Impact of a Systematic Social Work Driven Approach on Medical Power of Attorney Documentation, Knowledge, Attitudes, and Beliefs in Participants With Stage I-IV Gynecological Cancers

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03037346
Collaborator
National Cancer Institute (NCI) (NIH)
734
1
1
60.5
12.1

Study Details

Study Description

Brief Summary

This trial evaluates the impact of a systemic social work driven approach on medical power of attorney documentation, knowledge, attitudes, and beliefs in participants with stage I-IV gynecological cancers. Social work counseling and education may help increase the number of participants who complete medical power of attorney documents. Counseling and education may also affect attitudes about decision-making and willingness to take part in these conversations in participants with stage I-IV gynecological cancers and their family members and/or caregivers.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire Administration
  • Other: Questionnaire Administration
  • Other: Video
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate medical power of attorney documents (MPOAD) completion rate after a systematic social work counseling and education clinical process.
SECONDARY OBJECTIVES:
  1. To determine change in medical power of attorney (MPOA)/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate medical decision-making (MDM).

  2. To determine change in MPOA/primary family caregivers' knowledge of patients' values and goals for MDM.

  3. Evaluate patients' and MPOA/primary family caregivers' willingness to participate in future advance care planning discussions to discuss patients' values and goals important to MDM.

  4. Evaluate predictors of patient subgroups most likely to respond to the social work counseling and education clinical process.

  5. Explore aspects of the Spanish language version of the advance care planning engagement survey to inform future validation studies.

OUTLINE:

Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge, attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational video about the importance of the role of MPOA.

After completion of intervention, participants are followed up at 3 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
734 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Preparing Patients and Family Caregivers for Medical Decision Making: Evaluating the Impact of a Systematic Social Work Driven Approach on Medical Power of Attorney Documentation, Knowledge, Attitudes and Beliefs
Actual Study Start Date :
Jul 17, 2017
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive Care (questionnaires, educational video)

Participants (patients and family caregiver/MPOA) complete questionnaires about knowledge, attitudes, and beliefs of MPOAD. Participants without a MPOAD watch a 4-minute educational video about the importance of the role of MPOA.

Other: Questionnaire Administration
Complete questionnaires about MPOAD

Other: Questionnaire Administration
Ancillary studies

Other: Video
Watch educational video

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients who decline to participate in the study [Up to 3 months]

    Will be reported with 95% confidence intervals. Descriptive demographic and disease characteristics for patients who decline study participation but allow collection of demographic and disease characteristics will be compared to those of participating patients.

  2. Proportion of patients who already have medical power of attorney (MPOAD) at consult [Up to 3 months]

    Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate medical decision-making (MDM), in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.

  3. Proportion of patients who completed MPOAD at the first social work counselor visit [Up to 3 months]

    Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.

  4. Proportion of participants who completed MPOAD after the first educational video [Up to 3 months]

    Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.

  5. Proportion of participants who completed MPOAD within 3 months after the educational video [Up to 3 months]

    Will be reported with 95% confidence intervals. Baseline and changes in MPOA/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate MDM, in patients/primary family caregivers' self-efficacy and readiness for MPOA, and in patients/Primary family caregivers' knowledge of patients' values and goals for MDM, will be summarized and compared among the four patient groups: 1) had MPOAD at the consult already, 2) complete MPOAD at the first visit, 3) complete MPOAD after initial social work counselor visit and by 3 months, 4) do not complete MPOAD by 3 months, using Kruskal-Wallis test for continuous variables and either Chi-square test or Fisher's exact test for discrete variables, whenever appropriate. Univariate/multi-covariate logistic regression will be employed to evaluate the effect of potential factors on completion of MPOAD.

  6. Willingness to participate in future advance care planning discussions [Up to 3 months]

    Willingness to participate in future Advance Care Planning discussions for patients' values and goals important to MDM will be tabulated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • PATIENTS

  • Diagnosis of invasive gynecologic malignancy stages 1-4.

  • New patient in the Gynecologic Oncology Center.

  • Adequate capacity to understand and complete MPOAD in the opinion of the study investigator or research assistant.

  • Able to speak and understand English and/or Spanish.

  • Provision of Institutional Review Board (IRB)-approved informed consent.

  • Available MPOA or primary family caregiver who consents to study participation.

  • FAMILY CAREGIVER/MPOA

  • MPOA or if none documented in electronic health record (EHR), primary family caregiver, as designated by the patient.

  • Permission to contact provided by patient.

  • Adequate capacity to understand and complete study measures in the opinion of the study investigator or research assistant.

  • Provision of IRB-approved informed consent.

Exclusion Criteria:
  • Without a MPOA or available family caregiver.

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Donna S Zhukovsky, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT03037346
Other Study ID Numbers:
  • 2016-0704
  • NCI-2018-01745
  • 2016-0704
First Posted:
Jan 31, 2017
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2022