Advance Care PlanningACPNCT02302820
Nurse-led Patient-centered Advance Care Planning: A Pilot Study
A study testing Advance Care Planning Intervention in people with Advance Care Planning and Nurse Care Coordination, run by Mayo Clinic at 1 site in United States.
Trial summary
This study begins to look at ways nurses in primary care might help patients engage in Advance Care Planning and communicate their values and preferences to family and doctors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Care Planning, Nurse Care Coordination, Multiple Chronic Health Conditions
- What is being tested?
- Advance Care Planning Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients on the list of each NCC who do not have an Advance Directive on file in the Mayo electronic health record will be invited to participate.
Inclusion Criteria: This study will include community-dwelling adult patients with multiple chronic health conditions who do not have an Advance Directive document on file and their SDM/HCA if identified during the course of the intervention. We will accrue 40 patients and up to 40 SDM/HCAs to participate in this pilot study as subjects (80 total participants).
Exclusion Criteria: Because the ACP process, as part of self-management, is a deliberative process, patients with dementia or a serious, persisting psychiatric diagnosis identified in the medical record will be excluded. Patients whose cannot speak or read English will be excluded since it is beyond the scope of this pilot study to employ interpreters.
No vulnerable populations will be included in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study begins to look at ways nurses in primary care might help patients engage in Advance Care Planning and communicate their values and preferences to family and doctors.
Read the detailed description
The purpose of this pilot study is to determine the feasibility and acceptability of study procedures in comparing the effectiveness of four advance care planning (ACP) decision aids when used by Nurse Care Coordinators (NCCs) with their patients in primary care. Study activities include face-to-face participation in primarily 3 one-hour meetings with their NCC and completion of study questionnaires at baseline and at completion of the intervention. If during the ACP process the patient identifies a surrogate decision maker/health care agent (SDM/HCA), the SDM/HCA will be invited to also participate in the study by answering a questionnaire when the patient has completed the ACP intervention.
Findings from prior studies provide evidence of the success of the ACP decision aids for use in the ACP process. The proposed study is a logical next step to meet the need to enhance patient-centeredness in primary care practices. The study team is strategically positioned to successfully conduct the proposed study with adequate support and skills available. The proposed study is innovative in that it compares the effectiveness of evidence-based ACP decision aids when used by primary care nurses in collaboration with the patients they serve.
A four-arm, prospective, comparative, feasibility design is proposed. Participants will be recruited from the caseloads of NCCs from Mayo Clinic's primary care practice. After enrollment patients will be randomly assigned to either one of 3 ACP web-based decision aids or an ACP educational brochure decision aid arm to receive education and guidance related to the ACP process.
The central hypothesis is that ACP by NCCs in collaboration with patients in primary care settings is feasible and effective when supported by a decision aid. All 4 ACP decision aids have been proven successful when used by patients independently, but no evidence exists regarding their success when used in a patient/clinician collaboration in primary care. Group differences will direct us to explore whether one or more ACP decision aid performs better than others, thereby indicating that successful ACP by NCCs in primary care settings may be supported by particular decision aids. Direct benefits to subjects involved are not assured, but information regarding the ACP process and the possibility of identifying a surrogate decision maker and completion of an advance directive provides a potential benefit.
- Being tested
- Advance Care Planning Intervention
- Keywords
- Advance Care Planning, Nurse Care Coordination, Comparative Effectiveness, Advance Directive, Decision Aides
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care Planning InterventionOther
ACP Intervention The ACP intervention involves structured discussions between patients and NCCs using 1 of 4 decision aids in order to clarify patient's values, goals and preferences for "living well" and sharing goals with family, SDM/HCA, and the health care team. Because the time needed for reflective thinking, decision making and discussions with family are important components of the ACP process, the intervention is designed to occur in at least 3 NCC/patient visits over approximately 4 weeks. The NCC will assist patients in the ACP process following scripts specific to each of the decision aids.
| Study group | Role | What they receive |
|---|---|---|
| Make Your Wishes Known | Active comparator | A Decision Aid that uses interactions, videos, vignettes.
A formatted Advance Directive; saved data that may be revisited to produce a revised Advance Directive Receives: Other: Advance Care Planning Intervention |
| Mayo Clinic-Advance Health Care Planning | Active comparator | Not an online decision aid
Written instructions, worksheets, and Advance Directive to complete Receives: Other: Advance Care Planning Intervention |
| Mydirectives.com | Active comparator | Online decision aid that uses interactions, videos, and vignettes.
An electronically stored Advance Directive that may be printed. Receives: Other: Advance Care Planning Intervention |
| Prepare | Active comparator | An online decision aid that uses interactions, videos and vignettes.
A printed summary useful for transposing values and treatment wishes into an Advance Directive; a list of action steps. Receives: Other: Advance Care Planning Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measure of Acceptability and Feasibility
Data regarding acceptability and feasibility of the study methods will be recorded following CONSORT Guidelines to monitor accrual and retention and include the percent of patients eligible for the study over the study period; percent of patients who are approached and accept study participation, percent of patients who complete the intervention and percent of forms completed. Patient satisfaction with the ACP decision aids will be measured using the Patient Satisfaction with ACP Survey.
Measured: 4 months
Secondary outcomes (1)
Composite Measure of Effects and Comparisons of the Four ACP Decision Aids
To conduct preliminary effects and comparisons of the four ACP decision aids, the ACP Engagement Survey consisting of Process and Action components will be mailed to the patient or administered via a telephone call by the study coordinator after the intervention is completed. There are 31 Process questions organized into 4 subscales, each with a Likert response set ranging from 1-5. There are 19 dichotomous (yes/no) Action measure questions. The formal identification of a SDM/HCA and the proportions of Advance Directives will be obtained from patients' electronic health records. Names of SDM/HCAs and Advance Directive documents are stored in a specific location with the electronic health record. The study coordinator will review the electronic health record for SDM/HCA and an advance directive one month after the patient has completed the intervention.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 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 Holland, RN, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302820
- Sponsor's protocol ID
- 14-006947
- Acronym
- ACP
- Status last verified
- Jan 2016
- First submitted
- 3 Oct 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Patient-centered Advance Care Planning: A Pilot Study
- ClinicalTrials.gov ID
- NCT02302820
- Acronym / sponsor ID
- ACP / 14-006947
- Keywords
- Advance Care Planning, Nurse Care Coordination, Comparative Effectiveness, Advance Directive, Decision Aides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Nov 2014 (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.
This study begins to look at ways nurses in primary care might help patients engage in Advance Care Planning and communicate their values and preferences to family and doctors.
Detailed description
The purpose of this pilot study is to determine the feasibility and acceptability of study procedures in comparing the effectiveness of four advance care planning (ACP) decision aids when used by Nurse Care Coordinators (NCCs) with their patients in primary care. Study activities include face-to-face participation in primarily 3 one-hour meetings with their NCC and completion of study questionnaires at baseline and at completion of the intervention. If during the ACP process the patient identifies a surrogate decision maker/health care agent (SDM/HCA), the SDM/HCA will be invited to also participate in the study by answering a questionnaire when the patient has completed the ACP intervention.
Findings from prior studies provide evidence of the success of the ACP decision aids for use in the ACP process. The proposed study is a logical next step to meet the need to enhance patient-centeredness in primary care practices. The study team is strategically positioned to successfully conduct the proposed study with adequate support and skills available. The proposed study is innovative in that it compares the effectiveness of evidence-based ACP decision aids when used by primary care nurses in collaboration with the patients they serve.
A four-arm, prospective, comparative, feasibility design is proposed. Participants will be recruited from the caseloads of NCCs from Mayo Clinic's primary care practice. After enrollment patients will be randomly assigned to either one of 3 ACP web-based decision aids or an ACP educational brochure decision aid arm to receive education and guidance related to the ACP process.
The central hypothesis is that ACP by NCCs in collaboration with patients in primary care settings is feasible and effective when supported by a decision aid. All 4 ACP decision aids have been proven successful when used by patients independently, but no evidence exists regarding their success when used in a patient/clinician collaboration in primary care. Group differences will direct us to explore whether one or more ACP decision aid performs better than others, thereby indicating that successful ACP by NCCs in primary care settings may be supported by particular decision aids. Direct benefits to subjects involved are not assured, but information regarding the ACP process and the possibility of identifying a surrogate decision maker and completion of an advance directive provides a potential benefit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Make Your Wishes Known | Active comparator | Other: Advance Care Planning InterventionA Decision Aid that uses interactions, videos, vignettes. A formatted Advance Directive; saved data that may be revisited to produce a revised Advance Directive |
| Mayo Clinic-Advance Health Care Planning | Active comparator | Other: Advance Care Planning InterventionNot an online decision aid Written instructions, worksheets, and Advance Directive to complete |
| Mydirectives.com | Active comparator | Other: Advance Care Planning InterventionOnline decision aid that uses interactions, videos, and vignettes. An electronically stored Advance Directive that may be printed. |
| Prepare | Active comparator | Other: Advance Care Planning InterventionAn online decision aid that uses interactions, videos and vignettes. A printed summary useful for transposing values and treatment wishes into an Advance Directive; a list of action steps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Advance Care Planning InterventionACP Intervention The ACP intervention involves structured discussions between patients and NCCs using 1 of 4 decision aids in order to clarify patient's values, goals and preferences for "living well" and sharing goals with family, SDM/HCA, and the health care team. Because the time needed for reflective thinking, decision making and discussions with family are important components of the ACP process, the intervention is designed to occur in at least 3 NCC/patient visits over approximately 4 weeks. The NCC will assist patients in the ACP process following scripts specific to each of the decision aids. | Other | Make Your Wishes Known, Mayo Clinic-Advance Health Care Planning, Mydirectives.com, Prepare |
Primary outcome
Composite Measure of Acceptability and Feasibility
Time frame: 4 months
Data regarding acceptability and feasibility of the study methods will be recorded following CONSORT Guidelines to monitor accrual and retention and include the percent of patients eligible for the study over the study period; percent of patients who are approached and accept study participation, percent of patients who complete the intervention and percent of forms completed. Patient satisfaction with the ACP decision aids will be measured using the Patient Satisfaction with ACP Survey.
1 secondary outcome
Composite Measure of Effects and Comparisons of the Four ACP Decision Aids
Time frame: 4 months
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 5 Jan 2016.
Related trials for Advance Care Planning
Active, not recruiting
ACP Video Intervention for Patients With Life-Limiting Illness
Health Care Utilization, End Stage Disease
Recruiting
Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
Hematopoietic and Lymphatic System Neoplasm
Not yet recruiting
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
Not yet recruiting
Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
Heart Failure, Older Adults (65 Years and Older)
Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
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 Holland, RN, PhD 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 Advance Care Planning Intervention in people with Advance Care Planning and Nurse Care Coordination, 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?
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 5 Jan 2016. 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?
Composite Measure of Acceptability and Feasibility (time frame: 4 months). 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 5 Jan 2016.