Seriously Ill PatientsLSTDINCT05001009
Goals of Care Conversations Study
A study testing Clinician Implementation Strategy Stage 1: low intensity clinician training, Clinician Implementation Strategy Stage 2: high intensity clinician training and Low patient engagement in people with Seriously Ill Patients and Cancer, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seriously Ill Patients, Cancer, Heart Failure
- What is being tested?
- Clinician Implementation Strategy Stage 1: low intensity clinician training, Clinician Implementation Strategy Stage 2: high intensity clinician training and Low patient engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,859 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Sep 2022to 30 Sep 2025
- Phase
- Interventional
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
- CLINICIANS VA primary care advance practice clinicians (MDs, APRNs, PAs) at one of the three study sites able to complete goals of care conversation notes and orders. Advance practice clinicians will be eligible for randomization if they have at least 15 eligible patients without goals of care conversation notes at the start of stage 1 (to allow participating clinicians ample opportunities to write notes) and have written fewer than 4 goals of care conversation notes in the previous 6 months (to select clinicians who need improvement), and can potentially receive the planned implementation strategies, i.e., clinicians who regularly attend the Patient Aligned Care Team (PACT) team meetings.
- PATIENTS
- Veteran enrolled in VHA health care in one of the three study sites who is a current patient of one of the eligible primary care clinicians
- Diagnosis of cancer, heart failure, interstitial lung disease, chronic obstructive pulmonary disease, end-stage renal disease, end-stage liver disease, and dementia
- Care Assessment Need score of > or equal to 90 using the one-year combined hospitalization/mortality variable
Who cannot join
- PATIENTS
- Prisoner
- Pregnant
- under 18 years of age.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
About this study
Official title: Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness
The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care conversations. The study will use interviews with and surveys of medical providers, patients, and caregivers, along with medical record data. This work is significant because it tests ways Veterans can express their goals and preferences for life sustaining treatments and have them honored.
Read the detailed description
The aims of this study are as follows:
Aim 1. Use a clinician-level SMART in three VA health systems to determine the effectiveness of clinician and patient implementation strategies to improve the occurrence of documented goals of care conversations in Veterans with serious medical illness. Hypothesis 1 (first stage of the SMART): Compared to a low intensity clinician strategy alone, a low intensity clinician and patient strategy will lead to increased documentation of goals of care conversations. Hypothesis 2. Among those who do not respond to low intensity strategies, compared to a high intensity clinician strategy paired with a low intensity patient strategy, a high intensity clinician and patient strategy will lead to increased documentation of goals of care conversations.
Aim 2a. Identify the sequence of implementation strategies that leads to the overall greatest increase in documentation of goals of care conversations. Aim 2b (exploratory). Identify patient and clinician characteristics that modify the effect of sequences of implementation strategies on documentation of goals of care conversations.
Aim 3. Understand clinician and patient implementation strategy success or failure using a mixed method evaluation involving clinicians, leaders, patients, and caregivers.
- Conditions
- Seriously Ill Patients, Cancer, Heart Failure, Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, End-stage Renal Disease
- Being tested
- Clinician Implementation Strategy Stage 1: low intensity clinician training, Clinician Implementation Strategy Stage 2: high intensity clinician training, Low patient engagement, High patient engagement
- Keywords
- implementation science, primary health care, advance care planning, patient care planning, palliative care, goals of care conversation, serious illness
- Medical subject headings
- Neoplasms, Heart Failure, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Kidney Failure, Chronic, End Stage Liver Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician Implementation Strategy Stage 1: low intensity clinician trainingBehavioural
A "booster" of the established LSTDI implementation strategy. Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study. Online training options and when and how to complete goals of care conversations and documentation will be highlighted.
Clinician Implementation Strategy Stage 2: high intensity clinician trainingBehavioural
This includes two components:
- Team facilitation to help the primary care team (advance practice provider, nurse, social worker) work together to create roles and responsibilities for accomplishing goals of care conversations with patients
- A patient list "trigger" of patients potentially eligible for goals of care conversations (the patient study population) will be sent to the primary care clinicians.
Low patient engagementBehavioural
Also called PREPARE information and website
Patients will be sent information about goals of care conversations, including the PREPARE website.
High patient engagementBehavioural
Also called PREPARE information and website and phone call
Patients will be sent information about goals of care conversations, including the PREPARE website. Follow-up phone calls to discuss goals of care conversations and the PREPARE website will be made.
| Study group | Role | What they receive |
|---|---|---|
| No then high patient engagement | Active comparator | First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training.
Second stage (non-responders only): High patient engagement and high intensity clinician training. Receives: Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training; Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training; Behavioral: High patient engagement |
| No then low patient engagement | Active comparator | First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training.
Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training. Receives: Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training; Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training; Behavioral: Low patient engagement |
| Low then high patient engagement | Active comparator | First stage: Low intensity patient engagement. Low intensity clinician training.
Second stage (responders only): No patient engagement and high intensity clinician training.
Second stage (non-responders only): High patient engagement and high intensity clinician training. Receives: Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training; Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training; Behavioral: Low patient engagement; Behavioral: High patient engagement |
| Low then low patient engagement | Active comparator | First stage: Low patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training.
Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training. Receives: Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training; Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training; Behavioral: Low patient engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients With a Goals of Care Conversation Note Documented in Stage 2
Amongst patients attributed to a clinician who was randomized in Stage 2, whether or not a goals of care conversation note was written by primary care during Stage 2.
Measured: From the start of stage 2 to 9 months later
Secondary outcomes (2)
Percent of Patients With a Goals of Care Conversation Note Documented in Stage 1 or 2
Amongst all patients in the study, whether or not a goals of care conversation note was written by primary care during the study.
Measured: From the start of stage 1 to 9 months after the start of stage 2
Percent of Patients With a Goals of Care Conversation Note Documented in Stage 1
Amongst all patients in the study, whether or not a goals of care conversation note was written by primary care during stage 1
Measured: From the start of stage 1 to the beginning of stage 2 (approximately 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start13 Sep 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2025
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 (9)Papers the sponsor has linked to this study.
- Other trials for Seriously Ill PatientsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Sequential
- Model description
- Sequential multiple-assignment randomized clinical trial (SMART)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David Bekelman, MD MPH, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, COAnne M Walling, MD PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001009
- Sponsor's protocol ID
- IIR 19-018
- Other IDs
- HX002935
- Acronym
- LSTDI
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2021
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ha DM, Deng LR, Lange AV, Swigris JJ, Bekelman DB. Reliability, Validity, and Responsiveness of the DEG, a Three-Item Dyspnea Measure. J Gen Intern Med. 2022 Aug;37(10):2541-2547. doi: 10.1007/s11606-021-07307-1. Epub 2022 Jan 3.
PubMed 34981344Bekelman DB, Giannitrapani K, Linn KA, Langner P, Sudore RL, Rabin B, Lorenz KA, Foglia M, Glickman A, Pawlikowski S, Sloan M, Gamboa RC, McCaa MD, Hines A, Walling AM. Increasing goals of care conversations in primary care: Study protocol for a cluster randomized, pragmatic, sequential multiple assignment randomized trial. Contemp Clin Trials. 2024 Oct;145:107643. doi: 10.1016/j.cct.2024.107643. Epub 2024 Jul 27.
PubMed 39074531Haverfield MC, Ma J, Walling A, Bekelman DB, Brown-Johnson C, Lo N, Lorenz KA, Giannitrapani KF. Communication processes in an advance care planning initiative: A socio-ecological perspective for service evaluation. Palliat Med. 2024 Dec;38(10):1134-1143. doi: 10.1177/02692163241277394. Epub 2024 Sep 10.
PubMed 39254148Gambino J, Schlichte LM, Haverfield MC, Libman C, Bekelman DB, Ma JE. Uncovering Psychosocial Contexts in Goals of Care Conversations: A Qualitative Study in a Multi-Centered Randomized Controlled Trial. Clin Gerontol. 2025 Oct-Dec;48(5):1320-1327. doi: 10.1080/07317115.2025.2464023. Epub 2025 Feb 17.
PubMed 39957477Lange AV, Feser WJ, Hess E, Baron AE, Ma JE, Bekelman DB. Serious Illness Communication in a Randomized Trial of a Nurse and Social Worker Palliative Telecare Team. J Am Geriatr Soc. 2025 Mar 22:10.1111/jgs.19445. doi: 10.1111/jgs.19445. Online ahead of print.
PubMed 40119839Schillok H, Gensichen J, Panagioti M, Gunn J, Junker L, Lukaschek K, Jung-Sievers C, Sterner P, Kaupe L, Dreischulte T, Ali MK, Aragones E, Bekelman DB, Herbeck Belnap B, Carney RM, Chwastiak LA, Coventry PA, Davidson KW, Ekstrand ML, Flehr A, Fletcher S, Holzel LP, Huijbregts K, Mohan V, Patel V, Richards DA, Rollman BL, Salisbury C, Simon GE, Srinivasan K, Unutzer J, van der Feltz-Cornelis CM, Wells KB, Zimmermann T, Buhner M; POKAL Group. Effective Components of Collaborative Care for Depression in Primary Care: An Individual Participant Data Meta-Analysis. JAMA Psychiatry. 2025 Sep 1;82(9):868-876. doi: 10.1001/jamapsychiatry.2025.0183.
PubMed 40136273Lange AV, Bekelman DB, DeGroot L, Douglas IS, Mehta AB. Use of Noninvasive vs Invasive Ventilation for Patients Hospitalized With Acute Exacerbation of COPD, 2010 to 2019. Am J Crit Care. 2025 May 1;34(3):220-229. doi: 10.4037/ajcc2025261.
PubMed 40307172Kaufman BG, Lanford TJ, Sperber NR, Stanwyck C, Ma JE, Thorpe JM, Hastings SN, Bekelman DB, Van Houtven CH. Multi-Level Factors Impacting Implementation of Outpatient Palliative Care: Perceptions of VA Providers. J Appl Gerontol. 2026 Mar;45(3):453-465. doi: 10.1177/07334648251343484. Epub 2025 May 27.
PubMed 40424539Kaufman BG, Woolson S, Stanwyck C, Burns M, Dennis P, Ma J, Feder S, Thorpe JM, Hastings SN, Bekelman DB, Van Houtven CH. Veterans' use of inpatient and outpatient palliative care: The national landscape. J Am Geriatr Soc. 2024 Nov;72(11):3385-3397. doi: 10.1111/jgs.19141. Epub 2024 Aug 23.
PubMed 39180221