Results of a Feasibility Pilot Pragmatic Trial Implementing Palliative Care in Skilled Nursing Facilities

Abstract

Background:

Seriously ill older adults are admitted for post-acute care in skilled nursing facilities (SNFs) for curative, rehabilitative treatments, yet experience high rates of re-hospitalization, and death. The primary palliative care in post-acute care (PPC-PAC) intervention is an evidence-based approach designed to help people with serious illness align treatment plans with goals of care, optimize quality of life, and improve satisfaction with their care.

Objectives:

To conduct a preliminary study and evaluate the feasibility of implementing the PPC-PAC intervention in the post-acute care SNF setting.

Design:

Two-group, multisite feasibility pilot pragmatic clinical trial with a non-equivalent design.

Measurements:

Primary outcome measures—eligibility, enrollment, and data collection rates; consultation satisfaction; and fidelity. Effectiveness outcome measure—quality of life using the Palliative Outcomes Scale version 2.

Results:

Close to 70% of those who were eligible and approached by the study team (45/65) enrolled in the trial throughout 12 SNFs in the Northeast and Mid-Atlantic United States. Thirty-five were enrolled from intervention sites; 10 were enrolled from control sites (usual care). Most participants (80%) expressed general satisfaction with PPC-PAC, and 90% of clinicians implemented the PPC-PAC intervention as intended. At 21 days follow-up, there were no significant differences in effectiveness outcomes.

Conclusion:

Implementation of the PPC-PAC intervention proved to be feasible and acceptable among older adults and clinicians. Future research should focus on testing the effectiveness of PPC-PAC and explore strategies for optimal intervention implementation and SNF staff engagement in the post-acute care setting.

Key Message

Skilled nursing facility services may not fully attend to the complex needs of seriously ill older adults after hospitalization. To address this, we conducted a preliminary study of a palliative care intervention during post-acute skilled nursing facility care; findings indicate it is feasible and acceptable among patients and their surrogates.

Introduction

Older adults are often admitted to skilled nursing facilities (SNFs) for curative and rehabilitative post-acute care after a hospitalization. However, close to one-third of Medicare decedents use SNF care in the 6 months prior to death and one in ten die while receiving care in SNFs.¹ SNF care is associated with high rates of rehospitalization, aggressive treatments (e.g., feeding tubes, intravenous fluids), and unrecognized or undertreated symptoms.^2–4 To some extent, the poor outcomes occur because SNF care is short term, and its purpose is to support recovery after a hospitalization primarily through skilled rehabilitation and curative specialized treatments.⁵ As a result, SNF services may not fully address the complex physical and psychosocial needs of older adults living with serious chronic illnesses after hospital transition.⁶ Palliative care is supportive care to ameliorate symptoms, align treatment plans with goals of care, and address quality of life; this approach has the potential to improve care and quality of life for older adults with serious illness in SNFs.⁷

Nursing homes provide both post-acute SNF care and long-term residential care. Studies among long stay nursing home residents indicate that palliative care consultations by external specialists reduce hospitalizations,^8,9 providing evidence that this approach is effective in improving processes and outcomes. However, no empirical research has reported outcomes among those receiving post-acute SNF care. Further, there have been multiple calls for providing comprehensive access to palliative care for all older adults in nursing homes—both those in SNF and long-term care.^7,10 A challenge to expanding palliative services is the inadequate supply of specialists to meet the suggested need. One solution is enhancing palliative care skillset among SNF primary care providers.

To meet this need, we developed, manualized, and pilot tested the primary palliative care in post-acute care (PPC-PAC) intervention using evidence-based guidelines to address the needs of older adults during SNF care. Its implementation strategy included: training for primary care providers, timely identification of older adults on admission to SNF care with serious illness and palliative care needs, a protocolized palliative care encounter, and documentation templates embedded in the electronic medical record. Details about the training for primary care providers and the study design have been published elsewhere.^11,12 This article describes the outcomes of a feasibility pilot pragmatic clinical trial of the PPC-PAC program.¹³ This is the first study to examine an evidence-based palliative care intervention created for seriously ill older adults receiving post-acute SNF care.

Methods

From October 2019 to December 2022, we conducted a two-group, multisite, non-randomized cluster pilot clinical trial of the PPC-PAC intervention versus usual care.¹³ Due to the COVID-19 outbreak, all study activities were halted from March 2020 to May 2021. We followed the Consolidated Standards of Reporting Trials (CONSORT [https://www.equator-network.org/reporting-guidelines/consort/]) reporting guideline. The study was registered on clinicaltrials.gov (NCT03958552), and it was approved by the Institutional Review Boards at University of Pennsylvania and the University of Maryland, Baltimore.

Study setting and participants

We conducted the trial at 12 SNFs co-located in continuing care retirement communities in the mid-Atlantic and Northeastern United States owned by the same organization. The organization employed a nurse practitioner at each community who provided primary care to SNF patients during daytime hours. One full-time specialty palliative care nurse practitioner was available for several participating SNFs—typically within a few days—to consult with patients onsite. These specialty consults required an order from a primary care provider.

At the inception of the clinical trial, in-person recruitment and enrollment were performed by study staff. In keeping with the pragmatic nature of the trial, we used broadcast notification with an opt-out option for study enrollment. Each SNF displayed an approved study flyer which was also included in each older adult’s admission packet and study staff asked potential participants or their surrogate if they wanted to opt out. Details about this approach have been previously published.¹⁴ Due to the COVID-19 pandemic, procedures were modified when the study resumed in May 2021 to accommodate virtual recruitment which required verbal consent. Upon resuming study activities, the study team re-oriented all SNF nurse practitioners and staff to the study.

During the initial screening, adults over age 60 newly admitted for post-acute care were identified by a liaison at each site (usually the social worker). A research team member then initiated further screening for eligibility in collaboration with the SNF nurse practitioner to identify participants based on the following¹: ≥1 serious illness diagnoses (Supplementary Table S1) and a² ≥1 global indicator for palliative care consultation (Supplementary Table S2). Eligibility criteria are included in Supplementary Table S3. Patients were not excluded based on cognitive ability. If SNF staff reported a participant was unable to self-report, study measures were elicited via surrogate’s response. We originally aimed to enroll 80 participants; however, we reduced the sample size in half due to effects of the COVID-19 pandemic.¹⁵

Assignment

We assigned participating sites to the intervention or control group because PPC-PAC was applied at the SNF level, based on the nurse practitioner’s exposure to the PPC-PAC training. We used a 2:1 (intervention:control) assignment ratio to gain as much experience as possible implementing PPC-PAC. The unit of analysis was the individual older adult. At the inception of the study in October 2019, eight sites were assigned to the intervention and four assigned to control. However, due to changes in study site nurse practitioners, only four original intervention sites remained in May 2021 after resuming study activities during the COVID-19 pandemic. The remaining seven were reassigned to control as the nurse practitioners were not exposed to the PPC-PAC training. One SNF chose to not continue in the study due to staff turnover. Figure 1 displays the assignment schema.

FIG. 1.

Assignment schema.

Intervention

Intervention Group (PPC-PAC). Intervention facility nurse practitioners received additional palliative care education and training described in detail previously.¹¹ We delivered PPC-PAC education via five 1-hour self-paced online learning modules, a day-long communication skills workshop using role play and simulation, and ongoing monthly virtual meetings to support the online learning and communication workshop. Content and skills training included assessing and managing symptoms, conducting goals of care discussions, assisting with decision making and communicating findings with SNF staff. Nurse practitioners were oriented to a progress note template embedded in the electronic health record to document in detail the palliative care encounter which was available for all staff to view. In addition, we provided “on the go” pocket-size serious illness conversation guides and access to online symptom management tools. Nurse practitioners provided routine primary care and delivered the intervention to study participants.

Control Group (Usual care). Participants in the control group received routine primary care by nurse practitioners including all support deemed necessary by the SNF staff including specialty palliative care.

Data collection

Participating patients or their surrogate respondent completed questionnaires with trained study staff in person or on the telephone at baseline and 21 days. Demographic data were collected at baseline. Data collectors were not blinded to treatment group.

Primary outcome measures

To measure feasibility, we calculated the number of eligible older adults at each site per number of admissions, contact rate, enrollment rate, intervention visit completion rates, follow-up data collection rates at 14–21 days, and percentage of completed assessments of the effectiveness outcome measure.

We used the Consultation Satisfaction Questionnaire (CSQ) to measure acceptability.^16,17 The CSQ is an 18-item questionnaire. Each item is measured on 1–5 Likert scale; the average is used to calculate the overall score; higher scores indicate greater satisfaction. The measure consists of four subscales: general satisfaction; professional care; depth of relationship; and perceived time/length of consultation. A CSQ score of 4 or greater indicated participant acceptability.

Fidelity measure

We measured nurse practitioner fidelity to the standardized PPC-PAC protocol on 20% of the sample and used 90% adherence to the six steps of the PPC-PAC intervention as a benchmark of success. We also measured SNF staff adherence to PPC-PAC recommendations at 30 days post-intervention.

Effectiveness outcome measure

We measured the effect of the PPC-PAC intervention on quality of life using the Palliative Outcomes Scale version 2 (POSv2) at 14–21 days after baseline data collection. The POSv2 (https://pos-pal.org/) is widely used in palliative care practice, research, and teaching.¹⁸ It is a brief, 10-item instrument that measures quality of life across physical, psychological, spiritual, and information and support needs. Each item is measured on a 0–4 scale, and total scores range from 0 to 40; higher scores are indicative of more palliative care needs. Its use has been validated among patients receiving palliative care with advanced serious illnesses.^19–21

Data analysis

We used descriptive statistics (mean, standard deviation [SD], range, frequency, and proportion) for each variable to summarize the data and to assess PPC-PAC feasibility and acceptability. An intent-to-treat approach was applied in analysis. Prior to hypothesis testing, we checked the normality, outliers, and missing values to ensure the assumptions were met. We also examined the baseline differences between the PPC-PAC and usual care groups in demographic variables and health conditions. We used linear mixed models (LMMs) to test whether changes in outcome measures (POSv2) from baseline to the end of intervention were significantly different between PPC-PAC and usual care groups. Mixed models allowed inclusion of all available data if an individual dropped out and was not assessed at end of intervention. LMMs included a random intercept to account for correlation between the repeated measurements. The clustering of participants in the same facility was tested and was not included in the final model due to its non-significance (p = 0.248). The fixed effects included group, time indicator variable (baseline and end of intervention), and the interaction between group and time. The significance of the group-by-time interaction tests whether the change (baseline to end of intervention) differs between PPC-PAC and usual care groups. Data were analyzed using IBM SPSS Statistics (version 29).

Results

Sample characteristics

Participants were assigned to the PPC-PAC group (n = 35) and control group (n = 10) at the SNF level based on the nurse practitioner’s exposure to the PPC-PAC training. Baseline characteristics for control and intervention groups were very similar in terms of age, sex, race, and ethnicity. Mean age for the control group was 87 (SD = 5) compared with 86 (SD = 5) for the intervention group. Most participants were female with 7 (70%) in the control group and 27 (77%) in the intervention group. Overall, 98% of participants were White and all participants were non-Hispanic/non-Latino. About half of the participants were widowed and 44% married or in domestic partnership (Table 1). Over one-third of the sample (n = 16 [36%]) qualified for the study due to multiple chronic conditions. Other major serious illnesses included organ failure and cancer (n = 13 [28%]) followed by dementia (n = 8 [18%]) and other neurological disorders (n = 8 [18%])). Decline in function was the most common indicator of need for palliative care among older adults in the sample (n = 21 [47%]). Almost a quarter of the sample (n = 10 [22%]) were appropriate for palliative care consultation based on clinician assessment (e.g., symptoms of advance care planning). More than half of the participants (n = 26 [58%]) had decision-making capacity, whereas 19 (42%) relied on a legally authorized representative for study participation.

Table 1.

Descriptive Statistics of Recently Hospitalized Patients Admitted to Skilled Nursing Facilities for Post-Acute Care

Characteristic	Full trial population	Intervention group	Control group
	(n = 45)	(n = 35)	(n = 10)
Age mean (SD)	86 (5)	86 (5)	87 (5)
Sex (n, %)
Female	34 (76%)	27 (77%)	7 (70%)
Male	11 (24%)	8 (23%)	3 (30%)
Race (n, %)
Black/African American	1 (2%)	1 (3%)	0 (0%)
White	44 (98%)	34 (97%)	10 (100%)
Ethnicity (n, %)
Not Hispanic or Latino	45 (100%)	45 (100%)	45 (100%)
Marital status (n, %)
Divorced	2 (4%)	0 (0%)	2 (20%)
Married or domestic partnership	20 (44%)	17 (49%)	3 (30%)
Single—never married	1 (2%)	1 (3%)	0 (0%)
Widowed	22 (49%)	17 (49%)	5 (50%)
Decision-making capacity (n, %)
No	19 (42%)	15 (43%)	4 (40%)
Yes	26 (58%)	20 (57%)	6 (60%)
Serious illness (n, %)
Dementia	8 (18%)
Major organ failure or cancer	13 (28%)
Neurological	8 (18%)
Multiple chronic conditions	16 (36%)
Cardiac + Cancer	1
Cardiac + Cardiac	1
Cardiac + Renal	2
Dementia + Cardiac	2
Dementia + Neurological	1
Neurological + Cancer	1
Neurological + Cardiac	1
Respiratory + Cardiac	7
Global indicator of need for palliative care (n, %)
Decline in function	21 (47%)
Clinician assessment	10 (22%)
Complex care requirements	7 (16%)
Frequent hospitalization or admissions	3 (7%)
Feeding intolerance	3 (6%)
Unintended decline in weight	1 (2%)

Feasibility and acceptability

The primary outcome measures are presented in Table 2. Of the 318 potential participants, 37% (n = 119) qualified for the study. Of those who were eligible and able to be approached by the study team (n = 65), 69% (n = 45) enrolled in the study (Fig. 2). Through the electronic health record and primary care provider report, we were able to confirm that 51% (n = 18) of older adults in the intervention group received the PPC-PAC intervention. Among all 45 participants, we collected 60% of the effectiveness outcome data at follow up.

Table 2.

Primary Outcome Measures

Feasibility	Rate
Patients who meet eligibility criteria	37%
Eligible n = 119
Skilled nursing facility patients n = 318
Eligible patients who consent to participate	38%
Consent n = 45
Eligible n = 119
Eligible patients approached who enroll	69%
Consent n = 45
Eligible and able to approach/reach n = 65
Intervention completion	34%
Received intervention n = 18
Consent (intervention group) n = 35
Effectiveness outcome measure data collection
Baseline and follow up complete n = 27	60%
Consent n = 45
Acceptability	Score
Consultation satisfaction mean score (range 1–5; higher score = greater satisfaction); n = 10 received intervention and answered survey
Total score	3.89
General satisfaction	4.03
Professional care satisfaction	4.13
Depth of relationship satisfaction	3.95
Perceived time spent satisfaction	2.95

FIG. 2.

Consort diagram.

Using a CSQ cutoff score of 4.0 (range 0–5), 73% of participants reported general satisfaction with the consultation (range 2.7–5) and 80% reported satisfaction with the professional care (range 2.6–4.8). Less were satisfied with the depth of the relationship (40% [range 3.2–5]) and the time spent during the consult (20% [range 2.0–4.0]).

Intervention fidelity

We were unable to collect data regarding SNF staff adherence to PPC-PAC recommendations due to COVID-19 related disruptions and lack of virtual access to the electronic health record. Review of templated palliative care notes in the SNF’s electronic health record (n = 8 [20%]) showed high fidelity to the PPC-PAC intervention with 90% of the intervention components being delivered as intended. During fidelity assessment, we noted that some nurse practitioners did not consistently document PCC-PAC communication to the interdisciplinary team and address follow-up (e.g., documentation of continued need for symptom assessment and management and ongoing goals of care discussions). In addition, in several instances when the patient was hospice-eligible, the hospice conversation was delayed because the patient or surrogate “was not ready.”

Effectiveness

At baseline, the mean quality of life POSv2 scores were similar for the control group (mean = 8.10, SD = 6.15) and the intervention group (mean = 9.22, SD = 4.53); the difference was not statistically significant (t⁴³ =.64, p = .528). At follow-up (14–21 days), the mean (SD) quality of life score POSv2 scores for the control group and intervention were 8.79 (5.11) and 10.03 (5.02), respectively. The change in the POSv2 score for the intervention group was not significantly different from the control group (p = .724) (Table 3).

Table 3.

Effectiveness Outcome Measure

Measure	Full trial population (n = 45)	Intervention group (n = 35)	Control group (n = 10)	p valuea
	Mean (SD)	Mean (SD)	Mean (SD)
Palliative outcome scale version 2
Baseline	8.97 (4.88)	8.86 (4.82)	9.05 (5.01)
Follow-up	9.66 (4.98)	10.29 (5.92)	9.16 (4.23)	0.724

^a Linear mixed model was used to evaluate the effect of intervention on POS score over time. The p value for the two-way interaction of study group and time was used to test the intervention effect over time.

Discussion

In this two-group, multisite, non-randomized feasibility pilot clinical trial, we found that an intervention to train nurse practitioners in palliative care skills relevant to older adults in post-acute SNF care is feasible and well accepted. The PPC-PAC intervention is novel because it is the first such intervention designed to reach seriously ill older adults in post-acute SNF care, and because it uses innovative methods for implementation. First, the approach to identifying seriously ill older adults with palliative care needs upon admission to SNF care is unique, because the intended focus of care is on rehabilitation. Second, our approach engaged existing primary care providers to enhance their palliative care skillset thus increasing patient access to palliative care in a setting with limited access to specialists in palliative care. Third, we sought to integrate clinical encounters into providers usual workflow, increasing its potential for future adoption.

The primary goal of this project was to establish the feasibility of the PCC-PAC intervention. The primary outcome measures indicated we successfully enrolled close to 70% of older adults who were approached. This demonstrates that patients and their families are willing to receive concurrent palliative and post-acute SNF care. Further, we found general satisfaction was high with PPC-PAC, and study participants were pleased with the professional aspect of care during the encounter. This may be due to in part to palliative care being explained as an essential layer of support for patients with serious illness and their families. One concern is the lower ratings of satisfaction related to the time spent in consultation and depth of relationship. This may be in part due to the care needs of people with serious illness as well as the extra demands on providers workload and needs to be explored in future work.

Past research has demonstrated that clinicians in SNFs and nursing homes find it difficult to determine when a patient may benefit from palliative care and few screening tools exist to assist in this process.²² Additionally, palliative care referrals can be especially challenging when patients are receiving SNF care. First, the length of stay may be too short to be approached for palliative care. Second, SNF care is intended to improve health and functional status; patients may interpret palliative care referral as a signal that clinicians are “giving up” on care.²³ However, we were able to identify potential needs for palliative care among a population at high risk for decline using evidence-based criteria for disease diagnosis and global indicators for palliative care needs.¹²

The COVID-19 pandemic created overwhelming clinical demands in SNF and nursing home care, and justifiably disrupted this research. Some feasibility measures were low: notably the targets for intervention completion (due to study team’s limited access to the medical record during after COVID-related delays) and for effectiveness data completion (due to loss to follow up). In addition, we were unable to determine what recommendations were integrated into participating older adults’ plan of care and we experienced significant provider turnover that created a barrier to study implementation. It is beyond the scope of this article to report all the barriers and possible solutions to implementing PPC-PAC; however, this work is ongoing. In addition, research suggests that successful implementation of complex interventions depends upon many factors including readiness for change and equipping SNF staff with skills needed for successful implementation.²⁴ Our experience highlights the importance of serious pre-study and ongoing partnership when conducting research in SNF care. Future research on the PPC-PAC intervention will incorporate rapid re-training to support incoming staff and use guidance for research partnerships such as the 10-step framework for Comparative Effectiveness Research.²⁵

The PPC-PAC intervention did not improve quality of life measured at 14–21 days compared with usual care; however, this trial was not powered for effectiveness, but rather for feasibility.^26,27 In both intervention and control groups, POSv2 scores were relatively low at baseline (indicating better quality of life) and worsened over time. We believe effectiveness to improve quality of life may depend upon a highly tailored intervention and longer term follow-up.

Limitations

There were several limitations to this clinical trial. The trial was conducted in continuing care retirement community SNF settings owned by one non-profit organization limiting its translation to other SNF settings. Our sample was small and represented a majority White, non-Latino/Latina, Hispanic, or Latin American population and findings may not be generalizable. This pilot trial was not randomized, and it is not possible to know if unknown confounders affected the outcomes we chose to measure. We were unable to approach about half of eligible participants and had a large amount of missing data, with higher rates after restarting the study during the COVID-19 pandemic. Further, we were unable to assess fidelity as intended. Despite these limitations, we were successful at conducting a feasibility pilot pragmatic clinical trial in a complex setting using validated outcome measures.

Conclusion

Overall, implementation of the PPC-PAC intervention proved to be a feasible and acceptable intervention for older adults in the post-acute SNF setting. Future research is needed to identify effective palliative care models for older adults in various SNF settings and explore barriers and facilitators to improve intervention implementation and facility engagement.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

This work was supported by the National Institute of Nursing Research of the National Institutes of Health under Award Number K23NR017663 and the Rita & Alex Hillman Foundation, New York.