Ongoing or Significant Medical ConditionNCT01746446
LifeCourse: A Supportive Care Approach for Patients Late in Life
A study testing Care team in people with Ongoing or Significant Medical Condition, run by Allina Health System at 3 sites in United States.
Trial summary
The purpose of the study is to test a new model of care for patients with an ongoing or significant medical condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ongoing or Significant Medical Condition
- What is being tested?
- Care team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 903 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to 31 Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has an Allina Health primary or specialty provider
- Patient's medical chart indicates an on-going or significant medical condition
- LifeCourse will invite vulnerable patients to enroll, including:
- Critically ill patients
- Cognitively impaired patients
- Elderly patients, some of whom may have cognitive impairment and/or be institutionalized
Who cannot join
- Patient resides in a zip code which does not lie partially within a 45 mile radius from the Allina Health Commons in Minneapolis, Minnesota.
- Patient has not visited an Allina facility, affiliate, or community partner within the last year.
- Patient is eligible for hospice.
- Patient is actively dying.
- Patient is abusive or is discharged against medical advice (AMA).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Augustana Health Care Center
Minneapolis, Minnesota, 55404
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Walker Methodist Health Center
Minneapolis, Minnesota, 55409
About this study
The purpose of the study is to test a new model of care for patients with an ongoing or significant medical condition.
Read the detailed description
LifeCourse is a late life care approach that promotes whole person care through a structured approach built upon an expanded set of palliative care domains and chronic illness care practices. It includes a trained lay healthcare worker as the primary contact who follows the patient across care settings and over time. The care guide asks patients and caregivers to articulate individualized goals and take part in decision making, and uses a family-oriented approach to understand needs, leverage strengths, and empower families to effectively support the individual living with serious illness.
- Conditions
- Ongoing or Significant Medical Condition
- Being tested
- Care team
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care teamOther
Provides additional support to patients, family, and friends.
| Study group | Role | What they receive |
|---|---|---|
| Care team | Experimental | Patients are offered the support and services of the care team. Receives: Other: Care team |
| Usual Care | No intervention | Patients receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Quality of Life
Patient QOL was measured using the Functional Assessment of Chronic Illness Therapy-Palliative v4 (FACIT-Pal) survey, a general measure of health-related QOL in 4 domains: physical, social, emotional, and functional, plus a measure of end-of-life experiences. Items were reverse scored according to scoring guidelines and domain scores were calculated via prorated scores when there were <50% missing items for a given domain and <20% missing domains for a total score.
Measured: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Patient Care Experience
Patient care experience was collected via a previously validated survey tool focused on the patient's experience with their care team in the last 30 days. Three domains were scored: care team, goals, and communication with prorated scores when there were <50% missing items for a given domain and <20% missing domains for a total score.
Measured: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Caregiver care experience
Caregiver care experience was measured by a developed tool, addressing various aspects of care experience. An overall score was calculated by summing answers to all items. Scores were also calculated in 3 domains: care team, communication, and support.
Measured: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Caregiver Quality of Life
aregiver QOL was assessed via the patient-reported outcomes measurement information system (PROMIS) which asks caregivers to report their QOL in 8 domains. The PROMIS-29 scores were calculated by summing answers to all items within each domain.
Measured: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startOct 2012
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ongoing or Significant Medical ConditionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Robina Foundation
- Responsible party
- Sponsor
- Investigators
- Eric W Anderson, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746446
- Sponsor's protocol ID
- 38632
- Status last verified
- Jun 2022
- First submitted
- 27 Nov 2012
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schellinger S, Cain CL, Shibrowski K, Elumba D, Rosenberg E. Building New Teams for Late Life Care: Lessons From LifeCourse. Am J Hosp Palliat Care. 2016 Jul;33(6):561-7. doi: 10.1177/1049909115574692. Epub 2015 Mar 5.
PubMed 25747670Fernstrom KM, Shippee ND, Jones AL, Britt HR. Development and validation of a new patient experience tool in patients with serious illness. BMC Palliat Care. 2016 Dec 30;15(1):99. doi: 10.1186/s12904-016-0172-x.
PubMed 28038669Anderson EW, Frazer MS, Schellinger SE. Expanding the Palliative Care Domains to Meet the Needs of a Community-Based Supportive Care Model. Am J Hosp Palliat Care. 2018 Feb;35(2):258-265. doi: 10.1177/1049909117705061. Epub 2017 Apr 20.
PubMed 28423918Anderson EW, White KM. "It Has Changed My Life": An Exploration of Caregiver Experiences in Serious Illness. Am J Hosp Palliat Care. 2018 Feb;35(2):266-274. doi: 10.1177/1049909117701895. Epub 2017 Apr 16.
PubMed 28413927Schellinger SE, Anderson EW, Frazer MS, Cain CL. Patient Self-Defined Goals: Essentials of Person-Centered Care for Serious Illness. Am J Hosp Palliat Care. 2018 Jan;35(1):159-165. doi: 10.1177/1049909117699600. Epub 2017 Mar 23.
PubMed 28330379Shippee ND, Shippee TP, Mobley PD, Fernstrom KM, Britt HR. Effect of a Whole-Person Model of Care on Patient Experience in Patients With Complex Chronic Illness in Late Life. Am J Hosp Palliat Care. 2018 Jan;35(1):104-109. doi: 10.1177/1049909117690710. Epub 2017 Jan 29.
PubMed 28133973Cain CL, Taborda-Whitt C, Frazer M, Schellinger S, White KM, Kaasovic J, Nelson B, Chant A. A mixed methods study of emotional exhaustion: Energizing and depleting work within an innovative healthcare team. J Interprof Care. 2017 Nov;31(6):714-724. doi: 10.1080/13561820.2017.1356809. Epub 2017 Sep 18.
PubMed 28922038Anderson EW, White KM. "This Is What Family Does": The Family Experience of Caring for Serious Illness. Am J Hosp Palliat Care. 2018 Feb;35(2):348-354. doi: 10.1177/1049909117709251. Epub 2017 Jun 30.
PubMed 28662594Britt HR, JaKa MM, Fernstrom KM, Bingham PE, Betzner AE, Taghon JR, Shippee ND, Shippee TP, Schellinger SE, Anderson EW. Quasi-Experimental Evaluation of LifeCourse on Utilization and Patient and Caregiver Quality of Life and Experience. Am J Hosp Palliat Care. 2019 May;36(5):408-416. doi: 10.1177/1049909118817740. Epub 2018 Dec 13.
PubMed 30541333
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LifeCourse: A Supportive Care Approach for Patients Late in Life
- ClinicalTrials.gov ID
- NCT01746446
- Acronym / sponsor ID
- 38632
- Conditions
- Ongoing or Significant Medical Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Collaborators
- Robina Foundation
- Study start
- Oct 2012 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 11 Dec 2012 (estimated)
- 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.
The purpose of the study is to test a new model of care for patients with an ongoing or significant medical condition.
Detailed description
LifeCourse is a late life care approach that promotes whole person care through a structured approach built upon an expanded set of palliative care domains and chronic illness care practices. It includes a trained lay healthcare worker as the primary contact who follows the patient across care settings and over time. The care guide asks patients and caregivers to articulate individualized goals and take part in decision making, and uses a family-oriented approach to understand needs, leverage strengths, and empower families to effectively support the individual living with serious illness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care team | Experimental | Other: Care teamPatients are offered the support and services of the care team. |
| Usual Care | No intervention | –Patients receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has an Allina Health primary or specialty provider
- Patient's medical chart indicates an on-going or significant medical condition
- LifeCourse will invite vulnerable patients to enroll, including:
- Critically ill patients
- Cognitively impaired patients
Key exclusion criteria (5 listed)
- Patient resides in a zip code which does not lie partially within a 45 mile radius from the Allina Health Commons in Minneapolis, Minnesota.
- Patient has not visited an Allina facility, affiliate, or community partner within the last year.
- Patient is eligible for hospice.
- Patient is actively dying.
- Patient is abusive or is discharged against medical advice (AMA).
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 |
|---|---|---|
| Care teamProvides additional support to patients, family, and friends. | Other | Care team |
Primary outcome
Patient Quality of Life
Time frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Patient QOL was measured using the Functional Assessment of Chronic Illness Therapy-Palliative v4 (FACIT-Pal) survey, a general measure of health-related QOL in 4 domains: physical, social, emotional, and functional, plus a measure of end-of-life experiences. Items were reverse scored according to scoring guidelines and domain scores were calculated via prorated scores when there were <50% missing items for a given domain and <20% missing domains for a total score.
Patient Care Experience
Time frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Patient care experience was collected via a previously validated survey tool focused on the patient's experience with their care team in the last 30 days. Three domains were scored: care team, goals, and communication with prorated scores when there were <50% missing items for a given domain and <20% missing domains for a total score.
Caregiver care experience
Time frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Caregiver care experience was measured by a developed tool, addressing various aspects of care experience. An overall score was calculated by summing answers to all items. Scores were also calculated in 3 domains: care team, communication, and support.
Caregiver Quality of Life
Time frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
aregiver QOL was assessed via the patient-reported outcomes measurement information system (PROMIS) which asks caregivers to report their QOL in 8 domains. The PROMIS-29 scores were calculated by summing answers to all items within each domain.
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 8 Jun 2022.
- Background: PubMed 25747670Schellinger S, Cain CL, Shibrowski K, Elumba D, Rosenberg E. Building New Teams for Late Life Care: Lessons From LifeCourse. Am J Hosp Palliat Care. 2016 Jul;33(6):561-7. doi: 10.1177/1049909115574692. Epub 2015 Mar 5.
- Background: PubMed 28038669Fernstrom KM, Shippee ND, Jones AL, Britt HR. Development and validation of a new patient experience tool in patients with serious illness. BMC Palliat Care. 2016 Dec 30;15(1):99. doi: 10.1186/s12904-016-0172-x.
- Background: PubMed 28423918Anderson EW, Frazer MS, Schellinger SE. Expanding the Palliative Care Domains to Meet the Needs of a Community-Based Supportive Care Model. Am J Hosp Palliat Care. 2018 Feb;35(2):258-265. doi: 10.1177/1049909117705061. Epub 2017 Apr 20.
- Background: PubMed 28413927Anderson EW, White KM. "It Has Changed My Life": An Exploration of Caregiver Experiences in Serious Illness. Am J Hosp Palliat Care. 2018 Feb;35(2):266-274. doi: 10.1177/1049909117701895. Epub 2017 Apr 16.
- Background: PubMed 28330379Schellinger SE, Anderson EW, Frazer MS, Cain CL. Patient Self-Defined Goals: Essentials of Person-Centered Care for Serious Illness. Am J Hosp Palliat Care. 2018 Jan;35(1):159-165. doi: 10.1177/1049909117699600. Epub 2017 Mar 23.
- Background: PubMed 28133973Shippee ND, Shippee TP, Mobley PD, Fernstrom KM, Britt HR. Effect of a Whole-Person Model of Care on Patient Experience in Patients With Complex Chronic Illness in Late Life. Am J Hosp Palliat Care. 2018 Jan;35(1):104-109. doi: 10.1177/1049909117690710. Epub 2017 Jan 29.
- Background: PubMed 28922038Cain CL, Taborda-Whitt C, Frazer M, Schellinger S, White KM, Kaasovic J, Nelson B, Chant A. A mixed methods study of emotional exhaustion: Energizing and depleting work within an innovative healthcare team. J Interprof Care. 2017 Nov;31(6):714-724. doi: 10.1080/13561820.2017.1356809. Epub 2017 Sep 18.
- Background: PubMed 28662594Anderson EW, White KM. "This Is What Family Does": The Family Experience of Caring for Serious Illness. Am J Hosp Palliat Care. 2018 Feb;35(2):348-354. doi: 10.1177/1049909117709251. Epub 2017 Jun 30.
- Derived from this study: PubMed 30541333Britt HR, JaKa MM, Fernstrom KM, Bingham PE, Betzner AE, Taghon JR, Shippee ND, Shippee TP, Schellinger SE, Anderson EW. Quasi-Experimental Evaluation of LifeCourse on Utilization and Patient and Caregiver Quality of Life and Experience. Am J Hosp Palliat Care. 2019 May;36(5):408-416. doi: 10.1177/1049909118817740. Epub 2018 Dec 13.
- Individual participant dataSharing planned: No
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.
Eric W Anderson, MD principal investigator
Allina Health System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care team in people with Ongoing or Significant Medical Condition, run by Allina Health System at 3 sites 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 6 inclusion and 5 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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Patient Quality of Life (time frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01746446, which also lists 9 linked publications.
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 8 Jun 2022.