End Stage Renal DiseaseSPIRITNCT01259011
A Representational Intervention to Promote Preparation for End-of-life Decision Making
A study testing the SPIRIT intervention in people with End Stage Renal Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness Representations to Increase Trust) intervention designed to improve discussions about end-of-life care between patients and their surrogate decision makers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- the SPIRIT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Apr 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- for patients,
- self-identified Caucasian or African American;
- receiving either center-hemodialysis or home-peritoneal dialysis for at least 6 months prior to enrollment;
- availability of an individual chosen by the patient who can be present during the intervention as a surrogate decision maker;
- age 18 years or older;
- ability to participate in health care decisions as evidenced by less than 3 errors on the Short Portable Mental Status Questionnaire (SPMSQ), suggesting normal mental functioning;
Show all 13Show fewer
- ability to read, write, and speak English.
- a CCI score of ≥6;
- hospitalization in the last 6 months, a CCI score of 5, including congestive heart failure (CHF).
- for surrogates,
- age 18 years or older (to serve as a surrogate decision maker, the individual must be an adult);
- willingness to serve as the surrogate decision maker and participate in the intervention with the patient;
- ability to read, write, and speak English.
Who cannot join
- -Patients who are too sick to participate in an hour-long interview, who require special care and assistance, who would not be able to care for their needs will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: A Randomized Controlled Trial of SPIRIT: A Representational Intervention to Promote Preparation for End-of-Life Decision Making
The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness Representations to Increase Trust) intervention designed to improve discussions about end-of-life care between patients and their surrogate decision makers. Subjects will be 200 Caucasian and African-American patients with ESRD (end-stage renal disease) recruited from outpatient dialysis clinics and their chosen surrogate decision makers. We hypothesize that (1) SPIRIT will lead to significantly less patient decisional conflict and significantly greater dyad congruence and surrogate decision making confidence than the standard care control at 2, 6, and 12 months post-intervention and (2) SPIRIT will reduce surrogate decisional conflict and psychosocial morbidities at 2 weeks after the patient's hospitalization requiring surrogate decision making significantly more than the standard care control.
Read the detailed description
Dialysis is central to survival for 450,000 Americans with end-stage renal disease (ESRD). Yet patients on dialysis have significant comorbidities and high mortality rates (24% annually). One out of four ESRD patient deaths occurs after a decision to stop dialysis. However, when persons have lost their decision capacity if there has been no prior discussion between the patient and surrogate regarding goals of care, the issue of whether to continue dialysis can pose an ethical impasse and cause profound psychological distress for surrogate decision makers. Using the representational approach to patient education, we developed and pilot tested the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers. SPIRIT is a 6-step, 2-session, face-to-face intervention presented to both patient and surrogate by a trained interventionist in an interview format.
The proposed randomized controlled trial will test the effects of the SPIRIT intervention in improving preparedness for end-of-life decision making among ESRD patients and their surrogates and reducing surrogates' conflict during decision making and psychosocial morbidities. Subjects will be 200 Caucasian and African-American patients with ESRD recruited from outpatient dialysis clinics and their chosen surrogate decision makers. Preparedness outcomes (dyad congruence, patient decisional conflict, and surrogate decision making confidence) will be measured at 2, 6, and 12 months post-intervention. Surrogate decisional conflict and psychosocial morbidities (anxiety, depression, and post-traumatic distress symptoms) will be measured 2 weeks after the patient's hospitalization that required surrogate decision making. To compare the effects of SPIRIT to those of standard care on surrogates after the patient's death, psychosocial morbidities will be measured at 3 and 6 months after the patient's death. We will also explore the potential impact of race on intervention effects and examine mediators and moderators of the intervention effects.
- Conditions
- End Stage Renal Disease
- Being tested
- the SPIRIT intervention
- Keywords
- end stage renal disease, dialysis, end of life decision making, surrogate psychological morbidities
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the SPIRIT interventionBehavioural
the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. A social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record. |
| SPIRIT intervention | Experimental | The SPIRIT intervention is a two-session, 1½ hour-long, structured intervention that is composed of six steps (assessing representations, identifying and exploring gaps and concerns, creating conditions for conceptual change, introducing replacement information, summarizing, and setting goals and planning), presented to both patient and surrogate by a trained nurse interventionist in a face-to-face interview format based on the representational approach. Receives: Behavioral: the SPIRIT intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyad Congruence
patient and surrogate congruence on the goals of care
Measured: 2, 6, 12 months
Secondary outcomes (2)
Change Over Time: Hospital Anxiety and Depression Scale Scores
Hospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity.
Measured: 2 Weeks, and at 3 and 6 months post death
Change Over Time: Post-traumatic Distress Symptom Score
The Post-Traumatic Symptoms Scale-10 (PTSS-10) was used to assess the presence and intensity of PTSD symptoms during the preceding 7 days. This self-report scale consists of 10 statements that specifically mention symptoms related to PTSD criteria (e.g., sleep problems, nightmares, tension in the body, irritation, startle, etc.) rated on a 7-point Likert scale from 1 (Never/Rare) to 7 (Very often/Always). A total score (range 10 - 70) of > 35 is associated with a high probability that the person meets the diagnostic criteria for PTSD.
Measured: 2 weeks and 3 and 6 months after patient death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2014
- Study completionApr 2014
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 (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Mi-Kyung Song, PhD, RN, FAAN, University of North Carolina, Chapel Hill
- Investigators
- Mi-Kyung Song, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259011
- Sponsor's protocol ID
- 09-1190
- Other IDs
- R01NR011464
- Acronym
- SPIRIT
- Status last verified
- Jul 2017
- First submitted
- 6 Dec 2010
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Song MK, Ward SE, Fine JP, Hanson LC, Lin FC, Hladik GA, Hamilton JB, Bridgman JC. Advance care planning and end-of-life decision making in dialysis: a randomized controlled trial targeting patients and their surrogates. Am J Kidney Dis. 2015 Nov;66(5):813-22. doi: 10.1053/j.ajkd.2015.05.018. Epub 2015 Jun 30.
PubMed 26141307Song MK, Ward SE, Lin FC, Hamilton JB, Hanson LC, Hladik GA, Fine JP. Racial Differences in Outcomes of an Advance Care Planning Intervention for Dialysis Patients and Their Surrogates. J Palliat Med. 2016 Feb;19(2):134-42. doi: 10.1089/jpm.2015.0232.
PubMed 26840848Song MK, Ward SE, Hanson LC, Metzger M, Kim S. Determining Consistency of Surrogate Decisions and End-of-Life Care Received with Patient Goals-of-Care Preferences. J Palliat Med. 2016 Jun;19(6):610-6. doi: 10.1089/jpm.2015.0349. Epub 2016 Mar 16.
PubMed 26982909Song MK, Metzger M, Ward SE. Process and impact of an advance care planning intervention evaluated by bereaved surrogate decision-makers of dialysis patients. Palliat Med. 2017 Mar;31(3):267-274. doi: 10.1177/0269216316652012. Epub 2016 Jul 10.
PubMed 27272317Song MK, Ward SE. The extent of informed decision-making about starting dialysis: does patients' age matter? J Nephrol. 2014 Oct;27(5):571-6. doi: 10.1007/s40620-014-0061-4. Epub 2014 Feb 12.
PubMed 24519843
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of SPIRIT: A Representational Intervention to Promote Preparation for End-of-Life Decision Making
- ClinicalTrials.gov ID
- NCT01259011
- Acronym / sponsor ID
- SPIRIT / 09-1190
- Conditions
- End Stage Renal Disease
- Keywords
- end stage renal disease, dialysis, end of life decision making, surrogate psychological morbidities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Mar 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness Representations to Increase Trust) intervention designed to improve discussions about end-of-life care between patients and their surrogate decision makers. Subjects will be 200 Caucasian and African-American patients with ESRD (end-stage renal disease) recruited from outpatient dialysis clinics and their chosen surrogate decision makers. We hypothesize that (1) SPIRIT will lead to significantly less patient decisional conflict and significantly greater dyad congruence and surrogate decision making confidence than the standard care control at 2, 6, and 12 months post-intervention and (2) SPIRIT will reduce surrogate decisional conflict and psychosocial morbidities at 2 weeks after the patient's hospitalization requiring surrogate decision making significantly more than the standard care control.
Detailed description
Dialysis is central to survival for 450,000 Americans with end-stage renal disease (ESRD). Yet patients on dialysis have significant comorbidities and high mortality rates (24% annually). One out of four ESRD patient deaths occurs after a decision to stop dialysis. However, when persons have lost their decision capacity if there has been no prior discussion between the patient and surrogate regarding goals of care, the issue of whether to continue dialysis can pose an ethical impasse and cause profound psychological distress for surrogate decision makers. Using the representational approach to patient education, we developed and pilot tested the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers. SPIRIT is a 6-step, 2-session, face-to-face intervention presented to both patient and surrogate by a trained interventionist in an interview format.
The proposed randomized controlled trial will test the effects of the SPIRIT intervention in improving preparedness for end-of-life decision making among ESRD patients and their surrogates and reducing surrogates' conflict during decision making and psychosocial morbidities. Subjects will be 200 Caucasian and African-American patients with ESRD recruited from outpatient dialysis clinics and their chosen surrogate decision makers. Preparedness outcomes (dyad congruence, patient decisional conflict, and surrogate decision making confidence) will be measured at 2, 6, and 12 months post-intervention. Surrogate decisional conflict and psychosocial morbidities (anxiety, depression, and post-traumatic distress symptoms) will be measured 2 weeks after the patient's hospitalization that required surrogate decision making. To compare the effects of SPIRIT to those of standard care on surrogates after the patient's death, psychosocial morbidities will be measured at 3 and 6 months after the patient's death. We will also explore the potential impact of race on intervention effects and examine mediators and moderators of the intervention effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Written information on advance directives and the patient's right to have an advance directive is provided to every patient on the first day of dialysis treatment by a social worker at the clinic. A social worker documents whether the patient has an advance directive, a surrogate decision maker, and/or a Do-Not-Resuscitate (DNR) Order on a Comprehensive Interdisciplinary Assessment form. The social worker encourages patients to complete an advance directive and addresses their questions about life-sustaining treatment options. If completed, the advance directive is placed in the medical record. |
| SPIRIT intervention | Experimental | Behavioral: the SPIRIT interventionThe SPIRIT intervention is a two-session, 1½ hour-long, structured intervention that is composed of six steps (assessing representations, identifying and exploring gaps and concerns, creating conditions for conceptual change, introducing replacement information, summarizing, and setting goals and planning), presented to both patient and surrogate by a trained nurse interventionist in a face-to-face interview format based on the representational approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- for patients,
- self-identified Caucasian or African American;
- receiving either center-hemodialysis or home-peritoneal dialysis for at least 6 months prior to enrollment;
- availability of an individual chosen by the patient who can be present during the intervention as a surrogate decision maker;
- age 18 years or older;
Key exclusion criteria (1 listed)
- -Patients who are too sick to participate in an hour-long interview, who require special care and assistance, who would not be able to care for their needs will be excluded.
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 |
|---|---|---|
| the SPIRIT interventionthe SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers | Behavioural | SPIRIT intervention |
Primary outcome
Dyad Congruence
Time frame: 2, 6, 12 months
patient and surrogate congruence on the goals of care
2 secondary outcomes
Change Over Time: Hospital Anxiety and Depression Scale Scores
Time frame: 2 Weeks, and at 3 and 6 months post death
Change Over Time: Post-traumatic Distress Symptom Score
Time frame: 2 weeks and 3 and 6 months after patient death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26141307Song MK, Ward SE, Fine JP, Hanson LC, Lin FC, Hladik GA, Hamilton JB, Bridgman JC. Advance care planning and end-of-life decision making in dialysis: a randomized controlled trial targeting patients and their surrogates. Am J Kidney Dis. 2015 Nov;66(5):813-22. doi: 10.1053/j.ajkd.2015.05.018. Epub 2015 Jun 30.
- Results publication: PubMed 26840848Song MK, Ward SE, Lin FC, Hamilton JB, Hanson LC, Hladik GA, Fine JP. Racial Differences in Outcomes of an Advance Care Planning Intervention for Dialysis Patients and Their Surrogates. J Palliat Med. 2016 Feb;19(2):134-42. doi: 10.1089/jpm.2015.0232.
- Results publication: PubMed 26982909Song MK, Ward SE, Hanson LC, Metzger M, Kim S. Determining Consistency of Surrogate Decisions and End-of-Life Care Received with Patient Goals-of-Care Preferences. J Palliat Med. 2016 Jun;19(6):610-6. doi: 10.1089/jpm.2015.0349. Epub 2016 Mar 16.
- Results publication: PubMed 27272317Song MK, Metzger M, Ward SE. Process and impact of an advance care planning intervention evaluated by bereaved surrogate decision-makers of dialysis patients. Palliat Med. 2017 Mar;31(3):267-274. doi: 10.1177/0269216316652012. Epub 2016 Jul 10.
- Derived from this study: PubMed 24519843Song MK, Ward SE. The extent of informed decision-making about starting dialysis: does patients' age matter? J Nephrol. 2014 Oct;27(5):571-6. doi: 10.1007/s40620-014-0061-4. Epub 2014 Feb 12.
- Individual participant dataSharing planned: Undecided
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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.
Mi-Kyung Song, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the SPIRIT intervention in people with End Stage Renal Disease, run by University of North Carolina, Chapel Hill 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 13 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 25 Sep 2017. 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 25 Sep 2017). 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?
Dyad Congruence (time frame: 2, 6, 12 months). 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 NCT01259011, which also lists 5 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 25 Sep 2017.