End-stage Renal DiseasePhase 2NCT00374010
Improving Patient-clinician Communication About End-of-life Care
A Phase 2 study testing Patient-Centered Advance Care Planning in people with End-stage Renal Disease, run by University of Pittsburgh.
Trial summary
The specific aims are: 1. to evaluate the feasibility and acceptability of PC-ACP among African American patients with End-stage Renal Disease and their surrogates and 2. to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients' perceived quality of communication, surrogates' level of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Patient-Centered Advance Care Planning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 2
- 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
- have been on either center-hemodialysis or home-peritoneal dialysis
- are cognitively intact,i.e., able to communicate, able to understand information, able to make choices and give rationale,
- have an individual who can be present during the intervention as a surrogate decision maker,
- are over 18 years of age, and
- are able to communicate in English. Surrogates must be over 18 years of age and be able to communicate in English.
Who cannot join
None listed.
About this study
Official title: Improving Patient-clinician Communication Among End-stage Renal Disease African Patients and Their Families
The specific aims are:
- to evaluate the feasibility and acceptability of PC-ACP among African American patients with End-stage Renal Disease and their surrogates and
- to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients' perceived quality of communication, surrogates' level of comfort in decision making for the patient, patients' difficulty in making choices, patient-surrogate congruence in goals of care, and patients' and surrogates' psychosocial/spiritual receptiveness) at one week following receipt of the intervention.
Read the detailed description
Despite the increasing emphasis placed on patient-clinician communication about end of life care, efforts to guide the patient to make an informed end-of-life treatment decision often fail. Past efforts to enhance end-of-life discussions were insufficient to create treatment decisions that were consistent with the patient's values and the surrogate's ability to make end-of-life decisions for his/her loved one when required. The importance of effective end-of-life discussions has been documented extensively, yet systematic explorations of the effects of such dialogue with African Americans are nearly absent from the literature. The proposed study is designed to test the ability of an hour-long intervention, Patient-Centered Advance Care Planning (PC-ACP), to enhance clinicians' communication about end-of-life care with patients and surrogates. The specific aims are (1) to evaluate the feasibility and acceptability of PC-ACP among African American patients with End-stage Renal Disease and their surrogates and (2) to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients' perceived quality of communication, surrogates' level of comfort in decision making for the patient, patients' difficulty in making choices, patient-surrogate congruence in goals of care, and patients' and surrogates' psychosocial/spiritual receptiveness) at one week following receipt of the intervention. A randomized, controlled, pre and post study will be conducted. Subjects (patient-surrogate dyads) will be randomized to PC-ACP or to a usual care control group. Data to assess feasibility, clinical and sociodemographic data, and baseline measures of patient and surrogate outcomes will be collected when subjects enter the study. Measures of the patient and surrogate outcomes and data to assess acceptability of the intervention will be administered at one week follow up. Findings from this study are critical to strengthening PC-ACP and designing a randomized controlled trial to test its efficacy for improving the quality of patient-clinician communication and the quality of decision making for future medical care with African American patients, in comparison with non-Hispanic Whites.
- Conditions
- End-stage Renal Disease
- Being tested
- Patient-Centered Advance Care Planning
- Keywords
- end-of-life decision making, advance care planning
- 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.
Patient-Centered Advance Care PlanningBehavioural
The PC-ACP is a scheduled interview with the dyad, delivered by a trained nurse facilitator. It consists of 5 stages and lasts about an hour:
- Representational assessment (10 - 15 minutes);
- Exploring concerns related to planning for future medical decision-making (10 - 15 minutes);
- Creating conditions for conceptual change (5 minutes);
- Introducing replacement information using a disease-specific Statement of Treatment Preferences document (15 minutes); and
- Summary (3 - 5 minutes)
What is being measured
The primary outcome is the main question the study is designed to answer.
congruence between patient and surrogate at one week after intervention
Measured: one week post intervention
patient and surrogate satisfaction with communication
Measured: one week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJan 2005
- Primary completionJun 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mi-Kyung Song, PhD, Principal investigator, University of Pittsburgh School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374010
- Sponsor's protocol ID
- 0412044
- Status last verified
- Mar 2008
- First submitted
- 6 Sep 2006
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient-clinician Communication Among End-stage Renal Disease African Patients and Their Families
- ClinicalTrials.gov ID
- NCT00374010
- Acronym / sponsor ID
- 0412044
- Conditions
- End-stage Renal Disease
- Keywords
- end-of-life decision making, advance care planning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Sep 2006 (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 specific aims are:
- to evaluate the feasibility and acceptability of PC-ACP among African American patients with End-stage Renal Disease and their surrogates and
- to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients' perceived quality of communication, surrogates' level of comfort in decision making for the patient, patients' difficulty in making choices, patient-surrogate congruence in goals of care, and patients' and surrogates' psychosocial/spiritual receptiveness) at one week following receipt of the intervention.
Detailed description
Despite the increasing emphasis placed on patient-clinician communication about end of life care, efforts to guide the patient to make an informed end-of-life treatment decision often fail. Past efforts to enhance end-of-life discussions were insufficient to create treatment decisions that were consistent with the patient's values and the surrogate's ability to make end-of-life decisions for his/her loved one when required. The importance of effective end-of-life discussions has been documented extensively, yet systematic explorations of the effects of such dialogue with African Americans are nearly absent from the literature. The proposed study is designed to test the ability of an hour-long intervention, Patient-Centered Advance Care Planning (PC-ACP), to enhance clinicians' communication about end-of-life care with patients and surrogates. The specific aims are (1) to evaluate the feasibility and acceptability of PC-ACP among African American patients with End-stage Renal Disease and their surrogates and (2) to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients' perceived quality of communication, surrogates' level of comfort in decision making for the patient, patients' difficulty in making choices, patient-surrogate congruence in goals of care, and patients' and surrogates' psychosocial/spiritual receptiveness) at one week following receipt of the intervention. A randomized, controlled, pre and post study will be conducted. Subjects (patient-surrogate dyads) will be randomized to PC-ACP or to a usual care control group. Data to assess feasibility, clinical and sociodemographic data, and baseline measures of patient and surrogate outcomes will be collected when subjects enter the study. Measures of the patient and surrogate outcomes and data to assess acceptability of the intervention will be administered at one week follow up. Findings from this study are critical to strengthening PC-ACP and designing a randomized controlled trial to test its efficacy for improving the quality of patient-clinician communication and the quality of decision making for future medical care with African American patients, in comparison with non-Hispanic Whites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have been on either center-hemodialysis or home-peritoneal dialysis
- are cognitively intact,i.e., able to communicate, able to understand information, able to make choices and give rationale,
- have an individual who can be present during the intervention as a surrogate decision maker,
- are over 18 years of age, and
- are able to communicate in English. Surrogates must be over 18 years of age and be able to communicate in English.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Patient-Centered Advance Care PlanningThe PC-ACP is a scheduled interview with the dyad, delivered by a trained nurse facilitator. It consists of 5 stages and lasts about an hour: 1. Representational assessment (10 - 15 minutes); 2. Exploring concerns related to planning for future medical decision-making (10 - 15 minutes); 3. Creating conditions for conceptual change (5 minutes); 4. Introducing replacement information using a disease-specific Statement of Treatment Preferences document (15 minutes); and 5. Summary (3 - 5 minutes) | Behavioural | – |
Primary outcome
congruence between patient and surrogate at one week after intervention
Time frame: one week post intervention
patient and surrogate satisfaction with communication
Time frame: one week post intervention
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 31 May 2017.
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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 Pittsburgh School of Nursing
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patient-Centered Advance Care Planning in people with End-stage Renal Disease, run by University of Pittsburgh.
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 0 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
congruence between patient and surrogate at one week after intervention (time frame: one week post intervention). The study lists 2 primary outcomes in all. 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 31 May 2017.