Trial Outcomes & Findings for Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions (NCT NCT02130570)

NCT ID: NCT02130570

Last Updated: 2019-08-20

Results Overview

Proportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date

Recruitment status

COMPLETED

Study phase

Target enrollment

1679 participants

Primary outcome timeframe

30 days after discharge

Results posted on

2019-08-20

Participant Flow

BWH participants were enrolled from 8/21/2013 to 5/15/2015. MGH participants were enrolled from 9/18/2013 to 10/13/2015. Participants were recruited while they were inpatients on the medical or surgical services at either BWH or MGH.

A total of 141 eligible participants were enrolled to 1 pilot practice at Brigham and Women's Hospital and 1 pilot practice at Massachusetts General Hospital. These participants received the study Intervention so that we could troubleshoot and refine the Intervention procedures. These participants are NOT counted in the final enrollment number.

Participant milestones

Participant milestones
Measure	Multi-Model Intensive Discharge Program Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information	Usual Care Patients receive the care that they would normally receive.
Overall Study STARTED	987	692
Overall Study COMPLETED	978	679
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Multi-Model Intensive Discharge Program Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information	Usual Care Patients receive the care that they would normally receive.
Overall Study Death	3	5
Overall Study Withdrawal by Subject	6	3
Overall Study Part of practice that discontinued study	0	5

Baseline Characteristics

Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multi-Model Intensive Discharge Program n=978 Participants Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information	Usual Care n=679 Participants Patients receive the same care they would normally receive.	Total n=1657 Participants Total of all reporting groups
Age, Customized Between 18 and 69 years	700 participants n=5 Participants	477 participants n=7 Participants	1177 participants n=5 Participants
Age, Customized >=70 years	278 participants n=5 Participants	202 participants n=7 Participants	480 participants n=5 Participants
Sex: Female, Male Female	540 Participants n=5 Participants	364 Participants n=7 Participants	904 Participants n=5 Participants
Sex: Female, Male Male	438 Participants n=5 Participants	315 Participants n=7 Participants	753 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after discharge

Population: 1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).

Proportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date

Outcome measures

Outcome measures
Measure	Multi-Model Intensive Discharge Program n=978 Participants Multi-Model Intensive Discharge Program Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information	Usual Care n=679 Participants Patients receive the care they would normally receive.
Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date	0.18 proportion of participants Interval 0.15 to 0.21	0.23 proportion of participants Interval 0.2 to 0.27

SECONDARY outcome

Timeframe: 30 days after discharge

New or worsening signs or symptoms, i.e. unpleasant symptoms, loss of function, abnormal lab results, and/or additional medical care within 30 days after discharge.

Outcome measures

Outcome measures
Measure	Multi-Model Intensive Discharge Program n=978 Participants Multi-Model Intensive Discharge Program Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information	Usual Care n=679 Participants Patients receive the care they would normally receive.
Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge	0.90 proportion of participants Interval 0.86 to 1.01	0.92 proportion of participants Interval 0.85 to 0.97

SECONDARY outcome

Timeframe: 30 days after discharge

Nonelective readmission within 30 days of the index discharge date

Outcome measures

Outcome measures
Measure	Multi-Model Intensive Discharge Program n=978 Participants Multi-Model Intensive Discharge Program Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information	Usual Care n=679 Participants Patients receive the care they would normally receive.
Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date	107 participants	78 participants

SECONDARY outcome

Timeframe: One month prior to admission to 30 days after discharge.

During the inpatient enrollment period, patients will complete a modified Medical Outcomes Survey Short Form-12 (SF-12v2). The SF-12v2 measures a patient's functional status and health-related quality of life one month prior to admission. 30 days after discharge, SF12 questions will be repeated so that functional status and health-related quality of life can be compared to prior to admission. This measure is a 12-item measure. Each item 5 possible responses with a value from 1 to 5 (with higher scores indicating worse outcomes). A summary score is computed by summing the score on each item. Therefore, the range of summary scores for the SF-12v2 is a minimum of 12 and a maximum of 60.

Outcome measures

Outcome measures
Measure	Multi-Model Intensive Discharge Program n=978 Participants Multi-Model Intensive Discharge Program Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information	Usual Care n=679 Participants Patients receive the care they would normally receive.
Change in Functional Status on the Modified Medical Outcomes Survey Short Form-12 (SF-12v2) From One Month Prior to Admission to 30 Days After Discharge.	47.25 units on a scale Standard Deviation 7.85	46.14 units on a scale Standard Deviation 8.11

SECONDARY outcome

Timeframe: 30 days after discharge

During the 30 day post-discharge follow-up phone call we asked patients about their participation in, understanding of, and ability to carry out the post-discharge plan. These questions include questions from the Interpersonal Processes of Care survey and several additional questions from the HOMERUN study of readmitted patients. In the table below, we have abbreviated each survey question since the number of characters is limited in this field in the table. We have pasted below the full survey question. 1. When you were getting ready to leave the hospital one month ago, how often did your care team use medical terminology that you did not understand? 2. How often did you feel confused about what was going on with your medical care because they did not explain things well? 3. How often did they give you enough time to say what you thought was important regarding your medical care? 4. How often did they listen carefully to what you had to say? 5. How often did you feel p

Outcome measures

Outcome measures
Measure	Multi-Model Intensive Discharge Program n=458 Participants Multi-Model Intensive Discharge Program Multi-Model Intensive Discharge Intervention: 1. Inpatient medication safety interventions 2. Inpatient "discharge advocate" 3. Structured visiting nurse (VNA) appointments 4. Post-discharge phone call by primary care personnel within 2 business days of discharge 5. Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge 6. Improved communication between inpatient and primary care teams 7. High-risk patients will receive additional interventions as needed: 1. Home pharmacist visit 2. Enrollment in the Partners integrated Care Management Program (iCMP) 3. Enrollment in telemedicine programs for patients with CHF 4. Palliative care consultation regarding goals of care 8. Novel health information technology to facilitate communication and transfer of clinical information	Usual Care n=414 Participants Patients receive the care they would normally receive.
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Used medical terminology you did not understand	.86 proportion of participants	.85 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Felt confused because things not explained well	.86 proportion of participants	.88 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Not given enough time to say what was important	.92 proportion of participants	.90 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process How often did care team listen carefully to you	.94 proportion of participants	.92 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Felt pressured to have treatment not sure about	.95 proportion of participants	.95 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Asked if you might have problems w/ recommended tx	.41 proportion of participants	.34 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Understood what to do to care for self	.98 proportion of participants	.97 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Able to take medications correctly every day	.95 proportion of participants	.95 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Knew danger signs to watch and what to do	.96 proportion of participants	.94 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Knew how to contact my doctor if needed	.98 proportion of participants	.96 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Able to get to my doctor's appointment or tests	.95 proportion of participants	.95 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Able to follow diet team ordered for me	.41 proportion of participants	.52 proportion of participants
Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process Had enough support from friends, family or others	.97 proportion of participants	.96 proportion of participants

SECONDARY outcome

Timeframe: 30 days after discharge

Population: Post Discharge ED visits within 30 days of discharge were not able to be obtained from the second site MGH. Post discharge readmissions were obtained, however, without the ED visit data from MGH we are unable to create a count for Post-Discharge Health Care Utilization (ED plus readmissions).

We will measure emergency department visits and hospital readmissions within 30 days of discharge using a combination of administrative data for all Partners hospitals plus patient report for all utilization outside the Partners system.

Outcome measures

Outcome data not reported

Adverse Events

Multi-Model Intensive Discharge Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey L Schnipper, MD, MPH, FHM

Brigham and Women's Hospital

Phone: 617-732-7063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place