ALIGN for Older Adults With Cancer in SNFs

Keywords

• Skilled Nursing Facility
• Caregiver

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Older patients with advanced cancer

  Older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities (SNF).

  Other: Assessing and Listening to Individual Goals and Needs (ALIGN)

• Experimental
  Caregivers of older patients with advanced cancer

  Caregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities.

  Other: Assessing and Listening to Individual Goals and Needs (ALIGN)

• No intervention
  Control Arm

  Control arm participants will receive enhanced usual care. Patients will be provided resources for advance care planning and interact with SNF staff and involved providers who may refer them to palliative care or hospice like previous rigorous palliative care trials.

Interventions

• OtherAssessing and Listening to Individual Goals and Needs (ALIGN)

  Assessing and Listening to Individual Goals and Needs (ALIGN). ALIGN utilizes the skills of palliative care social workers (PCSWs) trained in family and systems-level theory to address changing preferences for care, family distress, and to facilitate communication across care transitions to improve care aligned with preferences. A patient navigator supports the patient/caregiver and social worker dynamic by helping patients access care and resources. The intervention is implemented virtually in community SNFs and follows patients for 45 days after SNF discharge to reflect real-world patient flow.

Primary outcomes

1. Intervention fidelity as assessed by fidelity checklist

   Intervention fidelity will be assessed using a fidelity checklist. ALIGN will be considered feasible if at least one component of ≥ 80% of domains on the fidelity checklist are addressed, ≥ 50% of components of at least 1 intervention domain are delivered in follow up visits, and if a discharge note is entered for enrolled patients.

   Time frame: 2.5 years

2. Intervention fidelity as assessed by audio-recordings

   Intervention visits will be recorded and reviewed to assess fidelity to the core intervention components of ALIGN.

   Time frame: 2.5 years

3. Assessment of treatment contamination in community skilled nursing facilities

   The investigators will determine the proportion (% total) of caregivers in the control arm who reported that they received components of the ALIGN intervention during the skilled nursing facility stay. ALIGN will be considered feasible if contamination where ALIGN effects usual care is less than 10%.

   Time frame: 2.5 years

4. The proportion (% total) of screened patients that are eligible for enrollment in the trial

   The investigators will determine the proportion of screened patients (% total) who meet the inclusion criteria

   Time frame: 2.5 years

5. The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes

   The investigators will determine the proportion of (% total) of enrolled patients that are succesfully assessed for patient-reported and patient-centered outcomes (please see secondary outcomes below)

   Time frame: 2.5 years

6. The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes

   The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully assessed for person-centered outcomes (please see secondary outcomes below)

   Time frame: 2.5 years

7. The proportion (% total) of enrolled patients that are randomized

   The investigators will determine the proportion of (% total) of enrolled patients that are succesfully randomized

   Time frame: 2.5 years

8. The proportion (% total) of enrolled caregivers that are randomized

   The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully randomized

   Time frame: 2.5 years

Secondary outcomes

1. Assessing changes in days at home

   In this exploratory outcome measure, days at home will be calculated as 180 days minus the number of inpatient days in an acute care facility, an inpatient rehabilitation facility, a skilled nursing facility, or an inpatient hospice unit.

   Time frame: 6 months after randomization

2. Assessing Changes in hospice length of stay

   In this exploratory outcome measures, changes in the length of a hospice stay in both arms of the clinical trial will be measured

   Time frame: 6 months after randomization

3. Health Care Utilization

   Rehospitalization and emergency department visits for any cause and receipt of chemotherapy within 14 days of death will be collected

   Time frame: 6 months after randomization

4. Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)

   In this exploratory outcome measure, patients will be asked to complete this 14 item Likert-type scale that measures four primary quality of life domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and spiritual well-being. Scores range from 0-56. Lower scores indicate lower quality of life.

   Time frame: At enrollment and then at 1, 3, and 6 months after randomization

5. Changes in agreement with health-related outcome statements as assessed by the Attitude Scale

   In this exploratory outcome measure, patients will be asked to complete the Attitude Scale which is a 5-point Likert scale that identifies the extent to which patients agree with 8 health-related outcome statements such as: The most important thing to me is living as long as I can, no matter what my quality of life is. Changes in agreement will be measured in both groups of the trial.

   Time frame: From enrollment and then 1, 3 and 6 months after randomization

6. Change in frailty as assessed by the Practical Geriatric Assessment

   In this exploratory outcome measure, patients and caregivers will be asked to complete this 19 item assessment measures individual domain impairments in areas of physical function, nutrition/weight loss, social support, psychological, comorbidities, and cognitive functioning to guide treatment decisions. There is no composite score for this measure, rather scores from each domain help identify impairments. Higher scores in the physical function, comorbidities, psychological health, domain suggest greater impairment. Lower scores in cognitive and nutritional domains suggest greater impairment.

   Time frame: From enrollment and then 1, 3, and 6 months after randomization

7. Change in Advance Care Planning Documentation

   Advance Care Planning documents such as Medical Durable Power of Attorney (MDPOA) forms, cardiopulmonary resuscitation (CPR) directives, and the Medical Orders for Scope of Treatment (MOST) forms are documents that communicate end of life wishes for patients and also who they would designate to make medical decisions on their behalf if they are unable to do so themselves. We are measuring completion rates and changes to wishes expressed in these documents in all patients who participate in the trial.

   Time frame: From enrollment and then at 6 months after randomization

8. Changes in the Perception of Patient Centeredness of Care Delivered as assessed by the Perception of Patient Centeredness of Care Measure

   In this exploratory outcome measure, patients and caregivers will be asked to complete this 18-item instrument using a 4-point Likert scale. Scores range from 18 -72. Higher scores indicate a greater perception of patient-centeredness of care.

   Time frame: At enrollment and then 1, 3, and 6 months after randomization

9. Changes in caregiver coping as assessed by the Brief-Cope Questionaire

   This scale ascertains how people are responding emotionally to a serious circumstance and will be completed by caregivers in this study as an exploratory outcome measure. Scores are presented over three overarching coping styles (problem-focused, emotion-focused, and avoidant) as average scores indicating the degree to which the respondent has been engaging in that coping style. Scores for each coping strategy can range from 2-8. We will measure changes in coping styles over the course of the trial.

   Time frame: At enrollment and 1, 3, and 6 months after randomization

10. Changes in illness understanding and coping support as assessed by the Advanced Illness Coordinating Care Survey

    In this exploratory outcome measure, this 5 question survey assesses perceived illness understanding and coping support. The range of scores is from 0 - 24 with higher scores indicating increased illness understanding and coping support.

    Time frame: At enrollment and then 1, 3, and 6 months after randomization

11. Changes in the experience of feeling heard and understood as assessed by the Heard and Understood Survey

    In this exploratory outcome measure, this 4 question Likert scale survey will be completed by patients and caregivers to assess how well they felt heard and understood by their oncology team of clinicians. Scores can range from 0-16. Higher scores indicate delivery of higher quality care.

    Time frame: At enrollment and then 1, 3, and 6 months after randomization

12. Change in the burden or benefits of caregiving as assessed by the Caregiver Reaction Assessment

    In this exploratory outcome measure, caregivers will be asked to complete this 24 item instrument designed to measure the reactions of family members to caring for adults with a variety of illness. The instrument focuses on five dimensions: caregiver esteem, lack of family support, impact on finances, impact on schedule, and impact on health. The minimum score is 0 and the maximum score is 24. A higher score indicates greater caregiver burden.

    Time frame: At enrollment and then at 1, 3 and 6 months after randomization

13. Changes in congruence between patient and oncologist understanding of the goals of treatment

    In this exploratory outcome measure, patients, caregivers, and oncologists will be asked a focus of treatment question (Please select one of the options below that best describes your current focus of treatment) and asked to select from the following options: curative, life prolonging/rehabilitative, or comfort focused. Patients, caregivers, and oncologists will be asked this question at enrollment and when patients are discharged from ALIGN after the protocol has been completed. We are measuring whether there is increased congruence in the response between patient and their oncologists.

    Time frame: At enrollment and then post-intervention protocol completion

14. Assessing Oncology Clinican Acceptability

    Involved oncology clinicians will be asked using a Likert scale survey their experience working with the ALIGN social worker conducting the intervention in this exploratory outcome measure.

    Time frame: After completion of the ALIGN protocol

15. Assessing the Bereaved Caregivers Satisfaction with Care During the Last Month of Life

    In this exploratory outcome, bereaved caregivers will be asked to complete a 10-item validated bereaved family survey assessing their satisfaction with end-of-life care received by the patient. Domains assessed will include physical and emotional support, focus on the individual, and shared decision making. Higher scores indicate greater satisfaction with care.

    Time frame: 1 month or later after patient death