Trial Outcomes & Findings for Will Veterans Engage in Prevention After HRA-guided Shared Decision Making? (NCT NCT01828567)

Last Updated: 2018-09-10

Results Overview

Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.

Recruitment status

COMPLETED

Study phase

Target enrollment

417 participants

Primary outcome timeframe

1 and 6 months (cumulative)

Results posted on

2018-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control Usual care
Overall Study STARTED	208	209
Overall Study 1 Month	172	192
Overall Study COMPLETED	177	199
Overall Study NOT COMPLETED	31	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control Usual care
Overall Study Lost to Follow-up	27	9
Overall Study Excluded - did not meet criteria	4	1

Baseline Characteristics

Will Veterans Engage in Prevention After HRA-guided Shared Decision Making?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=208 Participants Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control n=209 Participants Usual care	Total n=417 Participants Total of all reporting groups
Age, Continuous	55.3 years STANDARD_DEVIATION 12.7 • n=5 Participants	56.3 years STANDARD_DEVIATION 11.7 • n=7 Participants	55.8 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	25 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	172 Participants n=5 Participants	184 Participants n=7 Participants	356 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	90 Participants n=5 Participants	79 Participants n=7 Participants	169 Participants n=5 Participants
Race/Ethnicity, Customized White	99 Participants n=5 Participants	110 Participants n=7 Participants	209 Participants n=5 Participants
Race/Ethnicity, Customized Other	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	208 Participants n=5 Participants	209 Participants n=7 Participants	417 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 and 6 months (cumulative)

Population: Unknowns were removed from the denominator: Intervention n=29; control n=15.

Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.

Outcome measures

Outcome measures
Measure	Intervention n=179 Participants Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control n=194 Participants Usual care
Enrollment in Prevention Services	91 participants	56 participants

SECONDARY outcome

Timeframe: Baseline assessment

Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant

Outcome measures

Outcome measures
Measure	Intervention n=208 Participants Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control n=209 Participants Usual care
Patient Activation Measures (PAM)	62.4 average score Standard Deviation 12.7	60.6 average score Standard Deviation 12.3

SECONDARY outcome

Timeframe: 1 month assessment

Outcome measures

Outcome measures
Measure	Intervention n=172 Participants Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control n=192 Participants Usual care
Patient Activation Measures	63.7 average score Standard Deviation 13.8	61.4 average score Standard Deviation 11.1

SECONDARY outcome

Timeframe: 6 months assessments

Outcome measures

Outcome measures
Measure	Intervention n=177 Participants Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control n=199 Participants Usual care
Patient Activation Measures	67.0 average score Standard Deviation 13.0	63.2 average score Standard Deviation 13.3

SECONDARY outcome

Timeframe: Baseline

Population: Unknowns were removed from the denominator: Intervention n=7; control n=2.

The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.

Outcome measures

Outcome measures
Measure	Intervention n=201 Participants Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control n=207 Participants Usual care
Framingham Risk Score	21.8 average score Standard Deviation 16.8	22.7 average score Standard Deviation 16.8

SECONDARY outcome

Timeframe: 6 months

Population: Unknowns were removed from the denominator: Intervention n=22; control n=18.

The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.

Outcome measures

Outcome measures
Measure	Intervention n=155 Participants Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control n=181 Participants Usual care
Framingham Risk Score	22.4 average score Standard Deviation 17.5	22.5 average score Standard Deviation 16.3

Adverse Events

Intervention

Serious events: 65 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 53 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Eugene Z Oddone, MD, MPSc

Durham VA Center of Innovation in Primary Care

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Intervention n=208 participants at risk Primary care phone-based prevention coaching using shared decision making following a Healthy Living Assessment Shared decision making with a Prevention Coach: A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to PACT, and a follow-up call one month later to assess the progress of the prevention plan.	Control n=209 participants at risk Usual care
Blood and lymphatic system disorders Study Safety Protocol	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.00% 0/209 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Blood and lymphatic system disorders Hospitalization	0.00% 0/208 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.96% 2/209 • Number of events 2 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Cardiac disorders Study Safety Protocol	1.9% 4/208 • Number of events 4 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.96% 2/209 • Number of events 2 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Cardiac disorders Hospitalization	0.96% 2/208 • Number of events 2 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.00% 0/209 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Cardiac disorders Important Medical Event	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.00% 0/209 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Endocrine disorders Hospitalization	0.00% 0/208 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.48% 1/209 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Gastrointestinal disorders Hospitalization	0.00% 0/208 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.48% 1/209 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
General disorders Hospitalization	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.00% 0/209 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Hepatobiliary disorders Hospitalization	0.96% 2/208 • Number of events 2 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.00% 0/209 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Investigations Protocol Deviation	21.6% 45/208 • Number of events 45 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	17.2% 36/209 • Number of events 36 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Musculoskeletal and connective tissue disorders Hospitalization	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.48% 1/209 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Musculoskeletal and connective tissue disorders Emergency Room Visit	0.00% 0/208 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	1.4% 3/209 • Number of events 3 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Musculoskeletal and connective tissue disorders Important Medical Event	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	1.4% 3/209 • Number of events 3 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Important Medical Event	0.96% 2/208 • Number of events 2 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.48% 1/209 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Psychiatric disorders Hospitalization	2.4% 5/208 • Number of events 5 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.96% 2/209 • Number of events 2 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Psychiatric disorders Important Medical Event	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.00% 0/209 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Respiratory, thoracic and mediastinal disorders Emergency Room Visit	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.00% 0/209 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Respiratory, thoracic and mediastinal disorders Hospitalization	0.96% 2/208 • Number of events 2 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	1.4% 3/209 • Number of events 3 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Respiratory, thoracic and mediastinal disorders Important Medical Event	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.00% 0/209 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.
Surgical and medical procedures Hospitalization	0.48% 1/208 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.	0.48% 1/209 • Number of events 1 • Through study completion, an average of 6 months. Adverse events information was collected from participants if they reported events at the 1 month and 6 month outcome assessments. Adverse event information was also collected from patients through contact with the coach interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient. Adverse events were monitored/assessed without regard to the specific Adverse Event Terms.