NCT02612688

Brief Summary

This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP) Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH facilities (intervention arm n=119; control arm n=241) within two NH health care systems: Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP Video Program, while the control NH facilities will follow their usual ACP procedures. The trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations, advance directives, and hospice use in the intervention vs. control NHs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197,692

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 18, 2020

Completed
Last Updated

October 12, 2020

Status Verified

September 1, 2020

Enrollment Period

3.2 years

First QC Date

November 19, 2015

Results QC Date

May 29, 2020

Last Update Submit

September 16, 2020

Conditions

Alzheimer DiseaseDementiaHeart FailurePulmonary Disease, Chronic Obstructive

Keywords

Advance Care PlanningAdvance DirectivesAlzheimer DiseaseDementiaDo-Not-Resuscitate OrdersEnteral NutritionHeart FailureHospicesHospitalizationInstructional Films and VideosIntubationNursing HomesParenteral NutritionPragmatic Clinical TrialsPulmonary Disease, Chronic ObstructiveRandomized Controlled TrialsResuscitation OrdersSkilled Nursing Facilities

Outcome Measures

Primary Outcomes (1)

  • Hospital Transfer Rate in Target Cohort

    Number of hospital transfers (number of transfers/person-days alive) over a 12-month observation period among Medicare fee-for-service long-stay residents (in a NH \>=90 days) who are \>=65 years old and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease

    12-month observation period

Secondary Outcomes (19)

  • Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness

    12-month observation period

  • Hospital Transfer Rate Among Short-stay Residents With Advanced Illness

    100-day observation period

  • Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness

    100-day observation period

  • Proportion of Target Cohort With Last Observed Advance Directive Status

    12-month observation period

  • Proportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive Status

    12-month observation period

  • +14 more secondary outcomes

Study Arms (2)

ACP Video Program

EXPERIMENTAL

Facility asked to implement ACP Video Program

Behavioral: ACP Video Program

Usual ACP procedures

NO INTERVENTION

Facility follows usual ACP procedures

Interventions

ACP Video ProgramBEHAVIORAL

The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting).

ACP Video Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Facilities are within Genesis HealthCare or PruittHealth health care systems
  • Facilities have facility identifiers that indicate that they are Medicare/Medicaid-certified nursing facilities in the U.S.
  • Facilities serve both short and long-stay patients
  • Facilities have \>50 beds
  • Facilities have an electronic medical records system
  • Facilities had at least 20 admissions and 20 annual Minimum Data Set (MDS) assessments (regardless of whether they were discharged alive) in 2013

You may not qualify if:

  • Facilities excluded per corporate leaders in health care system because of recent turnover in NH administrator or Director of Nursing
  • Facilities excluded per corporate leaders in health care system because of recent bad state or federal quality assurance survey (e.g. restriction on admissions, levied large civil monetary penalty, etc.)
  • Facilities excluded per corporate leaders in health care system because of current new initiatives/competing demands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PruittHealth

Norcross, Georgia, 30093, United States

Location

Genesis HealthCare

Kennett Square, Pennsylvania, 19348, United States

Location

Related Publications (6)

  • McCreedy EM, Yang X, Mitchell SL, Gutman R, Teno J, Loomer L, Moyo P, Volandes A, Gozalo PL, Belanger E, Ogarek J, Mor V. Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness. BMC Geriatr. 2022 Apr 8;22(1):298. doi: 10.1186/s12877-022-02970-3.

    PMID: 35392827DERIVED

  • Mitchell SL, Volandes AE, Gutman R, Gozalo PL, Ogarek JA, Loomer L, McCreedy EM, Zhai R, Mor V. Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Aug 1;180(8):1070-1078. doi: 10.1001/jamainternmed.2020.2366.

    PMID: 32628258DERIVED

  • Palmer JA, Parker VA, Barre LR, Mor V, Volandes AE, Belanger E, Loomer L, McCreedy E, Mitchell SL. Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting:a mixed-methods examination. Trials. 2019 Nov 28;20(1):656. doi: 10.1186/s13063-019-3725-5.

    PMID: 31779684DERIVED

  • Palmer JA, Parker VA, Mor V, Volandes AE, Barre LR, Belanger E, Carter P, Loomer L, McCreedy E, Mitchell SL. Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting. BMC Health Serv Res. 2019 Jul 29;19(1):527. doi: 10.1186/s12913-019-4309-5.

    PMID: 31357993DERIVED

  • Loomer L, McCreedy E, Belanger E, Palmer JA, Mitchell SL, Volandes AE, Mor V. Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention. J Am Med Dir Assoc. 2019 Jul;20(7):804-809.e1. doi: 10.1016/j.jamda.2019.01.133. Epub 2019 Mar 7.

    PMID: 30852167DERIVED

  • Palmer JA, Mor V, Volandes AE, McCreedy E, Loomer L, Carter P, Dvorchak F, Mitchell SL. A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems. Trials. 2018 Aug 22;19(1):453. doi: 10.1186/s13063-018-2817-y.

    PMID: 30134976DERIVED

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDementiaHeart FailurePulmonary Disease, Chronic ObstructiveHyperphagia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersHeart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Results Point of Contact

Title
Jessica A. Ogarek, Senior Biostatistician
Organization
Brown University
jessica_ogarek@brown.edu
401-863-9356

Study Officials

  • Vincent Mor, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

  • Susan Mitchell, MD, MPH

    Hebrew SeniorLife

    PRINCIPAL INVESTIGATOR

  • Angelo Volandes, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Science, Florence Pirce Grant University Professor, Health Services, Policy & Practice

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 24, 2015

Study Start

March 1, 2016

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

October 12, 2020

Results First Posted

June 18, 2020

Record last verified: 2020-09

Locations

US(2)