PainNCT02917603
Shared Decision Making to Improve Palliative Care in the Nursing Home
A study testing Web Conferencing in people with Pain, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has found the quality of care of end-of-life care in nursing homes to have many challenges. It has also been documented that family members, especially those living at a distance, want to be involved in the care of their resident and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Web Conferencing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Residents: Residents of The Bluffs nursing home, Columbia Missouri, over the age of 65, have at least one family member who agrees to participate, and have a serious life limiting illness. Residents enrolled in hospice or admitted to post hospital short term nursing home stay are excluded from participation.
- Family Members: Identified family member by a resident or nursing home staff at The Bluffs, over the age of 18, without cognitive impairment, and with access to a computer, tablet, or smartphone device.
Who cannot join
- Residents enrolled in hospice can not participate.
Trial locations and contacts
1 site in 1 country.
About this study
Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has found the quality of care of end-of-life care in nursing homes to have many challenges. It has also been documented that family members, especially those living at a distance, want to be involved in the care of their resident and family support can be beneficial to residents. Family members' involvement in decision-making in the nursing home setting improves outcomes for residents with life-limiting illnesses. Shared decision-making (SDM) is a process wherein a healthcare choice is jointly made by a healthcare provider and a resident or resident's proxy, often a family member. This proposal seeks to facilitate SDM among family members, residents with life-limiting illnesses (who are not enrolled in hospice), and the nursing home care team. The overall research question (RQ) asks: To what extent are outcomes for family member and residents with life limiting illnesses associated with SDM via web-conferencing in the nursing home? The overall hypothesis (H) is that SDM among family members, residents (when possible), and skilled nursing home staff via web-conferencing will improve outcomes for family members and residents with life-limiting illnesses. This is an exploratory mixed methods randomized clinical trial pilot to test the effect of shared decision making using web-based conferencing on the depression and burden of family members and the pain of nursing home residents.
Read the detailed description
Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has found that the quality of care at the end of life in these facilities is less than adequate. While some residents improve their care with the use of the Hospice Medicare benefit, considerable barriers remain for the majority of nursing home residents who do not enroll in hospice but have a serious illness. This project focuses on improving palliative care for geriatric nursing home residents who are not receiving hospice care. Two systematic reviews of end-of-life care in nursing homes found challenges in symptom burden, including unmanaged pain, inadequate discussions regarding goals of care and advance directives, poor communication, unmet family expectations, and inadequate staff education.
Residents' values, beliefs, and goals are often unknown by nursing home staff. Dementia, illness, or poor communication may prevent residents from articulating their wishes regarding care. In many cases, family members can act as mediators between the resident and staff as plans of care are developed and decisions are made. Despite the desire to remain involved in care of the nursing home resident, many family members are unable to be physically present in the nursing home and experience loss of control, dis-empowerment, and guilt. As frailty increases and goals of care become increasingly palliative, the frustrations and burdens for families can worsen. Family members, especially those living at a distance, want to be involved in the care of their resident, and their involvement in decision-making can improve outcomes for residents with serious illnesses.
This project facilitates SDM (shared decision making) among family members, residents with serious illnesses (not enrolled in hospice), and the nursing home care team. Based on a family-identified need, this proposal facilitates SDM among family members, residents with serious illnesses (not enrolled in hospice), and the nursing home care team.
- Conditions
- Pain
- Being tested
- Web Conferencing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web ConferencingBehavioural
Individuals will communicate with the nursing home team via web conferencing during quarterly care conference
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | These family members and residents will use web conferencing technology to attend their quarterly care conferences Receives: Behavioral: Web Conferencing |
| Control | No intervention | These family and residents will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Mean Patient Health Questionaire 9 Score From Baseline
9 questions that indicate depression- taken at 30 days-Scale is 0-27 with higher values representing more depression. Measure collected every 30 days. Analysis is a comparison of means between the last measure taken and the baseline scores- with an overall average then computed.
Measured: 30 days
Secondary outcomes (3)
Zarit Burden Interview
Family members will report which of their responsibilities are perceived as burdensome. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Total score computed with an average score response.
Measured: 30 days
Generalized Anxiety- 7
7 questions that measure family member anxiety. It has 7 items and is scored 0-21 with a higher number representing greater anxiety. A total score is computed.
Measured: 30 days
Caregiver Quality of Life
4 questions pertaining to family quality of life. There are 4 items each scored 0-9 with a total score of 0 to 36 and higher scores representing poorer quality of life.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Debra Parker Oliver, University of Missouri-Columbia
- Investigators
- Debra Oliver, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917603
- Sponsor's protocol ID
- 2003012
- Status last verified
- Jan 2020
- First submitted
- 23 Sep 2016
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Oliver DP, Rolbiecki AJ, Washington K, Kruse RL, Popejoy L, Smith JB, Demiris G. A Pilot Study of An Intervention to Increase Family Member Involvement in Nursing Home Care Plan Meetings. J Appl Gerontol. 2021 Sep;40(9):1080-1086. doi: 10.1177/0733464820946927. Epub 2020 Aug 13.
PubMed 32787506
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making to Improve Palliative Care in the Nursing Home
- ClinicalTrials.gov ID
- NCT02917603
- Acronym / sponsor ID
- 2003012
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has found the quality of care of end-of-life care in nursing homes to have many challenges. It has also been documented that family members, especially those living at a distance, want to be involved in the care of their resident and family support can be beneficial to residents. Family members' involvement in decision-making in the nursing home setting improves outcomes for residents with life-limiting illnesses. Shared decision-making (SDM) is a process wherein a healthcare choice is jointly made by a healthcare provider and a resident or resident's proxy, often a family member. This proposal seeks to facilitate SDM among family members, residents with life-limiting illnesses (who are not enrolled in hospice), and the nursing home care team. The overall research question (RQ) asks: To what extent are outcomes for family member and residents with life limiting illnesses associated with SDM via web-conferencing in the nursing home? The overall hypothesis (H) is that SDM among family members, residents (when possible), and skilled nursing home staff via web-conferencing will improve outcomes for family members and residents with life-limiting illnesses. This is an exploratory mixed methods randomized clinical trial pilot to test the effect of shared decision making using web-based conferencing on the depression and burden of family members and the pain of nursing home residents.
Detailed description
Twenty-eight percent of Americans over the age of 65 die in a nursing home. Research has found that the quality of care at the end of life in these facilities is less than adequate. While some residents improve their care with the use of the Hospice Medicare benefit, considerable barriers remain for the majority of nursing home residents who do not enroll in hospice but have a serious illness. This project focuses on improving palliative care for geriatric nursing home residents who are not receiving hospice care. Two systematic reviews of end-of-life care in nursing homes found challenges in symptom burden, including unmanaged pain, inadequate discussions regarding goals of care and advance directives, poor communication, unmet family expectations, and inadequate staff education.
Residents' values, beliefs, and goals are often unknown by nursing home staff. Dementia, illness, or poor communication may prevent residents from articulating their wishes regarding care. In many cases, family members can act as mediators between the resident and staff as plans of care are developed and decisions are made. Despite the desire to remain involved in care of the nursing home resident, many family members are unable to be physically present in the nursing home and experience loss of control, dis-empowerment, and guilt. As frailty increases and goals of care become increasingly palliative, the frustrations and burdens for families can worsen. Family members, especially those living at a distance, want to be involved in the care of their resident, and their involvement in decision-making can improve outcomes for residents with serious illnesses.
This project facilitates SDM (shared decision making) among family members, residents with serious illnesses (not enrolled in hospice), and the nursing home care team. Based on a family-identified need, this proposal facilitates SDM among family members, residents with serious illnesses (not enrolled in hospice), and the nursing home care team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Web ConferencingThese family members and residents will use web conferencing technology to attend their quarterly care conferences |
| Control | No intervention | –These family and residents will receive usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Residents: Residents of The Bluffs nursing home, Columbia Missouri, over the age of 65, have at least one family member who agrees to participate, and have a serious life limiting illness. Residents enrolled in hospice or admitted to post hospital short term nursing home stay are excluded from participation.
- Family Members: Identified family member by a resident or nursing home staff at The Bluffs, over the age of 18, without cognitive impairment, and with access to a computer, tablet, or smartphone device.
Key exclusion criteria (1 listed)
- Residents enrolled in hospice can not participate.
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 |
|---|---|---|
| Web ConferencingIndividuals will communicate with the nursing home team via web conferencing during quarterly care conference | Behavioural | Intervention |
Primary outcome
Difference in Mean Patient Health Questionaire 9 Score From Baseline
Time frame: 30 days
9 questions that indicate depression- taken at 30 days-Scale is 0-27 with higher values representing more depression. Measure collected every 30 days. Analysis is a comparison of means between the last measure taken and the baseline scores- with an overall average then computed.
3 secondary outcomes
Zarit Burden Interview
Time frame: 30 days
Generalized Anxiety- 7
Time frame: 30 days
Caregiver Quality of Life
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32787506Oliver DP, Rolbiecki AJ, Washington K, Kruse RL, Popejoy L, Smith JB, Demiris G. A Pilot Study of An Intervention to Increase Family Member Involvement in Nursing Home Care Plan Meetings. J Appl Gerontol. 2021 Sep;40(9):1080-1086. doi: 10.1177/0733464820946927. Epub 2020 Aug 13.
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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.
Debra Oliver, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web Conferencing in people with Pain, run by Washington University School of Medicine 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 2 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 20 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Mean Patient Health Questionaire 9 Score From Baseline (time frame: 30 days). 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 NCT02917603, which also lists 1 linked publication.
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 20 Jan 2021.