Trial Outcomes & Findings for Study the Impact of the CommunityRx Program on Health, Self-care and Cost (NCT NCT02435511)

Results Overview

Health-related quality of life will be measured using the Short Form Health Survey (SF-12) . Minimum value=0, maximum value=100. Higher scores equal better mental health.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

411 participants

Primary outcome timeframe

Assessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reported

Results posted on

2022-05-11

Participant Flow

No participants were excluded after enrollment, prior to randomization.

Participant milestones

Participant milestones
Measure	Control Arm The control group will receive usual care, no HealtheRx.	Intervention Arm The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs. HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.
Overall Study STARTED	202	209
Overall Study COMPLETED	158	174
Overall Study NOT COMPLETED	44	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study the Impact of the CommunityRx Program on Health, Self-care and Cost

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Arm n=202 Participants The control group will receive usual care, no HealtheRx.	Intervention Arm n=209 Participants The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs. HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.	Total n=411 Participants Total of all reporting groups
Age, Continuous	60.1 Years STANDARD_DEVIATION 8.4 • n=5 Participants	60.3 Years STANDARD_DEVIATION 8.3 • n=7 Participants	60.2 Years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	152 Participants n=7 Participants	281 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	57 Participants n=7 Participants	130 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	183 Participants n=5 Participants	187 Participants n=7 Participants	370 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	202 Participants n=5 Participants	209 Participants n=7 Participants	411 Participants n=5 Participants
Self-reported health Poor or fair	104 Participants n=5 Participants	104 Participants n=7 Participants	208 Participants n=5 Participants
Self-reported health Good	60 Participants n=5 Participants	68 Participants n=7 Participants	128 Participants n=5 Participants
Self-reported health Very good or excellent	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Confidence in finding resources Not at all confident	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Confidence in finding resources Not very confident	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Confidence in finding resources Uncertain	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Confidence in finding resources Somewhat confident	62 Participants n=5 Participants	70 Participants n=7 Participants	132 Participants n=5 Participants
Confidence in finding resources Completely confident	66 Participants n=5 Participants	68 Participants n=7 Participants	134 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reported

Population: The below mean includes only those who completed the 3 month follow-up survey; 1 control and 2 cases participated in the 3 months survey but did not complete the SF-12 needed for this data point

Health-related quality of life will be measured using the Short Form Health Survey (SF-12) . Minimum value=0, maximum value=100. Higher scores equal better mental health.

Outcome measures

Outcome measures
Measure	Control Arm n=157 Participants The control group will receive usual care, no HealtheRx.	Intervention Arm n=172 Participants The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs. HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.
Mental Health-related Quality of Life at 3 Months	50.0 score on a scale Standard Deviation 11.8	48.3 score on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: We were unable to obtain the claims data necessary to conduct the cost effectiveness analysis.

Using claims data and self-reported data on heath care utilization, we will use data from intervention baseline and at 3 months following the intervention to assess the cost effectiveness of HealtheRx.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported here

Population: Includes participates who completed 3 month survey; 1 control and 3 cases did not complete the PSQ.

Patient satisfaction will be measures using the domain of general satisfaction from the Patient Satisfaction Questionnaire (PSQ-18)

Outcome measures

Outcome measures
Measure	Control Arm n=157 Participants The control group will receive usual care, no HealtheRx.	Intervention Arm n=171 Participants The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs. HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.
Patient Satisfaction at 3 Months	4.4 units on a scale Standard Deviation 1.0	4.4 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported

Population: The below mean includes only participants with completed 3 month follow-up surveys; 1 control and 2 cases did not complete the SF-12 items needed to calculate this measure.

Health-related quality of life will be measured using the Short Form-12 (SF-12). Minimum value=0, maximum value=100. Higher scores equal better physical health.

Outcome measures

Outcome measures
Measure	Control Arm n=157 Participants The control group will receive usual care, no HealtheRx.	Intervention Arm n=172 Participants The intervention arm will receive the intervention, a HealtheRx, which includes a list of resources in their community tailored to their health needs. HealtheRx: The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.
Physical Health-related Quality of Life at 3 Months	38.1 score on a scale Standard Deviation 10.4	38.7 score on a scale Standard Deviation 10.5

SECONDARY outcome

Timeframe: Assessed at baseline, 1 week, 1 month and 3 months; score at 3 months reported

Population: The below results include only those with 3 month follow-up data; 1 control and 3 cases did not complete this survey item during the 3 month follow up.

Measure confidence in ability to find services to take care of health