STAMP: Sharing and Talking About My Preferences

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03137459
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 909
• Location: 1
• Arms: 2
• Actual Duration (Months): 47.4
• Patients Per Site Per Month: 19.2

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the effect of an individually transtheoretical model (TTM) tailored intervention on the completion of advance care planning (ACP) behaviors.

Condition or Disease	Intervention/Treatment	Phase
Advanced Care Planning (ACP)	Behavioral: Transtheoretical Model (TTM) of health behavior change; Other: Usual Care	N/A

Detailed Description

This will be a randomized controlled trial examining the effect of an individually TTM-tailored intervention on the proportion of middle-age and older persons recruited from primary care practices who complete four ACP behaviors (completion of a living will, assignment of a health care proxy, and communication with loved ones and with their clinician about views on quality versus quantity of life) over six months, compared with usual care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 909 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: STAMP: Sharing and Talking About My Preferences
• Actual Study Start Date: Jul 17, 2017
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TTM Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system.	Behavioral: Transtheoretical Model (TTM) of health behavior change; Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
Active Comparator: Usual Care Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites.	Other: Usual Care; Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Completed Four ACP Activities: Communication With Loved Ones About Quality Versus Quantity of Life, Completion of a Living Will, Assignment of a Healthcare Agent, and Confirmation of Documents in the Electronic Health Record. [6 months]

   The primary outcome of the study is to assess the proportion of participants that have completed the four ACP behaviors. The measure will be coded as a binary outcome where 'yes' indicates the completion of all 4 behaviors and 'no' indicates no completing the 4 behaviors.

Secondary Outcome Measures

1. Number of Participants Who Complete a Living Will [6-months]

2. Number of Participants Who Assign a Healthcare Agent [6 months]

3. Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants will be community-dwelling persons with an upcoming primary care visit in the study's practice settings.

Exclusion Criteria:

• Severe hearing impairment, defined as being unable to participate in a telephone conversation.

• Severe visual impairment, defined as being unable to read large-print materials.

• Moderate to severe cognitive impairment, defined as either a diagnosis of dementia and/or short-term recall of <2/3 objects at 2 minutes.

• Primary language other than English.

• Having completed all of the four ACP behaviors that are the focus of this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northeast Medical Groups	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Yale University
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Terri Fried, MD, Internal Medicine: Geriatrics: Claude D. Pepper Older Americans Independence Center; Dorothy Adler Geriatric Assessment Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 1, 2016

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03137459
• Other Study ID Numbers: 1604017648; 1R01NR016007-01
• First Posted: May 2, 2017
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yale University: Transtheoretical Model (TTM)

Study Results

Participant Flow

Recruitment Details

20 ambulatory internal medicine practices, matched in pairs according to practice type and percentage of patients age 65+, non-White, and receiving Medicaid

Pre-assignment Detail

Because randomization occurred at the level of the practice, participants' assignment to group was determined before any information was known about them. However, there were participants who were excluded from they study before beginning any study procedures. These included: 1 matched set of practices was excluded for failing to meet minimum enrollment with 12 participants; 6 participants consented in error; 25 participants refused the baseline interview.

Arm/Group Title	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report	Usual Care
Arm/Group Description	Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system. Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.	Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites. Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
Period Title: 2-month Assessment
STARTED	455	454
COMPLETED	387	412
NOT COMPLETED	68	42
Period Title: 2-month Assessment
STARTED	442	451
COMPLETED	364	405
NOT COMPLETED	78	46
Period Title: 2-month Assessment
STARTED	434	447
COMPLETED	413	430
NOT COMPLETED	21	17

Baseline Characteristics

Arm/Group Title	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report	Usual Care	Total
Arm/Group Description	Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system. Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.	Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites. Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.	Total of all reporting groups
Overall Participants	455	454	909
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.9 (8.5)	67.8 (8.0)	68.3 (8.3)
Sex: Female, Male (Count of Participants)
Female	292 64.2%	262 57.7%	554 60.9%
Male	163 35.8%	192 42.3%	355 39.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 2.6%	10 2.2%	22 2.4%
Not Hispanic or Latino	441 96.9%	439 96.7%	880 96.8%
Unknown or Not Reported	2 0.4%	5 1.1%	7 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.7%	2 0.4%	5 0.6%
Asian	6 1.3%	6 1.3%	12 1.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	76 16.7%	91 20%	167 18.4%
White	352 77.4%	339 74.7%	691 76%
More than one race	9 2%	6 1.3%	15 1.7%
Unknown or Not Reported	9 2%	10 2.2%	19 2.1%
Education (Count of Participants)
<=12th grade	137 30.1%	96 21.1%	233 25.6%
>12th grade	318 69.9%	358 78.9%	676 74.4%
Employment (Count of Participants)
Employed	157 34.5%	194 42.7%	351 38.6%
Unemployed	298 65.5%	260 57.3%	558 61.4%
Baseline stage of change: living will (Count of Participants)
Precontemplation	64 14.1%	86 18.9%	150 16.5%
Contemplation	224 49.2%	224 49.3%	448 49.3%
Preparation	59 13%	21 4.6%	80 8.8%
Action/maintenance	108 23.7%	120 26.4%	228 25.1%
Missing	0 0%	3 0.7%	3 0.3%
Baseline stage of change: healthcare agent (Count of Participants)
Precontemplation	69 15.2%	99 21.8%	168 18.5%
Contemplation	227 49.9%	217 47.8%	444 48.8%
Preparation	76 16.7%	31 6.8%	107 11.8%
Action/maintenance	83 18.2%	105 23.1%	188 20.7%
Missing	0 0%	2 0.4%	2 0.2%
Baseline stage of change: communication about quality versus quantity of life (Count of Participants)
Precontemplation	80 17.6%	112 24.7%	192 21.1%
Contemplation	60 13.2%	46 10.1%	106 11.7%
Preparation	11 2.4%	5 1.1%	16 1.8%
Action/maintenance	304 66.8%	289 63.7%	593 65.2%
Missing	0 0%	2 0.4%	2 0.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Completed Four ACP Activities: Communication With Loved Ones About Quality Versus Quantity of Life, Completion of a Living Will, Assignment of a Healthcare Agent, and Confirmation of Documents in the Electronic Health Record.
Description	The primary outcome of the study is to assess the proportion of participants that have completed the four ACP behaviors. The measure will be coded as a binary outcome where 'yes' indicates the completion of all 4 behaviors and 'no' indicates no completing the 4 behaviors.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report	Usual Care
Arm/Group Description	Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system. Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.	Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites. Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
Measure Participants	455	454
Count of Participants [Participants]	64 14.1%	37 8.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	.059
	Confidence Interval	(2-Sided) 95%; .014 to .105
	Parameter Dispersion	Type: Value:
	Estimation Comments	Analysis performed using GEE to account for clustering of participants within practices.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.83
	Confidence Interval	(2-Sided) 95%; 1.14 to 2.93
	Parameter Dispersion	Type: Value:
	Estimation Comments	Determined using mixed effects models, accounting for clustering of participants in practices and adjusting for unbalanced covariates: education, employment, stage of change for each ACP behavior

2. Secondary Outcome

Title	Number of Participants Who Complete a Living Will
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

Participants who had not completed a living will at baseline

Arm/Group Title	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report	Usual Care
Arm/Group Description	Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system. Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.	Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites. Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
Measure Participants	347	334
Count of Participants [Participants]	99 21.8%	68 15%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	.082
	Confidence Interval	(2-Sided) 95%; .014 to .150
	Parameter Dispersion	Type: Value:
	Estimation Comments	Adjusted for clustering

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.39
	Confidence Interval	(2-Sided) 95%; .96 to 2.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Accounting for clustering and adjusted for covariates as described in primary outcome

3. Secondary Outcome

Title	Number of Participants Who Assign a Healthcare Agent
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Individuals who had not assigned a healthcare agent at baseline

Arm/Group Title	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report	Usual Care
Arm/Group Description	Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system. Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.	Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites. Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
Measure Participants	372	349
Count of Participants [Participants]	122 26.8%	68 15%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	.133
	Confidence Interval	(2-Sided) 95%; .066 to .201
	Parameter Dispersion	Type: Value:
	Estimation Comments	Accounting for clustering

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.73
	Confidence Interval	(2-Sided) 95%; 1.22 to 2.47
	Parameter Dispersion	Type: Value:
	Estimation Comments	Accounting for clustering and adjusted for covariates as presenting for primary outcome

4. Secondary Outcome

Title	Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Individuals who had not communicated about quality versus quantity of life at baseline

Arm/Group Title	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report	Usual Care
Arm/Group Description	Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system. Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete advance care planning (ACP) engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.	Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites. Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
Measure Participants	151	165
Count of Participants [Participants]	93 20.4%	90 19.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	.070
	Confidence Interval	(2-Sided) 95%; -.05 to .188
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.15
	Confidence Interval	(2-Sided) 95%; .72 to 1.85
	Parameter Dispersion	Type: Value:
	Estimation Comments	Accounting for clustering and adjusting for covariates as described for primary outcome

Adverse Events

Time Frame	6 months
Arm/Group Title	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report		Usual Care
Arm/Group Description	Participants enrolled at the intervention site will receive four contacts, at baseline, two, four and six months. Each of the first three contacts consists of an integrated assessment and intervention feedback report, using an expert system. Transtheoretical Model (TTM) of health behavior change: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.		Participants enrolled in control sites will receive four assessment contacts on the same schedule and in the same manner as the participants enrolled in intervention sites. Usual Care: Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
All Cause Mortality
	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/455 (0%)		0/454 (0%)
Serious Adverse Events
	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/455 (0%)		0/454 (0%)
Other (Not Including Serious) Adverse Events
	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/455 (0%)		0/454 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.