A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery

Sponsor

Carilion Clinic (Other)

Overall Status

Unknown status

CT.gov ID

NCT03366805

Collaborator

(none)

221

Enrollment

Location

Arms

30.4

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity. The effect of this educational program on pain medications used, pain control efficacy, and other measures of satisfaction and recovery will be assessed.

Condition or Disease	Intervention/Treatment	Phase
Analgesics, Opioid Orthopedic Surgery Ambulatory Surgery Education, Patient Injuries and Wounds	Behavioral: Pain Management Patient Education Video Behavioral: Wound Care Patient Education Video	N/A

Detailed Description

Four hundred (400) adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be recruited by the surgeon-investigators. Patients will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity.

These patients will be encouraged to review the video online in the week before surgery. An intake enrollment form will be completed by an investigator using demographic information available in the chart.

Participants in both arms will complete their Patient Education Study Diary daily, for 7 days following their surgery. There are two versions of this diary: the Wound Education Version asks patients to report daily pain mediation use. The Pain Education Version does not include this section as patients in the pain management arm of the study record this information in their Recovery Diary.

The patient will be contacted again by phone and/or mail 1 year after surgery (12-14 months) using the contact information available in EPIC to determine the self-reported prevalence of chronic pain and pain medication use.

Study Design

Study Type:

Interventional

Actual Enrollment :

221 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, randomized clinical trialprospective, randomized clinical trial

Masking:

Single (Care Provider)

Masking Description:

Care provider is not informed of which patient education video(s) the patient was provided, unless that patient initiates a conversation with the provider regarding the video.

Primary Purpose:

Supportive Care

Official Title:

A Standardized Patient Education Video Program for Improvement of Post-Operative Recovery After Outpatient Upper Extremity Surgery

Actual Study Start Date :

Nov 30, 2017

Actual Primary Completion Date :

Nov 29, 2018

Anticipated Study Completion Date :

Jun 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Wound Care Video Wound Care Patient Education Video	Behavioral: Wound Care Patient Education Video Patient education video that were created in-house specifically for this project.
Experimental: Pain Management Video Group Pain Management Patient Education Video	Behavioral: Pain Management Patient Education Video Patient education video that were created in-house specifically for this project.

Arm

Intervention/Treatment

Active Comparator: Wound Care Video

Wound Care Patient Education Video

Behavioral: Wound Care Patient Education Video

Patient education video that were created in-house specifically for this project.

Experimental: Pain Management Video Group

Pain Management Patient Education Video

Behavioral: Pain Management Patient Education Video

Patient education video that were created in-house specifically for this project.

Outcome Measures

Primary Outcome Measures

Quality of Recovery 15 Score [2 days after surgery]
Score on the standardized Quality of Recovery 15 questionnaire How have you been feeling in the last 24 hours? (0 to 10, where 0= none of the time [poor] and 10=all of the time [excellent]) 0 1 2 3 4 5 6 7 8 9 10 Able to breath easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with family or friends Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being Have you had any of the following in the last 24 hours? (10 to 0, where: 10=none of the time [excellent] and 0=all of the time [poor]) 10 9 8 7 6 5 4 3 2 1 0 Moderate pain severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed

Secondary Outcome Measures

PROMIS [3 days after surgery]
PROMIS short forms administered on POD 3 - (GI belly pain 5a, GI nausea and vomiting 4a, Pain Intensity 3a, Pain Interference 4a, Sleep Disturbance 4a, Cognitive Function 4a)
number of narcotic pills used [7 days after surgery]
number of narcotic pills used
daily pain level [7 days after surgery]
0-10 rating scale
patient-reported satisfaction and feeling of control - pain management [7 days after surgery]
Today, I feel in control of my pain management. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree
patient-reported satisfaction and feeling of control- wound care [7 days after surgery]
Today, I feel in confident about how I am caring for my wound. Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree
patient-reported satisfaction and feeling of control - pain management satisfaction [7 days after surgery]
Today, I would rate my satisfaction with my pain control as (circle) Very satisfied Somewhat satisfied Neutral Somewhat dissatisfied Very dissatisfied
number of pain-related calls/visits to a healthcare provider [7 days after surgery]
patient-reported
use of non-narcotic adjunct pain relief medication and modalities [7 days after surgery]
incidence of high risk activities - sedating medication polytherapy [7 days after surgery]
combining narcotics with muscle relaxants/sedatives/alcohol, other sedating medications
incidence of high risk activities - NSAID polytherapy [7 days after surgery]
combining prn NSAIDs with regularly dosed prescription NSAIDs
incidence of high risk activities - overdosing [7 days after surgery]
exceeding daily recommended doses of pain medication
incidence of side effects and adverse events - Nausea/V omitting [7 days after surgery]
Nausea/Vomiting
incidence of side effects and adverse events - Dizziness/balance problems [7 days after surgery]
Dizziness/balance problems
incidence of side effects and adverse events - fatigue or sedation [7 days after surgery]
fatigue or sedation
incidence of side effects and adverse events - headache [7 days after surgery]
headache
incidence of side effects and adverse events - visual changes [7 days after surgery]
visual changes
incidence of side effects and adverse events - stomach pain [7 days after surgery]
stomach pain
incidence of side effects and adverse events - constipation [7 days after surgery]
constipation
incidence of side effects and adverse events - diarrhea [7 days after surgery]
diarrhea
incidence of side effects and adverse events - fever [7 days after surgery]
fever
incidence of side effects and adverse events - rash [7 days after surgery]
rash
incidence of side effects and adverse events - hives [7 days after surgery]
hives
incidence of side effects and adverse events - swelling [7 days after surgery]
swelling
incidence of side effects and adverse events - difficulty breathing/shortness of breath [7 days after surgery]
difficulty breathing/shortness of breath
incidence of side effects and adverse events - heart palpitations/arrythmia/heart racing [7 days after surgery]
heart palpitations/arrythmia/heart racing
incidence of side effects and adverse events - anaphylaxis [7 days after surgery]
anaphylaxis
incidence of side effects and adverse events - ringing in ears [7 days after surgery]
ringing in ears
incidence of side effects and adverse events - other [7 days after surgery]
other
demonstrated patient knowledge [7 days after surgery]
as measured by score on the follow-up quiz
prevalence of chronic opioid use [1 year after surgery]
patient reported

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.

Exclusion Criteria:

Patients unable or unwilling to provide informed consent
Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
Patients who are or suspect they may be pregnant.
Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)