Advanced Medical IllnessALIGNNCT03546920
Integrating Palliative Care Social Workers Into Sub-Acute Settings: A Feasibility Trial
A study testing ALIGN Intervention Phase in people with Advanced Medical Illness, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a feasibility trial utilizing a step wedge design of a social worker led palliative care intervention for 120 adult patients with advanced medical illness being cared for in a subacute nursing facility. Caregivers are also invited to participate. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advanced Medical Illness
- What is being tested?
- ALIGN Intervention Phase
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 16 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- High risk for hospital readmission based on LACE Score > 7;
- Length of stay in days,
- Caregivers must be > 18 years old,
- Comorbidity,
- ER Visits in past 6 months)
- Admitted to SNF
- Decisional capacity to consent or proxy available to consent
- English speaking
Who cannot join
- Lacking proxy available for consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Colorado-N/S/W
Denver, Colorado, 80231
About this study
This is a feasibility trial utilizing a step wedge design of a social worker led palliative care intervention for 120 adult patients with advanced medical illness being cared for in a subacute nursing facility. Caregivers are also invited to participate.
Read the detailed description
Of the nearly 800,000 seniors admitted to Skilled Nursing Facilities for rehabilitation (SNF rehab) annually in the U.S., approximately 20% will be newly institutionalized, 25-50% are readmitted back to the hospital within 30 days at a cost of $4.34 billion, and 9% will die in the next year. Clearly this population represents an ideal target for palliative care interventions such as decreasing symptom burden, improving quality of life, and ensuring that the medical care provided is congruent with patient goals and preferences. Unfortunately, health professionals working in the SNF rehab setting are rarely trained in palliative care. While the current standard of care in the SNF rehab setting typically includes social service assessment and case management, the care plans developed are frequently focused only on immediate, short-term issues and are not communicated as the patient is discharged to a different level of care. Existing literature supports the need to assist patients in navigating care transitions through standardized systems and patient/family activation. However, the transition from hospital to SNF and from SNF to community has received little attention, even though these are some of the most complex patients at high risk for poor outcomes. The broad goal of the research team is to optimize care for high-risk seniors admitted to SNF rehab by using a social work led, therapeutic intervention designed to align goals of care and improve communication across multiple care settings.
ALIGN (Assessing \& Listening to Individual Goals and Needs), a palliative social work led intervention, focuses on defining patient and caregiver goals and values through an ecological assessment with standardized monitoring and reassessment, providing education about disease trajectory, facilitating communication between the patient and the care team, and developing a patient-centered care plan that accompanies the patient across all future transitions. ALIGN was previously tested in a long-term acute care hospital setting as part of a quality improvement project that demonstrated decreased hospital readmissions, increased use of hospice, improved self-reported patient care experience, and higher levels of advance directive completion. This pilot study will be conducted to determine the feasibility of applying ALIGN to the SNF rehab population. The current protocol will enroll 60 patients aged 65+ at the time of admission to receive the ALIGN intervention along with at least 60 caregivers. The Investigators will also enroll 120 patients and 60 caregivers to receive care as usual. The proposed specific aims (SA) and Hypotheses (H) are:
SA1: To determine the feasibility of conducting a trial of ALIGN in older persons and their caregivers admitted to SNF rehab using a pragmatic, stepped-wedge design.
H1: The ALIGN intervention will be feasible if a) eligibility, enrollment, refusal, retention and attrition rates are within 20% of expected; b) facility staff/providers and participants (patients and caregivers) find the intervention acceptable (semi-structured qualitative interviews)
SA2: To conduct an exploratory analysis to estimate the effect size of ALIGN vs usual care on the primary patient-centered outcome, quality of life (FACT-G), and caregiver-centered outcome, caregiver burden (Zarit caregiver burden scale) and the secondary outcome (health care utilization). The investigators hypothesize that compared to control at 60-days post-enrollment, the ALIGN subjects will have:
H2a: A clinically meaningful difference in the FACT-G (3-7 points on the overall scale) for patients.
H2b: A clinically meaningful difference in the Zarit Caregiver burden scale (8±15) for caregivers.
H2c: A 20% relative decrease in 60-day readmission to hospital.
In addition to the key primary and secondary outcome measures listed above, the investigators will also explore the effect of ALIGN on utilization of palliative care/hospice, hospital length of stay, advance directive documentation, and care experience (Advanced Illness Coordinating Care Survey).
- Conditions
- Advanced Medical Illness
- Being tested
- ALIGN Intervention Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIGN Intervention PhaseBehavioural
Communication: The PCSW will follow this structured process to improve and facilitate communication for intervention patients. 1. Attend routine weekly facility-led rounds/meetings reviewing patients, their needs and attend discharge planning conference; 2. Visit with patient and caregiver after the discharge planning conference to ensure understanding of the plan of care; 3. Ensure all appropriate community programs (home health, community palliative care) have made contact and established care, assess the transition, and revisit domains from the initial assessment; 4. Suggest questions that need to be asked of community providers. Throughout the intervention, the PCSW will communicate updates from the visits to all involved providers.
Visits will also focus on increasing goal alignment with the objective that all participants have a ROLT score that is most aligned. Visits will also explore goals of care; this includes completion or review of advance directives.
| Study group | Role | What they receive |
|---|---|---|
| Control Phase | No intervention | Usual care for patients admitted to the SNF. |
| ALIGN Intervention Phase | Experimental | ALIGN Intervention delivered by Palliative Care Social Workers in the SNF setting. The intervention consists of aligning patient/caregiver goals of care, completing advance care planning, and connecting to community resources and services to ensure smooth transition from facility to home setting. Receives: Behavioral: ALIGN Intervention Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Number approached, enrolled, and retained in the collection of patient reported outcome measures
Measured: 60 days
Secondary outcomes (4)
Change in Quality of Life
FACT-G
Measured: Baseline and 60 days
Change in Caregiver Reaction Assessment
Caregiver burden and benefit finding
Measured: Baseline and 60 days
Change in Zarit Caregiver Burden
burdens of caregiving
Measured: Baseline and 60 days
Change in AICCES Survey
A survey of satisfaction with care for patients and caregivers
Measured: Baseline and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start8 Jan 2018
- Primary completion16 Jun 2019
- Study completion16 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Medical IllnessStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Step wedge design. Randomization occurred at the facility level. Facilities are randomized to the order of starting accrual in control phase and then transitioning to intervention phase once control sample has accrued.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Stacy M Fischer, MD, Principal investigator, University of Colorado SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546920
- Sponsor's protocol ID
- 17-2263
- Acronym
- ALIGN
- Status last verified
- Jul 2019
- First submitted
- 23 May 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD outside research team
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Palliative Care Social Workers Into Sub-Acute Settings: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03546920
- Acronym / sponsor ID
- ALIGN / 17-2263
- Conditions
- Advanced Medical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 16 Jun 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility trial utilizing a step wedge design of a social worker led palliative care intervention for 120 adult patients with advanced medical illness being cared for in a subacute nursing facility. Caregivers are also invited to participate.
Detailed description
Of the nearly 800,000 seniors admitted to Skilled Nursing Facilities for rehabilitation (SNF rehab) annually in the U.S., approximately 20% will be newly institutionalized, 25-50% are readmitted back to the hospital within 30 days at a cost of $4.34 billion, and 9% will die in the next year. Clearly this population represents an ideal target for palliative care interventions such as decreasing symptom burden, improving quality of life, and ensuring that the medical care provided is congruent with patient goals and preferences. Unfortunately, health professionals working in the SNF rehab setting are rarely trained in palliative care. While the current standard of care in the SNF rehab setting typically includes social service assessment and case management, the care plans developed are frequently focused only on immediate, short-term issues and are not communicated as the patient is discharged to a different level of care. Existing literature supports the need to assist patients in navigating care transitions through standardized systems and patient/family activation. However, the transition from hospital to SNF and from SNF to community has received little attention, even though these are some of the most complex patients at high risk for poor outcomes. The broad goal of the research team is to optimize care for high-risk seniors admitted to SNF rehab by using a social work led, therapeutic intervention designed to align goals of care and improve communication across multiple care settings.
ALIGN (Assessing \& Listening to Individual Goals and Needs), a palliative social work led intervention, focuses on defining patient and caregiver goals and values through an ecological assessment with standardized monitoring and reassessment, providing education about disease trajectory, facilitating communication between the patient and the care team, and developing a patient-centered care plan that accompanies the patient across all future transitions. ALIGN was previously tested in a long-term acute care hospital setting as part of a quality improvement project that demonstrated decreased hospital readmissions, increased use of hospice, improved self-reported patient care experience, and higher levels of advance directive completion. This pilot study will be conducted to determine the feasibility of applying ALIGN to the SNF rehab population. The current protocol will enroll 60 patients aged 65+ at the time of admission to receive the ALIGN intervention along with at least 60 caregivers. The Investigators will also enroll 120 patients and 60 caregivers to receive care as usual. The proposed specific aims (SA) and Hypotheses (H) are:
SA1: To determine the feasibility of conducting a trial of ALIGN in older persons and their caregivers admitted to SNF rehab using a pragmatic, stepped-wedge design.
H1: The ALIGN intervention will be feasible if a) eligibility, enrollment, refusal, retention and attrition rates are within 20% of expected; b) facility staff/providers and participants (patients and caregivers) find the intervention acceptable (semi-structured qualitative interviews)
SA2: To conduct an exploratory analysis to estimate the effect size of ALIGN vs usual care on the primary patient-centered outcome, quality of life (FACT-G), and caregiver-centered outcome, caregiver burden (Zarit caregiver burden scale) and the secondary outcome (health care utilization). The investigators hypothesize that compared to control at 60-days post-enrollment, the ALIGN subjects will have:
H2a: A clinically meaningful difference in the FACT-G (3-7 points on the overall scale) for patients.
H2b: A clinically meaningful difference in the Zarit Caregiver burden scale (8±15) for caregivers.
H2c: A 20% relative decrease in 60-day readmission to hospital.
In addition to the key primary and secondary outcome measures listed above, the investigators will also explore the effect of ALIGN on utilization of palliative care/hospice, hospital length of stay, advance directive documentation, and care experience (Advanced Illness Coordinating Care Survey).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Step wedge design. Randomization occurred at the facility level. Facilities are randomized to the order of starting accrual in control phase and then transitioning to intervention phase once control sample has accrued.
| Arm | Type | Receives |
|---|---|---|
| Control Phase | No intervention | –Usual care for patients admitted to the SNF. |
| ALIGN Intervention Phase | Experimental | Behavioral: ALIGN Intervention PhaseALIGN Intervention delivered by Palliative Care Social Workers in the SNF setting. The intervention consists of aligning patient/caregiver goals of care, completing advance care planning, and connecting to community resources and services to ensure smooth transition from facility to home setting. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- High risk for hospital readmission based on LACE Score > 7;
- Length of stay in days,
- Caregivers must be > 18 years old,
- Comorbidity,
- ER Visits in past 6 months)
Key exclusion criteria (1 listed)
- Lacking proxy available for consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALIGN Intervention PhaseCommunication: The PCSW will follow this structured process to improve and facilitate communication for intervention patients. 1. Attend routine weekly facility-led rounds/meetings reviewing patients, their needs and attend discharge planning conference; 2. Visit with patient and caregiver after the discharge planning conference to ensure understanding of the plan of care; 3. Ensure all appropriate community programs (home health, community palliative care) have made contact and established care, assess the transition, and revisit domains from the initial assessment; 4. Suggest questions that need to be asked of community providers. Throughout the intervention, the PCSW will communicate updates from the visits to all involved providers. Visits will also focus on increasing goal alignment with the objective that all participants have a ROLT score that is most aligned. Visits will also explore goals of care; this includes completion or review of advance directives. | Behavioural | ALIGN Intervention Phase |
Primary outcome
Feasibility
Time frame: 60 days
Number approached, enrolled, and retained in the collection of patient reported outcome measures
4 secondary outcomes
Change in Quality of Life
Time frame: Baseline and 60 days
Change in Caregiver Reaction Assessment
Time frame: Baseline and 60 days
Change in Zarit Caregiver Burden
Time frame: Baseline and 60 days
Change in AICCES Survey
Time frame: Baseline and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No. No plan to share IPD outside research team
Related trials for Advanced Medical Illness
RecruitingPhase 2
Pragmatic Trial of Psilocybin Therapy in Palliative Care
Demoralization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy M Fischer, MD principal investigator
University of Colorado SOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALIGN Intervention Phase in people with Advanced Medical Illness, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.