Palliative CareTPCNCT01934413
Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study
A study testing Technology-Enhanced Transitional Palliative Care in people with Palliative Care and Transitional Care, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this pilot study is to develop and test a technology-enhanced transitional palliative care (TPC) intervention for patients and caregivers living in rural locations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Palliative Care, Transitional Care
- What is being tested?
- Technology-Enhanced Transitional Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients hospitalized at study site, and their designated caregiver (if available)
- Receiving palliative care
- Returning home or to a facility for short term (30 days) rehabilitation
- Able to provide informed consent
- Able to complete self-reported questionnaires without assistance
Who cannot join
- Long-term placement in skilled nursing facility after hospitalization
- Receiving hospice
- Living within city limits of hospital
- Cognitive impairments
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to develop and test a technology-enhanced transitional palliative care (TPC) intervention for patients and caregivers living in rural locations. The investigators hypothesize that access to palliative care will be improved, thereby improving patient and caregiver reported outcomes and decreasing the use of costly health services.
Read the detailed description
The purpose of the proposed research is to design and evaluate a technology enhanced transitional palliative care (TPC) intervention for patients living in rural locations. The contributions of the proposed research are expected to address the gap in palliative care services and transitions of care for rural patients. This research is significant because it addresses the challenges of three independently important health care foci - needs of rural patients, care transitions, and the evolving field of palliative care. The study will not simply address the critical barrier imposed by distance, but also extend PC practice by improving transition management for the impending dramatic increase in seriously ill and dying patients in rural areas through evolving demographic shifts. The goal of the proposed research is to advance the development of transitional care strategies for rural PC patients and caregivers, and provide evidence of new ways to support continuity of care for patients with life-limiting conditions.
The study is guided by the "Transitional Care Model" or "TCM" as developed by Naylor which combines quality, cost, and satisfaction. The TCM has a solid evidence base from more than 15 years of multidisciplinary research. Unique features of the model include care that is delivered and coordinated by the same nurse across hospital and home settings 7 days per week for an average of 2 to 3 months using evidence-based protocols with a focus on long term outcomes. Core components of the model include a holistic, person/family centered approach and protocol guided care. The nurse functions as part of an interdisciplinary team with shared accountability, however, the nurse is the single "point person" across an episode of care providing the vital link from hospital to home. Inherent within the model is shared communication systems that span care settings.
A randomized control trial design will be used. Community dwelling adult patients and their caregivers who receive a palliative care consult while hospitalized in the hospital will be enrolled in the study, then randomized to group membership and followed for a total of 8 weeks after hospital discharge. Following a detailed protocol for TPC, the intervention group will receive weekly video session visits (using computer software that allows audio/visual contact through the computer screen) by the study nurse. The investigators will determine the feasibility and acceptability of the TPC intervention and study methods and procedures when engaging palliative care patients and their caregivers. The investigators will compare patient and caregiver reported outcomes and determine effect size for patients receiving technology-enhanced TPC (intervention group) to patients in the control group, and they will explore the impact of the technology-enhanced TPC intervention on health care service utilization.
- Conditions
- Palliative Care, Transitional Care
- Being tested
- Technology-Enhanced Transitional Palliative Care, Usual Standard of Care
- Keywords
- Palliative Care, Technology, Rural, Transitional Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Enhanced Transitional Palliative CareBehavioural
The Transitional Care intervention will be initiated within 24 hours after enrollment, and will include initial transitional care planning, daily hospital visits, crisis prevention planning by an experienced Palliative Care nurse. The intervention will continue after the patient is discharged to home or short term skilled nursing facility, and it will involve an in-person visit between 24-48 hours post discharge, weekly virtual visits via iPad and video conference technology, and additional home visits as needed. Care plans established during initial planning will be implemented and adjusted under the guidance of the palliative care nurse delivering the intervention.
Usual Standard of CareOther
Usual care includes routine hospital discharge planning and usual physician care in primary and specialty outpatient clinics post hospital discharge. The PC consulting service provides consulting services in the inpatient setting. There are no standardized, intentional services provided to outpatients by the PC consulting team. Services provided to outpatients may occur sporadically as initiated by the patient. The majority of PC follow-up if any is a single phone call to the patient/caregiver. To account for the time spent and number of contacts made with the intervention group, the control group will be contacted by phone weekly by a non-nurse member of the study team not involved with the intervention, asked to relate what, if any, medically-related events occurred.
| Study group | Role | What they receive |
|---|---|---|
| Technology-Enhanced TPC | Active comparator | In addition to receiving usual palliative care service in the hospital setting, Technology-Enhanced Transitional Palliative Care patients will receive Transitional Care from the Palliative Care consulting team beginning in the hospital within 24 hours of study enrollment and continuing post discharge for eight weeks in their homes in rural locations by means of video visits with the Palliative Care consulting team. Receives: Behavioral: Technology-Enhanced Transitional Palliative Care |
| Usual standard of care | Other | The control group will receive only the current standard palliative care service in the hospital setting, which includes standard in-hospital palliative care consultation and standard discharge planning. Receives: Other: Usual Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean scores on FACIT-Pal Questionnaire
The patient's quality of life will be determined by the change in mean scores from baseline to 1 month and 2 months post enrollment, using the Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal). The FACIT-Pal palliative subscale contains 19 questions specific to persons with life-limiting illness. Each item is rated on a 5 point numeric rating scale from 9 (not at all) to 4 (very much). Scores range from 0-76. Higher scores indicate better quality of life.
Measured: Baseline, 1 month post-enrollment, 2 months post-enrollment
Secondary outcomes (1)
Change in mean scores on ESAS-r Questionnaire
The patient's symptom intensity will be determined by the change in mean scores from baseline to 1 month and 2 months post enrollment, as measured by the Edmonton Symptom Assessment System (revised) ESAS-r scale, The ESAS-r captures the patient's perspective on 9 symptoms that are common in palliative care (pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, wellbeing). An optional 10th symptom can be reported. Each symptom is rated on an 11 point numeric rating scale from 0 (symptom absent or best) to 10 (worst possible). Scores range from 0-100, with lower scores indicating patient perceives fewer or no symptoms and higher scores indicating patient perceives worse symptoms.
Measured: Baseline, 1 month post-enrollment, 2 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane Holland, Mayo Clinic
- Investigators
- Diane E Holland, PhD, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934413
- Sponsor's protocol ID
- 13-006242
- Acronym
- TPC
- Status last verified
- Feb 2015
- First submitted
- 29 Aug 2013
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-enhanced Transitional Care for Rural Palliative Care Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT01934413
- Acronym / sponsor ID
- TPC / 13-006242
- Conditions
- Palliative Care, Transitional Care
- Keywords
- Palliative Care, Technology, Rural, Transitional Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Sep 2013 (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 this pilot study is to develop and test a technology-enhanced transitional palliative care (TPC) intervention for patients and caregivers living in rural locations. The investigators hypothesize that access to palliative care will be improved, thereby improving patient and caregiver reported outcomes and decreasing the use of costly health services.
Detailed description
The purpose of the proposed research is to design and evaluate a technology enhanced transitional palliative care (TPC) intervention for patients living in rural locations. The contributions of the proposed research are expected to address the gap in palliative care services and transitions of care for rural patients. This research is significant because it addresses the challenges of three independently important health care foci - needs of rural patients, care transitions, and the evolving field of palliative care. The study will not simply address the critical barrier imposed by distance, but also extend PC practice by improving transition management for the impending dramatic increase in seriously ill and dying patients in rural areas through evolving demographic shifts. The goal of the proposed research is to advance the development of transitional care strategies for rural PC patients and caregivers, and provide evidence of new ways to support continuity of care for patients with life-limiting conditions.
The study is guided by the "Transitional Care Model" or "TCM" as developed by Naylor which combines quality, cost, and satisfaction. The TCM has a solid evidence base from more than 15 years of multidisciplinary research. Unique features of the model include care that is delivered and coordinated by the same nurse across hospital and home settings 7 days per week for an average of 2 to 3 months using evidence-based protocols with a focus on long term outcomes. Core components of the model include a holistic, person/family centered approach and protocol guided care. The nurse functions as part of an interdisciplinary team with shared accountability, however, the nurse is the single "point person" across an episode of care providing the vital link from hospital to home. Inherent within the model is shared communication systems that span care settings.
A randomized control trial design will be used. Community dwelling adult patients and their caregivers who receive a palliative care consult while hospitalized in the hospital will be enrolled in the study, then randomized to group membership and followed for a total of 8 weeks after hospital discharge. Following a detailed protocol for TPC, the intervention group will receive weekly video session visits (using computer software that allows audio/visual contact through the computer screen) by the study nurse. The investigators will determine the feasibility and acceptability of the TPC intervention and study methods and procedures when engaging palliative care patients and their caregivers. The investigators will compare patient and caregiver reported outcomes and determine effect size for patients receiving technology-enhanced TPC (intervention group) to patients in the control group, and they will explore the impact of the technology-enhanced TPC intervention on health care service utilization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-Enhanced TPC | Active comparator | Behavioral: Technology-Enhanced Transitional Palliative CareIn addition to receiving usual palliative care service in the hospital setting, Technology-Enhanced Transitional Palliative Care patients will receive Transitional Care from the Palliative Care consulting team beginning in the hospital within 24 hours of study enrollment and continuing post discharge for eight weeks in their homes in rural locations by means of video visits with the Palliative Care consulting team. |
| Usual standard of care | Other | Other: Usual Standard of CareThe control group will receive only the current standard palliative care service in the hospital setting, which includes standard in-hospital palliative care consultation and standard discharge planning. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients hospitalized at study site, and their designated caregiver (if available)
- Receiving palliative care
- Returning home or to a facility for short term (30 days) rehabilitation
- Able to provide informed consent
- Able to complete self-reported questionnaires without assistance
Key exclusion criteria (5 listed)
- Long-term placement in skilled nursing facility after hospitalization
- Receiving hospice
- Living within city limits of hospital
- Cognitive impairments
- Non-English speaking
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 |
|---|---|---|
| Technology-Enhanced Transitional Palliative CareThe Transitional Care intervention will be initiated within 24 hours after enrollment, and will include initial transitional care planning, daily hospital visits, crisis prevention planning by an experienced Palliative Care nurse. The intervention will continue after the patient is discharged to home or short term skilled nursing facility, and it will involve an in-person visit between 24-48 hours post discharge, weekly virtual visits via iPad and video conference technology, and additional home visits as needed. Care plans established during initial planning will be implemented and adjusted under the guidance of the palliative care nurse delivering the intervention. | Behavioural | Technology-Enhanced TPC |
| Usual Standard of CareUsual care includes routine hospital discharge planning and usual physician care in primary and specialty outpatient clinics post hospital discharge. The PC consulting service provides consulting services in the inpatient setting. There are no standardized, intentional services provided to outpatients by the PC consulting team. Services provided to outpatients may occur sporadically as initiated by the patient. The majority of PC follow-up if any is a single phone call to the patient/caregiver. To account for the time spent and number of contacts made with the intervention group, the control group will be contacted by phone weekly by a non-nurse member of the study team not involved with the intervention, asked to relate what, if any, medically-related events occurred. | Other | Usual standard of care |
Primary outcome
Change in mean scores on FACIT-Pal Questionnaire
Time frame: Baseline, 1 month post-enrollment, 2 months post-enrollment
The patient's quality of life will be determined by the change in mean scores from baseline to 1 month and 2 months post enrollment, using the Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal). The FACIT-Pal palliative subscale contains 19 questions specific to persons with life-limiting illness. Each item is rated on a 5 point numeric rating scale from 9 (not at all) to 4 (very much). Scores range from 0-76. Higher scores indicate better quality of life.
1 secondary outcome
Change in mean scores on ESAS-r Questionnaire
Time frame: Baseline, 1 month post-enrollment, 2 months post-enrollment
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 16 Feb 2015.
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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.
Diane E Holland, PhD, RN principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Enhanced Transitional Palliative Care in people with Palliative Care and Transitional Care, run by Mayo Clinic 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 5 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 16 Feb 2015. 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?
Change in mean scores on FACIT-Pal Questionnaire (time frame: Baseline, 1 month post-enrollment, 2 months post-enrollment). 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 16 Feb 2015.