough self-assessment by patients of their overall health condition, a process that is potentially advantageous for effectively managing symptom burden and reflecting their current situation.²³

Despite evidence of the effectiveness of outcome measures in palliative care, their integration into routine practice presents challenges, influenced by factors at both the patient and organizational levels. Healthcare professional workload and inadequate technological infrastructure are key organizational barriers,^4,24,25 while patient-related challenges include health conditions and comfort with internet-enabled devices.²³ The adoption of these measures in palliative care, especially in home settings, remains limited.¹⁵

Additionally, due to the challenges in conducting studies in the field of palliative care arising from patient fragility and disease progression in terminal phases,²⁶ there is a significant loss of clinically relevant information, as evidenced by the literature; hence, it becomes crucial to conduct preliminary analyses on the feasibility of research procedures to refine techniques and effectively complete studies in this area.^27,28

To our knowledge, there is no published evidence regarding the routine use of e-PROMs in home palliative cancer care in Italy,²⁹ even in the most specialized settings, such as the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan (INT).

Aim

The aim of this study was to evaluate the feasibility of implementing the e-IPOS in routine care processes in home palliative cancer care.

Methods

Study design

This was a two-group, quasiexperimental, single-center clinical pilot study. This study design aims to establish a cause-and-effect relationship between an independent and dependent variable. Distinct from a true experiment, this quasiexperimental approach does not use random assignment for grouping.³⁰ To ensure thoroughness and transparency, the study followed to the Joanna Briggs Institute’s checklist for quasiexperimental studies and the Template for Intervention Description and Replication (TIDieR) checklist.^31,32

The research conducted was part of a larger project titled “Impact assessment of a system e-patient reported outcome measures on home palliative care: Mixed-methods study of feasibility and intervention” aimed at enhancing e-PROMs adoption in at-home palliative care for cancer patients at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan (INT).

Setting

The research was conducted at INT’s Palliative Care - Hospice, Pain Therapy, and Rehabilitation Complex Unit, which includes a home palliative care service. Annually, approximately 100 patients use home-based care supported by a team of physicians, nurses, social health workers, physiotherapists, psychologists, a nursing case manager, and a nursing coordinator.

Participants

The study enrolled patients from the home palliative care unit, including those who were older than 18 years, who had a good grasp of the Italian language, and who had metastatic or advanced cancer (stage III or IV). Patients with a prognosis of fewer than 30 days, those experiencing cognitive impairments that hindered their self-assessment abilities, and those with physical disabilities that could prevent the use of electronic devices were excluded.

Recruitment Procedures

From March to September 2023, INT palliative home care nurses and physicians identified potential participants during routine clinical work. The team initially approached potential participants, and if they agreed, the principal investigator (LC), a PhD student, discussed the study in more detail with them by telephone. After being confirmed to meet the inclusion criteria, patients were contacted by a researcher for a meeting where the study objectives and procedures were outlined and written consent was obtained. The enrolled patients were allocated 1:1 to the control or intervention group.

Sampling

Given the typical recruitment challenges in the palliative care context,²⁸ the study aimed to include at least 20 participants, chosen for practical purposes to assess the study’s feasibility, acceptance, and potential dropout rate. This aligns with guidelines for the sample size of an internal pilot study, which involves analyzing early data from a two-group study. This requires a minimum of twenty degrees of freedom. This interim analysis functioned as a preliminary assessment of the study’s methods and anticipated outcomes.^33,34

Measures

• The IPOS is a patient self-report and staff proxy-report outcome measure for advanced illness patients in palliative care that assesses physical symptoms, emotional symptoms, and communication/practical issues through ten questions (17 items)^35-37 focusing on symptom burden. The overall IPOS score is the sum of the scores for each of the questions and can vary from zero to 68.³⁶ We used the electronic format of the Italian version,³⁸ required at https://pos-pal.org.

• The European Organization for Research and Treatment of Cancer (EORTC) questionnaire, called EORTC-QLQ-C15-PAL,³⁹ is a 15-item questionnaire used to assess the quality of life of cancer patients in palliative care, required at https://www.eortc.org.

• The Australian Karfnosky Performance Status (AKPS)⁴⁰ is a quality of life rating scale compiled by healthcare professionals that yields a value from 0 to 100 in percentages, with numerical ratings in intervals of 10, accounting for 4 parameters: limitations in daily activities, self-care, autonomy and work activity.

Intervention

After being allocated to the control or intervention group, participants received standard palliative care (control) or standard care plus e-IPOS completion (intervention). Both groups were enrolled for 4 weeks. In each group, a research team member administered the EORTC-QLQ-C15-PAL questionnaire at home at two time points. The first administration occurred simultaneously at the first home visit by health care professionals after the patients provided informed consent (T0). The second administration was after 4 weeks (T3) in conjunction with the visit of health care professionals. Concurrently, the AKPS scores completed by clinicians were extracted from the medical records. Figure 1 shows the study flowchart. Additionally, weekly data for both groups, including sociodemographic data, clinical information and details on physiological needs, pain, symptoms, and emotional aspects, were extracted from medical records as outlined by the Canadian Hospice Palliative Care Association (CHPCA).^41,42

Figure 1.

Study flowchart. Legend: EORTC, European Organization for Research and Treatment of Cancer; e-IPOS, electronic version of Integrated Palliative Care Outcome Scale; AKPS, Australian Karfnosky Performance Status.

Standard Palliative Care Plus e-IPOS (Intervention)

The intervention group received standard home palliative care via a physician‒nurse pair and completed the e-IPOS every week at 4 time points (T0, T1, T2, and T3); in addition, they participated in visits from the researchers for the completion of the EORTC-QLQ-C15-PAL questionnaire (T0 and T3). The e-IPOS was completed via Ticuro Reply software using a touchscreen portable PC provided by healthcare staff during home visits.⁴³ This software facilitated the integration of the e-IPOS data with electronic records, which allowed response summaries to be exported and provided graphical representations to monitor progress over time.

Standard Palliative Care (Control)

The control group received standard home palliative care via a physician‒nurse pair, and the researchers visited the patients to complete the EORTC-QLQ-C15-PAL (T0 and T3) questionnaire.

Outcomes

Primary Outcomes

• Enrollment consent rate greater than or equal to 40%^44-49;

• Study retention rate at the end of follow-up greater than or equal to 80%.^44-49

• Percentage of patients with a completed e-IPOS response in the planned follow-up period greater than or equal to 80%^44-49;

• Percentage of completeness of each e-IPOS response greater than or equal to 50%^44,50;

• Number of medical and nursing clinical assessments performed at each home visit and tracked in the documentation in relation to end-of-life care needs and problems in the follow-up period^41,42;

• Number of medical and nursing clinical interventions performed at each home visit and tracked in the documentation in relation to end-of-life care needs and problems in the follow-up period^41,42

Secondary Outcomes

• Number of unscheduled visits performed by care staff and recorded in the electronic medical records;

• Overall quality of life, physical function, emotional function, and intensity of symptoms perceived by patients (EORTC-QLQ-C15-PAL).

Statistical Analysis

All the data were included and reported, adhering to an intention-to-treat analysis approach. A comprehensive analysis of patient characteristics, including age, gender, nationality, education, and oncological pathology, was conducted, involving calculations of frequencies, means, medians, and standard deviations for various variable types. This included evaluating unscheduled visits and biophysiological, symptomatic, and emotional-relational aspects in the control and intervention groups. Chi-square tests were used to explore the relationships between nominal qualitative variables in these groups. Additionally, the e-IPOS utilization rate and completeness were calculated, as were temporal differences in e-IPOS scores at T0 and T3; these differences were analyzed using Student's t test and the Wilcoxon W test, with normality verified by the Shapiro‒Wilk test (P values compared against an alpha of .05). Similarly, AKPS scores were calculated and compared at T0 and T3. Furthermore, the latent factors of the EORTC-QLQ-C15-PAL were examined after linear scaling (0 to 100),^51,52 calculating averages and ranges, and assessing response differences at T0 and T3 in both groups using Wilcoxon test post-normality verification. The software Jamovi (version 2.4)⁵³ was used for all the analyses.

Ethical Consideration

The participants in the study provided written consent. It was also guaranteed that their identity would remain anonymous and that the confidentiality of the data collected would be maintained. Strict data protection procedures were followed, and additional guarantees of confidentiality were provided. All the collected data were stored in a two-tier password-protected file to which the researchers had exclusive access to an encrypted computer. The study received ethical approval from the INT Ethics Committee [ref. 187/21].

Results

From March 2023, a total of 31 patients were found to be eligible, and 23 of them (74.19%) provided consent to participate in the study. Of the patients enrolled, 3 died before the T0 assessment. Of these, 2 patients were in the control group, and 1 was in the intervention group (retention rate of 86.96%)). These results show an enrolment consent rate greater than or equal to 40% and a study retention rate at the end of follow-up greater than or equal to 80%. No patients dropped out of the study during the planned follow-up period (Figure 2).

Figure 2.

Study enrollment flowchart.

Table 1 shows the characteristics of the enrolled sample.

Table 1.

Enrolled Sample Characteristics.

	Control Group		Intervention Group
Patient’s mean age in years (SD)	68.25	(15.39)	76.10	(18.89)
Women (%)	10	(83.33)	6	(54.54)
Men (%)	2	(16.67)	5	(45.45)
Nationality (patient) (%)
IT	12	(100)	11	(100)
UE (not IT)	0	(0)	0	(0)
Extra UE	0	(0)	0	(0)
Education level (patient) (%)
None	0	(0)	0	(0)
Primary school	5	(41.67)	4	(36.36)
Middle school	5	(41.67)	1	(9.09)
High school	1	(8.33)	2	(18.18)
Degree	1	(8.33)	4	(36.36)
Primary oncological pathology (%)
Liver cancer	2	(16.67)
Biliary tract cancer	2	(16.67)
Bronchus and lung cancer	1	(8.33)	3	(27.27)
Retroperitoneum cancer	1	(8.33)
Pancreas cancer	1	(8.33)
Ovarian cancer	1	(8.33)	1	(9.09)
Head and neck cancer	1	(8.33)
Esophagus cancer	1	(8.33)
Kidney cancer	1	(8.33)	1	(9.09)
Anal canal cancer	1	(8.33)
Brain cancer			1	(9.09)
Mouth cancer			1	(9.09)
Stomach cancer			1	(9.09)
Breast cancer			1	(9.09)
Blood cancer			1	(9.09)
Skin cancer			1	(9.09)
Australian Karfnosky performance status mean (SD) at T0	51.0	(12.0)^a	48.0	(14.8)^a
Australian Karfnosky performance status mean (SD) at T3	53.0	(8.23)^a	53.0	(8.23)^a

^aIn both groups, the AKPS values remained stable over time according to the Wilcoxon test, P = ns.

There were 16 women (83.3% in the control group and 54.54% in the intervention group), with an average age of 72 years (68 in the control group and 76 in the intervention group). According to Wilcoxon, the AKPS remained stable over time (T0 – T3) in both groups with no statistically significant differences detected. Specifically, with values of 51 vs 48 in the control group and 53 vs 53 in the intervention group. Although, in the control group, there was a slight worsening of patient conditions over time, moving from T0, where the score recorded by clinicians on AKPS indicated patients who “require considerable assistance” to T3, which indicated patients “in bed more than 50% of the time”.

Acceptability and Feasibility of Using the e-IPOS

In Table 2, data regarding the feasibility and acceptability in terms of percentage of completed e-IPOS in the planned follow-up period and percentage of completeness of each e-IPOS.

Table 2.

e-IPOS use Characteristics.

Total e-IPOS Responses (%)
e-IPOS responses expected	40
e-IPOS responses collected	33	(82.5)
Completeness of e-IPOS responses (%)
Complete e-IPOS responses	32	(96.97)
Incomplete e-IPOS responses	1	(3.03)
Items filled out	556	(99.11)
Items not filled out	5	(0.89)

Out of the 40 expected e-IPOS (4 per each patient within 4 weeks), 82.5% were completed. 96.9% of them were complete in all their parts. In 87.8% of e-IPOS, at least 1 optional open-ended question was answered, with pain identified as the main issue and other primary concerns including the course of the disease, relationships, family issues, and the clinical pathway.

Traceability in the Clinical Documentation of Assessments and Interventions Performed

Table 3 describes the relationships between the introduction of the e-IPOS and the number of assessments and interventions performed with respect to care needs, symptoms (eg, pain, dysphagia, fatigue, and dyspnea), and emotional-relational aspects (eg, depression, anxiety and problems with family), as well as in terms of unscheduled visits recorded during the follow-up period.

Table 3.

Frequencies of Unscheduled Visits, Assessments and Interventions Performed in the Control and Intervention Groups.

Unscheduled Visits		Control group		Intervention group		χ² Test
		N	(%)	N	(%)	P value
		8	8.8	1	1.03	.020*
Assessment	Fluids and nutrition	82	90.1	85	97.7	.036*
	Motor function	30	33.0	61	70.1	<.001*
	Constipation	75	82.4	56	75.9	.210
	Wounds	63	69.2	76	87.4	.007*
	Pain	86	94.5	87	100	.027*
	Dyspnea	65	71.4	84	96.6	<.001*
	Sleep problems	74	81.3	83	95.4	.004*
	Nausea and vomiting	63	69.2	84	96.6	<.001*
	Dysphagia	44	48.4	83	95.4	<.001*
	Fatigue	78	85.7	83	95.4	.028*
	Depression and anxiety	62	68.1	84	96.6	<.001*
	Problem/relationships with family	14	15.4	45	51.7	<.001*
Intervention	Fluids and nutrition	20	22.0	44	50.6	<.001*
	Motor function	5	5.5	18	20.7	.001*
	Constipation	23	25.3	22	25.3	.001*
	Wounds	11	12.1	38	43.7	<.001*
	Pain	29	31.9	45	51.7	.007*
	Dyspnea	9	9.9	16	18.4	.068
	Sleep problems	7	7.7	12	13.8	.273
	Nausea and vomiting	4	4.4	13	14.9	.028*
	Dysphagia	4	4.4	13	14.9	.028*
	Fatigue	3	3.3	14	16.1	.007*
	Depression and anxiety	6	6.6	37	42.5	<.001*
	Problem/relationships with family	8	8.8	26	29.9	<.001*

Notes. Total visits of the control group = 91; intervention group = 87 visits. For the counting of interventions, the presence of at least one intervention traced in the medical record was considered positive. Multiple interventions on the same need within the same visit were not considered.

(*) P < .05.

In the intervention group, a statistically significant decrease in unplanned visits was recorded during the follow-up period (P < .05), and a statistically significant increase in the number of identified needs during each home visit and documented interventions in the medical records was observed. These included those related to emotional and relational aspects, such as depression and anxiety, as well as issues with family relationships (P < .001).

Symptom Burden and Quality of Life

Table 4 describes the overall e-IPOS scores at T0 and T3, which correspond to the first and fourth assessments, respectively, as per the study’s weekly recall. Patients in the intervention group reported overall scores, with an average of 19.4 points out of a maximum of 68 points at T0 and an average overall score of 12.0 points at T3. However, a statistically significant decrease (P < .001) in symptom burden and patient-perceived issues was observed over the course of the follow-up period (4 weeks).

Table 4.

Overall e-IPOS Scores of Patients in the Intervention Group at T0 and T3.

Overall e-IPOS score	T0		T3		T test
Overall e-IPOS score	Mean (DS)	Median (IQR)	Mean (DS)	Median (IQR)	P value
	19.4 (8.69)	18.5 (8.25)	14.1 (7.55)	12.0 (10)	<.001*

Apparently, the completion of the e-IPOS did not seem to have any effect on the patient’s perceived quality of life. Table 5 shows the mean and median scores related to symptoms, emotional and physical functioning, and overall quality of life reported by patients enrolled in both study groups at T0 and T3 on the EORTC-QLQ-C15-PAL questionnaire. In both groups, no statistically significant differences over time were observed for any of the factors investigated by the questionnaire.

Table 5.

Patients’ EORTC-QLQ-C15-PAL Scores at T0 and T3.

EORTC QLQ-C15-PAL	Control Group				Wilcoxon	Intervention group				Wilcoxon
	T0		T3		Wilcoxon	T0		T3		Wilcoxon
	Mean (DS)	Median (IQR)	Mean (DS)	Median (±IQR)	P-Value	Mean (DS)	Median (IQR)	Mean (DS)	Median (±IQR)	P-Value
Global quality of life	45.0 (38.5)	41.7 (58.3)	36.7 (34.1)	33.3 (58.3)	.208	56.7 (17.9)	59.3 (16.7)	55.0 (27.3)	66.7 (16.7)	1.000
Physical function	42.7 (29.8)	40.0 (44.9)	38 (27.9)	30.0 (26.7)	.599	35.3 (18.6)	33.3 (31.7)	38 (22.9)	30.0 (26.6)	.675
Emotional function	60.8 (30.9)	58.4 (39.5)	46.7 (40.7)	41.7 (62.4)	.178	75.0 (24.8)	75.0 (45.8)	72.5 (31.4)	83.3 (29.1)	.787
Dyspnoea	20.0 (23.3)	16.7 (33.3)	26.7 (21.1)	33.3 (25.0)	.710	26.7 (30.6)	33.3 (33.3)	20.0 (32.2)	.0 (33.3)	.346
Pain	53.3 (51.7)	50.0 (16.7)	51.7 (29.9)	58.3 (45.8)	1.000	41.7 (38.7)	41.7 (62.5)	31.7 (28.8)	33.3 (41.7)	.201
Insomnia	36.7 (26.3)	33.3 (33.3)	33.3 (27.2)	33.3 (50.0)	.345	26.7 (21.1)	33.3 (25.0)	26.7 (30.6)	33.3 (33.3)	.850
Fatigue	80.0 (23.3)	88.9 (33.3)	73.3 (27.8)	88.9 (41.7)	.444	66.7 (27.2)	66.7 (91.7)	64.4 (30.5)	61.2 (97.2)	.789
Appetite loss	53.3 (42.2)	66.7 (83.3)	40.0 (37.8)	33.3 (50.0)	.399	33.3 (35.1)	33.3 (58.3)	36.7 (42.9)	16.7 (66.7)	.581
Nausea and vomiting	33.3 (40.1)	16.7 (50.0)	30.0 (39.9)	16.7 (41.7)	.586	13.3 (20.5)	.00 (16.7)	10.0 (21.1)	.00 (.00)	.789
Constipation	30.0 (33.1)	33.3 (33.3)	23.3 (31.6)	16.7 (33.3)	.371	26.7 (37.9)	.00 (58.3)	30 (36.7)	16.7 (58.3)	1.000

Discussion

This pilot study was conducted to assess the feasibility of integrating the administration of the e-IPOS into the routine care processes of home-based palliative cancer care at the INT, where such an implementation has not been previously attempted. To our knowledge, the current study is the first feasibility study of an e-PROM system involving palliative care patients with cancer at home in Italy.

Despite the numerous challenges faced by end-of-life research, the data from this pilot study showed that the administration of the e-IPOS via touchscreen computers in clinical practice was technically feasible for cancer patients in home palliative care. In fact, there was a high recruitment rate (74.19%) and a drop-out rate of 13.04% related solely to patient death, consistent with studies conducted in the palliative care setting. ^44-49 A high e-IPOS response rate and a high level of completeness of the responses were found, confirming that routinely collecting data through this tool was feasible and accepted by terminal cancer patients.

The compilation of the e-IPOS was primarily intended to facilitate the timely assessment and management of patients’ symptoms and problems by health care professionals. Additionally, it aimed to encourage patients to better self-assess their symptoms and the challenges related to their disease.

The integration of the e-IPOS system suggested a significant positive impact on monitoring, assessing, and managing patient symptoms and issues, especially notable in tracking data within electronic clinical records. Although the increase in the number of assessments and interventions due to this integration does not conclusively indicate a qualitative improvement in assessment and clinical actions targeted at the assisted person, it is certain that the introduction of the e-PROM has led to more complete and in-depth clinical documentation. This enhancement in documentation has improved the traceability of patients’ needs, suggesting a potential indirect benefit to the quality of care provided, potentially leading to superior patient outcomes and a more efficient allocation of healthcare resources, as suggested by previous literature.^18,20 This approach was particularly effective in addressing emotional and relational issues such as depression, anxiety, and family relationships. The broader range of examined areas with e-IPOS suggested that some symptoms and issues crucial to quality of life are often unmeasured or underestimated by clinicians during visits, as outlined by other previous studies.^8-10 Additionally, after 4 weeks of implementation, a statistically significant decrease in unplanned home visits was observed. This could not only underscore the effectiveness of the implemented system in enhancing patient care and monitoring but also imply a more proactive approach to managing patient conditions, potentially preventing acute episodes that necessitate unscheduled visits.

Concurrently, in the intervention group, a significant decrease in the overall e-IPOS score was noted, indicating a reduction in the patients’ perceived burden of symptoms and problems. The e-IPOS system, which also allows patients to answer open questions, led to reports of disease concerns, treatment management, and family tension. The expression of such concerns, along with the decrease in overall symptom burden over time and the significant increase in assessments and interventions recorded for psychological and relational reasons, offers initial insights regarding the extent of the impact of the introduction of the e-IPOS system on patient care in home palliative care. These results align with the existing literature on the effectiveness of e-PROMs for assisting patient communication about emotional, familial, and illness perspectives.^8-10

It appears that completing the e-IPOS had no discernible impact on the patients’ perceived quality of life or performance status. The limited follow-up time due to the patients’ terminal status and disease trajectory did not allow the detection of all the potential effects of the e-IPOS on the overall perception of quality of life, as patients’ completion of the relevant questionnaire did not significantly differ.

Strengths and Limitations

This is a novel study in Italy investigating the feasibility of using the e-IPOS for people with a terminal illness assisted at home. This study has several limitations. First, the selection of eligible patients, mainly assessed by clinicians trained in eligibility criteria, might have introduced bias into the sample. Second, study adherence and completion rates may have been influenced by the organizational structure, wherein clinicians prompted patients to complete the e-IPOS weekly during routine home visits. Finally, the study’s quantitative approach restricted thorough investigation of patients’ perspectives on the feasibility, usability, usefulness, and impact of the e-IPOS after usage. Additionally, the nonrandomized nature, single-center nature, and sample size of the present study limit the generalizability of the data about the effects of administration of the e-IPOS on the care process and quality of life.

Conclusion

This research suggested that recruiting people with advanced cancer in home palliative care for a study on the implementation of an e-PROM system is feasible. The preliminary results indicate improved traceability in the assessment and intervention of patients’ symptoms and issues, which are often overlooked in standard care. Notably, the burden of these symptoms and unscheduled visits significantly decreases in patients using the e-IPOS. Future studies should be fully powered to investigate the feasibility of implementing the e-IPOS in routine care and assess patients’ perceptions of its use, aiming to better understand the clinical benefits for patients receiving palliative care.

Footnotes

Author Contributions

All the authors contributed to writing and reviewing the manuscript; LC, ML and TC contributed to the study conception and design and were responsible for the protocol and study procedure design. After the health care team took an initial approach with the participants, the LC discussed the study in more detail with them by telephone. LC, DR and SC recruited the participants, visited them at home to obtain written consent, administered the questionnaires and, if necessary, clarified any doubts about completion. LC, DR and IB were responsible for the data analysis and wrote the paper. ML, AC and TC commented on previous versions of the manuscript. All the authors have read, commented on, and approved the final manuscript.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Letteria Consolo

Daniele Rusconi

Ilaria Basile

References

Johnston

Patrick

Devji

et al. Chapter 18: patient-reported outcomes. cochrane training. https://training.cochrane.org/handbook/current/chapter-18#section-18-1. Accessed 5 February 2023.

Nguyen

Butow

Dhillon

, et al.

Using patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in routine head and neck cancer care: what do health professionals perceive as barriers and facilitators?

J Med Imaging Radiat Oncol. 2020;64(5):704-710. doi:10.1111/1754-9485.13048

Lavallee

Chenok

Love

, et al. Incorporating patient-reported outcomes into health care to engage patients and enhance care. Health Aff. 2016;35(4):575-582. doi:10.1377/HLTHAFF.2015.136

Consolo

Colombo

Basile

, et al. Barriers and facilitators of electronic patient-reported outcome measures (e-PROMs) for patients in home palliative cancer care: a qualitative study of healthcare professionals’ perceptions. BMC Palliat Care. 2023;22:111. doi:10.1186/s12904-023-01234-0

Di Maio

Basch

Denis

, et al. The role of patient-reported outcome measures in the continuum of cancer clinical care: ESMO Clinical Practice Guideline. Ann Oncol. 2022;33(9):878-892. doi:10.1016/J.ANNONC.2022.04.007

Warsame

Fruth

Croghan

, et al. Patient-reported outcome driven case management system for hematology — a prospective study. Blood. 2018;132(Supplement 1):719. doi:10.1182/BLOOD-2018-99-118744

Warrington

Absolom

Conner

, et al. Electronic systems for patients to report and manage side effects of cancer treatment: systematic review. J Med Internet Res. 2019;21(1):e10875. doi:10.2196/10875

Yang

Manhas

Howard

Olson

. Patient-reported outcome use in oncology: a systematic review of the impact on patient-clinician communication. Support Care Cancer. 2018;26(1):41-60. doi:10.1007/S00520-017-3865-7

Greenhalgh

Gooding

Gibbons

, et al. How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis. J Patient Rep Outcomes. 2018;2:42. doi:10.1186/S41687-018-0061-6

10.

Nguyen-Nielsen

Moller

Tjonneland

Borre

. Patient-reported outcome measures after treatment for prostate cancer: results from the Danish Prostate Cancer Registry (DAPROCAdata). Cancer Epidemiol. 2020;64:101623. Research Support, Non-U.S. Gov’t. doi:10.1016/j.canep.2019.101623

11.

Antunes

Harding

Higginson

EUROIMPACT . Implementing patient-reported outcome measures in palliative care clinical practice: a systematic review of facilitators and barriers. Palliat Med. 2014;28(2):158-175. doi:10.1177/0269216313491619

12.

Antunes

Rodrigues

Higginson

Ferreira

. Outcome measurement-a scoping review of the literature and future developments in palliative care clinical practice. Ann Palliat Med. 2018;7(Suppl 3):S196-S206. doi:10.21037/APM.2018.07.03

13.

Dudgeon

. The Impact of measuring patient-reported outcome. J Palliat Med. 2018;21(S1):S76. doi:10.1089/jpm.2017.0447.

14.

Heydari

Hojjat-Assari

Almasian

Pirjani

. Exploring health care providers’ perceptions about home-based palliative care in terminally ill cancer patients. BMC Palliat Care. 2019;18(1):66. doi:10.1186/s12904-019-0452-3

15.

Consolo

Castellini

Cilluffo

Basile

Lusignani

. Electronic patient-reported outcomes (e-PROMs) in palliative cancer care: a scoping review. J Patient Rep Outcomes. 2022;6(1):102. doi:10.1186/s41687-022-00509-z

16.

Tang

Pang

, et al. Implementing symptom management follow-up using an electronic patient-reported outcome platform in outpatients with advanced cancer: longitudinal single-center prospective study. JMIR Form Res. 2022;6(5):e21458. doi:10.2196/21458

17.

Sørensen

Sjøgren

Stine

, et al. Patient-reported outcome measures (PROMs) and palliative-care clinician reported outcomes (ClinROs) mutually improve pain and other symptoms assessment of hospitalized cancer-patients. Scand J Pain. 2022;22(3):569-577. Research Support, Non-U.S. Gov’t. doi:10.1515/sjpain-2021-0162

18.

Meirte

Hellemans

Anthonissen

, et al. Benefits and disadvantages of electronic patient-reported outcome measures: systematic review. JMIR Perioper Med. 2020;3(1):e15588. doi:10.2196/15588

19.

Karamanidou

Natsiavas

Koumakis

, et al. Electronic patient-reported outcome–based interventions for palliative cancer care: a systematic and mapping review. JCO Clin Cancer Inform. 2020;4(4):647-656. doi:10.1200/cci.20.00015

20.

Benze

Nauck

Alt-Epping

, et al. PROutine: a feasibility study assessing surveillance of electronic patient reported outcomes and adherence via smartphone app in advanced cancer. Ann Palliat Med. 2019;8(2):104-111. doi:10.21037/APM.2017.07.05

21.

Zylla

Gilmore

Steele

, et al. Collection of electronic patient-reported symptoms in patients with advanced cancer using Epic MyChart surveys. Support Care Cancer. 2020;28(7):3153-3163. doi:10.1007/s00520-019-05109-0

22.

Bolzani

Ramsenthaler

Hodiamont

Burner-Fritsch

Bausewein

. Monitoring of palliative care symptoms and concerns in specialized palliative home care using an electronic version of the integrated palliative care outcome scale (Palli-MONITOR): protocol for a mixed-methods study. BMJ Open. 2021;11(6):e042266. doi:10.1136/BMJOPEN-2020-042266

23.

Burner-Fritsch

Bolzani

Hriskova

Kolmhuber

Bausewein

Hodiamont

. Challenges developing an electronic patient-reported outcome measurement for palliative home care: a qualitative interview and focus group study. Palliat Med. 2023;37(2):265-274. doi:10.1177/02692163221141487

24.

Bradshaw

Santarelli

Mulderrig

, et al. Implementing person-centred outcome measures in palliative care: an exploratory qualitative study using Normalisation Process Theory to understand processes and context. Palliat Med. 2021;35(2):397-407. doi:10.1177/0269216320972049

25.

Bolzani

Kupf

Hodiamont

Burner-fritsch

Bausewein

Ramsenthaler

. Measurement equivalence of the paper-based and electronic version of the integrated palliative care outcome scale (IPOS): a randomised crossover trial. 2023;37(5):760. doi:10.1177/02692163231157871, Published online.

26.

Frankenberg

. Attrition rates, reasons and predictive factors in supportive and palliative. Bone. 2012;23(1):1-7. doi:10.1002/cncr.27854, Attrition

27.

White

Noble

Watson

Swan

Nelson

Johnson

. Optimised clinical study recruitment in palliative care: success strategies and lessons learned. BMJ Support Palliat Care. 2020;10(2):216-220. doi:10.1136/BMJSPCARE-2019-001820

28.

Dunleavy

Preston

Walshe

. Health care professional recruitment of patients and family carers to palliative care randomised controlled trials: a qualitative multiple case study. Palliat Med. 2023;37(10):1540-1553. doi:10.1177/02692163231197917

29.

Brunelli

Borreani

Caraceni

, et al. PATIENT VOICES, a project for the integration of the systematic assessment of patient reported outcomes and experiences within a comprehensive cancer center: a protocol for a mixed method feasibility study. Health Qual Life Outcome. 2020;18(1):252. doi:10.1186/s12955-020-01501-1

30.

Thomas

. Quasi-experimental design | definition, types and examples. 2024. Published January 22 https://www.scribbr.com/methodology/quasi-experimental-design/ Accessed 3 March 2024.

31.

Hoffmann

Glasziou

Barbour

Macdonald

. Better reporting of interventions: template for intervention description and replication. TIDieR ) checklist and guide. 2014;1687(March):1-12. doi:10.1136/bmj.g1687

32.

Tufanaru

Munn

Aromataris

Campbell

Hopp

. Chapter 3: systematic reviews of effectiveness. In: Aromataris

Munn

, eds. JBI Manual for Evidence Synthesis. Adelaide, Australia: JBI; 2020. doi:10.46658/JBIMES-20-04

33.

Birkett

Day

. Internal pilot studies for estimating sample size. Stat Med. 1994;13(23-24):2455-2463. doi:10.1002/sim.4780132309

34.

Machin

Campbell

Tan Beng

Tan Huey

. Sample Size for Clinical, Laboratory and Epidemiology Studies. 4th ed. Hoboken, NJ: Wiley John and Sons; 2018.

35.

Murtagh

Ramsenthaler

Firth

, et al. A brief, patient-and proxy-reported outcome measure in advanced illness: validity, reliability and responsiveness of the integrated palliative care outcome scale (IPOS). Palliat Med. 2019;33(8):1045-1057. doi:10.1177/0269216319854264

36.

Högberg

Alvariza

Beck

. Patients’ experiences of using the Integrated Palliative care Outcome Scale for a person-centered care: a qualitative study in the specialized palliative home-care context. Nurs Inq. 2019;26(4):e12297. doi:10.1111/NIN.12297

37.

Veronese

. The Italian version of OACC: from needs assessment to palliative care planning. Rivista Italiana di Cure Palliative. 2020;22(3):147-158. https://www.ricp.it/archivio/3439/articoli/34277/, Accessed 8 January 2024.

38.

Veronese

Rabitti

Costantini

Valle

Higginson

. Translation and cognitive testing of the Italian Integrated Palliative Outcome Scale (IPOS) among patients and healthcare professionals. PLoS One. 2019;14(1):1-14. doi:10.1371/journal.pone.0208536

39.

Groenvold

Petersen

Aaronson

, et al. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. Eur J Cancer. 2006;42(1):55-64. doi:10.1016/j.ejca.2005.06.022

40.

Abernethy

Shelby-James

Fazekas

Woods

Currow

. The Australia-modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481]. BMC Palliat Care. 2005;4(1):7. doi:10.1186/1472-684X-4-7

41.

Ferris

Balfour

Bowen

, et al. A model to guide Hospice palliative care: based on national principles and norms of practice. 2013. https://www.chpca.ca/wp-content/uploads/2019/12/norms-of-practice-eng-web.pdf. Accessed 17 November 2023.

42.

Registered Nurses’ Association of Ontario . End-of-life care during the last days and hours. 2011. https://rnao.ca/bpg/guidelines/endoflife-care-during-last-days-and-hours. Accessed 17 November 2023.

43.

TiCuro reply. Accessed November 17, 2023. https://www.reply.com/ticuro-reply/it/

44.

Gabbard

McLouth

Brenes

, et al. Rapid electronic capturing of patient-reported outcome measures in older Adults with end-stage renal disease: a feasibility study. Am J Hosp Palliat Care. 2021;38(5):432-440. doi:10.1177/1049909120954805

45.

Abshire

Dinglas

Cajita

MIA

Eakin

Needham

Himmelfarb

. Participant retention practices in longitudinal clinical research studies with high retention rates. BMC Med Res Methodol. 2017;17(1):30. doi:10.1186/s12874-017-0310-z

46.

Walters

Bonacho dos Anjos Henriques-Cadby

Bortolami

, et al. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7(3):e015276. doi:10.1136/bmjopen-2016-015276

47.

Hernar

Graue

Richards

, et al. Electronic capturing of patient-reported outcome measures on a touchscreen computer in clinical diabetes practice (the DiaPROM trial): a feasibility study. Pilot Feasibility Stud. 2019;5(1):29. doi:10.1186/s40814-019-0419-4

48.

Langford

Ashe

Fleig

, et al. Back to the future – feasibility of recruitment and retention to patient education and telephone follow-up after hip fracture: a pilot randomized controlled trial. Patient Prefer Adherence. 2015;9:1343. doi:10.2147/PPA.S86922, Published online September 2015

49.

Blatch-Jones

Pek

Kirkpatrick

Ashton-Key

. Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study. BMJ Open. 2018;8(9):e022233. doi:10.1136/bmjopen-2018-022233

50.

Unni

Coles

Lavallee

Freel

Roberts

Absolom

. Patient adherence to patient-reported outcome measure (PROM) completion in clinical care: current understanding and future recommendations. Qual Life Res. 2024;33:281-290. doi:10.1007/s11136-023-03505-y

51.

Groenvold

Petersen

M. A.

“Addendum to the EORTC QLQ-C30 scoring manual: scoring of the EORTC QLQ-C15-PAL.” Brussels, Belgium: EORTC Quality of Life Unit (2006).

52.

Fayers

Aaronson

Bjordal

Groenvold

Curran

Bottomley

. EORTC QLQ-C30 Scoring Manual: This Manual Is Intended to Assist Users with Scoring Procedures for the QLQ-C30 Version 3 and Earlier, and the QLQ Supplementary Modules. 3rd ed. Brussels, Belgium: EORTC; 2001. scoring manual this manual is inten.pdf.files/3270/Fayers et al. - 2001 - EORTC QLQ-C30.

53.

JAMOVI . The jamovi project. 2023. Published online 2023 https://www.jamovi.org. Accessed 2 November 2023.

Implementation of the e-IPOS in Home Palliative Cancer Care: A Quasiexperimental Pilot Study

Abstract

Introduction

Aim

Outcomes

Design

Setting/participants

Results

Conclusion

Keywords

Introduction

Aim

Methods

Study design

Setting

Participants

Recruitment Procedures

Sampling

Measures

Intervention

Standard Palliative Care Plus e-IPOS (Intervention)

Standard Palliative Care (Control)

Outcomes

Primary Outcomes

Secondary Outcomes

Statistical Analysis

Ethical Consideration

Results

Acceptability and Feasibility of Using the e-IPOS

Traceability in the Clinical Documentation of Assessments and Interventions Performed

Symptom Burden and Quality of Life

Discussion

Strengths and Limitations

Conclusion

Footnotes

Author Contributions

Declaration of Conflicting Interests

Funding

ORCID iDs

References